Femoston

Leaflet accompanying the packaging: patient information

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

Femoston (Фемостон)

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston and Фемостон are the same trade names for the same drug written in Polish and Bulgarian.

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 packaging 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 female sex hormone (estrogen) deficiency and who have had their last menstrual period at least 6 months ago.

Femoston is used for the following purpose:

Treatment of postmenopausal 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 postmenopausal women. Femoston is prescribed if these symptoms significantly interfere with daily life.

Prevention of osteoporosis

In some postmenopausal women, bone fragility (osteoporosis) may occur. You should discuss all available treatment methods with your doctor.
In the case of increased risk of fractures due to osteoporosis and when the patient cannot take other medicines, Femoston can be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

Taking HRT involves risks that need to 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 taking HRT may be different. You should consult a doctor.
Before starting (or re-introducing) HRT, the doctor should conduct a medical interview with the patient, including a family medical history. The doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston, you should visit your doctor for regular check-ups (at least once a year). During these check-ups, you should discuss the benefits and risks associated with continuing to take Femoston with your doctor.
You should have regular breast screening tests as recommended by your doctor.
DO NOT TAKE FEMOSTONif you have or have had any of the following symptoms or medical conditions. If you are unsure about any of the following symptoms or medical conditions before taking Femoston, you should 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 the presence of a tumor whose growth is dependent on estrogen, such as endometrial cancer (endometrium cancer)
• if there is or the doctor suspects the presence of a tumor whose growth is dependent on progestogens, such as a brain tumor (meningioma)
• if there is vaginal bleeding 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 in the legs (deep vein thrombosis) or lungs (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 blood clot-related disease, 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, you should stop taking it and consult a doctor immediately.

Warnings and precautions

Before starting treatment, you should inform your doctor if you have ever had any of the following problems, as they may recur or worsen while taking Femoston. If you have ever had any of the following problems, you should have more frequent medical check-ups:

• 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 affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• ear 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
• inherited and acquired angioedema.

YOU SHOULD STOP TAKING FEMOSTON AND CONSULT A DOCTOR IMMEDIATELYif you experience 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) - these may be signs of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, in combination with difficulty breathing - these may be signs of angioedema
• 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. See "Stop taking Femoston and consult a doctor immediately".

NOTE:Femoston does not have a contraceptive effect. If it has been less than 12 months since your last menstrual period and you are under 50 years old, you may need to use additional contraception to prevent pregnancy. You should consult a doctor.

HRT and cancer

Excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer (endometrial cancer) are more common in women taking HRT with estrogen alone.
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

While taking Femoston, you will experience monthly bleeding (so-called withdrawal bleeding). However, if you experience unexpected bleeding or spotting that:

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

Breast cancer

Data confirms that taking HRT in the form of combined estrogen and progestogen, or estrogen alone, increases the risk of breast cancer. The additional risk depends on how long the patient takes HRT. 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 to 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 to 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 to 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).

• YOU SHOULD REGULARLY EXAMINE YOUR BREASTS. YOU SHOULD CONSULT A DOCTOR IF YOU NOTICE ANY CHANGES, 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 includes only 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 circulation

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. You should inform your doctor if you have any of the following conditions:

• inability to walk for an extended period due to major surgery, injury, or illness (see also section 3 "Planned surgery")
• the patient has significant obesity (BMI >30 kg/m)
• there are 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, lungs, or other organs
• the patient has been diagnosed with systemic lupus erythematosus
• the patient has been diagnosed with cancer.

Symptoms of blood clots, see "Stop taking Femoston and consult a doctor immediately".
Comparison
In women aged 50-60 who do not take HRT, blood clots in the veins will occur in approximately 4 to 7 out of 1000 women over a 5-year period.
In women aged 50-60 who take combined estrogen-progestogen HRT for more than 5 years, there will be 9 to 12 cases 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 women 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 in approximately 8 out of 1000 women over a 5-year period. In women aged 50-60 who take HRT for more than 5 years, there will be 11 cases out of 1000 women (i.e., 3 additional cases).

Other conditions

HRT does not prevent memory loss. There is evidence of increased risk of memory loss in women who start HRT at an age over 65. You should consult a doctor.

Children

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

Femoston and other medicines

Certain 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) HRT may affect the action of other medicines:
• medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures
• treatment regimen for combined hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and a treatment regimen using glecaprevir/pibrentasvir) may increase liver function test parameters in the blood (increased ALT enzyme activity) in women taking combined hormonal contraceptives containing ethinyl estradiol. Femoston contains estradiol instead of ethinyl estradiol. It is not known whether increased ALT enzyme activity may occur when taking Femoston with such a treatment regimen. The doctor will provide appropriate guidance.

While taking Femoston, the following medicines may have dangerously high blood levels:

• tacrolimus, cyclosporin - used, for example, after organ transplantation
• fentanyl - a pain reliever
• theophylline - used in asthma and other breathing problems.

