Femoston

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Femoston (Femoston 2/10)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Femoston 2/10 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, 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 someone else, 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 oestrogen deficiency and who have not had a menstrual period for at least 6 months.
Femoston is used for the following purpose:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogen produced by a woman's body decreases. This may lead to symptoms such as hot flushes affecting the face, neck and chest. Femoston 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). Please discuss all available treatment options with your doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women who have an increased risk of fractures due to osteoporosis and who 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. The risks associated with HRT in cases of premature menopause 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 gynaecological examination, if deemed 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 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, 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 a tumour dependent on oestrogens, e.g. endometrial cancer (cancer of the endometrium)
• if you have or your doctor suspects a tumour dependent on progestogens, e.g. brain tumour (meningioma)
• if you have vaginal bleeding of unknown cause
• if you have untreated abnormal thickening of the lining of the uterus (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 have recently had an arterial disease caused by blood clots, e.g. heart attack, 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 during treatment with 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 had any of the conditions listed below, you should have more frequent medical check-ups:

• uterine fibroids
• endometriosis (presence of endometrial tissue outside the uterus) or history of abnormal thickening of the endometrium (endometrial hyperplasia)
• risk factors for blood clots (see "Blood clots in blood vessels (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
• 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.

Stop taking Femoston and contact your doctor immediately if you experience 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
• 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 veins (thrombosis)" for more information.

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

HRT and Cancer

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

Unexpected Bleeding
While taking Femoston, you will experience monthly bleeding (withdrawal bleeding). However, if in addition to regular monthly bleeding, unexpected bleeding or spotting occurs 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 oestrogen-progestogen HRT or oestrogen-only HRT increases the risk of developing breast cancer. The additional risk depends on how long HRT is used. This additional risk becomes apparent after 3 years of HRT 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 per 1,000 women over a 5-year period.
Among women aged 50 who start a 5-year course of oestrogen-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 oestrogen-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 per 1,000 women over a 10-year period.
Among women aged 50 who start a 10-year course of oestrogen-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 oestrogen-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).

• Regularly examine your breasts. Contact your doctor if you notice any changes such as:
  • skin indentation of the breast
  • changes around the nipple
  • any visible or palpable lumps

Ovarian Cancer
Ovarian cancer is rare – significantly rarer than breast cancer. Using oestrogen-only HRT or combined oestrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer 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 2,000 women over a 5-year period. Among women who have used HRT for 5 years, it will occur in about 3 per 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 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 any of the following conditions apply. 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 treatment
• history of blood clots in veins (in legs, lungs, or other organs) in close relatives
• systemic lupus erythematosus
• cancer.

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

Comparative Data
Among women aged 50–60 who do not use HRT, 4 to 7 per 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. 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 oestrogen-progestogen HRT, there is a slightly increased 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.

Comparison
Among women aged 50 to 60 who do not use HRT, stroke will occur in an average of 8 per 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 age 65. Consult your doctor.

Children
Femoston is indicated only for women with symptoms of oestrogen 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 (e.g. phenobarbital, carbamazepine, phenytoin)
• tuberculosis drugs (e.g. rifampicin, rifabutin)
• HIV (AIDS) drugs (e.g. nevirapine, efavirenz, ritonavir, nelfinavir)
• herbal products 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.

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 health 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 can be taken with or without food.

Pregnancy and Breast-feeding
Femoston is indicated only for women with symptoms of oestrogen deficiency in whom at least 6 months have passed since the last menstrual period.

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

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

Femoston contains lactose.
If you have previously been diagnosed with intolerance to certain sugars, 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 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 containing both an estrogen and a progestagen.

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

• the patient is switching from HRT used in a "cyclic" or "sequential" regimen. This regimen involves taking a tablet or applying a patch containing estrogen only during the first part of the cycle, followed by taking a tablet or applying a patch containing both estrogen and 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 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 the tablet.
  Dosage
• Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. If you feel the dose is too strong or too weak, discuss this with your doctor.
• 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 indicated on the calendar provided in 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 the procedure to reduce the risk of blood clots (see section 2 "Blood clots in the veins (venous thrombosis)"). Ask your doctor when you can resume taking Femoston.

Accidental overdose of Femoston

• If you (or someone else) take more Femoston tablets than prescribed, it is unlikely to cause serious harm. Possible symptoms include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually required; however, 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, 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 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 cancer of the endometrium)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart disease
• stroke
• possible memory loss if HRT is started 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):

• headache
• abdominal pain
• back pain
• breast tenderness or pain

Common (may affect up to 1 in 10 women):

• vaginal thrush (vaginal infection caused by fungi called 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 periods, excessive or scanty bleeding
• pelvic pain
• vaginal discharge
• 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):

• fibroid tumours in the pelvis 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 blockage in blood vessels of 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
• gallbladder disease
• breast swelling
• premenstrual syndrome
• weight loss

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

• heart attack
• swelling of tissues in the face and neck causing breathing difficulties (angioedema)
• purplish spots and patches on the skin (purpura)

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

• benign or malignant tumours which may be hormone-dependent, such as cancer of the lining of the womb (cancer of the endometrium), ovarian cancer (for more information see section 2)
• increased size of tumours which may be progestogen-dependent (such as meningioma)
• disease involving destruction of red blood cells (haemolytic anaemia)
• autoimmune disease (immunological disease) which may affect multiple organs (systemic lupus erythematosus)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle jerks (chorea)
• arterial blood clots (arterial thrombosis)
• pancreatitis in women with previously existing high levels of certain fats in the blood (hypertriglyceridaemia)
• various skin disorders: skin pigmentation, especially on the face and neck, known as "chloasma", painful red skin nodules (erythema nodosum), rash in the form of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• painful/lumpy breasts (fibrocystic breast changes)
• cervical erosion
• worsening of symptoms of a rare disease affecting blood 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 any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301; Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Femoston

Keep this medicine out of sight and reach of children.
Store below 25°C in the original, tightly closed packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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 components: monohydrate lactose, hypromellose, corn starch, anhydrous colloidal silicon dioxide, magnesium stearate.
  Brick-red tablet: coating: titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc.
  Yellow tablet: coating:
  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 pack contains 28 tablets.
• Femoston contains tablets of two 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).
• PVC/Aluminium blisters in a cardboard box.

For more detailed information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in Portugal, country of export
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 and 7.4
1990-095 Lisbon
Portugal
Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Portugal, country of export: 2587186
2590784 – 84 coated tablets
Parallel Import Authorisation Number: 121/22