Femoston mini

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 pack 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 symptoms occurring after menopause
During menopause, the levels of oestrogens produced by a woman's body decrease. This may cause symptoms such as flushing of the face, neck and chest (hot flushes). Taking 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 and during treatment.
Experience in treating premature menopause (due to ovarian dysfunction or surgery) 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 and family history.
Your doctor may decide to carry out additional tests, such as breast and/or pelvic examination, if necessary.
Once you start taking Femoston mini, you should have regular check-ups with your doctor (at least once a year). During these visits, you and your doctor should review the benefits and risks of continuing treatment with Femoston mini.
You should undergo regular breast screening examinations as recommended by your doctor.
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, have had, or are suspected of having breast cancer
• if you have, or are suspected of having, an estrogen-dependent tumour, e.g. endometrial cancer (cancer of the lining of the womb)
• if you have vaginal bleeding of unknown cause
• if you have untreated excessive thickening of the lining of the womb (endometrial hyperplasia)
• if you currently have or have had 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 with a tendency to thrombosis (such as protein C deficiency, protein S deficiency or antithrombin deficiency)
• if you currently have or have had arterial thromboembolic disease, e.g. myocardial infarction, stroke or angina pectoris
• if you currently have or have had liver disease and liver function tests have not returned to normal
• if you have the rare inherited blood disorder porphyria
• if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the tissue layer between the brain and skull).

If any of the above conditions occurs 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:

• uterine fibroids
• endometriosis or a history of excessive thickening of the lining of the womb (endometrial hyperplasia)
• a brain tumour
• an increased risk of blood clots (see section “Blood clots in the veins (thromboembolism)”)
• an increased risk of estrogen-dependent cancer (e.g. if a close relative such as mother, sister or grandmother had breast cancer)
• high blood pressure
• liver disease, e.g. benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• autoimmune diseases affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• very high levels of blood fats (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary or acquired angioedema.

Meningioma
The use of Femoston mini is associated with the development of usually benign tumours of the tissue layer between the brain and skull (meningioma). If meningioma is diagnosed, your doctor will discontinue treatment with Femoston mini (see section “When not to use Femoston mini”). If you notice any of the following symptoms, such as visual disturbances (e.g. double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in the arms or legs, you should inform your doctor immediately.
You must stop taking Femoston mini and contact your doctor immediately if any of the following symptoms occur during HRT:

• any of the conditions listed in the section “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 in combination with breathing difficulties, which may be symptoms of angioedema
• a significant increase in blood pressure (symptoms include headache, fatigue, dizziness)
• new-onset headaches resembling migraines
• pregnancy
• symptoms of blood clots, such as:
• painful swelling and redness in the legs
• sudden chest pain
• difficulty breathing.

For more information, see section “Blood clots in the veins (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 contraceptive method to prevent pregnancy. Consult your doctor.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and endometrial cancer
Using HRT containing only estrogens increases the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and endometrial cancer.
Femoston mini, which contains a progestagen, 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 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 Femoston mini, you should contact your doctor as soon as possible.

Breast cancer
Evidence shows that taking hormone replacement therapy (HRT) as a combination of estrogen and progestagen, 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 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 who do not use HRT, breast cancer will be diagnosed in an average of 13 to 17 per 1000 women over 5 years.
Among women aged 50 who start a 5-year course of estrogen-only HRT, the number of cases will be 16–17 per 1000 women (i.e. 0 to 3 additional cases).
Among women aged 50 who start a 5-year course of estrogen-progestagen HRT, the number of cases will be 21 per 1000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 per 1000 women over 10 years.
Among women aged 50 who start a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1000 women (i.e. 7 additional cases).
Among women aged 50 who start a 10-year course of estrogen-progestagen HRT, the number of cases will be 48 per 1000 women (i.e. 21 additional cases).
You should examine your breasts regularly. Contact your doctor if you notice any changes, such as:

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

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. The use of HRT containing only estrogens or a combination of estrogens and progestagens 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 who do not use HRT, ovarian cancer will be diagnosed in about 2 per 2000 women over 5 years. Among women who have used HRT for 5 years, it will occur in about 3 per 2000 women (i.e. about 1 additional case).
Effect of HRT on the heart and circulation
Blood clots in the veins (thromboembolism)
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 thromboembolism can have serious consequences and, if clots 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 to you. Contact your doctor if you have any of the following conditions:

• if you are unable to walk for a prolonged period due to major surgery, injury or illness (see also section 3 “Planned surgery”)
• if you are significantly overweight (BMI >30 kg/m²)
• if you have blood clotting disorders requiring long-term anticoagulant therapy
• if any close relative has had blood clots in the legs, lungs or other organs
• if you have systemic lupus erythematosus
• if you have cancer.

Symptoms of blood clots: see “You must stop taking Femoston mini and contact your doctor immediately”.
Comparison
Among women aged 50 to 59 who do not use HRT, venous thromboembolism is estimated to occur in 4 to 7 per 1000 women over 5 years.
Among women aged 50 to 59 who use estrogen-progestagen HRT for more than 5 years, venous thromboembolism is estimated to occur in 9 to 12 per 1000 women (i.e. 5 additional cases).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. In women over 60 years of age using estrogen-progestagen HRT, there is a slightly increased tendency to develop heart disease compared to women not using HRT.
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 an average of 8 per 1000 women over 5 years. Among women aged 50 to 59 using HRT for more than 5 years, there will be 11 strokes per 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 after the age of 65. Consult your doctor.
Inform your doctor if you have any of the following conditions to allow for increased monitoring:

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

Children and adolescents
Femoston mini is not indicated for use in children and adolescents.
Femoston mini and other medicines
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 alter the effect 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 for HIV infection (AIDS) (e.g. nevirapine, efavirenz, ritonavir, nelfinavir)

• herbal products containing St. John's wort (Hypericum perforatum)
  HRT may affect the action of other medicines:

• the antiepileptic drug lamotrigine, as this may increase seizure frequency

• combination treatment regimens for hepatitis C virus (HCV) infection with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and the regimen with glecaprevir/pibrentasvir, which may cause increased liver function parameters in blood tests (elevated alanine aminotransferase [AlAT] enzyme activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston mini contains estradiol instead of ethinylestradiol. It is not known whether elevated AlAT enzyme 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 taking or have recently taken, including over-the-counter medicines, herbal remedies or other natural products. Your doctor will provide appropriate advice.
  Laboratory tests
  Before blood tests, inform your doctor or medical staff that you are taking Femoston mini, as it may affect the results of certain tests.
  Femoston mini with food and drink
  Femoston mini can be taken independently of meals.
  Pregnancy and breastfeeding
  Femoston mini is indicated only for postmenopausal women.
  If you become pregnant:

• 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 previously been diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Femoston mini

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
When to start taking Femoston mini
Do not take Femoston mini until 12 months have passed since your last menstrual period.
You may start taking Femoston mini at any time if:

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

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

• you are switching from HRT administered in a "cyclic" or "sequential" regimen, meaning that during the first part of the cycle you take tablets or apply a transdermal system containing oestrogen, followed by 14 days of taking tablets or applying patches containing both oestrogen and progestogen.

Taking Femoston mini

• Swallow the tablet with water.
• Tablets may be taken independently of meals.
• Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in your body and helps you remember to take your tablet every day.
• Take 1 tablet every day without interruption between packs. The blister pack includes days of the week to help you remember when to take each tablet. See "Translation of day-of-the-week symbols on the immediate packaging" at the end of this leaflet.

What dose to take

• 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 for you.
• 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 surgery to reduce the risk of blood clots (see section 2 "Blood clots in veins (venous thromboembolism)"). Ask your doctor when you can restart taking Femoston mini.
Taking more Femoston mini than you should
If you (or someone else) take 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 your doctor.
Missing a 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. Breakthrough 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side 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 disease
• stroke
• memory loss, if HRT is started after the age of 65. For further information on these side effects, see section 2.

The following side effects may occur during treatment with this medicine:
Very common (may affect more than 1 in 10 users):

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

Common (may affect up to 1 in 10 users):

• vaginal fungal infection (yeast infection caused by Candida albicans)
• depression, nervousness
• migraine. If migraine-type headaches occur for the first time, treatment with Femoston mini should be discontinued immediately and you should contact your doctor without delay
• dizziness
• nausea, vomiting, flatulence (bloating)
• skin allergic reactions (such as rash, persistent itching, urticaria)
• bleeding disorders, such as irregular bleeding or spotting, painful menstruation, 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 affect up to 1 in 100 users):

• 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 immediately and you should contact your doctor without delay
• gallbladder disease
• breast swelling (breast oedema)
• premenstrual syndrome
• weight loss

Rare (may affect up to 1 in 1,000 users):
(*Side effects reported post-marketing, 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*
• heart attack
• stroke*
• swelling of tissues in the face and neck area. May cause breathing difficulties (angioedema)
• purpuric skin eruptions and spots (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin pigmentation, especially on the face and neck, known as "chloasma"*
• leg cramps*

The following side effects have been observed during use of other HRT medicines:

• benign or malignant tumours that may be hormone-dependent, such as endometrial cancer, ovarian cancer (see section 2 for further information)
• increased size of tumours that may be progestogen-dependent (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 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 the rare blood pigment disorder (porphyria)
• high levels of certain fats in the blood (hypertriglyceridaemia)
• increased total concentration of thyroid hormones

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions,
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 side effects helps provide more information on the safety of this medicine.

5. How to store Femoston mini

Keep this medicine out of the sight and reach of children.
No special requirements for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 in this medicine 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 are: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate. Yellow 1 coating: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (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 "379" embossed on one side. Each blister contains 28 tablets. The tablets are yellow in colour.
The tablets are packed in PVC/Aluminum blisters in a cardboard carton.
The pack contains 28 coated tablets.
A cardboard pouch is included in the package, in which the blister should be placed.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Latvia, country of export: 10-0501
Parallel Import Authorisation Number: 290/23
This medicine is authorised in the European Economic Area countries under the following names:

Translation of the weekday symbols found next to each tablet in the immediate packaging:
M./M./E – Monday
T./T./O – Tuesday
W./W./K – Wednesday
T./T./H – Thursday
F./F./R – Friday
S./S./L – Saturday
S./S./S – Sunday