FEMOSTON 0.5 mg/2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Femoston mini
3. 5 mg + 2.5 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Femoston mini and what is it used for
   1. Femoston mini is used to
   2. Relieve symptoms occurring after menopause
5. Important information before taking Femoston mini
   1. Medical history and periodic check-ups
   2. When not to take Femoston mini
   3. Warnings and precautions
   4. Stop taking Femoston mini and consult a doctor immediately
   5. HRT and cancer
   6. Endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer
   7. Irregular bleeding
   8. Breast cancer
   9. Regular breast examination is recommended. Consult a doctor if you notice any changes, such as:
   10. Ovarian cancer
   11. Effect of HRT on the heart and blood vessels
   12. Blood clots in the veins (thrombosis)
   13. Heart disease (heart attack)
   14. Stroke
   15. Other conditions
   16. Children and adolescents
   17. Femoston mini and other medicines
   18. Lab tests
   19. Femoston mini with food and drink
   20. Pregnancy and breastfeeding
   21. Driving and using machines
   22. Femoston mini contains lactose
6. How to take Femoston mini
   1. Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
   2. When to start taking Femoston mini
   3. How to take Femoston mini
   4. What dose to take
   5. Planned surgery
   6. Overdose
   7. Missed dose
   8. Stopping treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Femoston mini
9. Contents of the pack and other information
   1. What Femoston mini contains
   2. What Femoston mini looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Femoston mini

0.5 mg + 2.5 mg, coated tablets

Estradiol + Dydrogesterone

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 further questions, ask your 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 their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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: an estrogen called estradiol and a 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 occurring after menopause

During menopause, the level of estrogen produced by the 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 with HRT in premature menopause (due to ovarian dysfunction or surgery) is limited. The risk associated with HRT in premature menopause may be different. Consult a doctor. Before starting HRT for the first time (or resuming it), the doctor should conduct a medical history, including a family 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 of continued treatment with Femoston mini should be discussed with the doctor. Regular breast screening should be performed in accordance with the doctor's recommendations. Do not take Femoston miniif any of the following conditions apply to you. If in doubt, 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 cancer, such as endometrial cancer (cancer of the uterine lining)
• if you have vaginal bleeding of unknown cause
• 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 disorder with a tendency to thrombosis (such as protein C, protein S, or antithrombin deficiency)
• if you have been diagnosed with or have had a blood clot-related disease in the arteries, such as a heart attack, stroke, or angina
• if you have been diagnosed with or have had liver disease and liver function tests have not returned to normal
• if you have been diagnosed with a rare blood disorder called porphyria, which is inherited
• if you have a meningioma or have been diagnosed with a meningioma (usually a benign brain tumor). If any of the above conditions occur for the first time while taking Femoston mini, stop taking it and consult a doctor immediately.

Warnings and precautions

Before starting Femoston mini, tell 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. More frequent check-ups may be necessary if:

• you have uterine fibroids
• you have endometriosis or have had endometrial hyperplasia (thickening of the uterine lining)
• you have a brain tumor
• you have an increased risk of blood clots (see "Blood clots in the veins (thrombosis)")
• you have an increased risk of estrogen-dependent cancer (such as 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 migraine or severe headaches
• you have an immune system disease that affects multiple organs (systemic lupus erythematosus)
• you have epilepsy
• you have asthma
• you have a disease that affects the eardrum and hearing (otosclerosis)
• you have very high levels of fats in the blood (hypertriglyceridemia)
• you have fluid retention due to heart or kidney problems
• you have hereditary or acquired angioedema. Meningioma Taking Femoston mini may lead to the development of a usually benign brain tumor (meningioma). If a meningioma is diagnosed, the doctor will stop the treatment with Femoston mini (see "When not to take Femoston mini"). 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, consult a doctor immediately.

  Stop taking Femoston mini 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 mini"
  • yellowing of the skin or eyes (jaundice), which may be signs of liver disease
  • swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may be signs of angioedema
  • severe increase in blood pressure (symptoms include headache, fatigue, dizziness)
  • migraine-like headaches that occur for the first time
  • pregnancy
  • symptoms of blood clots, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty breathing See "When to stop taking Femoston mini and consult a doctor immediately". Note:Femoston mini is not a contraceptive. If it has been less than 12 months since your last period and you are under 50, you may need to use an additional contraceptive method to prevent pregnancy. Consult a doctor.

  HRT and cancer

  Endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer

  Taking HRT that only contains estrogen increases the risk of endometrial hyperplasia and endometrial cancer. Femoston mini, which contains a progestogen, helps 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 6 months after starting Femoston mini
  • occurs after more than 6 months of taking Femoston mini
  • does not stop after stopping Femoston mini consult a doctor immediately.

