Femoston mini

Package leaflet: Information for the patient

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Femoston mini (Femoston conti)
0.5 mg + 2.5 mg, coated tablets
Estradiol + Dydrogesterone
Femoston mini and Femoston conti are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Femoston mini is a medicine used in hormone replacement therapy (HRT). It contains two types of female hormones: an oestrogen called estradiol and a progestagen called dydrogesterone. Femoston mini is used in postmenopausal women, i.e. women in whom at least 12 months have passed since their last menstrual period.
Femoston mini is used to
Relieve postmenopausal symptoms
During menopause, the level of oestrogens produced by a woman's body decreases. This may cause symptoms such as flushing of the face, neck and chest (hot flushes). Treatment with Femoston mini reduces these postmenopausal symptoms. Your doctor will prescribe Femoston mini only if the symptoms significantly impair the patient's quality of life.

2. Important information before using Femoston mini

Medical history and periodic check-ups
Hormone replacement therapy (HRT) carries risks that should be considered before starting and during treatment.
Experience with treating premature menopause (due to ovarian dysfunction or surgical removal of ovaries) is limited. The risks associated with HRT in premature menopause may differ. Consult your doctor.
Before starting (or restarting) HRT, your doctor should take a full medical history, including family history.
Your doctor may decide to perform additional tests, such as breast and/or pelvic examination, if necessary.
After starting Femoston mini, you should have regular check-ups with your doctor (at least once a year). During these visits, you and your doctor should reassess the benefits and risks of continuing treatment with Femoston mini.
Regular breast screening should be performed according to your doctor's recommendations.

Do not take Femoston mini if any of the following apply to you. If you have any doubts, consult your doctor before taking Femoston mini.

When not to use 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 in the past, or are suspected of having breast cancer
• if you have been diagnosed with or suspected of having an estrogen-dependent tumor, e.g. endometrial cancer (cancer of the lining of the womb)
• if you have vaginal bleeding of unknown cause
• if you have untreated endometrial hyperplasia (excessive thickening of the womb lining)
• if you currently have or have had in the past blood clots in the veins (venous thromboembolism), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• if you have a blood clotting disorder predisposing to thrombosis (such as protein C, protein S or antithrombin deficiency)
• if you currently have or have had in the past an arterial disease caused by blood clots, e.g. heart attack, stroke, or angina pectoris
• if you currently have or have had in the past liver disease and liver function tests have not returned to normal
• if you have been diagnosed with a rare inherited blood disorder – porphyria.
  If any of the above conditions occur for the first time during treatment with Femoston mini, stop taking the medicine immediately and contact your doctor as soon as possible.

Warnings and precautions
Before starting Femoston mini, inform your doctor if you currently have or have had any of the following conditions, as they may worsen or recur during treatment. More frequent check-ups may be necessary if you have:

• fibroids (uterine myomas)
• endometriosis (presence of endometrial tissue outside the uterus) or a history of endometrial hyperplasia
• a brain tumor that may be sensitive to progestogen levels (meningioma)
• an increased risk of blood clots (see section “Venous thromboembolism”)
• an increased risk of estrogen-dependent tumors (e.g. if a close relative such as mother, sister, or grandmother had breast cancer)
• high blood pressure
• liver disease, e.g. benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• autoimmune diseases affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• a disease affecting the ear drum and hearing (otosclerosis)
• very high levels of blood fats (triglycerides)
• fluid retention due to heart or kidney dysfunction
• hereditary or acquired angioedema.

Stop taking Femoston mini and contact your doctor immediately if any of the following symptoms occur during HRT:

• any of the conditions listed under “When not to use Femoston mini”
• yellowing of the skin or eyes (jaundice) – these may be signs of liver disease
• swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives, possibly combined with breathing difficulties – these may be symptoms of angioedema
• a significant increase in blood pressure (symptoms include headache, fatigue, dizziness)
• new-onset migraine-like headaches
• pregnancy
• symptoms of blood clots such as:
  • painful swelling and redness in the legs
  • sudden chest pain
  • difficulty breathing
    For more information, see section “Venous thromboembolism”.

Note: Femoston mini is not a contraceptive. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, you may need to use an additional method of contraception to prevent pregnancy. Consult your doctor.

HRT and cancer

Endometrial hyperplasia and endometrial cancer
Using estrogen-only HRT increases the risk of endometrial hyperplasia (excessive thickening of the womb lining) and endometrial cancer.
Femoston mini contains a progestagen, which helps reduce this additional risk.

Irregular bleeding
Irregular bleeding or spotting may occur during the first 3 to 6 months of treatment with Femoston mini. However, if irregular bleeding:

• lasts longer than the first 6 months of treatment
• appears after a break of more than 6 months of treatment with Femoston mini
• does not stop after stopping the medicine
  contact your doctor immediately.

Breast cancer
Evidence shows that using combined estrogen-progestagen HRT or estrogen-only HRT increases the risk of developing breast cancer. The additional risk depends on how long HRT is used. This increased risk becomes apparent after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was used for more than 5 years.

Comparison
Among women aged 50 to 54 not using HRT, breast cancer will be diagnosed in an average of 13 to 17 out of 1,000 women over 5 years.
Among women aged 50 starting a 5-year course of estrogen-only HRT, the number of cases will be 16–17 per 1,000 women (i.e. 0 to 3 additional cases).
Among women aged 50 starting a 5-year course of estrogen-progestagen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 not using HRT, breast cancer will be diagnosed in an average of 27 out of 1,000 women over 10 years.
Among women aged 50 starting a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. 7 additional cases).
Among women aged 50 starting a 10-year course of estrogen-progestagen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).
Regularly examine your breasts. Contact your doctor if you notice any changes such as:

• skin dimpling
• changes around the nipples
• any visible or palpable lumps
  Additionally, participation in mammographic screening programs is recommended. It is important to inform the nurse or medical staff performing the mammogram that you are using HRT, as this product may increase breast density and affect the mammogram results. Increased breast density may make it harder for mammography to detect all tumors.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. Using estrogen-only HRT or combined estrogen-progestagen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 not using HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over 5 years.
Among women who have used HRT for 5 years, it will occur in about 3 out of 2,000 women (i.e. about 1 additional case).

Effects of HRT on the heart and circulatory system

Venous thromboembolism (blood clots in the veins)
The risk of venous thromboembolism is 1.3 to 3 times higher in women using HRT compared to non-users, especially during the first year of use.
Venous blood clots can have serious consequences and, if they travel to the lungs, may cause chest pain, breathlessness, fainting, or even death.
The risk of venous thromboembolism increases with age and if any of the following apply. Contact your doctor if you have any of the following:

• inability to walk for prolonged periods due to major surgery, injury, or illness (see also section 3 “Planned surgery”)
• significant overweight (BMI >30 kg/m²)
• blood clotting disorders requiring long-term anticoagulant treatment
• a close family history of blood clots in legs, lungs, or other organs
• systemic lupus erythematosus
• cancer
  Symptoms of blood clots: see “Stop taking Femoston mini and contact your doctor immediately”.

Comparison
Among women aged 50 to 59 not using HRT, venous thromboembolism is estimated to occur in 4 to 7 out of 1,000 women over 5 years.
Among women aged 50 to 59 using estrogen-progestagen HRT for more than 5 years, venous thromboembolism is estimated in 9 to 12 out of 1,000 women (i.e. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. In women over 60 using estrogen-progestagen HRT, there is a slightly higher tendency to develop heart disease compared to non-users.

Stroke
The risk of stroke is about 1.5 times higher in women using HRT compared to non-users. The number of additional stroke cases increases with age.

Comparison
Among women aged 50 to 59 not using HRT, stroke is estimated to occur in 8 out of 1,000 women over 5 years. Among women aged 50 to 59 using HRT for more than 5 years, there will be 11 strokes per 1,000 women (i.e. 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is evidence of increased risk of memory loss in women who start HRT after age 65. Consult your doctor.
Inform your doctor if you have any of the following conditions to ensure closer monitoring:

• heart disease
• kidney dysfunction
• elevated levels of certain blood fats (hypertriglyceridemia)

Children and adolescents
Femoston mini is not indicated for use in children or adolescents.

Femoston mini and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those you plan to use.
Some medicines may affect the action of Femoston mini, leading to irregular bleeding or spotting. These include:

• medicines for epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g. rifampicin, rifabutin)
• medicines used in HIV infection (AIDS) (e.g. nevirapine, efavirenz, ritonavir, nelfinavir)
• herbal products containing St. John's wort (Hypericum perforatum)
  HRT may also affect the action of other medicines:
• the antiepileptic drug lamotrigine, possibly increasing seizure frequency
• combination treatment regimens for hepatitis C virus (HCV) infection using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir, which may cause increased liver function test parameters (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston mini contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT activity may occur when Femoston mini is used concomitantly with such HCV combination therapies.

Tell your doctor or pharmacist about all other medicines you are currently or recently taking, including over-the-counter medicines, herbal remedies, or other natural products. Your doctor will provide appropriate advice.

Laboratory tests
Inform your doctor or medical staff that you are taking Femoston mini before having blood tests, as it may affect the results of certain tests.

Femoston mini with food and drink
Femoston mini can be taken with or without food.

Pregnancy and breastfeeding
Femoston mini is indicated only for postmenopausal women. In case of pregnancy:

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

Driving and using machines
No studies on the effects of Femoston mini on driving and operating machinery have been conducted. Such effects are not expected.

Femoston mini contains monohydrate lactose
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Femoston mini

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
When to start using Femoston mini
Femoston mini should not be used before 12 months have passed since the last menstrual period.
Treatment with Femoston mini may be started on any day if:

• the patient is not currently using HRT, or
• the patient is switching from another continuous combined HRT, i.e. if the patient is taking a tablet or using a transdermal system containing both an oestrogen and a progestagen every day.

Treatment with Femoston mini may be started immediately after completing a 28-day cycle if:

• the patient is switching from HRT administered in a "cyclical" or "sequential" regimen, i.e. taking or applying a system containing oestrogen during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both oestrogen and progestagen.

How to take Femoston mini

• Swallow the tablet with water.
• Tablets may be taken regardless of meals.
• Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in the body and assists in remembering to take the tablet daily.
• Take 1 tablet every day, without interruption between packs. The blister pack displays the days of the week to help remember when to take the tablet (the translation of the day abbreviations marked next to each tablet on the immediate packaging can be found at the end of this leaflet and on the sachet included in the package).

What dose to use

• Your doctor will prescribe the lowest effective dose needed to treat your symptoms for the shortest necessary duration. Consult your doctor if the dose seems too strong or too weak.
• Take one yellow tablet daily for 28 days.

Planned surgery
If you are scheduled for surgery, inform your surgeon that you are taking Femoston mini. You may need to stop taking Femoston mini approximately 4 to 6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in veins (venous thromboembolism)"). Consult your doctor about when you can restart taking Femoston mini.

Taking more than the recommended dose of Femoston mini
If a patient (or another person) takes too many Femoston mini tablets, it is unlikely to cause harmful effects. Symptoms may include nausea or vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness and/or fatigue, or withdrawal bleeding. Additional treatment is not usually necessary, but if in doubt, consult a doctor.

Missed dose of Femoston mini
Take the missed tablet as soon as possible. If more than 12 hours have passed, take the next tablet at the usual time without taking the missed tablet. Do not take a double dose to make up for a missed dose. Bleeding or spotting may occur if a dose is missed.

Stopping Femoston mini
Do not stop taking Femoston mini without consulting your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported more frequently in women using HRT than in women
not using HRT:

• breast cancer
• excessive growth or cancer of the lining of the womb (endometrial hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the legs or lungs (venous thromboembolic disease)
• heart diseases
• stroke
• memory loss, if HRT is started at age over 65.

For further information on these adverse effects, see section 2.
The following adverse effects may occur during treatment with this medicine:
Very common (may occur in more than 1 in 10 women):

• headaches
• abdominal pain
• back pain
• breast tenderness or pain

Common (may occur in 1 in 10 women):

• vaginal fungal infection (vaginal infection with Candida albicans)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, treatment with Femoston mini should be discontinued and you should contact your doctor immediately
• dizziness
• nausea, vomiting, flatulence (bloating)
• skin allergic reactions (such as rash, persistent itching, urticaria)
• bleeding disorders, such as irregular bleeding or spotting, painful periods, excessive or scanty bleeding
• pelvic pain
• hot flushes
• feeling of weakness, fatigue and general malaise
• swelling of ankles, feet or fingers (peripheral oedema)
• weight gain

Uncommon (may occur in 1 in 100 women):

• symptoms resembling cystitis
• enlargement of uterine fibroids
• hypersensitivity reactions, such as shortness of breath (allergic asthma)
• change in libido
• blood clots in legs or lungs (venous thromboembolic disease, pulmonary embolism)
• 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 (jaundice), feeling of weakness or general malaise and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Femoston mini should be discontinued and you should contact your doctor immediately
• gallbladder diseases
• swelling (oedema) of the breasts
• premenstrual tension syndrome
• weight loss

Rare (may occur in 1 in 1000 women):
(*Adverse effects originating from post-marketing reports, not observed in clinical trials, have been assigned the frequency "rare".)

• disease caused by destruction of red blood cells (haemolytic anaemia)*
• meningioma (brain tumour)*
• changes in the cornea of the eye (corneal maceration)*, intolerance to contact lenses*
• myocardial infarction
• stroke*
• swelling of tissues in the face and neck. May cause breathing difficulties (angioedema)
• purple spots and rashes on the skin (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin pigmentation, especially on the face and neck, known as "chloasma"*
• cramps in the lower limbs*

The following adverse effects have been observed during treatment with other HRT medicines:

• benign or malignant tumours which may be dependent on oestrogen levels, such as endometrial cancer, ovarian cancer (further information see section 2)
• increased size of tumours which may be dependent on progestogen levels (such as meningioma)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• probable dementia (memory loss)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle spasms (chorea)
• arterial blood clots (arterial thrombosis)
• pancreatitis, in women with previously existing elevated levels of certain blood fats (hypertriglyceridaemia)
• rash in the form of red rings or blisters (erythema multiforme)
• urinary incontinence
• painful and/or lumpy breasts (fibrocystic breast changes)
• cervical erosion
• worsening of symptoms of a rare blood pigment disease (porphyria)
• high levels of certain fats in the blood (hypertriglyceridaemia)
• increased total concentration of thyroid hormones

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Femoston mini

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Femoston mini contains

• The active substances are: estradiol in the form of estradiol hemihydrate and dydrogesterone. Each coated tablet of Femoston mini contains 0.5 mg of estradiol and 2.5 mg of dydrogesterone.
• Other ingredients include: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Yellow 1 coating: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

What Femoston mini looks like and contents of the pack
This medicine is available as coated tablets. The tablets are round, biconvex, with the imprint
“379” on one side. Each blister contains 28 tablets. The tablets are yellow in colour.
The tablets are packed in PVC/Aluminum foil blisters within a cardboard box.
The pack contains 28 coated tablets.
Responsible entity in Latvia, country of export:
MagnaPharm SK s. r. o.
Digital Park III/E, Einsteinova 19
Bratislava - mestská časť Petržalka 851 01
Slovakia
Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
Netherlands
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Authorisation number in Latvia, country of export: 10-0501
Parallel import authorisation number: 110/25
Translation of the weekday symbols printed next to each tablet on the immediate 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
This medicinal product is authorised for sale in the European Economic Area countries under the following names: