Femoston mite

Leaflet accompanying the packaging: patient information

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

Femoston mite (Climaston 1 mg/10 mg)

1 mg (white), 1 mg + 10 mg (gray), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston mite and Climaston 1 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 for a specific person. Do not pass it 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 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 symptoms occurring after menopause

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. You should discuss all available treatment methods with your doctor.
In cases of 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. You should consult a doctor.
Before starting (or re-introducing) HRT, the doctor will take 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, you should visit 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 to take Femoston mite with your doctor.
You should have regular breast screening tests as recommended by your doctor.
DO NOT TAKE FEMOSTON MITEif you have or have had any of the following symptoms or medical conditions. If you are unsure about any of the following symptoms or medical conditions before taking Femoston mite, you should contact your 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 lining of the uterus)
• if there is or is suspected to be a tumor that grows in response to progestogens, such as a brain tumor (meningioma)
• if there is vaginal bleeding of unknown cause
• if there is untreated abnormal thickening of the lining of the uterus (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 blood clot-related disease, such as a heart attack, stroke, or coronary artery disease
• if there is or has been liver disease, and liver function tests have not returned to normal
• if there is a rare, inherited blood disorder called porphyria
• if the patient is allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston 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 or a history of abnormal thickening of the lining of the uterus (endometrial hyperplasia)
• risk factors for blood clots (see "Blood clots in the veins (thrombosis)")
• increased risk of estrogen-dependent cancer (family history of breast cancer in mother, sister, grandmother)

and

• high blood pressure
• liver disease, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• an immune system disease that affects many organs (systemic lupus erythematosus)
• epilepsy
• asthma
• a 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 and acquired angioedema.

You should stop taking Femoston mite and contact your 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) - this may be a sign of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, in combination with difficulty 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 blood vessels, such as: painful swelling and redness of the legs, sudden chest pain, difficulty breathing. See "Stop taking Femoston mite and contact your doctor immediately".

Warning: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 your doctor.

HRT and cancer

Abnormal thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (endometrial cancer)

Taking HRT that only contains estrogen increases the risk of abnormal thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (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 in addition to your monthly bleeding, and it:

• lasts longer than the first 6 months of treatment
• starts after 6 months of taking Femoston mite
• continues after stopping Femoston mite you should contact your doctor as soon as possible.

Breast cancer

Data confirms that taking HRT that combines estrogen and progestogen, or estrogen alone, 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 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).

• You should have regular breast exams. You should contact your doctor if you notice any changes, such as:
• indentation of the breast skin
• changes in the nipple area
• any visible or palpable lumps

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that only contains estrogen or combines 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 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")
• severe obesity (BMI >30 kg/m)
• blood clotting disorders that require long-term use of anticoagulant medications
• 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 contact your doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in the veins will occur in approximately 4 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 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 years old who take combined estrogen-progestogen HRT, there is a significantly higher risk of heart disease than in women who do not take 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 cases of stroke due to HRT increases with age.
Comparative data
In women aged 50-60 who do not take HRT, stroke will occur in approximately 8 out of 1000 women over a 5-year period. In women aged 50-60 who take HRT for more than 5 years, 11 cases will occur out of 1000 women (i.e., 3 additional cases).

Other conditions

HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT at an age over 65. You should consult your 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:

• 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:

• an antiepileptic medicine (lamotrigine), as it may increase the frequency of seizures
• a treatment regimen for combined hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with dasabuvir 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 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.

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.
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 natural remedies (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 suspected, you should stop taking Femoston mite and contact your doctor.

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, you should contact your 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 your doctor or pharmacist.

When to start taking Femoston mite

You should not start taking 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 hormone replacement therapy
• you are changing from another HRT medicine 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 changing from a cyclic or sequential HRT regimen. This method involves taking a tablet or applying a patch that contains estrogen only during the first part of the cycle, and then taking a tablet or applying a patch that contains both estrogen and progestogen for the next 14 days.

Taking Femoston mite

• Swallow the tablet with water.
• The 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 level of the 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 (translation of the day symbols on the packaging is at the end of the leaflet and on the sachet attached to the packaging).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary period to treat your symptoms. You should 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 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 every day for the remaining 14 days. The 28-day treatment cycle 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 to 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 start taking Femoston mite again.

Taking more Femoston mite than prescribed

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 your 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 you should have taken the tablet, 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

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

• If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

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 it:

• 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 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 albicansfungus)
• depression, nervousness
• migraine. If you experience migraine headaches for the first time, you should stop taking Femoston mite and contact your doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• skin allergic 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 shortness of breath (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• change in libido
• blood clots that cause blockages in the blood vessels of the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or whites of the eyes, you should stop taking Femoston mite and contact your doctor 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 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 treatment with HRT, including Femoston mite, with an unknown frequency:

• hormone-dependent tumors, such as cancer of the lining of the uterus (endometrial cancer), ovarian cancer (more information in section 2)
• growth of tumors that are 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 many 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 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 that affects the blood pigment (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 levels of thyroid hormones.

Reporting side effects

If you experience any side effects, including any side effects 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 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide 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.
Do not take 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. 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.
• 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, 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 pack contains 28 film-coated tablets.
• A cardboard sachet is attached to the packaging, which should contain the blister pack.

For more detailed information, you should contact the marketing authorization holder or the 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 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:3400935264350
Parallel import authorization number:431/24
Translation of the day symbols on the packaging:
LUN –Monday
MAR –Tuesday
MER– Wednesday
JEU– Thursday
VEN– Friday
SAM– Saturday
DIM –Sunday.

Date of leaflet approval: 06.12.2024

[Information about the trademark]