  Breast cancer

  Data confirm that taking HRT in the form of combined estrogen and progestogen or estrogen alone increases the risk of breast cancer. The additional risk depends on how long the patient takes HRT. This additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT lasted more than 5 years. ComparisonIn women aged 50 to 54 who do not take HRT, breast cancer is 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 is 16 to 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 is 21 out of 1000 patients (i.e., 4 to 8 additional cases). In women aged 50 to 59 who do not take HRT, breast cancer is 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 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).

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

  • skin retraction
  • changes in the nipple area
  • any visible or palpable lumps Additionally, it is recommended to participate in mammographic screening programs. It is essential 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. In the case of increased breast density, mammography may not detect all tumors.

  Ovarian cancer

  Ovarian cancer is rare, much rarer than breast cancer. Taking HRT that only contains estrogen or combined estrogen and progestogen increases the risk of ovarian cancer slightly. The risk of ovarian cancer depends on age. For example, in women aged 50 to 54 who do not take HRT, ovarian cancer is diagnosed over a 5-year period in approximately 2 out of 2000 women. In women who take 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 veins is 1.3 to 3 times higher in women taking HRT compared to those not taking it, especially in the first year of treatment. The formation of blood clots can have serious consequences and can be life-threatening if they move to the lungs. The risk of blood clots is higher if you are older and if any of the following apply to you. Consult a doctor if you:

  • are unable to walk for an extended period due to major surgery, injury, or illness (see also section 3 "Planned surgery")
  • are significantly overweight (BMI >30 kg/m²)
  • have a blood clotting disorder that requires 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 "When to stop taking Femoston mini and consult a doctor immediately". ComparisonIn women aged 50 to 59 who do not take HRT, blood clots in the veins are estimated to occur over a 5-year period in approximately 4 to 7 out of 1000 women.

  In women aged 50 to 59 who take combined estrogen-progestogen HRT for more than 5 years, the estimated number of cases is 9 to 12 out of 1000 (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 risk of heart disease compared to those not taking HRT.

  Stroke

  The risk of stroke is approximately 1.5 times higher in women taking HRT compared to those not taking it. The number of additional stroke cases increases with age. ComparisonIn women aged 50 to 59 who do not take HRT, stroke is estimated to occur over a 5-year period in approximately 8 out of 1000 women. In women aged 50 to 59 taking HRT for more than 5 years, the estimated number of stroke cases is 11 out of 1000 (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 older age (over 65). Consult a doctor. Inform your doctor if you have any of the following conditions to increase monitoring:

  • heart disease
  • kidney dysfunction
  • 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

  Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription, herbal medicines, or other natural products. Some medicines may change the effect of Femoston mini, which may 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(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(such as 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 the treatment using glecaprevir/pibrentasvir, which may cause increased liver function test results in the blood (increased ALT enzyme activity) in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston mini contains estradiol instead of ethinylestradiol. It is not known whether increased ALT enzyme activity may occur when taking Femoston mini with this type of HCV treatment regimen. Inform your doctor or pharmacist about all other medicines you are taking or have recently taken, including those available without a prescription, herbal medicines, or other natural products. Your doctor will provide you with appropriate guidance.

  Lab tests

  Before a blood test, 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 for use in postmenopausal women only. If you become pregnant:

  • stop taking Femoston mini and consult a doctor.Femoston 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

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

  3. How to take Femoston mini

  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 mini

  Do 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., you are taking a tablet or using a transdermal system that contains both estrogen and progestogen every day. You can start 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 using a transdermal system containing estrogen for the first part of the cycle, followed by 14 days of taking a tablet or using a patch that contains estrogen and progestogen.

  How to take Femoston mini

  • Swallow the tablet with water.
  • The tablets can be taken with or without food.
  • Try to take the tablet at the same time every day. This helps maintain a constant level of the medicine in your body and reminds you to take the tablet every day.
  • Take one 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.

  What dose to take

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

  Planned surgery

  If you are scheduled for surgery, inform the surgeon that you are taking Femoston mini. It may be necessary to stop taking Femoston mini about 4 to 6 weeks before the planned surgery to reduce the risk of blood clots (see "Blood clots in the veins (thrombosis)"). Consult your doctor about when you can restart Femoston mini.

  Overdose

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

  Missed dose

  Take the missed tablet as soon as possible. If more than 12 hours have passed, 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 missing a dose may cause bleeding or spotting.

  Stopping treatment

  Do not stop taking Femoston mini without consulting your doctor. If you have any further questions about taking this medicine, 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 it:

  • breast cancer
  • endometrial hyperplasia or cancer (thickening or cancer of the uterine lining)
  • ovarian cancer
  • blood clots in the veins or lungs (thromboembolic disease)
  • heart disease
  • stroke
  • memory loss, if HRT is started at an older 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 thrush (infection with Candida albicans)
  • depression, nervousness
  • migraine. If migraine headaches occur for the first time, stop taking Femoston mini and consult a doctor immediately
  • dizziness
  • nausea, vomiting, bloating (flatulence)
  • skin allergic reactions (such as rash, persistent 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):
  • symptoms similar to cystitis
  • enlargement of uterine fibroids
  • allergic reactions, such as shortness of breath (asthma)
  • changes in libido
  • blood clots in the legs or lungs (venous thromboembolism)
  • high blood pressure (hypertension)
  • circulatory disorders (peripheral circulatory failure)
  • enlargement and twisting of veins (varicose veins)
  • indigestion
  • liver function disorders, sometimes with yellowing of the skin and eyes (jaundice), feeling unwell, or abdominal pain. If you experience yellowing of the skin or eyes, stop taking Femoston mini and consult a doctor immediately
  • gallbladder disease
  • breast swelling
  • premenstrual syndrome
  • weight loss Rare(may affect up to 1 in 1000 people):
  • blood disease that breaks down red blood cells (hemolytic anemia)*
  • meningioma (brain tumor)*
  • changes in the cornea (corneal edema)*, intolerance to contact lenses*
  • heart attack
  • stroke*
  • swelling of the tissues in the face and neck, which can cause difficulty breathing (angioedema)
  • purple spots and patches on the skin (purpura)
  • painful red lumps on the skin (erythema nodosum)*, skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma)*
  • leg cramps* The following side effects have been observed with 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)
  • immune system disease that affects multiple organs (systemic lupus erythematosus)
  • probable dementia (memory loss)
  • seizure worsening (epilepsy)
  • involuntary muscle contractions (chorea)
  • blood clots in the arteries (arterial thrombosis)
  • pancreatitis, especially in women with previously elevated levels of certain fats in the blood (hypertriglyceridemia)
  • erythema multiforme (skin rash)
  • urinary incontinence
  • breast pain or lumps (fibrocystic breast changes)
  • cervical erosion
  • worsening of porphyria (a rare blood disorder)
  • high levels of certain fats in the blood (hypertriglyceridemia)
  • increased total thyroid hormone levels

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at https://smz.ezdrowie.gov.pl or by phone at +48 22 49 21 301 or by fax at +48 22 49 21 309. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Femoston mini

  Keep the 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 blister pack and carton after EXP and the expiry date (EXP). The expiry date refers to the last day of the month stated. 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 mini contains

  • The active substances 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, cornstarch, colloidal silicon dioxide, 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 blister packs in a cardboard box. The pack contains 28 or 84 coated tablets. Not all pack sizes may be marketed.

  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

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

  AT	Femoston conti 0.5 mg/2.5 mg Filmtabletten
  BE	Femoston Low 0.5 mg/2.5 mg filmomhulde tabletten
  CZ	Femoston mini 0.5 mg/2.5 mg
  DE	Femoston mini 0.5 mg/2.5 mg Filmtablette
  DK	Femoston Conti
  EE	Femoston conti 0.5 mg/2.5 mg
  ES	Femoston 0.5mg/2.5mg comprimidos recubiertos con película
  FI	Femoston conti 0.5/2.5 tabletti, kalvopäällysteinen
  FR	Climaston 0.5mg/2.5 mg, comprimé pelliculé
  IE	Femoston-conti 0.5 mg/ 2.5 mg film-coated tablets
  IT	Femoston 0.5 mg/2.5 mg compresse rivestite con film
  LT	Femoston conti 0.5 mg/2.5 mg plėvele dengtos tabletės
  LU	Femoston Low 0.5 mg/2.5 mg comprimés pelliculés
  LV	Femoston conti 0.5 mg/2.5 mg apvalkotās tabletes
  MT	Femoston-conti 0.5 mg/2.5 mg filmcoated tablets
  NL	Femoston continu 0.5 mg/2.5 mg filmomhulde tabletten
  NO	Femostonconti
  PL	Femoston mini
  PT	Femoston, 2.5 mg + 0.5 mg, comprimido revestido
  SE	Femostonconti
  SI	Femphascon conti 0.5 mg/2.5 mg filmsko obložene tablete
  UK (Northern Ireland)	Femoston-conti 0.5 mg/2.5 mg, film-coated tablets

  Date of last revision of the package leaflet:October 2024