Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Femoston (Фемостон)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Фемостон are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read the entire 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, 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 identical.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Femoston is and what it is used for
Important information before taking Femoston
How to take Femoston
Possible side effects
How to store Femoston
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 deficiency of female sex hormones (oestrogens) 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 in 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 impair daily life.
Prevention of osteoporosis
Some women after menopause may develop brittle bones (osteoporosis). All available treatment options should be discussed with the doctor.
In cases of increased risk of fractures due to osteoporosis and when the patient cannot take other medicines, 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 with treating women with premature menopause (due to ovarian dysfunction or surgical removal of ovaries) is limited. The risks associated with HRT in cases of premature menopause may differ. Consult your doctor.
Before starting (or re-starting) HRT, your doctor should take a full medical history, including family medical history. Your doctor may decide to perform additional tests, including breast examination 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, you and your doctor should discuss 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 conditions are present or have occurred in the past. If you are uncertain about any of the conditions listed below before taking Femoston, please consult your doctor.

When not to take Femoston

if you have, have had, or your doctor suspects breast cancer
if you have or your doctor suspects a tumor whose growth is dependent on estrogens, e.g., cancer of the endometrium (endometrial cancer)
if you have or your doctor suspects a tumor whose growth is dependent on progestogens, e.g., a brain tumor (meningioma)
if you have vaginal bleeding of unknown cause
if you have untreated abnormal thickening of the endometrium (endometrial hyperplasia)
if you have or have had blood clots in the 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 deficiency, protein S deficiency, 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 a 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 (listed in section 6).

If any of the above conditions occurs for the first time during treatment with Femoston, you must 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 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 a history of abnormal thickening of the endometrium (endometrial hyperplasia)
risk factors for developing 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
a disease affecting the inner ear and causing hearing loss (otosclerosis)
very high levels of fats in the blood (triglycerides)
fluid retention due to heart or kidney problems
hereditary or acquired angioedema.

You must 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, together with breathing difficulties – these may be symptoms of angioedema
significantly increased blood pressure (symptoms may include: headache, 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. Please consult your doctor.

HRT and cancer

Excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer
HRT with estrogens 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, you will experience monthly bleeding (so-called withdrawal bleeding). However, if in addition to regular monthly bleeding, you experience unexpected bleeding or spotting that:

persists beyond the first 6 months of treatment
starts after 6 months of taking Femoston
continues after stopping Femoston

you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking combined estrogen-progestogen hormone replacement therapy (HRT), or estrogen-only HRT, increases the risk of developing breast cancer. The additional risk depends on how long the patient takes HRT. This additional risk becomes apparent after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but the risk 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 out of 1,000 women over a 5-year period.
Among women aged 50 who start a 5-year course of 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 who start a 5-year course of 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 to 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 out of 1,000 women over a 10-year period.
Among women aged 50 who start a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e., 7 additional cases).
Among women aged 50 who start a 10-year course of estrogen-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e., 21 additional cases).

You should examine your breasts regularly. Contact your doctor if you notice any changes such as:
skin indentation of the breast
changes in the nipple area
any visible or palpable lumps

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. The use of estrogen-only HRT or combined estrogen-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 out of 2,000 women over a 5-year period. Among women who have used HRT for 5 years, it will occur in about 3 out of 2,000 women (i.e., about 1 additional case).

Effects 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 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 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 therapy
history of venous blood clots in legs, lungs, or other organs in any close relative
systemic lupus erythematosus
cancer.

Symptoms of venous blood clots are described under "Stop taking Femoston and contact your doctor immediately."

Comparison
Among women aged 50–60 who do not use HRT, 4 to 7 out of 1,000 are expected to develop venous blood clots within 5 years.
Among women aged 50–60 who use combined estrogen-progestogen HRT for more than 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 years of age using combined estrogen-progestogen HRT, there is a slightly increased tendency to develop heart disease compared to women not using HRT.

Stroke
The risk of stroke is approximately 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.

Comparison
Among women aged 50 to 60 who do not use HRT, stroke is expected in an average of 8 out of 1,000 women over 5 years. Among women aged 50 to 60 who use HRT for more than 5 years, 11 cases per 1,000 women will occur (i.e., 3 additional cases).

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

Children
Femoston is indicated only for women with symptoms of estrogen deficiency who have had no menstrual period for at least 6 months.

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

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

antiepileptic drugs (such as: phenobarbital, carbamazepine, phenytoin)
tuberculosis medications (such as: rifampicin, rifabutin)
HIV (AIDS) medications (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., ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir) may increase liver function test parameters in blood (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether elevated AlAT liver enzyme activity may occur when Femoston is used concomitantly with such HCV combination therapies. Your doctor will provide appropriate advice.

During treatment with Femoston, dangerously high blood levels of the following drugs 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 of time, 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 health products (e.g., dietary supplements). Your doctor will provide appropriate advice.

Blood tests
Before any 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 may be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only for women with symptoms of estrogen deficiency who have had no menstrual period for at least 6 months.

If pregnancy is detected, stop taking Femoston and contact your doctor.

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

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

3. How to use Femoston

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
When to start using Femoston
Do not start treatment with Femoston before 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 hormone replacement therapy (HRT)
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 that contains both an estrogen and a progestogen.

Treatment with Femoston may be started the day after completion of a 28-day menstrual cycle 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 estrogen during the first part of the cycle, followed by taking a tablet or applying a patch containing both estrogen and a 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 the body and also helps you remember to take it.
Take one tablet every day without interruption between packs. The blister pack is marked with days of the week to help you remember when to take each tablet (see also the translation of day-of-the-week symbols located next to each tablet on the immediate packaging, provided at the end of the leaflet and on the sachet included in the package).

Dosage

Your doctor will prescribe the lowest effective dose for the shortest necessary duration to treat your symptoms. Consult your doctor if the dose seems too strong or too weak.
If Femoston is being used to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on 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 shown on the blister pack (see also the translation of day-of-the-week symbols located next to each tablet on the immediate packaging, provided at the end of the leaflet and on the sachet included in the package).

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 "Blood clots in veins (venous thromboembolism)"). Ask your doctor when you can resume taking Femoston.

Accidental overdose of Femoston
If a patient (or another person) takes more tablets than recommended, it is unlikely to cause harmful effects. Possible symptoms include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. No additional treatment is usually required; however, if in doubt, consult a doctor.

Missed dose of Femoston
Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet was due, take the next tablet at the usual time and do not take the missed tablet. Do not take a double dose to make up for a missed dose. Breakthrough bleeding or spotting may occur.

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

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

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
The following conditions 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 womb (endometrial hyperplasia or endometrial cancer)
ovarian cancer
blood clots in the veins of the legs or lungs (venous thromboembolic disease, pulmonary embolism)
heart disease
stroke
probable memory loss if HRT is initiated after the age of 65.

For more information on the above adverse reactions, see section 2.
The following adverse reactions 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 (wind)
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
hot flushes
feeling of weakness, fatigue, and general malaise
swelling of ankles, feet, or fingers (peripheral oedema)
weight gain

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

pelvic growths (e.g. fibroids) may increase in size
hypersensitivity reactions, such as shortness of breath (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhoea, or hypotension
change in libido
blood clots causing embolism in blood 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 should be discontinued and you should contact your doctor immediately
gallbladder disease
breast swelling (oedema)
premenstrual syndrome
weight loss

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

myocardial infarction (heart attack)
swelling of tissues in the face and neck causing breathing difficulties (angioedema)
purple skin spots or rashes (purpura).

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

benign or malignant tumours that may be influenced by oestrogen levels, such as cancer of the lining of the womb (endometrial cancer), ovarian cancer (see section 2 for more information)
growth of tumours that may be influenced by progestagen levels (e.g. meningioma)
a condition involving destruction of red blood cells (haemolytic anaemia)
an immune system disorder 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, especially on the face and neck, known as "pregnancy mask" (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 oedema), inability to wear contact lenses (contact lens intolerance)
increased total concentration of thyroid hormones

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

5. How to store Femoston

Keep this medicine out of 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. This will 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, maize starch, colloidal anhydrous silica, magnesium stearate.
Coating (brick-red tablets): titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, polyethylene glycol 400, talc.

Coating (yellow tablets): titanium dioxide (E 171), iron oxide yellow (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 blister contains 28 tablets.
Femoston contains tablets in two colours. Each blister 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).
Tablets are packed in PVC/PVDC or PVC/Al blisters. A cardboard sleeve is included with the package, in which the blister should be placed.
The pack contains 28 or 84 coated tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer:
Abbott Biologicals B.V.
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, country of export: 9700102
Parallel Import Authorisation Number: 428/24

Translation of the symbols for days of the week printed next to each tablet on the immediate packaging:
ПОН – Monday
ВТ – Tuesday
CP – Wednesday
ЧЕТ – Thursday
ПЕТ – Friday
СЪБ – Saturday
НЕД – Sunday