Femoston

Leaflet accompanying the packaging: patient information

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

Femoston(Climaston 2 mg/10 mg)

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets

Estradiol, Estradiol + Dydrogesterone
Femoston and Climaston 2 mg/10 mg 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 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 a lack of female sex hormones (estrogens) 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 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 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 with 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. 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 conditions or diseases listed below, consult a doctorbefore 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 estrogen-dependent tumors are present or suspected, such as endometrial cancer (endometrium cancer)
• if progestogen-dependent tumors are present or suspected, such as brain tumors (meningioma)
• if there is vaginal bleeding of unknown cause
• if there is untreated endometrial hyperplasia (endometrium thickening)
• if blood clots in the veins (thrombosis) have occurred or are occurring
• if there is a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if a blood clot-related disease has occurred, such as a heart attack, stroke, or coronary artery disease
• if liver disease has occurred and liver function tests have not returned to normal
• if a rare, inherited blood disorder called porphyria is present
• 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 while taking Femoston. If any of the following problems have ever occurred, more frequent medical check-ups should be performed:

• uterine fibroids
• endometriosis 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)
• high blood pressure
• liver disease, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• systemic immune 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 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
• 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. A doctor should be consulted.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasia (thickening of the lining of the uterus) 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 consult a doctor as soon as possible.

Breast cancer

Data confirms that taking combined estrogen-progestogen 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 more 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 exams should be performed. Consult a doctor if 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 includes only estrogen or combined 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. The doctor should be informed if the patient has 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/m2);
• there are problems with blood clotting 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 4-7 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 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 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. A doctor should be consulted.

Children

Femoston is indicated only for women with symptoms of a lack of female sex hormones (estrogens), 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). HRT may affect the action of other medicines:
• epilepsy medicine (lamotrigine), as it may increase the frequency of seizures;
• combined treatment for hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and a treatment regimen 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 regimen.

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 and possible dose reduction may be necessary.
Tell your doctor or pharmacist about all other medicines you are currently taking, 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, 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 a lack of female sex hormones (estrogens), who have had their last menstrual period at least 6 months ago.

• If pregnancy is suspected, 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 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 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 the last natural menstrual period.
Treatment with Femoston may be started on any day if:

• the patient is not currently taking hormone replacement therapy,
• the treatment is being switched 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 may be started after completing a 28-day menstrual cycle if:

• the patient is 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 with water.
• Tablets can be taken with or without food.
• Try to take the tablet at the same time every day. This will ensure that a constant amount of the medicine is 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 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 choose 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 for the patient.

In the case of taking Femoston to prevent osteoporosis, the doctor will adjust the dose individually according to the patient's 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, inform the surgeon about 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 taking Femoston.

Taking more Femoston than prescribed

If the patient (or someone else) takes 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 in doubt, 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 a doctor.

If you have any further questions about the use of 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 lining of the uterus (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 about these side effects can be found in 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 with Candida albicans fungus)
• 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 (asthmatic allergic reaction) 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 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 and patches on the skin (purpura).

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

• benign or malignant tumors that may be dependent on estrogen levels, such as endometrial cancer (endometrium cancer)
• 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)
• seizure frequency may increase (epilepsy)
• 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
• breast pain/lumps (fibrocystic breast changes)
• cervical erosion
• worsening of symptoms of a rare genetic disorder affecting the blood pigment (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• changes in the cornea of the eye (corneal degeneration), inability to wear contact lenses (intolerance to contact lenses)
• increased total thyroid hormone levels.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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

Keep the medicine out of sight and reach of children.
No special storage precautions are necessary.
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 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 tablet):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 tablet):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/Aluminum blisters in a cardboard box.
• The packaging contains 28 or 84 film-coated tablets.

A cardboard insert is included with the packaging, which should be placed in the blister pack.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin, D01YE64
Ireland

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, Netherlands

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Marketing authorization number in France, the country of export:3400934385247

Parallel import authorization number: 415/24

Translation of the day symbols on the packaging:
LUN– Monday
MAR– Tuesday
MER– Wednesday
JEU– Thursday
VEN– Friday
SAM– Saturday
DIM– Sunday.

Date of approval of the leaflet: 22.11.2024

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