FEMOSTON

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Femoston
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Femoston is and what it is used for
2. Important information 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 medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones: an oestrogen called estradiol and a progestagen called dydrogesterone.
Femoston is indicated for use in women who have symptoms of oestrogen deficiency and in whom at least 6 months have passed since their last menstrual period.
Femoston is used for the following purposes:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogens produced by a woman's body decreases. This may lead to symptoms such as hot flushes affecting the face, neck and chest.
Femoston relieves symptoms occurring in postmenopausal women.
Femoston is prescribed when these symptoms significantly interfere with daily life.
Prevention of osteoporosis
Some postmenopausal women may develop brittle bones (osteoporosis). All available treatment options should be discussed with the doctor.
In cases of increased fracture risk due to osteoporosis and when the patient cannot take other medications, Femoston may be used to prevent osteoporosis in postmenopausal women.

2. Important information before using Femoston

Medical history and regular check-ups
Hormone replacement therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or oophorectomy) is limited. The risks associated with HRT in premature menopause may differ. Consult your doctor.
Before starting (or restarting) HRT, your doctor should take a full medical history, including family history. Your doctor may decide to perform additional tests, including breast and/or gynecological examination, if considered necessary.
After starting Femoston, you should have regular check-ups with your doctor (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing Femoston treatment.
Regular breast screening should be performed according to your doctor's recommendations.

DO NOT take Femoston if any of the following symptoms or medical conditions are present or have occurred previously.
If you have any doubts about the conditions listed below before taking Femoston, consult your doctor.

When not to take Femoston

• if breast cancer has been diagnosed, occurred previously, or is suspected by your doctor;
• if there is or your doctor suspects a tumor dependent on estrogens, such as cancer of the endometrium (endometrial cancer);
• if there is or your doctor suspects a tumor dependent on progestogens;
• if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumor of the membrane between the brain and skull);
• if you have vaginal bleeding of unknown cause;
• if there is untreated abnormal thickening of the endometrium (endometrial hyperplasia);
• if you have or have had blood clots in veins (thrombosis), e.g., in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• if you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency);
• if you have or recently had an arterial disease caused by blood clots, e.g., heart attack, stroke or coronary heart disease;
• if you have liver disease and liver function test results have not returned to normal;
• if you have a rare inherited blood disorder called porphyria;
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston (listed in section 6).

If any of the above conditions occurs for the first time while taking Femoston, stop taking the medicine immediately and consult your doctor.

Warnings and precautions
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Femoston. If any of the following conditions have occurred in the past, more frequent medical check-ups are recommended:

• uterine fibroids;
• endometriosis (presence of endometrial tissue outside the uterus) or previous abnormal thickening of the endometrium (endometrial hyperplasia);
• risk factors for blood clots (see "Blood clots in veins (thrombosis)");
• increased risk of estrogen-dependent cancer (e.g., family history of breast cancer in mother, sister, or grandmother);
• high blood pressure;
• liver diseases, such as benign liver tumors;
• diabetes;
• gallstones;
• migraine or severe headaches;
• systemic autoimmune disease affecting multiple organs (systemic lupus erythematosus);
• epilepsy;
• asthma;
• ear disease causing hearing loss (otosclerosis);
• very high levels of fats in the blood (triglycerides);
• fluid retention due to heart or kidney disorders;
• hereditary or acquired angioedema.

Stop taking Femoston and contact your doctor immediately if you notice any of the following symptoms during HRT:

• any of the conditions listed under "When not to take 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, combined with breathing difficulties – these may be symptoms of angioedema;
• significantly increased blood pressure (symptoms may include: headaches, fatigue, dizziness);
• new-onset migraine headaches;
• pregnancy;
• symptoms of blood clots, such as: painful swelling and redness in the legs, sudden chest pain, difficulty breathing. See more information under "Blood clots in veins (thrombosis)".

Note: Femoston does not have a contraceptive effect. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, additional contraception may be needed to prevent pregnancy. Consult your doctor.

HRT and cancer

Excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer
Using HRT with estrogen alone increases the risk of abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. The progestogen contained in Femoston protects against this additional risk.

