Femoston mite

Package Leaflet: Information for the Patient

Important: Keep the package leaflet. The information on the immediate packaging is in a foreign language.

Femoston mite

1 mg (white), 1 mg + 10 mg (gray), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 estrogen deficiency, and who have had their last menstrual period at least 6 months ago.

What it is 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 options should be discussed with your doctor.
In cases of increased risk of fractures due to osteoporosis, and when the patient cannot take other medicines, Femoston mite may be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston mite

Medical history and regular check-ups

HRT use carries 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 HRT may be different. Consult your doctor.
Before starting (or re-starting) HRT, your doctor will take your medical history and that of your family. Your doctor may decide to perform additional tests, including breast and/or gynecological examinations, if deemed necessary.
After starting Femoston mite, you should see 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 Femoston mite with your doctor.
Regular breast screening should be performed in accordance with your doctor's recommendations.
DO NOT TAKE Femoston miteif 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 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 your doctor
• if you have or your doctor suspects you have a tumor that grows in response to estrogens, such as endometrial cancer (cancer of the lining of the uterus)
• if you have or your doctor suspects you have a tumor that grows in response to progestogens
• if you have or have had a meningioma (a usually benign tumor of the tissue layer between the brain and the skull)
• if you have vaginal bleeding of unknown cause
• if you have untreated endometrial hyperplasia (thickening of the lining of the uterus)
• if you have or have had blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if you have or have recently had a blood clot-related disease, such as a heart attack, stroke, or coronary heart disease
• if you have or have had liver disease, and liver function tests have not returned to normal
• if you have a rare, inherited blood disorder called porphyria
• if you are 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, stop taking it and consult your doctor immediately.

Warnings and precautions

Before starting treatment, tell your doctor if you have ever had any of the following problems, as they may recur or worsen during treatment. 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 tissue outside the uterus) or a history of endometrial hyperplasia
• blood clot risk factors (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 lupus erythematosus (an immune system disease that affects multiple organs)
• epilepsy
• asthma
• otosclerosis (a disease that affects the bone of the middle ear and can cause hearing loss)
• very high levels of triglycerides in the blood
• fluid retention due to heart or kidney problems
• inherited or acquired angioedema. Stop taking Femoston mite 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 mite"
• jaundice (yellowing of the skin or eyes) - this may be a sign of liver disease
• facial, tongue, or throat swelling, or difficulty swallowing or breathing - this may be a sign 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 veins, such as painful swelling and redness of the legs, sudden chest pain, or difficulty breathing. See "Stop taking Femoston mite and consult your doctor immediately".

Note:Femoston mite 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. Consult your doctor.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer. The progestogen in Femoston mite protects against this additional risk.

Unexpected bleeding

While taking Femoston mite, 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 treatment
• continues after stopping Femoston mite consult your 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 you take HRT. This additional risk becomes apparent after 3 years of HRT use. 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 per 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 per 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 per 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 per 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 per 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 per 1000 patients (i.e., 21 additional cases).

Regular breast examination is necessary. Consult your doctor if you notice any changes, such as:

• skin retraction of the breast
• changes in the nipple area
• any visible or palpable lumps

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking estrogen-only or combined estrogen-progestogen HRT 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 per 2000 women. In women who have taken HRT for 5 years, it will occur in approximately 3 per 2000 women (i.e., approximately 1 additional case).

Effect of HRT on the heart and blood vessels

Blood clots in the veins (thrombosis)

The risk of blood clots in the veins is 1.3-3 times higher in women taking HRT than in those not taking it, especially during the first year of treatment.
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 you have any of the following conditions. Tell your doctor if you have 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 treatment
• any of your close relatives have had blood clots in the veins, lungs, or other organs
• you have systemic lupus erythematosus
• you have cancer.

Symptoms of blood clots, see "Stop taking Femoston mite and consult your doctor immediately".
Comparison data
In women aged 50-60 who do not take HRT, blood clots in the veins will occur in approximately 4-7 per 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 per 1000 women (i.e., 5 additional cases).

Coronary heart 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.
Comparison data
In women aged 50-60 who do not take HRT, stroke will occur in approximately 8 per 1000 women over a 5-year period. In women aged 50-60 who take HRT for more than 5 years, 11 cases will occur per 1000 women (i.e., 3 additional cases).

Meningioma

Taking Femoston mite is associated with the development of usually benign tumors of the tissue layer between the brain and the skull (meningioma). If a meningioma is diagnosed, your doctor will stop Femoston mite treatment (see "When not to take Femoston mite"). If you experience any symptoms such as vision disturbances (e.g., double vision or blurred vision), hearing loss, or ringing in the ears, worsening headaches, memory loss, seizures, or weakness in the arms or legs, you should consult your doctor immediately.

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 your doctor.

Children

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

Femoston mite and other medicines

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

• epilepsy medicines (such as phenobarbital, carbamazepine, phenytoin)
• tuberculosis medicines (such as rifampicin, rifabutin)
• HIV medicines (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal medicines containing St. John's Wort (Hypericum perforatum)

HRT may affect the action of other medicines:

• the epilepsy medicine lamotrigine, as this may increase the frequency of seizures
• the treatment regimen for combined hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and the treatment regimen using glecaprevir/pibrentasvir) may increase liver function test results in the blood in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston mite contains estradiol instead of ethinylestradiol. It is not known whether increased liver function test results may occur when Femoston mite is taken with this type of HCV treatment regimen.

During treatment with Femoston mite, 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.

Therefore, careful monitoring of the medicine level and possible dose reduction of the medicine may be necessary.
Tell your doctor or pharmacist about all other medicines you are taking, including those available without a prescription, herbal medicines, or other natural remedies (e.g., dietary supplements). Your doctor will provide you with appropriate guidance.

Blood tests

Before a blood test, tell your doctor or laboratory staff that you are taking Femoston mite, as this 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 estrogen deficiency, and who have had their last menstrual period at least 6 months ago.

• If pregnancy is suspected, stop taking Femoston mite and consult your doctor. Femoston mite is not indicated during breastfeeding.

Driving and using machines

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

Femoston mite contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking Femoston mite.

3. How to take Femoston mite

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

When to start taking Femoston mite

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

• you are not currently taking HRT
• you are switching from another HRT product to continuous combined HRT. This method involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

Treatment with Femoston mite 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 that contains estrogen alone for the first part of the cycle, followed by a tablet or patch that contains both estrogen and progestogen for the next 14 days.

How to take Femoston mite

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• Try to take the tablet at the same time every day. This will help keep a constant level of the 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 package leaflet and the package insert).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary period to treat your symptoms. Consult your doctor if the dose seems too strong or too weak for you.
• When taking Femoston mite to prevent osteoporosis, your doctor will adjust the dose individually according to your bone mass.
• Take 1 white tablet every day for the first 14 days, followed by 1 gray tablet every day for the remaining 14 days. The 28-day treatment cycle is indicated on the calendar in the packaging.

Planned surgery

• If you are scheduled for surgery, tell your surgeon that you are taking Femoston mite. It may be necessary to stop taking Femoston mite 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 mite.

Overdose

If you (or someone else) have taken too many Femoston mite tablets, it is unlikely to cause harmful effects. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. No additional treatment is necessary, but if you are concerned, consult your doctor.

Missed dose

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

Stopping treatment

Do not stop taking Femoston mite without consulting your doctor.

• If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

The following side effects may occur 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 candidiasis (vaginal infection with Candida albicans fungus)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, stop taking Femoston mite and consult your 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 asthma (allergic asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• changes in libido
• blood clots in the veins, causing blockages in the legs or lungs (venous thromboembolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or eyes, stop taking Femoston mite and consult your doctor immediately
• gallbladder disease
• breast swelling
• premenstrual syndrome
• weight loss.

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

• heart attack
• angioedema (swelling of the face, tongue, or throat, which can cause difficulty breathing). This can cause difficulty breathing
• purpura (purple spots or patches on the skin).

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

• estrogen-dependent tumors, such as endometrial cancer (cancer of the uterine lining) or ovarian cancer (more information in section 2)
• progestogen-dependent tumors, 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)
• epileptic seizures (worsening of epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis (inflammation of the pancreas), especially in women with high levels of triglycerides in the blood
• 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 or lumps (fibrocystic breast changes)
• cervical erosion
• worsening of porphyria (a rare blood disorder)
• high levels of triglycerides in the blood (hypertriglyceridemia)
• changes in the cornea (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 those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Femoston mite

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Femoston mite contains

• The active substances are estradiol (as 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 anhydrous silica, 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 contents of the pack

• The film-coated tablets are round, biconvex, and marked with "379" 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 pack contains 28 film-coated tablets.
• A cardboard wallet is included with the packaging.

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

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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian marketing authorization number: 1-23189

Parallel import authorization number: 112/25

Translation of day symbols on the packaging:

MO

• Monday DI
• Tuesday MI
• Wednesday DO
• Thursday

FR

• Friday SA
• Saturday SO
• Sunday

Date of revision of the package leaflet: 26.03.2025

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