FEMOSTON

PACKAGE LEAFLET: INFORMATION FOR THE USER

Femoston 1/10 film-coated tablets

Active substances: estradiol + estradiol/dydrogesterone
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 1/10 film-coated tablets. In this leaflet, the abbreviated name Femoston is used.
Contents of this leaflet:

1. What Femoston is and what it is used for
2. What you need to know before taking Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Contents of the pack and other information

1. What Femoston is and what it is used for

Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones: an
oestrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in women who have been postmenopausal for at least 6 months.
Femoston is used to
Relieve symptoms occurring after menopause
During menopause, the amount of oestrogen produced by the female body decreases.
This may cause symptoms such as flushing of the face, neck and chest ("hot flushes").
Femoston relieves these symptoms after menopause. Femoston should only be prescribed if symptoms seriously interfere with daily life.
Prevent osteoporosis
After menopause, some women may develop brittle bones (osteoporosis). You should discuss all available options with your doctor.
If you are at high risk of fractures due to osteoporosis and other medicines are not suitable, Femoston may be used to prevent osteoporosis after menopause.

2. What you should know before taking Femoston

Medical history and regular check-ups
The use of hormone replacement therapy (HRT) involves certain risks that must be considered when deciding whether to start or continue treatment.
Experience with women treated for early menopause (due to ovarian damage or surgical intervention) is limited. In cases of early menopause, the risks associated with HRT may differ. Discuss this with your doctor.
Before starting (or restarting) HRT, your doctor will ask about your personal and family medical history. Your doctor may perform a breast and/or pelvic examination (lower abdomen), if necessary.
Once HRT has been initiated, periodic medical check-ups (at least once a year) should still be performed to carefully evaluate the ongoing risks and benefits of continuing the therapy.
Have regular breast examinations as recommended by your doctor.

Do not take Femoston if you are in any of the following conditions. If you are unsure about any of the points below, inform your doctor before starting treatment with Femoston.

Do not take Femoston:

• if you have, have had, or are suspected of having breast cancer
• if you have or are suspected of having a tumour whose growth is sensitive to oestrogens, for example in the endometrium (lining of the uterus)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you currently have or have previously been treated for blood clots in the veins (thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)
• if you have blood clotting disorders (such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
• if you currently have or have previously had blood clotting disorders in the arteries, such as myocardial infarction, stroke, or angina (severe chest pain)
• if you currently have or have previously had liver disease and liver function tests have not returned to normal levels
• if you have porphyria (an inherited metabolic disorder due to a disturbance in the metabolism of blood pigments)
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of this medicine (listed in section 6).

During treatment with Femoston, if any of the above conditions develops for the first time, stop taking the medicine and consult your doctor immediately.

Warnings and precautions
Inform your doctor or pharmacist before taking Femoston if you have previously experienced any of the following conditions, as they may recur or worsen during treatment with Femoston. If so, your doctor may require more frequent check-ups:

• uterine fibroids
• growth of uterine tissue outside the uterus (endometriosis) or previous excessive thickening of the uterine lining (endometrial hyperplasia)
• brain tumour that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “Blood clots in the veins (thrombosis)”)
• increased risk of developing a tumour whose growth is sensitive to oestrogens (having a first-degree relative, such as mother, sister, or grandmother, who had breast cancer)
• hypertension (high blood pressure)
• liver disorders such as benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (an autoimmune disease)
• epilepsy
• asthma
• otosclerosis (a hereditary middle ear disease)
• hypertriglyceridaemia (marked increase in triglycerides in the blood)
• fluid retention due to heart or kidney failure
• hereditary or acquired angioedema

Stop treatment with Femoston and consult your doctor immediately
If you experience any of the following conditions when starting HRT:

• any of the conditions listed in the section “Do not use Femoston”
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disease
• swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives with breathing difficulties, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• first occurrence of migraine headache
• if you are pregnant
• if you notice signs of blood clots such as: painful swelling and redness in the legs or sudden chest pain or difficulty breathing

For more information, see the section “Blood clots in the veins (thrombosis)”.

Note: Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need an additional contraceptive method to prevent pregnancy. Consult your doctor.

HRT and cancer

Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
Taking oestrogen-only HRT may increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.

Unexpected vaginal bleeding
While taking Femoston, you will have a monthly bleed (known as withdrawal bleeding). However, if you experience unexpected bleeding or spotting (drops of blood) outside of the monthly bleed that:

• occurs for more than 6 months
• starts after taking Femoston for more than 6 months
• occurs after stopping treatment with Femoston

contact your doctor as soon as possible.

Breast cancer
Evidence shows that the risk of breast cancer increases with combined oestrogen-progestogen HRT or oestrogen-only HRT. The additional risk depends on how long HRT is used and becomes evident within 3 years of use. After stopping HRT, the additional risk decreases over time, but this risk may persist for 10 years or more if HRT has been used for more than 5 years.

Comparative data
Among women aged 50 to 54 years who do not use HRT for more than 5 years, an average of 13 to 17 cases of breast cancer are diagnosed per 1,000 women.
In women aged 50 who start oestrogen-only HRT for a period of 5 years, there will be 16–17 cases per 1,000 users (i.e. 0–3 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (4 to 8 additional cases).
Among women aged 50 to 59 years who do not use HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 over a 10-year period.
In women aged 50 who start oestrogen-only HRT for 10 years, there will be 34 cases per 1,000 users (i.e. 7 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e. 21 additional cases).

Check your breasts regularly. See your doctor if you notice any changes in the breasts such as:

• small dents in the skin
• changes in the nipple
• any visible or palpable lumps.

Also, participate in mammography screening programmes when offered. For mammography, it is important that you inform the healthcare professional performing the X-ray that you are taking HRT, as this medicine can increase breast density, which may affect the mammogram result. Where breast density is increased, mammography may not detect all lumps.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of oestrogen-only or combined oestrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, among women aged 50 to 54 years who do not use HRT, about 2 out of 2,000 women will receive an ovarian cancer diagnosis within 5 years. For women using HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e. about 1 additional case).

Effects of HRT on the heart and circulation

Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is approximately 1.3 to 3 times higher in users of HRT, especially during the first year of use.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, shortness of breath, fainting, and even death.
The risk of venous blood clots increases with age. If you have any of the following conditions, discuss them with your doctor:

• if you will be immobile for a long time due to major surgery, trauma, or illness (see also section 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m²)
• if you have coagulation disorders requiring long-term anticoagulant treatment
• if a first-degree relative has previously had blood clots in the legs, lungs, or another organ
• if you have a rare condition such as systemic lupus erythematosus (SLE)
• if you have a tumour.

For symptoms of a blood clot, see “Stop treatment with Femoston and consult your doctor immediately”.