Unexpected bleeding
While taking Femoston, a monthly withdrawal bleed will occur. However, if unexpected bleeding or spotting occurs in addition to the monthly bleeds, and:

• persists beyond the first 6 months of treatment;
• starts after 6 months of taking Femoston;
• continues after stopping Femoston,
  contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking hormone replacement therapy (HRT), either estrogen alone or combined estrogen-progestogen, increases the risk of breast cancer. The additional risk depends on how long HRT is used. This additional risk becomes apparent after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or more if HRT was used for over 5 years.

Comparison
Among women aged 50–54 years not using HRT, breast cancer will be diagnosed in an average of 13 to 17 per 1,000 women over 5 years.
Among women aged 50 starting 5-year estrogen-only HRT, the number of cases will be 16–17 per 1,000 women (i.e., 0 to 3 additional cases).
Among women aged 50 starting 5-year combined estrogen-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e., 4 to 8 additional cases).
Among women aged 50–59 not using HRT, breast cancer will be diagnosed in an average of 27 per 1,000 women over 10 years.
Among women aged 50 starting 10-year estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e., 7 additional cases).
Among women aged 50 starting 10-year combined estrogen-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e., 21 additional cases).

• Regularly examine your breasts. Contact your doctor if you notice any changes such as:
  • skin indentation of the breast,
  • changes around the nipple,
  • any visible or palpable lumps.

Ovarian cancer
Ovarian cancer is rare—much rarer than breast cancer. Using HRT containing only estrogens or combined estrogen-progestogen therapy is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer increases with age. For example, among women aged 50–54 not using HRT, ovarian cancer will be diagnosed in about 2 per 2,000 women over 5 years.
Among women who have used HRT for 5 years, about 3 per 2,000 women will develop ovarian cancer (i.e., about 1 additional case).

Effect of HRT on the heart and circulatory system

Blood clots in veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women using HRT than in non-users, especially during the first year of use.
Blood clots can have serious consequences. If they travel to the lungs, they may cause chest pain, shortness of breath, fainting, or even death.
The risk of venous thrombosis increases with age and if any of the following conditions apply. Inform your doctor if you have any of the following:

• inability to walk for prolonged periods due to major surgery, injury, or illness (see also section 3 "Planned surgery"),
• significant overweight (BMI >30 kg/m²),
• any blood clotting disorders requiring long-term anticoagulant treatment,
• history of venous blood clots in legs, lungs, or other organs in close relatives,
• systemic lupus erythematosus,
• cancer.

Symptoms of blood clots: see "Stop taking Femoston and contact your doctor immediately."

Comparative data
Among women aged 50–60 not using HRT, venous thrombosis is expected in 4 to 7 per 1,000 over 5 years.
Among women aged 50–60 using combined estrogen-progestogen HRT for over 5 years, 9 to 12 cases per 1,000 women will occur (i.e., 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
In women over 60 using combined estrogen-progestogen HRT, there is a slightly increased tendency to develop heart disease compared to non-users.

Stroke
The risk of stroke is about 1.5 times higher in women using HRT than in non-users. The number of additional stroke cases due to HRT increases with age.

Comparison
Among women aged 50–60 not using HRT, stroke is expected in an average of 8 per 1,000 women over 5 years.
Among women aged 50–60 using HRT for over 5 years, 11 cases per 1,000 women will occur (i.e., 3 additional cases).

Meningioma
Using Femoston is associated with the development of usually benign tumors of the membrane between the brain and skull (meningioma). If meningioma is diagnosed, your doctor will discontinue Femoston treatment (see section "When not to take Femoston"). If you notice any symptoms such as vision disturbances (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in hands or legs, inform your doctor immediately.

Other conditions
HRT does not prevent memory loss. There is evidence of increased risk of memory loss in women who start HRT after age 65.
Consult your doctor.

Children
Femoston is indicated only for women with symptoms of estrogen deficiency who have had at least 6 months since their last menstrual period.

