FEMOSTON MITE

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Femoston mite (Femoston 1 mg + 1 mg/10 mg)
1 mg (white), 1 mg + 10 mg (grey), film-coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston mite and Femoston 1 mg + 1 mg/10 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Femoston mite is and what it is used for

Femoston mite 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 mite is indicated for use in women who have symptoms of oestrogen deficiency and who have been postmenopausal for at least 6 months.

What it is used for
Femoston mite is indicated for:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogen produced by a woman's body decreases. This may lead to symptoms such as hot flushes affecting the face, neck, and chest. Femoston mite helps reduce these symptoms in postmenopausal women. Femoston mite 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 your doctor.
Femoston mite may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and who cannot take other medications.

2. Important information before using Femoston mite

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 after surgical removal of ovaries) is limited. The risk of using HRT may differ in cases of premature menopause. Consult your doctor.
Before starting (or restarting) HRT, your doctor will take a detailed medical history, including family history. The doctor may decide to carry out additional tests, including breast examination and/or gynaecological examination, if considered necessary.
After starting Femoston mite, you should attend regular check-ups with your doctor (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing treatment with Femoston mite.
Regular breast screening should be performed according to your doctor's recommendations.

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

When not to take Femoston mite

• if you have been diagnosed with, have had in the past, or your doctor suspects breast cancer
• if you currently have or your doctor suspects the presence of a tumour dependent on oestrogens, e.g. endometrial cancer (endometrium cancer)
• if you currently have or your doctor suspects the presence of a tumour dependent on progestogens
• if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the membrane between the brain and the skull)
• if you have vaginal bleeding of unknown cause
• if you have untreated abnormal thickening of the endometrium (endometrial hyperplasia)
• if you currently have or have had blood clots in the veins (venous thromboembolism), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
• if you currently have or have recently had an arterial blood clot disease, e.g. heart attack, stroke, or coronary artery disease
• if you have liver disease and liver function tests 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 mite (listed in section 6).

If any of the above conditions occur for the first time while taking Femoston mite, 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 mite. If you have ever had any of the conditions listed below, you should have more frequent medical check-ups:

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

You must stop taking Femoston mite 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 mite"
• 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, especially with breathing difficulties – these may be symptoms of angioedema
• significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness)
• new-onset migraine headaches
• pregnancy
• symptoms of blood clots in blood vessels, 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 mite does not have contraceptive effects. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, additional contraception may be necessary to prevent pregnancy. Consult your doctor.

HRT and cancer
Abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer
Using oestrogen-only HRT increases the risk of abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. The progestogen contained in Femoston mite protects against this additional risk.

Unexpected bleeding
While taking Femoston mite, you will experience monthly bleeding (so-called withdrawal bleeding). However, if in addition to monthly bleeding you experience unexpected bleeding or spotting that:

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

Breast cancer
Evidence confirms that taking combined oestrogen-progestogen HRT or oestrogen-only HRT increases the risk of developing breast cancer. The additional risk depends on how long HRT is used. This additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT lasted more than 5 years.

Comparison
Among women aged 50 to 54 who do not use HRT, breast cancer will be diagnosed in an average of 13 to 17 per 1000 women over 5 years.
Among women aged 50 who start a 5-year oestrogen-only HRT, the number of cases will be 16–17 per 1000 women (i.e. 0 to 3 additional cases).
Among women aged 50 who start a 5-year combined oestrogen-progestogen HRT, the number of cases will be 21 per 1000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 per 1000 women over 10 years.
Among women aged 50 who start a 10-year oestrogen-only HRT, the number of cases will be 34 per 1000 women (i.e. 7 additional cases).
Among women aged 50 who start a 10-year combined oestrogen-progestogen HRT, the number of cases will be 48 per 1000 women (i.e. 21 additional cases).

• You should 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 – significantly rarer than breast cancer. Using oestrogen-only HRT or combined oestrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 per 2000 women over 5 years. Among women who have used HRT for 5 years, it will occur in about 3 per 2000 women (i.e. about 1 additional case).

Effects of HRT on the heart and circulation
Blood clots in veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women using HRT than in those not using it, especially during the first year of treatment.
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 blood clots increases with age and if any of the following conditions apply to you. Inform your doctor if you have any of the following:

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

Symptoms of blood clots are described under "You must stop taking Femoston mite and contact your doctor immediately".

Comparative data
Among women aged 50–60 who do not use HRT, 4 to 7 per 1000 are expected to develop venous blood clots over 5 years.
Among women aged 50–60 who use combined oestrogen-progestogen HRT for more than 5 years, 9 to 12 cases per 1000 women will occur (i.e. 5 additional cases).

Coronary heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. In women over 60 years of age using combined oestrogen-progestogen HRT, the risk of heart disease is significantly higher than in women not using HRT.

Stroke
The risk of stroke is 1.5 times higher in women using HRT than in those not using it. The number of additional stroke cases due to HRT increases with age.

Comparative data
Among women aged 50–60 who do not use HRT, stroke is expected in an average of 8 per 1000 women over 5 years. Among women aged 50–60 who use HRT for more than 5 years, 11 cases per 1000 women will occur (i.e. 3 additional cases).

Meningioma
Using Femoston mite is associated with the development of a usually benign tumour of the membrane between the brain and the skull (meningioma). If meningioma is diagnosed, your doctor will discontinue treatment with Femoston mite (see section "When not to take Femoston mite"). 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, you should inform your doctor immediately.

Other conditions
HRT does not prevent memory loss. Evidence suggests an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.

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

Femoston mite and other medicines
Some medicines may affect the action of Femoston mite, potentially causing irregular bleeding. These include:

The following medicines may reduce the effectiveness of Femoston mite, leading to bleeding or spotting:

• antiepileptic drugs (epilepsy) (e.g. phenobarbital, carbamazepine, phenytoin)
• tuberculosis medications (e.g. rifampicin, rifabutin)
• HIV (AIDS) medications (e.g. nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal remedies 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 therapy for hepatitis C virus (HCV) infection (e.g. ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir combination) may increase liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol.

Femoston mite contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT liver enzyme activity may occur when Femoston mite is used concurrently with such HCV combination therapies.

During treatment with Femoston mite, 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, careful monitoring of drug levels may be necessary for a period, and dose reduction of the affected medicine 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). Your doctor will provide appropriate advice.

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

Femoston mite with food and drink
Femoston mite may be taken with or without food.

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

• If pregnancy is confirmed, stop using Femoston mite and contact your doctor. Femoston mite is not indicated during breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of Femoston mite on driving or operating machinery. Such effects are unlikely.

Femoston mite 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 mite

This medicine should always be used as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
When to start taking Femoston mite

Do not start treatment with Femoston mite before 6 months have passed since the last natural menstrual period.

Treatment with Femoston mite may be started on any day if:

• the patient is not currently using hormone replacement therapy (HRT)
• switching from another HRT product administered using the "continuous combined" method. This method involves taking a tablet or applying a patch daily containing both an oestrogen and a progestagen.

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

• the patient is switching from HRT administered using the "cyclical" or "sequential" method. This method involves taking a tablet or applying a patch containing oestrogen alone during the first part of the cycle, followed by taking a tablet or applying a patch containing both oestrogen and progestagen for the next 14 days.

How to take Femoston mite

• 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 the body and also 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 the tablet (the translation of the day symbols located next to each tablet on the immediate packaging can be found at the end of the leaflet and on the sachet included in the pack).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. Consult your doctor if the dose seems too strong or too weak.
• When using Femoston mite to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone mass.
• Take one white tablet daily for the first 14 days, followed by one grey tablet once 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 mite. You may need to stop taking Femoston mite approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Venous thromboembolism (blood clots in the veins)"). Ask your doctor when you can resume taking Femoston mite.

Taking more than the recommended dose of Femoston mite
If you (or someone else) take more Femoston mite tablets than recommended, it is unlikely to cause harmful effects. Symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually necessary, but if in doubt, consult a doctor.

Missed dose of Femoston mite
Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been taken, take the next tablet at the usual time without taking the missed tablet. Do not take a double dose to make up for a missed dose. Breakthrough bleeding or spotting may occur if a dose is missed.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 uterine lining (endometrial hyperplasia or cancer of the endometrium)
• ovarian cancer
• blood clots in the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart diseases
• stroke
• possible 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 mite:

Very common (may affect more than 1 in 10 women):

• headache
• 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 mite should be discontinued and you should contact your doctor immediately
• dizziness
• nausea, vomiting, flatulence (bloating)
• skin allergic 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 ankles, feet, or fingers (peripheral edema)
• weight gain

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

• proliferative changes in the pelvis (e.g. fibroids) may increase in size
• 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 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 mite should be discontinued and you should contact your doctor immediately
• gallbladder diseases
• breast swelling (breast 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). May cause breathing difficulties.
• purple spots and skin lesions (purpura).

Other adverse effects reported during HRT use, including Femoston mite, with unknown frequency of occurrence:

• benign or malignant estrogen-dependent tumors, such as cancer of the endometrial lining (endometrial cancer), ovarian cancer (see section 2 for more information)
• increased size of tumors that may be progestogen-dependent (e.g. meningioma)
• disease involving destruction of red blood cells (hemolytic anemia)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle contractions (chorea)
• arterial blood clots (arterial thrombosis)
• pancreatitis in women with previously existing elevated levels of certain blood fats (hypertriglyceridemia)
• various skin disorders: skin discoloration, especially on 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 disease affecting blood pigment (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• 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 any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Femoston mite

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

6. Contents of the pack and other information

What Femoston mite contains

• The active substances are: estradiol (in the form of 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.
• Other ingredients are: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate.
  Coating Opadry Y-1-7000 White (white tablets): titanium dioxide (E 171), hypromellose, polyethylene glycol 400.
  Coating Opadry II Grey 85F27664 (grey tablets): titanium dioxide (E 171), black iron oxide (E 172), polyvinyl alcohol, polyethylene glycol 3350, talc.

What Femoston mite looks like and contents of the pack

• The coated tablets are round, biconvex, with "379" embossed on one side. Each blister contains 28 tablets.
• Femoston mite contains tablets in two colours. 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/Al blisters in a cardboard box.
• The pack contains 28 coated tablets.
• A cardboard wallet is included with the pack, into which the blister should be placed.

For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
MagnaPharm SK s.r.o.
Digital Park III/E, Einsteinova 19
Bratislava - mestská časť Petržalka 851 01
Slovakia
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
Netherlands
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation number in Latvia, country of export: 02-0129
Parallel import authorisation number: 314/23
Translation of the symbols for days of the week printed next to each tablet on the immediate packaging:
P./Pirmd./E – Monday
A./Otrd./T – Tuesday
T./Trešd./K – Wednesday
K./Ceturtd./N – Thursday
Pn./Piektd./R – Friday
Š./Sestd./L – Saturday
S./Svētd./P – Sunday