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
Estradiolum, Estradiolum + Dydrogesteronum
Please read the entire 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. The medicine may harm another person, even if their symptoms are the same.
• 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

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 deficiency of female sex hormones (oestrogens) and in whom at least 6 months have passed since the last menstrual period.
Femoston is used for the following purpose:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogens produced by a woman's body decreases. This may cause 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 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 risk associated with HRT use may differ in cases of premature menopause. Consult your doctor.
Before starting (or re-introducing) HRT, your doctor should take a full medical history, including family history. Your doctor may decide to carry out additional tests, including breast examination and/or gynaecological 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 the benefits and risks of continuing Femoston treatment.
You should undergo regular breast screening as recommended by your doctor.

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, consult your doctor before taking Femoston.

When not to take Femoston

• if you have been diagnosed with, have had in the past, or your doctor suspects breast cancer
• if you have or your doctor suspects the presence of a tumour dependent on oestrogens, such as cancer of the lining of the womb (cancer of the endometrium)
• if you have or your doctor suspects the presence of a tumour dependent on progestogens, e.g. a brain tumour (meningioma)
• if you have vaginal bleeding of unknown cause
• if you have untreated abnormal thickening of the lining of the womb (endometrial hyperplasia)
• if you 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, protein S or antithrombin deficiency)
• if you have or recently had an arterial disease caused by blood clots, e.g. heart attack, stroke or angina pectoris
• if you have a 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 occur for the first time while taking Femoston, you must stop taking it 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:

• fibroids of the uterus
• presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal thickening of the lining of the womb (endometrial hyperplasia)
• risk factors for developing blood clots (see "Blood clots in veins (thrombosis)")
• increased risk of oestrogen-dependent cancer (e.g. history of breast cancer in close relatives such as mother, sister, grandmother)
• high blood pressure
• liver diseases, such as benign liver tumours
• diabetes
• gallstones
• migraine or severe headaches
• an 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 disorders
• hereditary or acquired angioedema.

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) – 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
• a significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness)
• new-onset migraine headaches
• pregnancy
• symptoms of blood clots such as: painful swelling and redness of 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 for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Using oestrogen-only HRT increases the risk of abnormal thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (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, unexpected bleeding or spotting occurs that:

• continues for longer than 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 hormone replacement therapy (HRT) in the form of oestrogen-progestogen combination or oestrogen alone 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 use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was used for more than 5 years.

Comparative data
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 5-year oestrogen-only HRT, the number of cases will be 16–17 per 1,000 women (i.e. an additional 0 to 3 cases).
Among women aged 50 who start 5-year oestrogen-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e. an additional 4 to 8 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 10-year oestrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. an additional 7 cases).
Among women aged 50 who start 10-year oestrogen-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e. an additional 21 cases).

• You should regularly examine your breasts. 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. 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 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 circulation

Blood clots in veins (thrombosis)
The risk of blood clots in veins 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 you have any of the following conditions. Inform your doctor if any of the following apply to you:

• inability to walk for a prolonged period due to major surgery, injury or illness (see also section 3 "Planned surgery")
• you are significantly overweight (BMI >30 kg/m²)
• you have any blood clotting disorders requiring long-term anticoagulant treatment
• any close relative has ever had blood clots in the legs, lungs or other organs
• you have systemic lupus erythematosus
• you have cancer.

Symptoms of blood clots, 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 out of 1,000 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 1,000 women will occur (i.e. an additional 5 cases).

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, there is a slightly higher tendency to develop heart disease compared to women not using HRT.

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

Comparative data
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 the age of 65. Consult your doctor for advice.

Children
Femoston is indicated only for women with symptoms of oestrogen 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, which may cause 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 drugs (such as: rifampicin, rifabutin)
• drugs used in HIV (AIDS) infection (such as: 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 the frequency of seizures
• combination treatment regimens for hepatitis C virus (HCV) infection (e.g. using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir regimens) 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 not known whether elevated AlAT liver enzyme activity may occur when Femoston is used concurrently with such combination HCV treatment regimens.

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, careful monitoring of drug levels may be necessary for a period of time, and dosage 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 can be taken with or without food.

Pregnancy and breastfeeding
Femoston 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 taking Femoston and contact your doctor.

Driving and using machines
No studies on the effect of Femoston on driving and using machines 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 Femoston.

3. How to use Femoston

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
When to start using 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 hormone replacement therapy (HRT), or
• 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 oestrogen and a progestagen.

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

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

How to take 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 displays days of the week to help you remember when to take each tablet.

(Translation of the day-of-the-week symbols marked 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 necessary duration to treat your symptoms. Consult your doctor if the dose seems 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 day-of-the-week symbols 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 venous thromboembolism (see section 2, "Blood clots in the veins (venous thromboembolism)"). Ask your doctor when you can resume taking Femoston.

If you take more Femoston than prescribed

If you (or someone else) take more Femoston tablets than recommended, 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. No additional treatment is usually required, but if in doubt, consult your doctor.

If you forget to take 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 forgotten tablet. Breakthrough bleeding or spotting may occur.

Stopping Femoston

Do not stop taking Femoston without consulting your doctor.

• If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 womb lining (endometrial hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the veins of 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 occur in more than 1 in 10 women):

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

Common (may occur in 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 immediately and you should contact your doctor without delay
• 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
• hot flushes
• feeling of weakness, fatigue, and general malaise
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain.

Uncommon (may occur in 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 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 stopped immediately and you should contact your doctor without delay
• gallbladder diseases
• breast swelling (edema)
• premenstrual syndrome
• weight loss.

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

• myocardial infarction
• swelling of tissues in the face and neck causing breathing difficulties (angioedema)
• purplish skin spots and lesions (purpura).

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

• benign or malignant tumours that may be hormone-dependent, such as endometrial cancer (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 (hemolytic anemia)
• autoimmune disease which 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 existing elevated levels of certain blood fats (hypertriglyceridemia)
• various skin disorders: skin pigmentation changes, especially on the face and neck known as "melasma", painful red skin nodules (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 pigments (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 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 conditions are required.
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 should 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 are: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate.
  Coating Opadry OY-6957 pink (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.
  Coating Opadry OY-02B2264 yellow (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 blister contains 28 tablets.
• Femoston contains tablets in 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. A cardboard sachet 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 responsible party or the parallel importer.
Marketing Authorisation Holder in Austria, the country of export:
Theramex Ireland Limited
3rd Floor Spencer Dock Kilmore House Park Lane -
D01 YE64 Dublin 1
Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The 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 Austria, the country of export: 1-21632
Parallel Import Authorisation Number: 354/24

Translation of the symbols for days of the week printed next to each tablet in the immediate packaging:
MO – Monday
DI – Tuesday
MI – Wednesday
DO – Thursday
FR – Friday
SA – Saturday
SO – Sunday