Femoston

Leaflet attached to the packaging: patient information

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

Femoston(Femoston 2/10)
2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Femoston 2/10 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 necessary.
• 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 their illness 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. All available treatment methods should be discussed with the doctor.
In the case of an 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. Consult a doctor.
Before starting (or re-introducing) 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 the 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 you have or have had any of the following conditions or symptoms. If you are unsure about any of the conditions or symptoms listed below, consult your doctor before taking Femoston.

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 is suspected to be a tumor that grows in response to estrogens, such as endometrial cancer (cancer of the lining of the uterus)
• if there is or is suspected to be a tumor that grows in response to progestogens, such as a brain tumor (meningioma)
• if there is vaginal bleeding of unknown cause
• if there is untreated endometrial hyperplasia (thickening of the lining of the uterus)
• if there are or have been 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 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 (growth of uterine lining outside the uterus) or a history of 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 due to heart or kidney problems
• inherited or acquired angioedema.

STOP TAKING FEMOSTON AND CONSULT YOUR 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) - may be signs of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along with difficulty breathing - 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 "Blood clots in the veins (thrombosis)" for more information.

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. Consult a doctor.

HRT and cancer

Excessive thickening of the uterine lining (endometrial hyperplasia) and uterine lining cancer (endometrial cancer)

Taking HRT with only estrogens increases the risk of endometrial hyperplasia and endometrial cancer.
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

While taking Femoston, 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 taking Femoston
• continues after stopping Femoston you should consult your doctor as soon as possible.

Breast cancer

Data confirms that taking combined estrogen and progestogen HRT or estrogen-only HRT 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.
Comparative data
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 exams should be performed. Consult your 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 with only estrogens or combined estrogen and progestogen increases the risk of ovarian cancer slightly.
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. Inform your doctor if you have any of the following:

• inability to walk for an extended 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 close relatives have had blood clots in the veins of the legs, lungs, or other organs
• the patient has systemic lupus erythematosus
• the patient has cancer.

Symptoms of blood clots, see "Stop taking Femoston and consult your doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in the veins will occur in approximately 4-7 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, 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 taking combined estrogen-progestogen HRT, there is a slightly increased risk of 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.
Comparative data
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, 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. 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

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 for HIV infection (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal medicines containing St. John's Wort (Hypericum perforatum)
• combined treatment for hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and using glecaprevir/pibrentasvir) may increase liver function test results 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 this type of combined HCV treatment. 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, careful monitoring of the medicine level may be necessary for a while, and it may be necessary to reduce the dose of the medicine.
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).

Blood tests

Before a planned blood test, 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.

• If pregnancy is detected, stop taking Femoston and consult a doctor.

Driving and using machines

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

Femoston contains lactose monohydrate.

If you have been diagnosed with intolerance to some sugars, you should consult your 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

Do 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 hormone replacement therapy
• you are switching from another HRT medication 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 switching from cyclic or sequential HRT. This method involves taking a tablet or applying a patch containing estrogen for the first part of the cycle, followed by a tablet or 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.
• Try to take the tablet at the same time every day. This will keep a steady amount of medicine in your body. It will also help you remember to take the tablet.
• 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 included with the packaging).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary time to treat your symptoms. 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 bone mass.
• Take 1 brick-red tablet every day for the first 14 days, and then 1 yellow tablet every 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).

Planned surgery

• In case of planned surgery, inform the surgeon that you are taking Femoston. 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 your doctor when you can restart Femoston.

Taking more Femoston than prescribed

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

Missing a 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 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 Femoston

Do not stop taking Femoston without consulting your doctor.

• If you have any further questions about the use of this medicine, ask your 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 than in those not taking HRT:

• breast cancer
• abnormal thickening or cancer of the uterine lining (endometrial hyperplasia or 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.

For 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 yeast infection (infection with Candida albicans)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, stop taking Femoston and consult your doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• allergic skin 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 weak, tired, and unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain.

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

• growth of uterine fibroids
• allergic reactions, such as difficulty breathing (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• changes in libido
• blood clots causing blockages in the veins of the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or whites of the eyes, stop taking Femoston and consult your 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 and patches on the skin (purpura).

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

• benign or malignant tumors that may be estrogen-dependent, such as endometrial cancer (endometrial cancer), ovarian cancer (more information in section 2)
• increased size of tumors that may be progestogen-dependent (such as meningioma)
• a disease in which red blood cells are broken down (hemolytic anemia)
• an immune system disease affecting multiple organs (systemic lupus erythematosus)
• seizure worsening (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, especially in women with high triglyceride levels
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy spots" (chloasma), painful red lumps on the skin (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• breast pain or lumps (fibrocystic breast changes)
• cervical erosion
• worsening of porphyria symptoms
• high levels of certain fats in the blood (hypertriglyceridemia)
• corneal changes, inability to wear contact lenses (intolerance to contact lenses)
• increased total thyroid hormone levels.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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

Keep the medicine out of sight and reach of children.
Store in a temperature below 30°C, in the original packaging.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines. 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. Pink Opadry OY-6957 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. Yellow Opadry OY-02B2264 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

pack contains 28 tablets.

• Femoston contains tablets in two colors. Each 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 blisters. The packaging includes an insert to be placed in the blister.
• The pack contains 28 or 84 film-coated tablets.

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

Marketing authorization holder in Romania, the country of export:

Mylan Healthcare B.V.
Krijgsman 20
1186 DM Amstelveen
Netherlands

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
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 Romania, the country of export:6468/2006/01
6468/2006/02
Parallel import authorization number:80/18
Translation of day symbols on the packaging:
Luni –Monday
Mar –Tuesday
Mie– Wednesday
Joi– Thursday
Vin– Friday
Sâm– Saturday
Dum –Sunday.
Date of leaflet approval: 23.02.2023
[Information about the trademark]