Femoston

Patient information leaflet

Warning! Keep this leaflet. The 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 trade 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, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

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 due to a 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 purposes:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogens produced by a woman's body decreases.
This may lead to symptoms such as hot flushes affecting the face, neck and chest.
Femoston relieves symptoms occurring in postmenopausal women.
Femoston is prescribed when these symptoms significantly interfere with daily life.
Prevention of osteoporosis
Some women after menopause may develop brittle bones (osteoporosis). Please discuss all available treatment options with your doctor.
In cases of increased risk of fractures due to osteoporosis and when the patient cannot take other medications, Femoston may be used to prevent osteoporosis in postmenopausal women.

2. Important information before using Femoston

Medical history and regular check-ups
Hormone replacement therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.
Experience 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 history, including family history. Your doctor may decide to perform additional tests, including breast examination and/or gynecological examination, if considered necessary.
Once you start taking Femoston, you should have 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.
Regular breast screening should be performed according to your doctor's recommendations.

DO NOT take Femoston if any of the following symptoms or medical conditions are present or have occurred in the past. If you are uncertain about any of the conditions listed below, you should contact 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 currently have or your doctor suspects a tumour dependent on estrogens, e.g. cancer of the endometrium (endometrial cancer);
• if you currently have or your doctor suspects 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 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 in the lungs (pulmonary embolism);
• if you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency);
• if you currently have or recently had an arterial disease caused by blood clots, e.g. heart attack, stroke or coronary heart disease;
• if you have liver disease and liver function tests have not returned to normal;
• if you have the rare inherited blood disorder called porphyria;
• if you are allergic (hypersensitive) to estradiol, dydrogesterone or any of the other ingredients of Femoston (listed in section 6).

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

Warnings and precautions
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Femoston. If 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 previous history of abnormal thickening of the endometrium (endometrial hyperplasia);
• risk factors for venous thromboembolism (see "Blood clots in the 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 tumours;
• diabetes;
• gallstones;
• migraine or severe headaches;
• an autoimmune disease affecting multiple organs (systemic lupus erythematosus);
• epilepsy;
• asthma;
• a disease affecting the middle ear and causing hearing loss (otosclerosis);
• very high levels of fats in the blood (triglycerides);
• fluid retention due to heart or kidney problems.

You should stop taking Femoston and contact your doctor immediately if you notice any of the following symptoms while taking 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;
• 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 in the legs, sudden chest pain, difficulty breathing. See "Blood clots in the veins (thrombosis)" for more information.

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. Please consult your doctor.

HRT and cancer

Excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer
Using HRT containing 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 a monthly bleed (so-called withdrawal bleed). However, if in addition to these regular monthly bleeds, unexpected bleeding or spotting occurs that:

• continues for longer than the first 6 months of treatment,
• starts after more than 6 months of taking Femoston,
• continues after stopping Femoston,
  you should contact your doctor as soon as possible.

Breast cancer
Evidence shows that taking combined estrogen-progestogen HRT or estrogen-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 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.

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 combined estrogen-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50 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 combined 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 around the nipple,
  • any visible or palpable lumps.

Ovarian cancer
Ovarian cancer is rare – significantly less common than breast cancer. 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 increases with 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).

Effect of HRT on the heart and circulation

Blood clots in the 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.
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 blood clots in legs, lungs or other organs in close relatives,
• systemic lupus erythematosus,
• cancer.

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

Comparative data
Among women aged 50–60 who do not use HRT, an average of 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 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 use 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. Evidence suggests an increased risk of memory loss in women who start HRT after the age of 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 menstrual period.

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 remedies containing St. John's wort (Hypericum perforatum).

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 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).

Blood tests
Before undergoing blood tests, 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 in whom at least 6 months have passed since the last menstrual period.

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

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

Femoston contains lactose
If you have been previously 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 prescribed by your doctor. If in doubt, 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 hormone replacement therapy (HRT),
• the patient is 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 cycle of a monthly HRT preparation if:

• the patient is switching from HRT administered using a "cyclical" or "sequential" regimen. This regimen involves taking or applying an estrogen-containing tablet or patch during the first part of the cycle, followed by an additional 14 days of taking a tablet or applying a patch containing both an estrogen and a 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 is marked with days of the week to help you remember when to take each tablet.

Dosage

• 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 Femoston is 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 dosing schedule is indicated on the calendar printed on the packaging.

Planned surgery

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

Overdose of Femoston
If a patient (or another person) takes 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. 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 should have been taken, take the next tablet at the usual time—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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 uterine lining (endometrial hyperplasia or cancer of the endometrium),
• ovarian cancer,
• blood clots in the veins of the legs or lungs (venous thromboembolic disease, pulmonary embolism),
• heart diseases,
• 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 occur in more than 1 in 10 women):

• headache;
• 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 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 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 vessels of the legs or lungs (venous thromboembolic disease or pulmonary embolism);
• liver function disorders, sometimes with jaundice, feeling of weakness or general malaise, and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Femoston should be 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 area causing breathing difficulties (angioedema);
• purplish skin spots or rashes (purpura).

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

• benign or malignant tumors that may be estrogen-dependent, such as cancer of the endometrium (cancer of the endometrium), ovarian cancer (see section 2 for more information);
• increase in size of tumors 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 contractions (chorea);
• arterial blood clots (arterial thrombosis);
• pancreatitis in women with previously existing elevated levels of certain fats in the blood (hypertriglyceridemia);
• various skin disorders: skin pigmentation, especially on the face and neck known as "pregnancy mask" (chloasma), 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 disorder 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 reactions
If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions 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) 4921301
Fax: +48 (22) 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.
No special storage precautions are required 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Femoston contains

• The active substances in the medicine are: estradiol (in the form of 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, corn starch, colloidal silicon dioxide, magnesium stearate.
  Coating:
  Brick-red tablets – Opadry OY-6957 pink: titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, polyethylene glycol 400, talc;
  Yellow tablets – Opadry OY-02B22764 yellow: 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 pack contains 28 tablets.
• Femoston contains tablets of two different colours. Each pack contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the following 14 days of the cycle).
• The tablets are packed in PVC/Al blisters.
• The pack contains either 28 coated tablets or 84 coated tablets.

A cardboard sleeve is included with the package, in which the blister should be placed.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
BGP Products LTD
63 Agiou Dimitriou Street
174 56 Alimos
Athens
Greece
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Greece, the country of export: 8565/06-02-2007
10643/18/08-02-2019
Parallel Import Authorisation number: 292/15
Translation of the symbols for days of the week printed next to each tablet on the immediate packaging:
ΔΕΥ – Monday
ΤΡΙ – Tuesday
ΤΕΤ – Wednesday
ΠΕΜ – Thursday
ΠΑΡ – Friday
ΣΑΒ – Saturday
ΚΥΡ – Sunday