Therefore, it may be necessary to carefully monitor the level of the medicine and it may be necessary to reduce the dose of the medicine for a while.
You should tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including those available without a prescription, herbal medicines, or other natural remedies (e.g., dietary supplements). The doctor will provide appropriate guidance.

Blood tests

Before a planned blood test, you should inform your doctor or laboratory staff that you are taking Femoston, 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 female sex hormone (estrogen) deficiency, who have had their last menstrual period at least 6 months ago.

• In case of pregnancy, you should stop taking Femoston and consult a doctor.

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 you have been diagnosed with intolerance to some sugars, you should consult a doctor before taking Femoston.

3. How to take Femoston

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

When to start taking Femoston

You should not start Femoston before at least 6 months have passed since your last natural menstrual period.
Treatment with Femoston can be started on any day if:

• you are not currently taking HRT
• you are changing from another HRT medicine to continuous combined HRT. This method involves taking a tablet or applying a patch containing both estrogen and progestogen every day.

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

• you are changing from cyclic or sequential HRT. This method involves taking a tablet or applying a patch containing estrogen for the first part of the cycle, and then taking a tablet or applying a patch containing estrogen and progestogen for the next 14 days.

Taking Femoston

• Swallow the tablet and drink water.
• Tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This will ensure that there is a constant amount of medicine in your body. This will also help you remember to take the tablet.

tabletki.

• You should take 1 tablet every day, without interruption between packs. The blister pack is marked with the days of the week to help you 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

• Your doctor will prescribe the smallest effective dose for the shortest necessary time to treat your symptoms. You should consult your doctor if the dose seems too strong or too weak for you.
• When taking Femoston to prevent osteoporosis, your doctor will adjust the dose individually according to your needs. It will depend on your bone mass.
• You should take one brick-red tablet every day for the first 14 days, and then one 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, you should inform the surgeon that you are taking Femoston. It may be necessary to stop taking Femoston for about 4 to 6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (thrombosis)"). You should ask your doctor when you can restart taking Femoston.

Taking more Femoston than prescribed

If you (or someone else) take too many Femoston tablets, it is unlikely to cause harm. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding. No additional treatment is necessary, but if you are unsure, you should consult a doctor.

Missing a dose of Femoston

You should take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been taken, you should take the next tablet at the scheduled time without taking the missed tablet. You should not take a double dose to make up for the missed dose. You may experience bleeding or spotting.

Stopping Femoston

You should not stop taking Femoston without consulting your doctor.

• IF YOU HAVE ANY FURTHER DOUBTS ABOUT THIS MEDICINE, YOU SHOULD 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 women not taking HRT:

• breast cancer
• abnormal thickening or cancer of the endometrium (endometrial hyperplasia or cancer)
• 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 at an age over 65.

More information on these side effects, see section 2.
The following side effects may occur while taking Femoston:

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 albicans fungus)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, you should stop taking Femoston and consult a doctor immediately
• dizziness
• nausea (nausea), vomiting, gas (bloating)
• skin allergic reactions (such as rash, severe itching, hives)
• bleeding disorders, such as irregular bleeding or spotting, painful periods, heavy or light bleeding
• pelvic pain
• discharge
• feeling of weakness, fatigue, and general malaise
• 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 (asthmatic allergic reaction) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• libido changes
• blood clots causing blockages in the veins 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 you experience yellowing of the skin or whites of the eyes, you should stop taking Femoston and consult a doctor immediately
• gallbladder disease
• breast swelling (breast edema)
• premenstrual syndrome
• weight loss.

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

• heart attack
• swelling of the tissues in the face and neck, making it difficult to breathe (angioedema)
• purple spots and patches on the skin (purpura).

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

• benign or malignant tumors that may be dependent on estrogen levels, such as endometrial cancer (endometrial cancer), 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 frequency of epileptic seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, 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 spots" (chloasma), painful red skin lumps (erythema nodosum), rash in the shape 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 the 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 (intolerance to contact lenses)
• increased total thyroid hormone levels.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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. Coating (brick-red tablets): titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, macrogol 400, talc.

Coating (yellow tablets): titanium dioxide (E 171), iron oxide yellow (E 172), hypromellose, macrogol 400, talc.

What Femoston looks like and contents of the pack

• The film-coated tablets are round, biconvex, with "379" embossed 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/PVDC or PVC/Al blisters. The packaging includes a cardboard carton in which the blister pack should be placed.
• The packaging contains 28 or 84 film-coated tablets.

For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Manufacturer:

Abbott Biologicals B.V.
C.J. van Houtenlaan 36
1381 CP Weesp
Netherlands

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:9700102
Parallel import authorization number:428/24
Translation of day symbols on the packaging:
ПОН –Monday
ВТ –Tuesday
CP– Wednesday
ЧЕТ– Thursday
ПЕТ– Friday
СЪБ– Saturday
НЕД –Sunday.

Date of approval of the leaflet: 05.12.2024

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