Femoston and other medicines
Some medicines may affect the action of Femoston.
This may cause irregular bleeding. The following medicines may reduce the effectiveness of Femoston, leading to bleeding or spotting:

• antiepileptic drugs (such as: phenobarbital, carbamazepine, phenytoin),
• tuberculosis drugs (such as: rifampicin, rifabutin),
• HIV (AIDS) drugs (such as: nevirapine, efavirenz, ritonavir and nelfinavir),
• herbal products containing St. John’s wort (Hypericum perforatum).

HRT may affect the action of other medicines:

• the antiepileptic drug lamotrigine, which may increase seizure frequency;
• combination treatment regimens for hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir) may increase liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT liver enzyme activity may occur when Femoston is used concurrently with such HCV combination therapies. Your doctor will provide appropriate advice.

During treatment with Femoston, dangerously high blood levels of the following medicines may occur:

• tacrolimus, cyclosporine – used, for example, after organ transplantation,
• fentanyl – a painkiller,
• theophylline – used in asthma and other breathing problems.

Therefore, close monitoring of drug levels may be necessary for a period, and dose reduction of the affected drug may be required.

Inform your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including over-the-counter medicines, herbal remedies, or other natural medicinal products (e.g., dietary supplements).

Blood tests
Before a planned blood test, inform your doctor or laboratory staff that you are taking Femoston, as this medicine may affect the results of certain laboratory tests.

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

Pregnancy and breastfeeding
Femoston is indicated only for women with symptoms of estrogen deficiency who have had at least 6 months since their last menstrual period.

• If pregnancy is detected, stop taking Femoston and contact your doctor. Femoston is not indicated during breastfeeding.

Driving and operating machinery
No studies on the effect of Femoston on driving and operating machinery have been conducted. Such an effect is unlikely.

Femoston contains monohydrate lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Femoston

This medicine should always be used exactly as your doctor has told you. If you are unsure,
please consult your doctor or pharmacist.
When to start taking Femoston
Do not start treatment with Femoston until at least 6 months have passed since your last natural
menstrual period.
Treatment with Femoston may be started on any day if:

• the patient is not currently using any hormonal replacement therapy,
• the patient is switching from another HRT product used in a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily containing both an oestrogen and a progestogen.

Treatment with Femoston may be started the day after completion of a 28-day menstrual cycle pack
if:

• the patient is switching from HRT used in a "cyclical" or "sequential" regimen. This regimen involves taking a tablet or applying a patch containing oestrogen during the first part of the cycle, followed by taking a tablet or applying a patch containing both oestrogen and progestogen for the next 14 days.

Taking Femoston

• Swallow the tablet with water.
• Tablets may be taken with or without food.
• Try to take the tablet at the same time each day. This helps maintain a constant level of 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 pack to help you remember when to take your tablet.

Dosage

• Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. If you feel the dose is too strong or too weak, discuss this with your doctor.
• When Femoston is used to prevent osteoporosis, the dose will be individually adjusted by your doctor according to your bone mass.
• Take one brick-red tablet daily for the first 14 days, followed by one yellow tablet daily for the next 14 days. The 28-day treatment schedule is indicated on the calendar provided in the packaging.

Planned surgery

• If you are scheduled for surgery, inform your surgeon that you are taking Femoston. It may be necessary to stop taking Femoston approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, "Venous thrombosis (blood clots in the veins)"). Ask your doctor when you can resume taking Femoston.

If you take more Femoston than you should
If you (or someone else) take too many Femoston tablets, it is unlikely to cause serious harm. Symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually required, but if in doubt, consult your doctor.

If you forget to take Femoston
Take the missed tablet as soon as you remember.
If more than 12 hours have passed since the tablet should have been taken, skip the missed tablet and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet. Breakthrough bleeding or spotting may occur.

Stopping Femoston
Do not stop taking Femoston without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following diseases have been reported more frequently in women using HRT compared to women not using HRT:

• breast cancer,
• abnormal growth or cancer of the lining of the uterus (endometrial hyperplasia or cancer of the endometrium),
• ovarian cancer,
• blood clots in the legs or lungs (venous thromboembolism, pulmonary embolism),
• heart diseases,
• stroke,
• probable memory loss if HRT is initiated after the age of 65.

