Femoston

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Femoston (Femaston)

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston and Femaston are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Femoston and what is it 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 is Femoston and what is it used for

Femoston is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen called estradiol and a progestogen called dydrogesterone.
Femoston is indicated for use in women who have symptoms of estrogen deficiency and who have had their last menstrual period at least 6 months ago.

Femoston is used for the following purpose:

Treatment of post-menopausal symptoms

During menopause, the amount of estrogen produced in a woman's body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest. Femoston alleviates symptoms in post-menopausal women. Femoston is prescribed if these symptoms significantly interfere with daily life.

Prevention of osteoporosis

In some post-menopausal women, bone fragility (osteoporosis) may occur. All available treatment options should be discussed with a 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 post-menopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

HRT use involves risks that should be considered when deciding to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or after ovarian surgery) is limited. In the case of premature menopause, the risk of HRT may be different. A doctor should be consulted.
Before starting (or re-starting) HRT, the doctor should conduct a medical history with the patient, including a family history. The doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston, regular check-ups with a doctor should be scheduled (at least once a year). During these check-ups, the benefits and risks associated with continuing Femoston should be discussed with the doctor.
Regular breast screening should be performed in accordance with the doctor's recommendations.
DO NOT TAKE FEMOSTONif any of the following conditions or diseases have occurred or are occurring. In case of doubts about the following conditions or diseases before taking Femoston, consult a doctor.

When not to take Femoston

• if breast cancer has been diagnosed, has occurred in the past, or is suspected by the doctor
• if there is or the doctor suspects a tumor whose growth is dependent on estrogen, such as endometrial cancer (cancer of the endometrium)
• if there is or the doctor suspects a tumor whose growth is dependent on progestogens, such as a brain tumor (meningioma)
• if there is bleeding from the genital tract of unknown cause
• if there is untreated abnormal thickening of the endometrium (endometrial hyperplasia)
• if there have been or are blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism
• if there is a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if there is or has recently been a disease caused by blood clots in the arteries, such as a heart attack, stroke, or coronary artery disease
• if there is or has been liver disease, and liver function tests have not returned to normal
• if there is a rare, inherited blood disorder called porphyria
• if the patient is 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, the medicine should be stopped immediately and a doctor consulted.

Warnings and precautions

Before starting treatment, the doctor should be informed if the patient has ever had any of the following problems, as they may recur or worsen during Femoston treatment. If any of the following problems have ever occurred, more frequent medical check-ups should be performed:

• uterine fibroids
• endometriosis or a history of abnormal thickening of the endometrium (endometrial hyperplasia)
• risk factors for blood clots (see "Blood clots in the veins (thrombosis)")
• increased risk of estrogen-dependent cancer (family history of breast cancer in mother, sister, grandmother)
• high blood pressure
• liver disease, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• immune system disease that affects multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• disease that damages the eardrum and impairs hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention in the body due to heart or kidney problems. STOP TAKING FEMOSTON AND CONSULT A DOCTOR IMMEDIATELYif the patient experiences any of the following symptoms while taking HRT:
• any of the conditions listed in "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: headaches, fatigue, dizziness)
• migraine headaches that occur for the first time
• pregnancy
• symptoms of blood clots, such as: painful swelling and redness of the legs, sudden chest pain, difficulty breathing. More information, see "Blood clots in the veins (thrombosis)".

NOTE:Femoston does not have a contraceptive effect. If it has been less than 12 months since the last menstrual period and the patient is under 50 years old, additional contraception may be necessary to prevent pregnancy. A doctor should be consulted.

HRT and cancer

Taking HRT that only contains estrogen increases the risk of abnormal thickening of the endometrium (hyperplasia) and endometrial cancer.
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

During Femoston treatment, monthly bleeding (so-called withdrawal bleeding) will occur. However, if unexpected bleeding or spotting occurs, which:

• lasts longer than the first 6 months of treatment
• starts after 6 months of Femoston treatment
• continues after stopping Femoston consult a doctor as soon as possible.

Breast cancer

Data confirm that taking HRT that combines estrogen and progestogen, or only estrogen, increases the risk of breast cancer. The additional risk depends on how long HRT is taken. This additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
Comparison
In women aged 50-54 who do not take HRT, breast cancer will be diagnosed in approximately 13-17 out of 1000 women over a 5-year period.
In women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 out of 1000 patients (i.e., 0-3 additional cases).
In women aged 50 who start 5-year combined estrogen-progestogen HRT, the number of cases will be 21 out of 1000 patients (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer will be diagnosed in approximately 27 out of 1000 women over a 10-year period.
In women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 out of 1000 patients (i.e., 7 additional cases).
In women aged 50 who start 10-year combined estrogen-progestogen HRT, the number of cases will be 48 out of 1000 patients (i.e., 21 additional cases).

• REGULAR BREAST EXAMINATIONS SHOULD BE PERFORMED. CONSULT A DOCTOR IF ANY CHANGES ARE NOTICED, SUCH AS:
• indentation of the breast skin
• changes in the nipple area
• any visible or palpable lumps

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that only contains estrogen or a combination of estrogen and progestogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed over a 5-year period in approximately 2 out of 2000 women.
In women who have taken HRT for 5 years, it will occur in approximately 3 out of 2000 women (i.e., approximately 1 additional case).

Effect of HRT on the heart and blood vessels

Blood clots in the veins (thrombosis)

The risk of blood clots in the veins is 1.3-3 times higher in women taking HRT than in those not taking it, especially during the first year of treatment.
The formation of blood clots can have serious consequences. If they move to the lungs, they can cause chest pain, shortness of breath, fainting, or even death.
The risk of blood clots in the veins increases with age and if the patient has any of the following conditions. The doctor should be informed if the patient has any of the following:

• inability to walk for a long period due to major surgery, injury, or illness (see also section 3 "Planned surgery")
• the patient is significantly overweight (BMI >30 kg/m)
• there are any blood clotting problems that require long-term treatment with anticoagulant medications
• any of the patient's close relatives have had blood clots in the veins of the legs or lungs
• the patient has been diagnosed with systemic lupus erythematosus
• the patient has had cancer. Symptoms of blood clots, see "STOP TAKING FEMOSTON AND CONSULT A DOCTOR IMMEDIATELY". Comparative dataIn women aged 50-60 who do not take HRT, blood clots in the veins will occur over a 5-year period in approximately 4-7 out of 1000 women. In women aged 50-60 who take combined estrogen-progestogen HRT for more than 5 years, 9-12 cases will occur out of 1000 women (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.
In women over 60 years old taking combined estrogen-progestogen HRT, there is a slightly increased tendency to develop heart disease compared to those not taking HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in women taking HRT than in those not taking it.
The number of additional stroke cases due to HRT increases with age.
Comparison
In women aged 50-60 who do not take HRT, stroke will occur over a 5-year period in approximately 8 out of 1000 women. In women aged 50-60 who take HRT for more than 5 years, 11 cases will occur out of 1000 women (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 at an age over 65. A doctor should be consulted.

Children

Femoston is indicated only for women with symptoms of estrogen deficiency, who have had their last menstrual period at least 6 months ago.

Femoston and other medicines

Some medicines may affect the action of Femoston. This may cause irregular bleeding. This applies to the following medicines:

• medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (such as rifampicin, rifabutin)
• medicines used in HIV infection (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal medicines containing St. John's Wort (Hypericum perforatum). During Femoston treatment, potentially hazardous high blood levels of the following medicines may occur:
• tacrolimus, cyclosporin - used, for example, after organ transplantation
• fentanyl - a pain reliever
• theophylline - used in asthma and other breathing problems. For this reason, careful monitoring of drug levels may be necessary for a period, and it may be necessary to reduce the dose of the given medicine.

The doctor or pharmacist should be told about all other medicines currently being taken, including those available without a prescription, herbal medicines, or other natural remedies (e.g., dietary supplements).

Blood tests

Before a planned blood test, the doctor or laboratory staff should be informed about Femoston treatment, as this medicine may affect the results of some 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, who have had their last menstrual period at least 6 months ago.

• In case of pregnancy, Femoston treatment should be stopped and a doctor consulted.

Driving and using machines

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

Femoston contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking Femoston.

3. How to take Femoston

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

When to start taking Femoston

Femoston treatment should not be started before at least 6 months have passed since the last natural menstrual period.
Femoston treatment can be started on any day, if:

• the patient is not currently taking HRT
• the treatment is being switched from another HRT medicine to a continuous combined regimen. This regimen involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

Femoston treatment can be started after completing a 28-day menstrual cycle, if:

• the patient is switching from a cyclic or sequential HRT regimen. This regimen involves taking a tablet or applying a patch that contains estrogen alone during the first part of the cycle, and then taking a tablet or applying a patch that contains both estrogen and progestogen for the next 14 days.

How to take Femoston

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• Try to take the tablet at the same time every day. This will help keep a constant amount of medicine in the body. It will also help remember to take the tablet.
• Take 1 tablet every day, without interruption between packs. The blister pack is marked with symbols for the days of the week to help remember when to take the tablet (translation of the day symbols on the packaging is at the end of the leaflet and on the insert in the packaging).

How much to take

• The doctor will prescribe the smallest effective dose for the shortest necessary time to treat the symptoms. Consult a doctor if the dose seems too strong or too weak.
• In the case of taking Femoston to prevent osteoporosis, the doctor will adjust the dose individually according to the patient's needs, depending on bone mass.
• Take 1 brick-red tablet every day for the first 14 days, and then 1 yellow tablet once a day for the remaining 14 days. The 28-day treatment cycle is shown on the blister pack (see also the translation of the day symbols on the packaging - at the end of the leaflet and on the insert in the packaging).

Planned surgery

• In case of planned surgery, the surgeon should be informed about Femoston treatment. It may be necessary to stop taking Femoston about 4-6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (thrombosis)"). Ask the doctor when it is possible to restart Femoston treatment.

Overdose

If the patient (or another person) takes too many Femoston tablets, it is unlikely to cause harm. Nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding may occur. No additional treatment is necessary, but in case of doubts, a doctor should be consulted.

Missed dose

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 scheduled time without taking the missed tablet. Do not take a double dose to make up for the missed dose. Bleeding or spotting may occur.

Stopping treatment

Do not stop taking Femoston without consulting a doctor.

• IN CASE OF ANY FURTHER DOUBTS ABOUT TAKING THIS MEDICINE, CONSULT A DOCTOR OR PHARMACIST.

4. Possible side effects

Like all medicines, Femoston can cause side effects, although not everybody gets them.
The following diseases have been reported to occur more frequently in women taking HRT compared to those not taking HRT:

• breast cancer
• abnormal thickening or cancer of the endometrium (endometrial hyperplasiaor endometrial cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism or pulmonary embolism)
• heart disease
• stroke
• possible memory loss, if HRT is started at an age over 65. More information on these side effects can be found in section 2.

The following side effects may occur during Femoston treatment:

Very common (may affect more than 1 in 10 people):

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

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

• vaginal thrush (infection of the vagina with Candida albicansfungus)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, stop taking Femoston and consult a doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• allergic skin reactions (such as rash, severe itching, hives)
• bleeding disturbances, such as irregular bleeding or spotting, painful periods, heavy or light bleeding
• pelvic pain
• discharge
• feeling weak, tired, and unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain.

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

• uterine fibroids may increase in size
• allergic reactions, such as shortness of breath (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• changes in libido
• blood clots in the veins, causing blockages in the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If the skin or whites of the eyes turn yellow, stop taking Femoston and consult a doctor immediately
• gallbladder disease
• breast swelling
• premenstrual syndrome
• weight loss.

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

• heart attack
• swelling of the face and neck, making it difficult to breathe (angioedema)
• purple spots or patches on the skin (purpura)
• other side effects reported during HRT treatment, including Femoston, with unknown frequency:
• benign or malignant tumors that may be dependent on estrogen levels, such as endometrial cancer (endometrial cancer) or ovarian cancer (more information in section 2)
• increased size of tumors that may be dependent on progestogen levels (such as meningioma)
• a disease in which red blood cells are broken down (hemolytic anemia)
• an immune system disease that affects multiple organs (systemic lupus erythematosus)
• increased severity of epilepsy (seizures)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, especially in women with previously elevated levels of certain fats in the blood (hypertriglyceridemia)
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma), painful red lumps on the skin (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• painful or lumpy breasts (fibrocystic breast changes)
• cervical erosion
• worsening of symptoms of a rare disease affecting the blood pigment (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• changes in the cornea (corneal edema), inability to wear contact lenses (intolerance to contact lenses)
• increased levels of thyroid hormones.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Femoston

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Femoston contains

• The active substances of Femoston 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, cornstarch, colloidal anhydrous silica, magnesium stearate. The coating of the brick-red tablet contains: titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, macrogol 400, talc. The coating of the yellow tablet contains: titanium dioxide (E 171), iron oxide yellow (E 172), hypromellose, macrogol 400, talc.

What Femoston looks like and contents of the pack

• The tablets are round, biconvex, and marked with "379" on one side. Each blister pack contains 28 tablets.
• Femoston contains tablets in two colors. Each blister pack contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the next 14 days of the cycle).
• The tablets are packaged in PVC/Al foil blisters, in a cardboard box. A cardboard insert is included with the packaging.
• The pack contains 28 or 84 film-coated tablets.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the 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 Czeski Cieszyn
Czech Republic

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Wytwórnia Euceryny Laboratorium Farmaceutyczne 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 authorization numbers in Greece, the country of export: 8565/06-02-2007

10643/18/08-02-2019

Parallel import authorization number: 163/22

Translation of day symbols on the packaging:

ΔΕY - Monday
ΤΡI - Tuesday
ΤΕΤ - Wednesday
ΠΕΜ - Thursday
ΠΑΡ - Friday
ΣΑΒ - Saturday
ΚYΡ- Sunday
Date of leaflet approval: 05.04.2022
[Information about the trademark]