Femoston

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Femoston (Femaston)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Femaston are different brand names for the same medicine.
Please read this leaflet carefully before taking this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 low levels of female sex hormones (oestrogens) and who have had at least 6 months 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 helps relieve symptoms occurring after menopause. Femoston is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some women after menopause may develop brittle bones (osteoporosis). All available treatment options should be discussed with the doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women when there is an increased risk of fractures due to osteoporosis and when the patient cannot take other medicines.

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. In cases of premature menopause, the risks associated with HRT may differ. Consult your doctor.
Before starting (or restarting) HRT, your doctor should take a full medical and family history. Your doctor may decide to perform additional tests, including breast examination and/or gynecological examination, if considered necessary.
After starting Femoston, you should attend regular check-ups with your doctor (at least once a year). During these visits, you and your doctor should discuss together the benefits and risks of continuing Femoston treatment.
You should undergo regular breast screening 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 have any doubts about the conditions listed below before taking Femoston, you should contact your doctor.

When not to take Femoston

• if you have or have had breast cancer, or your doctor suspects its presence
• if you have or your doctor suspects the presence of a tumour dependent on estrogens, e.g. cancer of the endometrium (endometrial cancer)
• if you have or your doctor suspects the presence of a tumour dependent on progestogens, e.g. a brain tumour (meningioma)
• if you have unexplained vaginal bleeding
• if you have untreated endometrial hyperplasia (abnormal thickening of the endometrium)
• if you have or have had venous thromboembolism (blood clots in the veins), 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. myocardial infarction, stroke, or coronary heart disease
• if you have or have had 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 occur for the first time while taking 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 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 venous thromboembolism (see "Venous thromboembolism (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 tumours
• diabetes
• gallstones
• migraine or severe headaches
• systemic autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• otosclerosis (a disease affecting the ear's ossicles and causing hearing loss)
• very high levels of blood fats (triglycerides)
• fluid retention due to heart or kidney disorders

You must stop taking Femoston and contact your doctor immediately if you notice any of the following symptoms while using HRT:

• any of the conditions listed under "When not to take Femoston"
• yellowing of the skin or whites of the eyes (jaundice) – may be signs of liver disease
• significant increase in 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
  For more information, see "Venous thromboembolism (thrombosis)".

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

HRT and cancer

Abnormal 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, you will experience monthly 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 HRT or estrogen-only H0RT 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 over time, but may persist for 10 years or longer if HRT was used for more than 5 years.

Comparison
Among women aged 50 to 54 years 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 course of estrogen-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 course of estrogen-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 course of estrogen-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 course of estrogen-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 less common than breast cancer. Using estrogen-only HRT or combined estrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer increases with 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 circulatory system

Venous thromboembolism (thrombosis)
The risk of venous thromboembolism is 1.3 to 3 times higher in women using HRT than in non-users, especially during the first year of treatment.
Venous 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 thromboembolism 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 a prolonged period 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 thromboembolism in a close relative (e.g. in legs, lungs, or other organs)
• systemic lupus erythematosus
• cancer
  Symptoms of venous thromboembolism, see "You must stop taking Femoston 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 thromboembolism over 5 years.
Among women aged 50–60 who use estrogen-progestogen HRT for more than 5 years, 9 to 12 cases per 1000 women will occur (i.e. 5 additional cases).

Heart disease (myocardial infarction)
There is no evidence that HRT prevents heart attacks.
Women over 60 years of age using combined estrogen-progestogen HRT have a slightly higher risk of developing 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 to 60 who do not use HRT, stroke is expected in an average of 8 per 1000 women over 5 years. Among women aged 50 to 60 who use HRT for more than 5 years, 11 cases per 1000 women will occur (i.e. 3 additional cases).

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 is indicated only for women with symptoms of estrogen deficiency in whom at least 6 months have passed since the last menstruation.

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 (e.g. phenobarbital, carbamazepine, phenytoin)
• anti-tuberculosis drugs (e.g. rifampicin, rifabutin)
• drugs used in HIV (AIDS) infection (e.g. nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal remedies containing St John's wort (Hypericum perforatum)

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

• 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.

Tell 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 undergoing a 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 in whom at least 6 months have passed since the last menstruation.

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

Driving and operating machinery
No studies have been conducted on the effect of Femoston on driving or operating machinery. Such effects are 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 taken 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
• switching from another HRT product administered using a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily containing both an estrogen and a progestagen.

Treatment with Femoston may be started immediately after completing a 28-day menstrual cycle if:

• the patient is switching from HRT administered using a "cyclical" or "sequential" regimen. This regimen involves taking or applying an estrogen-only tablet or patch during the first part of the cycle, followed by taking or applying a tablet or patch containing both an estrogen and a progestagen 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 1 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 (the translation of the day-of-the-week symbols next to each tablet on the immediate packaging can be found at the end of this leaflet and on the sachet included in the package).

Dosage

• Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. Consult your doctor if you feel the dose is too strong or too weak.

• If Femoston is being taken 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 the day-of-the-week symbols next to each tablet on the immediate packaging – located 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, "Venous thromboembolism (blood clots in the veins)"). Ask your doctor when you can restart taking Femoston.

Accidental overdose of Femoston
If you (or someone else) take more Femoston tablets than prescribed, it is unlikely to cause harmful effects. Possible 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.

Missed dose of Femoston
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 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, please 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 hormone replacement therapy (HRT) compared to women not using HRT:

• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer of the endometrium)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart disease
• 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 thrush (vaginal infection caused by the fungus 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)
• 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
• hot flushes
• feeling of weakness, fatigue and general malaise
• swelling of the ankles, feet or fingers (peripheral oedema)
• weight gain

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

• growth of pelvic lesions (e.g. fibroids)
• 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 the legs or lungs (venous thromboembolism 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
• 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 area causing breathing difficulties (angioedema)

• purple spots and skin lesions (purpura). Other adverse effects reported during use of HRT, including Femoston, with unknown frequency:

• benign or malignant tumours that may be hormone-dependent, such as cancer of the endometrium (cancer of the endometrium), ovarian cancer (see section 2 for more information)

• increase in size of tumours that may be progestogen-dependent (e.g. meningioma)

• condition involving destruction of red blood cells (haemolytic anaemia)

• autoimmune disease (immunological 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 pre-existing 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 nodules on the skin (nodular erythema), 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 (hypertriglyceridaemia)

• changes in the cornea of the eye (corneal opacity), 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 adverse effects not listed in this leaflet, inform your doctor or pharmacist. 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, Phone: +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 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. Following this advice helps 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 are: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate.
  Coating of the brick-red tablet: titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc.
  Coating of the yellow tablet: 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 blister contains 28 tablets.
• Femoston contains tablets of two different 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).
• The tablets are packed in PVC/Al blisters, placed in a cardboard box. A cardboard sachet is included in the package, in which the blister should be stored.
• The pack contains 28 or 84 coated tablets.

For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, country of export:
BGP PRODUCTS LTD
Agiou Dimitriou 63, 174 56 Alimos, Greece
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12, 8121 AA Olst, Netherlands
Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czesky Tesin
Czech Republic
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Numbers in Greece, country of export: 8565/06-02-2007
10643/18/08-02-2019
Parallel Import Authorisation Number: 163/22
Translation of symbols for days of the week printed next to each tablet on the immediate packaging:
ΔΕY - Monday
ΤΡI - Tuesday
ΤΕΤ - Wednesday
ΠΕΜ - Thursday
ΠΑΡ - Friday
ΣΑΒ - Saturday
ΚΥΡ - Sunday