For more information on the above adverse effects, see section 2.
The following adverse effects may occur during treatment with Femoston:
Very common (may affect more than 1 in 10 women):

• headaches;
• abdominal pain;
• back pain;
• breast tenderness or pain.

Common (may affect up to 1 in 10 women):

• vaginal candidiasis (yeast infection of the vagina caused by Candida albicans);
• depression, nervousness;
• migraine. If migraine-type headaches occur for the first time, treatment with Femoston should be discontinued and you should contact your doctor immediately;
• dizziness;
• nausea, vomiting, flatulence (bloating);
• allergic skin reactions (such as rash, severe itching, urticaria);
• bleeding disorders, such as irregular bleeding or spotting, painful menstruation, excessive or scanty bleeding;
• pelvic pain;
• vaginal discharge;
• feeling of weakness, fatigue, and general malaise;
• swelling of the ankles, feet, or fingers (peripheral edema);
• weight gain.

Uncommon (may affect up to 1 in 100 women):

• growth of pelvic lesions (e.g., fibroids) may increase;
• hypersensitivity reactions, such as shortness of breath (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhea, or hypotension;
• change in libido;
• blood clots causing embolism in vessels of the legs or lungs (venous thromboembolic disease or pulmonary embolism);
• liver function disorders, sometimes with jaundice, feeling of weakness or general malaise, and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Femoston should be discontinued and you should contact your doctor immediately;
• gallbladder disease;
• breast swelling (edema);
• premenstrual syndrome;
• weight loss.

Rare (may affect up to 1 in 1000 women):

• heart attack;
• swelling of tissues in the face and neck causing breathing difficulties (angioedema);
• purple skin spots and lesions (purpura).

Other adverse effects reported during HRT, including Femoston, with unknown frequency:

• benign or malignant tumours that may be hormone-dependent, such as cancer of the uterine lining (cancer of the endometrium), ovarian cancer (see section 2 for more information);
• increase in size of tumours that may be progestogen-dependent (such as meningioma);
• condition involving destruction of red blood cells (haemolytic anaemia);
• autoimmune disease that may affect multiple organs (systemic lupus erythematosus);
• worsening of epileptic seizures (epilepsy);
• involuntary muscle spasms (chorea);
• arterial blood clots (arterial thrombosis);
• pancreatitis in women with previously elevated levels of certain blood fats (hypertriglyceridaemia);
• various skin disorders: skin pigmentation changes, especially on the face and neck known as "melasma" (chloasma), painful red skin nodules (erythema nodosum), rash in the form of red rings or blisters (erythema multiforme);
• leg cramps;
• urinary incontinence;
• painful/lumpy breasts (fibrocystic breast changes);
• cervical erosion;
• worsening of symptoms of a rare disorder affecting blood pigments (porphyria);
• high levels of certain fats in the blood (hypertriglyceridaemia);
• changes in the cornea of the eye (corneal edema), inability to wear contact lenses (contact lens intolerance);
• increased total concentration of thyroid hormones.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Femoston contains

• The active substances are: estradiol (as estradiol hemihydrate) and dydrogesterone:
  • each brick-red tablet contains 2 mg of estradiol;
  • each yellow tablet contains 2 mg of estradiol and 10 mg of dydrogesterone.
• Other ingredients: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate. Coating: brick-red tablets: titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc; yellow tablets: titanium dioxide (E 171), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc.

What Femoston looks like and contents of the pack

• The coated tablets are round, biconvex, with "379" embossed on one side. Each pack contains 28 tablets.
• Femoston contains tablets in two different colours. Each pack contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the following 14 days of the cycle).
• The tablets are packed in PVC/Al blisters.
• The pack contains 28 coated tablets.

A cardboard sleeve is included with the pack, in which the blister should be placed.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Ireland, the country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock
Dublin, D01 YE64
Ireland
Manufacturer:
Abbott Biologicals BV
Veerweg 12
8121 AA Olst
The Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Irish Marketing Authorisation Number (country of export): PA 22668/014/002
Parallel Import Licence Number: 348/22
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
MON - Monday
TUE - Tuesday
WED - Wednesday
THU - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday