Femoston mite

Leaflet accompanying the packaging: patient information

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 you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 lack 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 disrupt daily life.

Prevention of osteoporosis

In some postmenopausal women, bone fragility (osteoporosis) may occur. You should discuss all available treatment methods with your doctor.
In the case of an increased risk of fractures due to osteoporosis, and if 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. You should consult a doctor.
Before starting (or re-starting) HRT, the doctor will conduct a medical interview about the patient and her family. The doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting to take Femoston mite, you should visit your doctor for regular check-ups (at least once a year). During these check-ups, you should discuss with your doctor the benefits and risks associated with continuing to take Femoston mite.
You should have regular breast screening tests in accordance with your doctor's recommendations.
DO NOT TAKE Femoston miteif you have or have had any of the following symptoms or conditions. If you are unsure about any of the following symptoms or conditions before taking Femoston mite, you shouldconsult a doctor.

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 is suspected to be a tumor that grows in response to estrogens, such as endometrial cancer (cancer of the endometrium)
• if there is or is suspected to be a tumor that grows in response to progestogens
• if you have or have ever been diagnosed with 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 endometrialhyperplasia (unusual 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 artery 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, you should stop taking it immediately and consult a doctor.

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 mite. 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 unusual thickening of the uterine lining (endometrialhyperplasia)
• 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
• disease damaging the eardrum and impairing hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• inherited or acquired angioedema.

You should stop taking Femoston mite and consult a doctor immediately,

if you experience 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) - these may be signs of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along with difficulty breathing - these may be signs of angioedema
• significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness)
• migraine headaches that occur for the first time
• pregnancy
• symptoms of blood clots in the blood vessels, such as: painful swelling and redness of the legs, sudden chest pain, difficulty breathing. See "Stop taking Femoston mite and consult a 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. You should consult a doctor.

HRT and cancer

Unusual thickening of the uterine lining (endometrialhyperplasia) and uterine lining cancer (endometrialcancer) are more common in women taking HRT with estrogens alone. 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 taking Femoston mite
• continues after stopping Femoston mite you should consult a doctor as soon as possible.

Breast cancer

Data confirm 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 taking 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).

• You should have regular breast exams. You should consult a doctor if you notice any changes, such as:
• retraction 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 estrogens or a combination of estrogens and progestogens 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 take 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 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.
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 you have any of the following conditions. You should inform your doctor if you have any of the following conditions:

• 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 your close relatives have had blood clots in the veins of the legs, lungs, or other organs
• you have been diagnosed with systemic lupus erythematosus
• you have 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 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).

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 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).

Meningioma

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

Children

Femoston mite is indicated only for women with symptoms of a lack of female sex hormones (estrogens), 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:
• 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, or using glecaprevir/pibrentasvir) may increase liver function test results in the blood in women taking combined hormonal contraceptives containing ethinyl estradiol. Femoston mite contains estradiol instead of ethinyl estradiol. It is not known whether increased liver function test results may occur when taking Femoston mite with this type of combined HCV treatment.

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

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

Therefore, it may be necessary to closely monitor the level of the medicine and adjust the dose of the medicine.
You should tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including those available without a prescription, herbal medicines, or other medicinal products (e.g., dietary supplements). Your doctor will provide you with appropriate instructions.

Blood tests

Before a planned blood test, you should inform 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 a lack of female sex hormones (estrogens), and who have had their last menstrual period at least 6 months ago.

• If pregnancy is detected, you should stop taking Femoston mite and consult a 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.

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

3. How to take Femoston mite

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

When to start taking Femoston mite

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

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

Femoston mite treatment 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 patch containing estrogen alone during the first part of the cycle, and then taking a tablet or patch containing both estrogen and progestogen for the next 14 days.

Taking Femoston mite

• Swallow the tablet and drink water.
• Tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This will help keep a constant amount of medicine in your body. It will also help you remember to take the tablet.
• You should take 1 tablet every day, without interruption between packs. The blister pack is marked with the days of the week to help you remember when to take the tablet.

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary time to treat your symptoms. You should consult a 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 needs. It will depend on your bone mass.
• You should take 1 white tablet every day for the first 14 days, and then 1 gray tablet once a day for the remaining 14 days. The 28-day cycle of taking Femoston mite is indicated on the calendar included in the packaging.

Planned surgery

• In case of planned surgery, you should inform the 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)"). You should ask your doctor when you can restart Femoston mite.

Taking more than the recommended dose of Femoston mite

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

Missing a dose of Femoston mite

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

Stopping Femoston mite treatment

You should not stop taking Femoston mite without consulting a doctor.

• If you have any further doubts about taking this medicine, you should consult a 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 to occur more frequently in women taking HRT than in those not taking it:

• breast cancer
• unusual thickening or cancer of the uterine lining (endometrialhyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart disease
• stroke
• possible memory loss, if HRT is started at an age over 65.

More information on these side effects 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 yeast infection (infection with Candida albicans)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, you should stop taking Femoston mite and consult a doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (flatulence)
• 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):

• growth of uterine fibroids may increase
• 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 that can cause blockages in the lungs or legs (venous thromboembolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or whites of the eyes, you should stop taking Femoston mite 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 tissues in the face and neck, making it difficult to breathe (angioedema). This can cause difficulty breathing
• 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 uterine lining cancer (cancer of the endometrium), ovarian cancer (more information in section 2)
• increased size of tumors that may be dependent on progestogen levels (such as meningioma)
• a disease in which red blood cells are broken down (hemolytic anemia)
• an immune system disease affecting multiple organs (systemic lupus erythematosus)
• increased frequency of epileptic seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, in women with previously elevated levels of certain fats in the blood (hypertriglyceridemia)
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma), painful red skin lumps (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 blood disorder (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• changes in the cornea of the eye (corneal edema), inability to wear contact lenses (intolerance to contact lenses)
• increased total thyroid hormone levels.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this 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 for this medicine.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Femoston 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
• The other ingredients are: lactose monohydrate, hypromellose, cornstarch, colloidal silicon dioxide, magnesium stearate. Coating (white tablets): titanium dioxide (E171), hypromellose, Macrogol 400. Coating (gray tablets): titanium dioxide (E171), iron oxide black (E172), polyvinyl alcohol, Macrogol 3350, talc.

What Femoston mite looks like and contents of the pack

• The tablets are round, biconvex, and have "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 or PVC/PVDC/Al blisters.
• The pack contains 28 film-coated tablets.

Marketing authorization holder

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

Manufacturer

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, Netherlands
To obtain more detailed information, you should contact the local representative of the marketing authorization holder at phone number: 22 307 71 66.

Date of last revision of the leaflet: