Femoston mini

Leaflet accompanying the packaging: patient information

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

Femoston mini(Femoston conti 0.5 mg/2.5 mg)

0.5 mg + 2.5 mg, coated tablets

Estradiol + Dydrogesterone
Femoston mini and Femoston conti 0.5 mg/2.5 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Femoston mini and what is it used for
• 2. Important information before taking Femoston mini
• 3. How to take Femoston mini
• 4. Possible side effects
• 5. How to store Femoston mini
• 6. Contents of the packaging and other information

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

Femoston mini is a medicine used in hormone replacement therapy (HRT). It contains two types of female hormones: estrogen called estradiol and progestogen called dydrogesterone. Femoston mini is used in postmenopausal women, i.e., women who have not had a period for at least 12 months.

Femoston mini is used to

Relieve symptoms that occur after menopause

During menopause, the level of estrogen produced by the woman's body decreases. This can cause symptoms such as flushing of the face, neck, and chest ("hot flashes"). Taking Femoston mini reduces these symptoms after menopause. The doctor will prescribe Femoston mini only if the symptoms significantly impair the patient's quality of life.

2. Important information before taking Femoston mini

Medical history and periodic check-ups

Taking HRT involves risks that need to be considered before and during treatment.
Experience in treating premature menopause (due to ovarian disorders or surgery) is limited. The risk associated with HRT in premature menopause may be different. You should consult a doctor.
Before starting (or restarting) HRT, the doctor should conduct a medical interview with the patient, including a family medical history.
The doctor may decide to perform additional tests, such as a breast examination and/or an internal organ examination, if necessary.
From the moment Femoston mini is taken, regular check-ups with the doctor should be performed (at least once a year). During these check-ups, the benefits and risks associated with continued treatment with Femoston mini should be discussed with the doctor.
Regular breast screening tests should be performed, in accordance with the doctor's recommendations.
You should not take Femoston miniif you have any of the following conditions. If you have any doubts, you should consult a doctor before taking Femoston mini.

When not to take Femoston mini

• if you are allergic(hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of this medicine (listed in section 6)
• if you have been diagnosed with, have had, or are suspected of having breast cancer
• if you have been diagnosed with or are suspected of having estrogen-dependent tumors, such as endometrial cancer (cancer of the uterine lining)
• if you have unexplained vaginal bleeding
• if you have untreated endometrial hyperplasia(thickening of the uterine lining)
• if you have been diagnosed with or have had blood clots in the veins(thrombosis), such as deep vein thrombosis or pulmonary embolism
• if you have a blood clotting disorderwith a tendency to form clots (such as protein C, protein S, or antithrombin deficiency)
• if you have been diagnosed with or have had arterial thromboembolic diseases, such as heart attack, stroke, or angina pectoris
• if you have been diagnosed with or have had liver diseaseand liver function tests have not returned to normal
• if you have been diagnosed with a rare blood disorder - porphyria, which is inherited.

If any of the above conditions occur for the first time while taking Femoston mini, you should stop taking it immediately and contact your doctor as soon as possible.

Warnings and precautions

Before starting Femoston mini, you should inform your doctor if you have or have had any of the following conditions, as they may worsen or recur under the influence of this medicine. You should have more frequent check-ups if:

• you have uterine fibroids
• you have endometriosisor have had endometrial hyperplasiain the past
• you have a brain tumorthat may be sensitive to progestogen levels (meningioma)
• you have an increased risk of blood clots(see "Blood clots in the veins (thrombosis)")
• you have an increased risk of estrogen-dependent tumors(e.g., a history of breast cancer in your mother, sister, or grandmother)
• you have high blood pressure
• you have liver disease, such as a benign liver tumor
• you have diabetes
• you have gallstones
• you have migrainesor severe headaches
• you have systemic immune system diseasesthat affect multiple organs (systemic lupus erythematosus)
• you have epilepsy
• you have asthma
• you have a disease affecting the eardrum and hearing(otosclerosis)
• you have very high levels of fats in the blood(triglycerides)
• you have fluid retentiondue to heart or kidney problems
• you have hereditary or acquired angioedema.

You should stop taking Femoston mini and contact your doctor immediatelyif you experience any of the following symptoms while taking HRT:

• any of the conditions listed in "When not to take Femoston mini"
• jaundice(yellowing of the skin or eyes). These may be signs of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, in combination with difficulty breathing, which may be signs of angioedema
• significant increase in blood pressure(symptoms include headache, fatigue, dizziness)
• migraine-like headachesthat occur for the first time
• pregnancy
• symptoms of blood clots, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing

For more information, see "Blood clots in the veins (thrombosis)".
Note:Femoston mini is not a contraceptive. If it has been less than 12 months since your last period and you are under 50 years old, you may need to use an additional contraceptive method to prevent pregnancy. You should consult your doctor.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasia(thickening of the uterine lining) and endometrial cancer.
Femoston mini, which contains progestogen, helps to reduce this additional risk.

Irregular bleeding

During the first 3 to 6 months of taking Femoston mini, irregular bleeding or spotting may occur. However, if irregular bleeding:

• lasts longer than the first 6 months of treatment
• starts after more than 6 months of treatment with Femoston mini
• does not stop after stopping Femoston mini you should contact your 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 HRT. After stopping HRT, the additional risk will decrease over time but 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 is diagnosed in approximately 13-17 out of 1000 women over 5 years.
In women aged 50 who start 5-year estrogen-only HRT, the number of cases is 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 is 21 out of 1000 patients (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer is diagnosed in approximately 27 out of 1000 women over 10 years.
In women aged 50 who start 10-year estrogen-only HRT, the number of cases is 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 is 48 out of 1000 patients (i.e., 21 additional cases).

You should have regular breast examinations. You should contact your doctor if you notice any changes, such as:

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

In addition, it is recommended to participate in mammographic screening programs. It is important to inform the nurse or medical staff about HRT during the screening mammography, as this product may cause increased breast density and affect the mammography result. If breast density increases, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that contains only estrogen or a combination of 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 is diagnosed in approximately 2 out of 2000 women over 5 years. In women who have taken HRT for 5 years, it occurs in approximately 3 out of 2000 women (i.e., 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 veinsis 1.3-3 times higher in women taking HRT than in those not taking it, especially in the first year of treatment.
The formation of blood clots can have serious consequences, and 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 is higher if you are older and if any of the following apply to you. You should contact your doctor if you:

• are unable to walk for a long period due to a serious operation, injury, or illness (see also section 3 "Planned surgery")
• are significantly overweight (BMI >30 kg/m)
• have diseases related to blood clotting that require long-term treatment with anticoagulant medications
• have a close relative who has had blood clots in the legs, lungs, or other organs
• have been diagnosed with systemic lupus erythematosus
• have been diagnosed with cancer

Symptoms of blood clots, see "You should stop taking Femoston mini and contact your doctor immediately".
Comparison
In women aged 50-59 who do not take HRT, blood clots in the veins are estimated to occur in approximately 4-7 out of 1000 women over 5 years.
In women aged 50-59 who take combined estrogen-progestogen HRT for more than 5 years, blood clots are estimated to occur in 9-12 out of 1000 women (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks. In women over 60 taking combined estrogen-progestogen HRT, there is a slightly increased tendency to develop heart disease compared to those not taking HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in women taking HRT than in those not taking it. The number of additional cases of stroke increases with age.
Comparison
In women aged 50-59 who do not take HRT, stroke is estimated to occur in approximately 8 out of 1000 women over 5 years. In women aged 50-59 taking HRT, stroke occurs in 11 out of 1000 women over more than 5 years (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.
You should inform your doctor about the presence of any of the following conditions to increase monitoring:

• heart disease
• kidney problems
• high levels of certain fats in the blood(hypertriglyceridemia)

Children and adolescents

Femoston mini is not intended for use in children and adolescents.

Femoston mini and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may change the effect of Femoston mini, which can lead to irregular bleeding or spotting. These include:

• medicines for epilepsy(such as phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis(such as rifampicin, rifabutin)
• medicines used to treat HIV infection(AIDS) (such as nevirapine, efavirenz, ritonavir, nelfinavir)
• herbal products containing St. John's Wort(Hypericum perforatum) HRT may affect the action of other medicines:
• medicines for epilepsy(lamotrigine), as it may increase the frequency of seizures
• combined treatment of hepatitis C virus(HCV) infection using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and treatment using glecaprevir/pibrentasvir, which may cause increased liver enzyme levels in blood tests in women taking combined hormonal contraceptives containing ethinyl estradiol. Femoston mini contains estradiol instead of ethinyl estradiol. It is not known whether increased liver enzyme levels may occur when taking Femoston mini with this type of combined HCV treatment.

You should tell your doctor or pharmacist about all other medicines you are currently taking, including those available without a prescription, herbal medicines, or other natural products. Your doctor will provide you with appropriate instructions.

Lab tests

Before a blood test, you should inform your doctor or medical staff that you are taking Femoston mini, as it may affect the results of some tests.

Femoston mini with food and drink

Femoston mini can be taken with or without food.

Pregnancy and breastfeeding

Femoston mini is intended only for postmenopausal women.
In case of pregnancy:

• stop taking Femoston mini and contact your doctorFemoston mini is not intended for use in breastfeeding women.

Driving and using machines

No studies have been conducted on the effect of Femoston mini on driving or using machines. No such effect is expected.

Femoston mini contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Femoston mini.

3. How to take Femoston mini

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

When to start taking Femoston mini

You should not take Femoston mini before 12 months have passed since your last period.
You can start taking Femoston mini on any day if:

• you are not currently taking HRT
• you are switching from another continuous combined HRT, i.e., if you are taking a tablet or using a transdermal system that contains both estrogen and progestogen every day.

You can start taking Femoston mini after completing a 28-day cycle if:

• you are switching from a cyclic or sequential HRT, i.e., a treatment that involves taking a tablet or applying a transdermal system containing estrogen for the first part of the cycle, followed by 14 days of taking a tablet or applying a patch that contains both estrogen and progestogen.

Taking Femoston mini

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This helps maintain a constant level of the medicine in your body and helps you remember to take the tablet every day.
• 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. See "Translation of day symbols on the packaging" at the end of the leaflet.

What dose to take

• Your doctor will prescribe the lowest effective dose needed to treat your symptoms for the shortest necessary time. You should consult your doctor if you think the dose is too strong or too weak.
• You should take 1 yellow tablet every day for 28 days.

Planned surgery

In case of planned surgery, you should inform the surgeon that you are taking Femoston mini. It may be necessary to stop taking Femoston mini 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 consult your doctor about when you can restart taking Femoston mini.

Taking more than the prescribed dose of Femoston mini

If you (or someone else) take too many Femoston mini tablets, it is unlikely to cause harmful effects. You may experience nausea or vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness, or withdrawal bleeding. No additional treatment is necessary, but if you have any doubts, you should consult your doctor.

Missing a dose of Femoston mini

You should take the missed tablet as soon as possible. If more than 12 hours have passed, 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 mini

You should not stop taking Femoston mini 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 mini can cause side effects, although not everybody gets them.
The following side effects have been reported more frequently in women taking HRT than in those not taking HRT:

• breast cancer
• endometrial hyperplasia or cancer (thickening or cancer of the uterine lining)
• ovarian cancer
• blood clots in the veins (thromboembolic disease)
• heart disease
• stroke
• memory loss, if HRT is started at an age over 65.

For more information on these side effects, see section 2.
The following side effects may occur while taking this medicine:
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 (yeast infection)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, you should stop taking Femoston mini and contact your doctor immediately
• dizziness
• nausea, vomiting, bloating
• skin allergic reactions (such as rash, persistent itching, hives)
• bleeding disorders, 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):
• symptoms similar to cystitis
• enlargement of uterine fibroids
• allergic reactions, such as shortness of breath (asthma)
• change in libido
• blood clots in the legs or lungs (venous thromboembolism)
• high blood pressure
• circulatory disorders (peripheral circulatory failure)
• enlargement and twisting of veins (varicose veins)
• indigestion
• liver function disorders, sometimes with yellowing of the skin or eyes (jaundice), feeling unwell, or abdominal pain. If you experience yellowing of the skin or eyes, you should stop taking Femoston mini and contact your doctor immediately
• gallbladder disease
• breast engorgement
• premenstrual syndrome
• weight loss
• Rare(may affect up to 1 in 1000 people):
• hemolytic anemia (a blood disorder)*
• meningioma (a brain tumor)*
• corneal changes*, intolerance to contact lenses*
• heart attack
• stroke*
• swelling of the tissues around the face and neck. This can cause difficulty breathing (angioedema)
• purpura (purple spots on the skin)
• erythema nodosum (painful red lumps on the skin)*, skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma)*
• leg cramps*.

The following side effects have been observed in women taking other HRT medicines:

• benign or malignant tumors that may be estrogen-dependent, such as endometrial cancer or ovarian cancer (see section 2 for more information)
• enlargement of tumors that may be progestogen-dependent (such as meningioma)
• systemic immune system diseases that affect multiple organs (systemic lupus erythematosus)
• possible dementia (memory loss)
• worsening of epilepsy (seizures)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, in women with pre-existing high levels of triglycerides in the blood (hypertriglyceridemia)
• erythema multiforme (a skin rash)
• urinary incontinence
• painful and/or lumpy breasts (fibrocystic breast changes)
• cervical erosion
• worsening of porphyria (a rare blood disorder)
• high levels of triglycerides in the blood (hypertriglyceridemia)
• increased levels of thyroid hormones.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety, Ministry of Health, via the internet (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 mini

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 mini contains

• The active substances of Femoston mini are estradiol as estradiol hemihydrate and dydrogesterone. Each Femoston mini coated tablet contains 0.5 mg of estradiol and 2.5 mg of dydrogesterone.
• The other ingredients are lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Yellow coating: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Femoston mini looks like and contents of the pack

Femoston mini is available in the form of coated tablets. The tablets are round, biconvex, and have "379" embossed on one side. Each blister pack contains 28 tablets. The tablets are yellow.
The tablets are packaged in PVC/Aluminum blisters in a cardboard box.
The packaging contains 28 coated tablets.
A cardboard sleeve is included with the packaging, in which the blister pack should be placed.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
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 Latvia, the country of export:10-0501

Parallel import authorization number: 290/23

This medicine is authorized in the Member States of the European Economic Area under the following names:

Translation of day symbols on the packaging:
P./P./E –Monday
A./O./T –Tuesday
T./T./K– Wednesday
K./C./N– Thursday
Pn./Pk./R– Friday
Š./S./L– Saturday
S./Sv./P –Sunday.

Date of leaflet approval: 18.12.2023

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