Comparative data
Among women around 50 years of age who have not taken HRT for more than 5 years, an average of 4 to 7 women per 1,000 may expect to develop a venous thrombosis.
Among women around 50 years of age who have taken combined oestrogen-progestogen HRT for more than 5 years, there will be 9 to 12 cases per 1,000 (e.g. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. Women over 60 years of age who use combined oestrogen-progestogen HRT are slightly more likely to develop heart disease than women not using HRT.

Stroke
The risk of stroke is approximately 1.5 times higher in users of HRT compared to non-users. The number of additional stroke cases due to HRT use may increase with advancing age.

Comparative data
Among women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 may expect to have a stroke.
Among women around 50 years of age who have been taking HRT for over 5 years, there will be 11 cases per 1,000 (e.g. 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.
Inform your doctor if you have or have had any of the following medical conditions, as you may need more frequent monitoring:

• heart disease
• kidney failure
• abnormally high levels of certain blood fats (hypertriglyceridaemia).

Children
Femoston is not intended for use in children.

Other medicines and Femoston
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with the effectiveness of Femoston. This can lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g. rifampicin, rifabutin)
• medicines for HIV infection [AIDS] (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John's wort (Hypericum perforatum).

HRT may affect how some other medicines work:

• an epilepsy medicine (lamotrigine), as it may increase the frequency of epileptic seizures
• the combination regimen against hepatitis C virus (HCV) consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results related to liver function (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination regimen.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription, herbal medicines, or other natural products. Your doctor will provide you with the necessary instructions.

Laboratory tests
If you need to have a blood test, inform your doctor or nurse that you are taking Femoston, as this medicine may interfere with the results of certain tests.

Femoston with food and drink
Femoston can be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.

Driving and using machines
The effect of Femoston on driving or operating machinery has not been studied. An effect is unlikely.

Femoston tablets contain lactose.
If you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take Femoston

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.

When to start treatment with Femoston
Do not start treatment with Femoston until at least 6 months after your last menstrual period.
You may start taking Femoston on any day if:

• you are currently not taking any hormone replacement therapy (HRT)
• you are switching from a continuous combined HRT, i.e. when you take a tablet or apply a patch every day containing both an oestrogen and a progestogen.

Start taking Femoston the day after completing day 28 of your pack if:

• you are switching from a cyclic or sequential HRT, i.e. when you take a tablet or use a patch containing oestrogen during the first part of your cycle, followed by a tablet or patch containing both oestrogen and progestogen for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you may take the tablet with or without food
• try to take the tablet at the same time each day. This will ensure a constant level of medicine in your body and help you remember to take it
• take one tablet every day, without interruption between packs. The days of the week are marked on the blister to help you remember when to take your tablet.

How long to take Femoston

• your doctor will prescribe the lowest effective dose to treat your symptoms for the shortest possible duration. If you feel this dose is too strong or too weak, consult your doctor.
• if you are taking Femoston to prevent osteoporosis, your doctor will adjust your dose depending on your bone mass.
• take one white tablet daily for the first 14 days, followed by one grey tablet daily for the next 14 days. The 28 days are printed on the blister.

If you need surgery
If you are scheduled for surgery, inform your doctor that you are taking Femoston. You may need to stop taking Femoston approximately 4–6 weeks before the procedure to reduce the risk of blood clots (see section 2, "Blood clots in the veins"). Ask your doctor when you can restart taking Femoston.

If you take more Femoston than you should
Taking too many Femoston tablets (or someone else taking them) is unlikely to cause harm. You may experience nausea or vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or breakthrough bleeding. No specific treatment is required, but if you are concerned, contact your doctor for advice.

If you forget to take Femoston
Take the missed tablet as soon as you remember. If more than 12 hours have passed since the missed dose, take the next tablet at your usual time. Do not take the missed tablet and do not double the next dose. Missing a dose may lead to irregular bleeding or spotting.

If you stop taking Femoston
Do not stop taking Femoston without consulting your doctor.

• If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following disorders occur more frequently in women using HRT than in women who do not use HRT:

• breast cancer
• abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For further information about these side effects, see Section 2.
The following side effects may occur with this medicine:
Very common (may affect more than 1 in 10 treated patients):

• headache
• abdominal pain
• back pain
• breast pain/tenderness

Common (may affect up to 1 in 10 treated patients):

• vaginal candidiasis (fungal infection caused by Candida albicans)
• feeling depressed, nervousness
• migraine. If you experience a migraine headache for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling unwell (nausea), vomiting, bloating (abdominal swelling), including gas (flatulence)
• skin allergic reactions (rash, severe itching, or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light menstruation
• pelvic pain
• vaginal discharge
• feeling weak, tired, or unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain

Uncommon (may affect up to 1 in 100 treated patients):

• symptoms resembling cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as shortness of breath (allergic asthma)
• changes in sexual desire
• blood clots in the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged or twisted veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia), or generally feeling unwell (malaise), and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms resembling premenstrual syndrome
• weight loss

Rare (may affect up to 1 in 1,000 treated patients):
(* post-marketing adverse effects not observed in clinical trials, assigned the frequency "rare")

• disease characterized by destruction of red blood cells (haemolytic anaemia)*
• meningioma (brain tumour)*
• changes to the surface of the eye (increased curvature of the cornea)*, causing inability to wear contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This may cause breathing difficulties (angioedema)
• purple spots or small dots on the skin (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin discolouration, especially on the face or neck, known as “pregnancy mask” (chloasma or melasma)*
• leg cramps*

The following side effects have been associated with the use of other HRTs:

• oestrogen-dependent tumours (both benign and malignant), such as cancer of the uterine lining, ovarian cancer (for further information see Section 2)
• increased size of progestin-dependent tumours (such as meningioma)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain blood fats (hypertriglyceridaemia)
• skin rash with red or irritated target-like lesions (erythema multiforme)
• urinary incontinence
• painful nodular breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare blood pigment disorder (porphyria)
• elevated levels of certain blood fats (hypertriglyceridaemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Femoston contains

• The active substances are estradiol as estradiol hemihydrate and dydrogesterone: each white tablet contains 1 mg of estradiol; each grey tablet contains 1 mg of estradiol and 10 mg of dydrogesterone.
• The other components of the tablet core are monohydrate lactose, hypromellose, maize starch, anhydrous colloidal silica and magnesium stearate.
• The other components of the tablet coating are: titanium dioxide (E171), black iron oxide (E172), polyvinyl alcohol, macrogol, talc, and hypromellose.

Description of the appearance of Femoston and pack contents

• The film-coated tablets are round, biconvex and marked with "379" on one side.
• Each blister contains 28 tablets.
• Femoston contains two different coloured tablets. Each pack contains 14 white tablets (for the first 14 days of the cycle) and 14 grey tablets (for the following 14 days of the cycle).
• The tablets are packed in PVC/aluminium blisters.
• Packs contain 28, 84 (3x28) or 280 (10x28) film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland

Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands.

This medicinal product is authorised in the European Economic Area countries under the following names:

PATIENT LEAFLET: INFORMATION FOR THE USER

Femoston 2/10 film-coated tablets 2 mg/10 mg

Active substances: estradiol + estradiol/drospirenone
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 2/10 film-coated tablets 2 mg/10 mg. In
this leaflet, the abbreviated name Femoston is used.
Contents of this leaflet:

1. What Femoston is and what it is used for
2. What you need to know before taking Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Package contents and other information

1. What Femoston is and what it is used for

Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones: an
oestrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in women who have been postmenopausal for at least 6 months.
Femoston is used to
Relieve symptoms occurring after menopause
During menopause, the amount of oestrogen produced by the female body decreases.
This may cause symptoms such as flushing of the face, neck and chest ("hot flushes").
Femoston relieves these symptoms after menopause. Femoston should only be prescribed if symptoms seriously interfere with daily life.
Prevent osteoporosis
After menopause, some women may develop brittle bones (osteoporosis). All available treatment options should be discussed with your doctor.
If you are at high risk of fractures due to osteoporosis and other medicines are not suitable, Femoston may be used to prevent osteoporosis after menopause.

2. What you should know before taking Femoston

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue treatment.
Experience in women treated due to early menopause (due to ovarian damage or surgical intervention) is limited. In cases of early menopause, the risks associated with HRT may differ. Discuss this with your doctor.
Before starting (or restarting) HRT, your doctor will ask about your personal and family medical history. Your doctor may perform a breast and/or pelvic examination (lower abdomen), if necessary.
Once HRT has been started, periodic medical check-ups (at least annually) must still be performed to carefully evaluate the risks and benefits related to continuing the therapy.
Have regular breast examinations as recommended by your doctor.
Do not take Femoston if you are in any of the following conditions. If you are unsure about any of the points below, inform your doctor before starting treatment with Femoston.
Do not take Femoston:

• if you have, have had, or are suspected of having breast cancer
• if you have or are suspected of having a tumour whose growth is sensitive to oestrogens, for example in the endometrium (lining of the uterus)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you have or have previously been treated for the presence of blood clots in the veins (thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have conditions causing thrombosis (such as deficiency of protein C, protein S, or antithrombin)
• if you have or have previously had arterial thrombosis-related diseases, such as myocardial infarction, stroke, or angina (severe chest pain)
• if you have or have previously had liver disease and liver function tests have not returned to normal levels
• if you have porphyria (an inherited metabolic disorder due to a disturbance in the metabolism of blood pigments)
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other components of this medicine (listed in section 6).

During treatment with Femoston, if any of the above conditions appear for the first time, stop taking the medicine and consult your doctor immediately.
Warnings and precautions
Inform your doctor or pharmacist before taking Femoston if you have previously experienced any of the following
conditions, as they may recur or worsen during treatment with Femoston.
If so, your doctor may require more frequent monitoring:

• uterine fibroids
• growth of the uterine lining outside the uterus (endometriosis) or previous excessive thickening of the uterine lining (endometrial hyperplasia)
• brain tumour that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “Blood clots in the veins (thrombosis)”)
• increased risk of developing a tumour whose growth is sensitive to oestrogens (having a first-degree relative, such as mother, sister, or grandmother, who has had breast cancer)
• hypertension (high blood pressure)
• liver disorders such as benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (an autoimmune disease)
• epilepsy
• asthma
• otosclerosis (a hereditary middle ear disease)
• hypertriglyceridaemia (marked increase in triglycerides in the blood)
• fluid retention due to heart or kidney failure
• hereditary or acquired angioedema

Stop treatment with Femoston and consult your doctor immediately
If you notice any of the following conditions when starting HRT:

• any of the conditions listed in the section “Do not use Femoston”
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with breathing difficulties, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• first-time occurrence of migraine-type headache
• if you are pregnant
• if you notice signs of blood clots such as: painful swelling and redness in the legs or sudden chest pain or difficulty breathing

For further information, see section “Blood clots in the veins (thrombosis)”.
Note: Femoston is not a contraceptive. If you are under 50 years of age or your last menstrual period was less than 12 months ago, you may need an additional contraceptive to prevent pregnancy. Consult your doctor.
HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining
(endometrial cancer)
Taking oestrogen-only HRT may increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.
Unexpected vaginal bleeding
While taking Femoston, you will have a monthly bleed (called a withdrawal bleed). However, if you experience unexpected bleeding or spotting (light bleeding) outside the monthly bleed, which:

• occurs for more than 6 months
• starts after taking Femoston for more than 6 months
• occurs after stopping treatment with Femoston, contact your doctor as soon as possible.

Breast cancer
Evidence shows that the risk of breast cancer increases with combined oestrogen-progestogen HRT or oestrogen-only HRT. The additional risk depends on how long HRT is used and becomes evident within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT has been used for more than 5 years.
Comparative data
Among women aged 50 to 54 years who do not use HRT for more than 5 years, an average of 13 to 17 cases of breast cancer are diagnosed per 1,000 women.
In women aged 50 who start oestrogen-only HRT for 5 years, there will be 16–17 cases per 1,000 users (i.e., 0–3 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (4 to 8 additional cases).
Among women aged 50 to 59 years who do not use HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 over a 10-year period.
In women aged 50 who start oestrogen-only HRT for 10 years, there will be 34 cases per 1,000 users (i.e., 7 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e., 21 additional cases).
Regularly check your breasts. See your doctor if you notice any changes in your breasts such as:

• small indentations in the skin
• changes in the nipple
• any visible or palpable lumps.

Additionally, participate in mammography screening programmes when offered. For mammography, it is important that you inform the healthcare professional performing the X-rays that you are taking HRT, as this medicine can increase breast density, affecting the mammogram result. Where breast density is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of oestrogen-only or combined oestrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, among women aged 50 to 54 years who do not use HRT, about 2 women in 2,000 will receive an ovarian cancer diagnosis within 5 years. For women using HRT for 5 years, there will be about 3 cases in 2,000 women treated (i.e., about 1 additional case).
Effects of HRT on the heart and circulation
Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is about 1.3 – 3 times higher in users of HRT, especially during the first year of use.
Blood clots can be serious, and if one reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death.
As you get older, you are more likely to develop blood clots in the veins. If you have any of the following conditions, discuss them with your doctor:

• if you will be immobile for a long time due to major surgery, trauma, or illness (see also section 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m²)
• if you have coagulation disorders requiring prolonged anticoagulant treatment
• if a first-degree relative has previously had blood clots in the legs, lungs, or another organ
• if you have a rare condition such as systemic lupus erythematosus (SLE)
• if you have a tumour.

For symptoms of a blood clot, see “Stop treatment with Femoston and consult your doctor immediately”.
Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4 – 7 women per 1,000 may expect to have a venous thrombosis.
In women around 50 years of age who have taken combined oestrogen-progestogen HRT for more than 5 years, there will be 9 – 12 cases per 1,000 (e.g., 5 additional cases).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. Women over 60 years of age using combined oestrogen-progestogen HRT are slightly more likely to develop heart disease compared to women not using HRT.
Stroke
The risk of stroke is about 1.5 times higher in users of HRT compared to non-users. The number of additional stroke cases due to HRT use may increase with advancing age.
Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 may expect to have a stroke.
In women around 50 years of age who have been taking HRT for more than 5 years, there will be 11 cases per 1,000 (e.g., 3 additional cases).
Other conditions
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after age 65. Consult your doctor.
Inform your doctor if you have or have had any of the following medical conditions, as you may need more frequent monitoring:

• heart disease
• kidney failure
• abnormally high levels of certain blood fats (hypertriglyceridaemia).

Children
Femoston is not intended for use in children.
Other medicines and Femoston
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can interfere with the effectiveness of Femoston. This may lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy (e.g., phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g., rifampicin, rifabutin)
• medicines for HIV infection [AIDS] (e.g., ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John’s wort (Hypericum perforatum)

HRT may affect how some other medicines work:

• an antiepileptic medicine (lamotrigine), as it may increase the frequency of epileptic seizures
• the hepatitis C virus (HCV) treatment regimen consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results related to liver function (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination regimen.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, or other natural products. Your doctor will provide you with the necessary instructions.
Laboratory tests
If you need to have a blood test, inform your doctor or nurse that you are taking Femoston, as this medicine may interfere with the results of certain tests.
Femoston with food and drink
Femoston can be taken with or without food.
Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.
Driving and using machines
The effect of Femoston on driving or operating machinery has not been studied. An effect is unlikely.
Femoston tablets contain lactose.
If you are intolerant to certain sugars, contact your doctor before taking this medicine.

3. How to take Femoston

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

When to start treatment with Femoston
Do not start treatment with Femoston until at least 6 months after your last menstrual period.

You may start taking Femoston on any day if:

• you are currently not taking any hormone replacement therapy (HRT), or
• you are switching from a continuous combined HRT, i.e. when you take a tablet or apply a patch daily containing both an oestrogen and a progestogen.

Start taking Femoston the day after completing day 28 of your cycle if:

• you are switching from a cyclic or sequential HRT, i.e. when you take a tablet or use a patch containing oestrogen only during the first part of your cycle, followed by a tablet or patch containing both an oestrogen and a progestogen for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you may take the tablet with or without food
• try to take the tablet at the same time each day. This will help maintain a constant level of the medicine in your body and will also help you remember to take it
• take one tablet every day, without interruption between packs. The days of the week are marked on the blister packs to help you remember when to take your tablet.

Duration of treatment

• your doctor will prescribe the lowest effective dose to treat your symptoms for the shortest duration necessary. If you feel the dose is too strong or too weak, consult your doctor.
• if you are taking Femoston to prevent osteoporosis, your doctor will adjust your dose based on your bone mass.
• take one red-brown tablet daily for the first 14 days, followed by one yellow tablet daily for the next 14 days. The 28 days are printed on the blister.

If you need surgery
If you are scheduled for surgery, inform your doctor that you are taking Femoston. You may need to stop taking Femoston approximately 4–6 weeks before the procedure to reduce the risk of blood clots (see section 2, "Blood clots in the veins"). Ask your doctor when you can restart Femoston.

If you take more Femoston than you should
Taking too many Femoston tablets (or someone else taking them by mistake) is unlikely to cause harm. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or breakthrough bleeding. No specific treatment is required, but if you are concerned, contact your doctor for advice.

If you forget to take Femoston
Take the missed tablet as soon as you remember. If more than 12 hours have passed since the usual time, take the next tablet at the regular time. Do not take the missed tablet and do not double the next dose. Missing a dose may lead to irregular bleeding or spotting.

If you stop taking Femoston
Do not stop taking Femoston without consulting your doctor.

• If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
The following conditions occur more frequently in women using HRT than in women who do not use HRT:

• breast cancer
• abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For more information about these side effects, see Section 2.
The following side effects may occur with this medicine:
Very common (may affect more than 1 in 10 treated patients):

• headache
• abdominal pain
• back pain
• breast pain/tenderness

Common (may affect up to 1 in 10 treated patients):

• vaginal candidiasis (fungal infection caused by Candida albicans)
• feeling depressed, nervousness
• migraine. If you experience a migraine headache for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling unwell (nausea), vomiting, bloating (abdominal swelling), including gas (flatulence)
• skin allergic reactions (rash, severe itching, or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light menstrual bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired, or unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain

Uncommon (may affect up to 1 in 100 treated patients):

• symptoms resembling cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as shortness of breath (allergic asthma)
• changes in sexual desire
• blood clots in the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged and twisted veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia), or generally feeling unwell (malaise), and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms resembling premenstrual syndrome
• weight loss

Rare (may affect up to 1 in 1,000 treated patients):
(*post-marketing adverse reactions not observed in clinical trials, assigned the frequency “rare”)

• disease characterized by destruction of red blood cells (hemolytic anemia)*
• meningioma (brain tumor)*
• changes to the surface of the eye (increased curvature of the cornea)*, causing inability to wear contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This may cause breathing difficulties (angioedema)
• purplish spots or dots on the skin (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin discoloration, especially on the face or neck, known as “pregnancy mask” (chloasma or melasma)*
• leg cramps*

The following side effects have been associated with the use of other HRTs:

• estrogen-dependent tumours (both benign and malignant), such as cancer of the uterine lining, ovarian cancer (for further information see Section 2)
• increased size of progestin-dependent tumours (such as meningioma)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• possible dementia
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain blood fats (hypertriglyceridemia)
• skin rash with red or irritated target-like lesions (erythema multiforme)
• urinary incontinence
• painful nodular breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare blood pigment disorder (porphyria)
• elevated levels of certain blood fats (hypertriglyceridemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Side effects can also be reported directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Femoston

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Femoston contains

• The active substances are estradiol as estradiol hemihydrate and dydrogesterone. Each red-brown tablet contains 2 mg of estradiol. Each yellow tablet contains 2 mg of estradiol and 10 mg of dydrogesterone.
• The other components of the tablet core are monohydrate lactose, hypromellose, maize starch, anhydrous colloidal silica and magnesium stearate.
• The other components of the tablet coating are: titanium dioxide (E171), yellow iron oxide (E 172), hypromellose, macrogol, talc, red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of Femoston and package contents

• The film-coated tablets are round, biconvex, and marked with "379" on one side.
• Each blister contains 28 tablets.
• Femoston contains two different coloured tablets. Each pack contains 14 red-brown tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the following 14 days of the cycle).
• The tablets are packaged in PVC/aluminum blisters.
• Packs contain 28, 84 (3x28) or 280 (10x28) film-coated tablets in blisters.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland
Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Femoston 0.5 mg/2.5 mg film-coated tablets

Active substances: estradiol/dydrogesterone
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 0.5 mg/2.5 mg film-coated tablets. In
this leaflet, the abbreviated name Femoston is used.
Contents of this leaflet:

1. What Femoston is and what it is used for
2. What you need to know before taking Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Contents of the pack and other information

1. What Femoston is and what it is used for

Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones: an estrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in women who have been postmenopausal for at least 12 months.
Femoston is used for
Relieving symptoms that occur after menopause
During menopause, the amount of estrogen produced by the female body decreases.
This can cause symptoms such as flushing of the face, neck, and chest ("hot flushes").
Femoston relieves these postmenopausal symptoms. Femoston should only be prescribed if symptoms seriously interfere with daily life.

2. What you should know before taking Femoston

Medical history and regular check-ups
The use of HRT carries risks that must be considered when deciding whether to start or continue treatment.
Experience in women with early menopause (due to ovarian damage or surgical intervention) is limited. In cases of early menopause, the risks associated with HRT may differ. Discuss this with your doctor.
Before starting (or restarting) HRT, your doctor will ask about your personal and family medical history. Your doctor may decide to perform an examination, which may include a breast examination and/or a gynecological examination, if necessary.
Once HRT has been started, regular medical check-ups should still be performed (at least once a year). During these check-ups, discuss with your doctor the risks and benefits of continuing treatment with Femoston.
Have regular breast examinations as recommended by your doctor.
Do not take Femoston if you are in any of the conditions listed below. If you are unsure about any of the points below, inform your doctor before starting treatment with Femoston.
Do not take Femoston:

• if you have, have had, or there is suspicion that you may have breast cancer
• if you have or there is suspicion that you may have a tumour whose growth is sensitive to oestrogens, such as endometrial cancer (lining of the uterus)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you have or have been previously treated for blood clots in the veins (thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have diseases caused by blood clots (such as deficiency of protein C, protein S, or antithrombin)
• if you have or have recently had a disease caused by blood clots in the arteries, such as myocardial infarction, stroke, or angina
• if you have or have had liver disease in the past and liver function tests have not returned to normal levels
• if you have a rare blood disorder called “porphyria” (an inherited condition)
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or to any of the other ingredients of this medicine (listed in section 6)

If, during treatment with Femoston, you develop for the first time any of the conditions listed above, stop taking the medicine and consult your doctor immediately.
Warnings and precautions
Contact your doctor or pharmacist before taking Femoston if you have previously had any of the following conditions, as they may recur or worsen during treatment with Femoston. If so, your doctor may require more frequent monitoring:

• fibroids in the uterus
• growth of uterine tissue outside the uterus (endometriosis) or previous excessive thickening of the uterine lining (endometrial hyperplasia)
• brain tumour possibly related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “blood clots in the veins (thrombosis)”)
• increased risk of developing a tumour whose growth is sensitive to oestrogens (such as having a mother, sister, or grandmother who had breast cancer)
• high blood pressure
• liver disorders such as benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• an autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• markedly increased triglyceride levels in the blood (hypertriglyceridaemia)
• fluid retention due to heart or kidney failure
• hereditary or acquired angioedema

Stop treatment with Femoston and consult your doctor immediately
If you experience any of the following conditions when starting HRT:

• any of the conditions listed in the section “Do not use Femoston”
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disease
• swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives with breathing difficulties, symptoms suggestive of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• new-onset migraine headache
• if you are pregnant
• if you notice signs of blood clots such as: painful swelling and redness in the legs or sudden chest pain or difficulty breathing

For more information, see the section “Blood clots in the veins (thrombosis)”.
Note: Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need an additional contraceptive to prevent pregnancy. Speak with your doctor for advice.
HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
Taking oestrogen-only HRT may increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.
Irregular bleeding
During the first 3–6 months of treatment with Femoston, you may experience irregular bleeding or spotting. However, if irregular bleeding:

• occurs for more than 6 months
• starts after taking Femoston for more than 6 months
• occurs after stopping treatment with Femoston, contact your doctor as soon as possible

Breast cancer
Evidence shows that the risk of breast cancer increases with combined oestrogen-progestogen HRT or oestrogen-only HRT. The additional risk depends on how long HRT is used and becomes evident within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT has been used for more than 5 years.
Comparative data
Among women aged 50 to 54 years who do not use HRT for more than 5 years, an average of 13 to 17 cases of breast cancer are diagnosed per 1,000 women.
In women aged 50 who start oestrogen-only HRT for 5 years, there will be 16–17 cases per 1,000 users (i.e. 0–3 additional cases). In women aged 50 who start combined oestrogen-progestogen HRT for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 years who do not use HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 over a 10-year period.
In women aged 50 who start oestrogen-only HRT for 10 years, there will be 34 cases per 1,000 users (i.e. 7 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e. 21 additional cases).
Regularly check your breasts. See your doctor if you notice any changes in the breast such as:

• small indentations in the skin
• changes in the nipple
• any visible or palpable lumps

Additionally, participate in mammography screening programmes when offered. For mammography, it is important that you inform the healthcare professional performing the X-rays that you are taking HRT, as this medicine can increase breast density, which may affect the mammogram results. Where breast density is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of oestrogen-only or combined oestrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years who do not use HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer within 5 years. For women using HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e. about 1 additional case).
Effects of HRT on the heart and circulation
Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is approximately 1.3–3 times higher in HRT users than in non-users, especially during the first year of use.
Blood clots can be serious, and if one reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death.
The likelihood of developing blood clots increases with age. If any of the following conditions apply to you, discuss them with your doctor:

• if you will be immobile for a long time due to major surgery, trauma, or illness (see also section 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m²)
• if you have blood clotting disorders requiring long-term anticoagulant treatment
• if a first-degree relative has previously had blood clots in the legs, lungs, or another organ
• if you have a rare condition such as systemic lupus erythematosus (SLE)
• if you have a tumour

For symptoms of a blood clot, see “Stop treatment with Femoston and consult your doctor immediately”.
Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4–7 women per 1,000 may expect to develop a venous clot.
In women around 50 years of age who have taken combined oestrogen-progestogen HRT for more than 5 years, there will be 9–12 cases per 1,000 (i.e. 5 additional cases).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. Women over 60 years of age who use combined oestrogen-progestogen HRT are slightly more likely to develop heart disease compared to women not using HRT.
Stroke
The risk of stroke is about 1.5 times higher in HRT users than in non-users. The number of additional stroke cases due to HRT use may increase with advancing age.
Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 may expect to have a stroke.
In women around 50 years of age who have been taking HRT for over 5 years, there will be 11 cases per 1,000 (i.e. 3 additional cases).
Other conditions
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after age 65. Consult your doctor.
Inform your doctor if you have or have had any of the following medical conditions, as you may require more frequent monitoring:

• heart disease
• kidney failure
• abnormally high levels of certain blood fats (hypertriglyceridaemia)

Children
Femoston is not intended for use in children.
Other medicines and Femoston
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with the effectiveness of Femoston. This can lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g. rifampicin, rifabutin)
• medicines for HIV infection [AIDS] (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John’s wort (Hypericum perforatum)

HRT may affect how some other medicines work:

• an antiepileptic medicine (lamotrigine), as it may increase the frequency of epileptic seizures
• The combination therapy for hepatitis C virus (HCV) consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results related to liver function (elevation of liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination therapy.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, or other natural products. Your doctor will provide you with the necessary instructions.
Laboratory tests
If you need a blood test, inform your doctor or nurse that you are taking Femoston, as this medicine may interfere with the results of certain tests.
Femoston with food and drink
Femoston can be taken with or without food.
Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.
Driving and using machines
The effect of Femoston on driving or operating machinery has not been studied. An effect is unlikely.
Femoston tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Femoston

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
When to start treatment with Femoston
Do not start treatment with Femoston until at least 12 months after your last menstrual period. You may start taking Femoston on any day if:

• you are currently not taking any hormone replacement therapy (HRT)
• you are switching from a continuous combined HRT, i.e. when you take a tablet or apply a patch daily containing both an oestrogen and a progestogen.

Start taking Femoston the day after completing day 28 of your cycle if:

• you are switching from a 'cyclical' or 'sequential' HRT, i.e. when you take a tablet or use a patch containing an oestrogen during the first part of your cycle, followed by a tablet or patch containing both an oestrogen and a progestogen for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you may take the tablet with or without food
• try to take the tablet at the same time each day. This will ensure a constant level of medicine in your body and help you remember to take it.
• take one tablet every day, without interruption between packs. The blister packs are marked with the days of the week to help you remember when to take your tablet.

How long to take it

• your doctor will prescribe the lowest effective dose to treat your symptoms for the shortest possible duration. If you feel this dose is too strong or too weak, consult your doctor.
• take one yellow tablet daily for a 28-day cycle.

If you need surgery
If you are due to have surgery, inform your doctor that you are taking Femoston. You may need to stop taking Femoston approximately 4–6 weeks before surgery to reduce the risk of blood clots (see section 2, "Blood clots in the veins"). Ask your doctor when you can restart taking Femoston.
If you take more Femoston than you should
If you have taken too many Femoston tablets (or someone else has), it is unlikely to cause harm. You may experience nausea or vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or breakthrough bleeding. No treatment is necessary. However, if you are concerned, contact your doctor for advice.
If you forget to take Femoston
Take the missed tablet as soon as you remember. If more than 12 hours have passed since the scheduled time, take the next dose at the usual time. Do not take the missed tablet. Do not double the dose. If you miss a dose, irregular bleeding or spotting may occur.
If you stop taking Femoston
Do not stop taking Femoston without consulting your doctor.

• If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following conditions are more frequently observed in women using HRT compared to women who do not use HRT:

• breast cancer
• abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65

For more information on these side effects, see Section 2.
The following side effects may occur with this medicine:
Very common (may affect more than 1 in 10 treated patients)

• headache
• abdominal pain
• back pain
• breast pain/tenderness

Common (may affect up to 1 in 10 treated patients):

• vaginal candidiasis (fungal infection caused by Candida albicans)
• feeling depressed, nervousness
• migraine. If you experience a migraine headache for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling unwell (nausea), vomiting, bloating, including gas (flatulence)
• skin allergic reactions (rash, severe itching, or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired, or unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain

Uncommon (may affect up to 1 in 100 treated patients):

• symptoms mimicking cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as shortness of breath (allergic asthma)
• changes in sexual desire
• blood clots in the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged and twisted veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia), or generally feeling unwell (malaise), and abdominal pain. If you notice yellowing of the skin or the whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms mimicking premenstrual syndrome
• weight loss

Rare (may affect up to 1 in 1,000 treated patients):
(*adverse reactions reported during post-marketing surveillance not observed in clinical trials, assigned the frequency "rare")

• disease characterized by destruction of red blood cells (haemolytic anaemia)*
• meningioma (brain tumour)*
• changes to the surface of the eye (increased curvature of the cornea)*, leading to inability to wear contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This may cause breathing difficulties (angioedema)
• purple spots or dots on the skin (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin discoloration, especially on the face or neck, known as "pregnancy mask" (chloasma or melasma)* leg cramps*

The following side effects have been reported with the use of other HRTs:

• oestrogen-dependent tumours, both benign and malignant, such as cancer of the uterine lining, ovarian cancer (for further information see Section 2)
• increased size of progesterone-dependent tumours (such as meningioma)
• disease in which the immune system abnormally attacks many organs of the body (systemic lupus erythematosus)
• possible dementia
• worsening of seizures (epilepsy)
• involuntary muscle movements (chorea)
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain blood fats (hypertriglyceridaemia)
• skin rash with red or inflamed target-like lesions (erythema multiforme)
• urinary incontinence
• nodular/painful breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare blood pigment disorder (porphyria)
• elevated levels of certain blood fats (hypertriglyceridaemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can report side effects via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FEMOSTON

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Femoston contains
➢ The active substances are estradiol as estradiol hemihydrate and dydrogesterone.
➢ Each tablet contains 0.5 mg of estradiol and 2.5 mg of dydrogesterone.
➢ The other components of the tablet core are monohydrate lactose, hypromellose, maize starch, anhydrous colloidal silica and magnesium stearate.
➢ The other components of the tablet coating are:
titanium dioxide (E171), yellow iron oxide (E172), polyvinyl alcohol, macrogol, talc.
Description of the appearance of Femoston and package contents
➢ This medicinal product is a film-coated tablet. The tablet is round, biconvex and marked with '379' on one side. Each blister contains 28 tablets.
➢ The tablets are yellow in colour.
➢ The tablets are packaged in PVC blisters sealed with an aluminium foil lid.
➢ Packs contain 28, 84 (3 x 28) or 280 (10 x 28) film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland
Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands.
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Femoston 1/5 Conti film-coated tablets 1 mg, 5 mg

Active substances: estradiol/dydrogesterone
Please read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 1/5 Conti film-coated tablets 1 mg, 5 mg.
In this leaflet, the abbreviated name Femoston is used.
Contents of this leaflet:

1. What Femoston is and what it is used for
2. What you need to know before taking Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Contents of the pack and other information

1. What Femoston is and what it is used for

Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones: an estrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in women who have been postmenopausal for at least 12 months.

Femoston is used to

Relieve symptoms occurring after menopause
During menopause, the amount of estrogen produced by the female body decreases. This can cause symptoms such as flushing of the face, neck, and chest ("hot flushes"). Femoston relieves these symptoms after menopause. Femoston should only be prescribed if symptoms seriously interfere with daily life.

Prevent osteoporosis
After menopause, some women may develop brittle bones (osteoporosis). You should discuss all available options with your doctor.
If you are at high risk of fractures due to osteoporosis and other medicines are not suitable, Femoston may be used to prevent osteoporosis after menopause.

2. What you should know before taking Femoston

Medical history and regular check-ups
The use of hormone replacement therapy (HRT) entails risks that must be considered when deciding whether to start or continue treatment.
Experience in women treated for early menopause (due to ovarian damage or surgical intervention) is limited. In cases of early menopause, the risks associated with HRT may differ. Discuss this with your doctor.
Before starting (or restarting) HRT, your doctor will ask about your personal and family medical history. Your doctor may perform a breast and/or pelvic examination (lower abdomen), if necessary.
Once HRT has been initiated, periodic medical check-ups (at least annually) must still be performed to carefully assess the risks and benefits related to continuing the therapy.
Have regular breast examinations as recommended by your doctor.

Do not take Femoston if you are in any of the following conditions. If you are unsure about any of the points below, inform your doctor before starting treatment with Femoston.

Do not take Femoston:

• if you have, have had, or are suspected of having breast cancer
• if you have, or are suspected of having, a tumour whose growth is sensitive to oestrogens, for example in the endometrium (lining of the uterus)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you currently have, or have had in the past, blood clots in the veins (thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have disorders caused by blood clots (such as protein C, protein S, or antithrombin deficiency)
• if you currently have, or have had in the past, arterial diseases caused by blood clots, such as myocardial infarction, stroke, or angina (severe chest pain)
• if you have, or have had in the past, liver disease and liver function tests have not returned to normal levels
• if you have porphyria (an inherited metabolic disorder due to a disturbance in the metabolism of blood pigments)
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or to any of the other ingredients of this medicine (listed in section 6).

During treatment with Femoston, if any of the above conditions develops for the first time, stop taking the medicine and consult your doctor immediately.

Warnings and precautions
Inform your doctor or pharmacist before taking Femoston if you have previously experienced any of the following conditions, as they may reappear or worsen during treatment with Femoston. If so, your doctor may require more frequent check-ups:

• uterine fibroids
• growth of uterine tissue outside the uterus (endometriosis) or previous excessive thickening of the uterine lining (endometrial hyperplasia)
• brain tumour that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “Blood clots in the veins (thrombosis)”)
• increased risk of developing a tumour whose growth is sensitive to oestrogens (e.g. having a first-degree relative, such as mother, sister, or grandmother, who had breast cancer)
• hypertension (high blood pressure)
• liver disorders such as benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (an autoimmune disease)
• epilepsy
• asthma
• otosclerosis (a hereditary middle ear disorder)
• hypertriglyceridaemia (marked increase in triglycerides in the blood)
• fluid retention due to heart or kidney failure
• hereditary or acquired angioedema

Stop treatment with Femoston and consult your doctor immediately
If you notice any of the following conditions when starting HRT:

• any of the conditions listed in the section “Do not use Femoston”
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with breathing difficulties, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• first occurrence of migraine-type headache
• if you are pregnant
• if you notice signs of blood clots such as: painful swelling and redness of the legs or sudden chest pain or difficulty breathing

For more information, see section “Blood clots in the veins (thrombosis)”.
Note: Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need an additional contraceptive to prevent pregnancy. Consult your doctor.

HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
Taking oestrogen-only HRT may increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and of cancer of the uterine lining (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.

Irregular bleeding
During the first 3–6 months of treatment with Femoston, you may experience irregular bleeding or spotting (blood drops). However, contact your doctor as soon as possible if irregular bleeding:

• occurs for more than 6 months
• starts after taking Femoston for more than 6 months
• occurs after stopping treatment with Femoston

Breast cancer
Evidence shows that the risk of breast cancer increases with combined oestrogen-progestogen hormone replacement therapy (HRT) or oestrogen-only HRT. The additional risk depends on how long HRT is used and becomes evident within 3 years of use. After stopping HRT, the additional risk decreases over time, but this risk may persist for 10 years or more if HRT has been used for more than 5 years.

Comparative data
Among women aged 50 to 54 years who do not use HRT for more than 5 years, an average of 13 to 17 cases of breast cancer are diagnosed per 1,000 women.
In women aged 50 who start oestrogen-only HRT for a period of 5 years, there will be 16–17 cases per 1,000 users (i.e. 0–3 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (4 to 8 additional cases).
Among women aged 50 to 59 years who do not use HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 over a period of 10 years.
In women aged 50 who start oestrogen-only HRT for 10 years, there will be 34 cases per 1,000 users (i.e. 7 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e. 21 additional cases).

Regularly examine your breasts. See your doctor if you notice any changes in the breasts such as:

• small depressions in the skin
• changes in the nipple
• any visible or palpable lumps.

Additionally, participate in mammographic screening programmes when offered. For mammography, it is important that you inform the healthcare professional performing the X-rays that you are taking HRT, as this medicine can increase breast density, which may affect the mammogram result. Where breast density is increased, mammography may not detect all lumps.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of oestrogen-only or combined oestrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years who do not use HRT, about 2 out of 2,000 women will receive an ovarian cancer diagnosis within 5 years. For women using HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e. about 1 additional case).

Effects of HRT on the heart and circulation
Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is approximately 1.3 to 3 times higher in users of HRT, especially during the first year of use.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting, and even death.
As you get older, you are more likely to develop blood clots. If any of the following conditions apply, discuss them with your doctor:

• if you will be immobile for a long time due to major surgery, trauma, or illness (see also section 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m²)
• if you have clotting disorders requiring prolonged anticoagulant treatment
• if a first-degree relative has previously had blood clots in the legs, lungs, or another organ
• if you have a rare condition such as systemic lupus erythematosus (SLE)
• if you have a tumour.

For symptoms of a blood clot, see “Stop treatment with Femoston and consult your doctor immediately”.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4–7 out of 1,000 women can expect to have a venous blood clot.
In women around 50 years of age who have taken combined oestrogen-progestogen HRT for more than 5 years, there will be 9–12 cases per 1,000 (e.g. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. Women over 60 years of age who use combined oestrogen-progestogen HRT are slightly more likely to develop heart disease compared to women not using HRT.

Stroke
The risk of stroke is approximately 1.5 times higher in users of HRT compared to non-users. The number of additional stroke cases due to HRT use may increase with advancing age.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 out of 1,000 women can expect to have a stroke.
In women around 50 years of age who have been taking HRT for over 5 years, there will be 11 cases per 1,000 (e.g. 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after age 65. Ask your doctor for advice.
Inform your doctor if you have or have had any of the following medical conditions, as you may need to be monitored more frequently:

• heart disease
• kidney failure
• abnormally high levels of certain blood fats (hypertriglyceridaemia).

Children
Femoston is not intended for use in children.

Other medicines and Femoston
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can interfere with the effectiveness of Femoston. This may lead to irregular bleeding and occurs with the following medicines:

• epilepsy medications (e.g. phenobarbital, carbamazepine, phenytoin)
• tuberculosis medications (e.g. rifampicin, rifabutin)
• HIV [AIDS] medications (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John’s wort (Hypericum perforatum)

HRT can affect how some other medicines work:

• an epilepsy medicine (lamotrigine), as it may increase the frequency of seizures
• the hepatitis C virus (HCV) treatment regimen containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results related to liver function (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV treatment regimen.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription, herbal medicines, or other natural products. Your doctor will provide you with the necessary instructions.

Laboratory tests
If you need to have a blood test, inform your doctor or nurse that you are taking Femoston, as this medicine may interfere with the results of certain tests.

Femoston with food and drink
Femoston can be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.

Driving and using machines
The effect of Femoston on driving or operating machinery has not been studied. An effect is unlikely.

Femoston tablets contain lactose.
If you are intolerant to certain sugars, contact your doctor before taking this medicine.

3. How to take Femoston

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

When to start treatment with Femoston
Do not start treatment with Femoston until at least 12 months after your last menstrual period.
You may start taking Femoston on any day if:

• you are currently not taking any HRT (hormone replacement therapy)
• you are switching from a continuous combined HRT, i.e. when you take a tablet or apply a patch every day containing both an oestrogen and a progestogen.

Start taking Femoston the day after completing day 28 of your cycle if:

• you are switching from a cyclic or sequential HRT, i.e. when you take a tablet or use a patch containing an oestrogen during the first part of your cycle, followed by a tablet or patch containing both an oestrogen and a progestogen for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you may take the tablet with or without food
• try to take the tablet at the same time each day. This ensures a constant level of the medicine in your body and helps you remember to take it
• take one tablet every day, without interruption between packs. The days of the week are marked on the blister packs to help you remember when to take your tablet.

How long to take it

• your doctor will prescribe the lowest effective dose to treat your symptoms for the shortest possible duration. If you feel this dose is too strong or too weak, consult your doctor.
• if you are taking Femoston to prevent osteoporosis, your doctor will adjust your dose depending on your bone mass.
• take one salmon-coloured tablet every day for a 28-day cycle.

If you need surgery
If you are due to have surgery, inform your doctor that you are taking Femoston. You may need to stop taking Femoston approximately 4–6 weeks before the procedure to reduce the risk of blood clots (see section 2, “Blood clots in veins”). Ask your doctor when you can restart taking Femoston.

If you take more Femoston than you should
If you have taken too many Femoston tablets (or someone else has), it is unlikely to cause harm. You may experience nausea or vomiting, breast pain/tenderness, dizziness, abdominal pain, drowsiness/tiredness, or breakthrough bleeding. No specific treatment is required, but if you are concerned, contact your doctor for advice.

If you forget to take Femoston
Take the missed tablet as soon as you remember. If more than 12 hours have passed since the usual time, take the next tablet at your regular time. Do not take the missed tablet. Do not double the dose. If you miss a dose, you may experience irregular bleeding or spotting.

If you stop taking Femoston
Do not stop taking Femoston without consulting your doctor.

• If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following conditions occur more frequently in women using HRT than in women who do not use HRT:

• breast cancer
• abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For more information about these side effects, see Section 2.
The following side effects may occur with this medicine:
Very common (may affect more than 1 in 10 treated patients):

• headache
• abdominal pain
• back pain
• breast pain/tenderness

Common (may affect up to 1 in 10 treated patients):

• vaginal candidiasis (fungal infection caused by Candida albicans)
• feeling depressed, nervousness
• migraine. If you experience a migraine headache for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling unwell (nausea), vomiting, bloating, flatulence
• allergic skin reactions (rash, severe itching, or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhoea), heavy or light bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired, or unwell
• swelling of ankles, feet, or fingers (peripheral oedema)
• weight gain

Uncommon (may affect up to 1 in 100 treated patients):

• symptoms mimicking cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as shortness of breath (allergic asthma)
• changes in sexual desire
• blood clots in the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged and twisted veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia), or generally feeling unwell (malaise), and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop taking Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms resembling premenstrual syndrome
• weight loss

Rare (may affect up to 1 in 1,000 treated patients):
(*post-marketing side effects not observed in clinical trials, assigned a frequency of "rare")

• a disease characterised by destruction of red blood cells (haemolytic anaemia)*
• meningioma (a brain tumour)*
• changes on the surface of the eye (increased curvature of the cornea)*, causing difficulty wearing contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat, which may cause breathing difficulties (angioedema)
• purple spots or pinpoint dots on the skin (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin discolouration especially on the face or neck, known as "pregnancy mask" (chloasma or melasma)*
• leg cramps*

The following side effects have been associated with the use of other HRTs:

• oestrogen-dependent tumours (both benign and malignant), such as cancer of the uterine lining, ovarian cancer (for further information see Section 2)
• increase in size of progestogen-dependent tumours (such as meningioma)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• possible dementia
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain blood fats (hypertriglyceridaemia)
• skin rash with target-like red or irritated lesions (erythema multiforme)
• urinary incontinence
• painful nodular breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare blood pigment disorder (porphyria)
• elevated levels of certain blood fats (hypertriglyceridaemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Femoston contains

• The active substances are estradiol as estradiol hemihydrate and dydrogesterone. Each tablet contains 1 mg of estradiol and 5 mg of dydrogesterone.
• The other components of the tablet core are monohydrate lactose, hypromellose, maize starch, anhydrous colloidal silica and magnesium stearate.
• The other components of the tablet coating are: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), hypromellose, macrogol.

Description of the appearance of Femoston and package contents

• This medicine is a film-coated tablet. The tablet is round, biconvex, salmon-coloured, and marked with "379" on one side (7 mm).
• Each blister contains 28 tablets.
• The tablets are packaged in PVC/aluminum blisters.
• The packages contain 28, 84 (3 x 28) or 280 (10 x 28) film-coated tablets in blisters.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland
Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
This medicinal product is authorised in the European Economic Area under the following names: