Femoston mite

Leaflet attached to the packaging: patient information

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

Femoston mite

1 mg (white), 1 mg + 10 mg (gray), film-coated tablets
Estradiol, Estradiol + Dydrogesterone

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 a certain person. It should not be passed 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 mite and what is it used for
• 2. Important information before taking Femoston mite
• 3. How to take Femoston mite
• 4. Possible side effects
• 5. How to store Femoston mite
• 6. Contents of the packaging and other information

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

Femoston mite 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 mite is indicated for use in women who have symptoms of a deficiency of female sex hormones (estrogens), and who have had their last menstrual period at least 6 months ago.

What is it used for

Femoston mite is indicated for:

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 mite reduces these symptoms in postmenopausal women. Femoston mite 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 a doctor.
In the case of an increased risk of fractures due to osteoporosis and when the patient cannot take other medicines, Femoston mite can be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston mite

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. A doctor should be consulted.
Before starting (or re-introducing) HRT, the doctor will conduct a medical history of the patient and their family. The doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston mite, 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 mite should be discussed with the doctor.
Regular breast screening tests should be performed in accordance with the doctor's recommendations.
DO NOT TAKE Femoston miteif 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 mite.

When not to take Femoston mite

• 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 origin
• 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 mite (listed in section 6).

If any of the above conditions occur for the first time while taking Femoston mite, 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 mite. 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 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
• disease damaging the eardrum and impairing hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention in the body due to heart or kidney problems
• hereditary and acquired angioedema.

Stop taking Femoston mite and consult a doctor immediately

if the patient notices any of the following symptoms while taking HRT:

• any of the conditions listed in "When not to take Femoston mite"
• yellowing of the skin or whites of the eyes (jaundice) - may be symptoms of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, in combination with difficulty breathing - may be symptoms 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 in the blood vessels, such as: painful swelling and redness of the legs, sudden chest pain, difficulty breathing. More information, see "Blood clots in veins (thrombosis)".

Warning:Femoston mite 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

Abnormal 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 mite protects against this additional risk.

Unexpected bleeding

While taking Femoston mite, 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 mite
• continues after stopping Femoston mite should consult a doctor as soon as possible.

Breast cancer

Data confirm 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.
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).

• Regular breast exams should be performed. A doctor should be consulted 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 with estrogen alone 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 taking it (i.e., approximately 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in 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. A 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")
• significant obesity (BMI > 30 kg/m)
• blood clotting disorders requiring long-term anticoagulant therapy
• 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 mite and consult a doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in the veins are expected to 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, 9 to 12 cases out of 1000 women will occur (i.e., 5 additional cases).

Coronary artery disease (heart attack)

There is no evidence that HRT prevents heart attacks. In women over 60 taking combined estrogen-progestogen HRT, the risk of heart disease is significantly higher than in women not taking HRT.

Stroke

The risk of stroke is 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 is expected to 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 out of 1000 women will occur (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 mite is indicated only for women with symptoms of a deficiency of female sex hormones (estrogens), and who have had their last menstrual period at least 6 months ago.

Femoston mite and other medicines

Certain medicines may affect the action of Femoston mite. This may cause irregular bleeding. These include:

• seizure medicines (epilepsy) (such as phenobarbital, carbamazepine, phenytoin)
• tuberculosis medicines (such as rifampicin, rifabutin)
• HIV medicines (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:

• seizure medicine (lamotrigine), as it may increase the frequency of seizures
• combined hepatitis C treatment (e.g., ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and glecaprevir/pibrentasvir treatment) 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 hepatitis C treatment.

While taking Femoston mite, potentially hazardous high levels of the following medicines may occur in the blood:

• 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 the medicine level may be necessary for a period, and it may be necessary to reduce the dose of the medicine.
A doctor or pharmacist should be informed about all other medicines currently being 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, the doctor or laboratory staff should be informed about taking Femoston mite, as the medicine may affect the results of some laboratory tests.

Femoston mite with food and drink

Femoston mite can be taken with or without food.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

No studies have been conducted on the effect of Femoston mite on driving and operating machinery. Such an effect is unlikely.

Femoston mite contains lactose monohydrate

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

3. How to take Femoston mite

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

When to start taking Femoston mite

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

• the patient is not currently taking hormone replacement therapy
• the treatment is being changed from another HRT to a continuous combined HRT. This method involves taking a tablet or applying a patch containing both estrogen and progestogen every day.

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

• the patient is changing treatment from a cyclic or sequential HRT. This method involves taking a tablet or applying a patch containing estrogen in 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 mite

• Swallow the tablet and wash it down with water.
• Tablets can be taken with or without food.
• An effort should be made to take the tablet at the same time every day. This ensures that a constant amount of the medicine is in the body. It also helps to remember to take the tablet.

One tablet should be taken 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 sachet attached to the packaging).

• The doctor will choose the smallest effective dose to be taken for the shortest necessary time to treat the symptoms. The doctor should be consulted if the dose seems too strong or too weak for the patient.
• When taking Femoston mite to prevent osteoporosis, the doctor will adjust the dose individually according to the patient's needs, depending on their bone mass.
• One white tablet should be taken every day for the first 14 days, and then one gray tablet once a day for the remaining 14 days. The 28-day cycle of taking Femoston mite is marked on the calendar in the packaging.

Planned surgery

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

Taking more Femoston mite than recommended

If the patient (or another person) takes too many Femoston mite tablets, it is unlikely to cause harmful effects. 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.

Missing a dose of Femoston mite

The missed tablet should be taken as soon as possible. If more than 12 hours have passed since the tablet should have been taken, the next tablet should be taken at the scheduled time without taking the missed tablet. A double dose should not be taken to make up for the missed dose. It is likely that missing a dose of Femoston mite may cause bleeding or spotting.

Stopping Femoston mite

Femoston mite should not be stopped without consulting a doctor.

• In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Femoston mite 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 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 the above side effects, see section 2.
The following side effects may occur while taking Femoston mite:

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, Femoston mite should be stopped and a doctor consulted immediately
• dizziness
• nausea (nausea), vomiting, gas (bloating)
• 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 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 (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• libido changes
• blood clots 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, Femoston mite should be stopped and a doctor consulted 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 breathing difficult (angioedema) May cause breathing difficulties.
• purple spots and patches on the skin (purpura).

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

• estrogen-dependent tumors, such as endometrial cancer (endometrial cancer), ovarian cancer (more information, see section 2)
• tumors whose growth is dependent on progestogen levels, 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)
• epilepsy seizures worsen
• 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 nodules (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 disease affecting the blood pigment (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• corneal changes (corneal edema), inability to wear contact lenses (intolerance to contact lenses)
• increased total thyroid hormone levels.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Femoston mite

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
The medicine should not be taken 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. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Femoston mite contains

• The active substances of Femoston mite are: estradiol (in the form of estradiol hemihydrate) and dydrogesterone
• each white tablet contains 1 mg of estradiol
• each gray tablet contains 1 mg of estradiol and 10 mg of dydrogesterone.
• Other ingredients are: lactose monohydrate, hypromellose, cornstarch, colloidal silicon dioxide, magnesium stearate. Coating (white tablets): titanium dioxide (E 171), hypromellose, macrogol. Coating (gray tablets): titanium dioxide (E 171), iron oxide black (E 172), polyvinyl alcohol, macrogol, talc.

What Femoston mite looks like and what the packaging contains

• The film-coated tablets are round, biconvex, with "379" embossed on one side. Each blister pack contains 28 tablets.
• Femoston mite contains tablets in two colors. Each pack contains 14 white tablets (for the first 14 days of the cycle) and 14 gray tablets (for the next 14 days of the cycle).
• The tablets are packaged in PVC-Al blisters in a cardboard box.
• The packaging contains 28 film-coated tablets.
• A cardboard sachet is attached to the packaging, in which the blister pack should be placed.

For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Austria, the country of export:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, country of export:1-23189
Parallel import authorization number:247/24
Translation of day symbols on the packaging:
MO –Monday
DI –Tuesday
MI– Wednesday
DO– Thursday
FR– Friday
SA– Saturday
SO –Sunday.

Date of leaflet approval: 18.06.2024

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