Femoston mite

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Femoston mite (Climaston 1 mg/10 mg)
1 mg (white), 1 mg + 10 mg (grey), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston mite and Climaston 1 mg/10 mg are different trade names of the same medicinal product.
Please read the following information carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Femoston mite 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 mite is indicated for use in women who have symptoms of low levels of female sex hormones (oestrogens) and who have been without menstruation for at least 6 months.

What it is used for
Femoston mite is indicated for:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogens produced by a woman's body decreases. This may lead to symptoms such as hot flushes affecting the face, neck, and chest. Femoston mite reduces these symptoms in postmenopausal women. Femoston mite is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some postmenopausal women may develop brittle bones (osteoporosis). Please discuss all available treatment options with your doctor.
Femoston mite may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and who cannot take other available medicines.

2. Important information before using Femoston mite

Medical history and regular check-ups
Hormone replacement therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or surgical removal of ovaries) is limited. In cases of premature menopause, the risks associated with HRT may differ. Consult your doctor.
Before starting (or restarting) HRT, your doctor will take a detailed medical history of you and your family. Your doctor may decide to perform additional tests, including breast and/or gynecological examination, if considered necessary.
While taking Femoston mite, you should attend regular check-ups with your doctor (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing treatment with Femoston mite.
You should undergo regular breast screening examinations according to your doctor's recommendations.

DO NOT take Femoston mite if any of the following symptoms or medical conditions are present or have occurred in the past. If you have any doubts about the conditions listed below before taking Femoston mite, you must consult your doctor.

When not to take Femoston mite

• if you have been diagnosed with, have had in the past, or your doctor suspects breast cancer
• if you have or your doctor suspects a tumour whose growth is dependent on estrogens, e.g. cancer of the uterine lining (cancer of the endometrium)
• if you have or your doctor suspects a tumour whose growth is dependent on progestogens, e.g. a brain tumour (meningioma)
• if you have vaginal bleeding of unknown cause
• if you have untreated abnormal thickening of the uterine lining (endometrial hyperplasia)
• if you 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 (such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
• if you have or recently had an arterial disease caused by blood clots, e.g. heart attack, stroke, or coronary heart disease
• if you have liver disease and liver function tests have not returned to normal
• if you have a rare inherited blood disorder called porphyria
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston mite (listed in section 6).

If any of the above conditions occur for the first time during treatment with Femoston mite, stop taking the medicine immediately and consult your doctor.

Warnings and precautions
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Femoston mite. If you have ever had any of the conditions listed below, you should have more frequent medical check-ups:

• uterine fibroids
• presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal thickening of the uterine lining (endometrial hyperplasia)
• risk factors for developing blood clots (see "Blood clots in the veins (thrombosis)")
• increased risk of estrogen-dependent cancer (e.g. history of breast cancer in close relatives such as mother, sister, or grandmother)
• high blood pressure
• liver diseases, such as benign liver tumours
• diabetes
• gallstones
• migraine or severe headaches
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• ear disease impairing hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney disorders
• hereditary or acquired angioedema.

Stop taking Femoston mite and contact your doctor immediately if you notice any of the following symptoms during HRT:

• any of the conditions listed under "When not to take Femoston mite"
• yellowing of the skin or whites of the eyes (jaundice) – these may be signs of liver disease
• swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, combined with breathing difficulties – these may be symptoms of angioedema
• significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness)
• migraine headaches occurring for the first time
• pregnancy
• symptoms of blood clots in blood vessels, such as:
  • painful swelling and redness in the legs
  • sudden chest pain
  • difficulty breathing See more information under "Blood clots in the veins (thrombosis)".

Note: Femoston mite does not have a contraceptive effect. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, additional contraception may be necessary to prevent pregnancy. Consult your doctor.

HRT and cancer

Abnormal thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
HRT with estrogen-only therapy increases the risk of abnormal thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).
The progestogen contained in Femoston mite protects against this additional risk.

Unexpected bleeding
While taking Femoston mite, you will experience monthly bleeding (so-called withdrawal bleeding). However, if in addition to monthly bleeding you experience unexpected bleeding or spotting that:

• persists longer than the first 6 months of treatment
• begins after 6 months of starting Femoston mite
• continues after stopping Femoston mite
  you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking hormone replacement therapy (HRT) in the form of combined estrogen-progestogen or estrogen-only therapy increases the risk of developing 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 the risk may persist for 10 years or longer if HRT was taken for more than 5 years.

Comparison
Among women aged 50 to 54 years who do not use 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 who start a 5-year 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 who start a 5-year combined estrogen-progestogen 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 who do not use HRT, breast cancer will be diagnosed in an average of 27 out of 1,000 women over 10 years.
Among women aged 50 who start a 10-year estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. 7 additional cases).
Among women aged 50 who start a 10-year combined estrogen-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).

• You should regularly examine your breasts. Contact your doctor if you notice any changes such as:
• skin indentation of the breast
• changes around the nipple
• any visible or palpable lumps

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. HRT containing only estrogens or combined estrogen-progestogen therapy 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 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 circulation

Blood clots in the veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women using HRT than in those not using it, especially during the first year of treatment.
The formation of blood clots can have serious consequences. If they travel to the lungs, they may cause chest pain, shortness of breath, fainting, or even death.
The risk of venous blood clots increases with age and if any of the following conditions apply to you. Inform your doctor if you have any of the following conditions:

• inability to walk for a prolonged period 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 therapy
• history of venous blood clots in legs, lungs, or other organs in any close relative
• systemic lupus erythematosus diagnosed in you
• cancer diagnosed in you.

Symptoms of blood clots: see "Stop taking Femoston mite and contact your doctor immediately".

Comparative data
Among women aged 50–60 who do not use HRT, venous blood clots are expected in 4 to 7 out of 1,000 over 5 years.
Among women aged 50–60 who use combined estrogen-progestogen HRT for more than 5 years, 9 to 12 cases per 1,000 women will occur (i.e. 5 additional cases).

Coronary heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. In women over 60 years of age using combined estrogen-progestogen HRT, the risk of heart disease is significantly higher than in women not using HRT.

Stroke
The risk of stroke is 1.5 times higher in women using HRT than in those not using it. The number of additional stroke cases due to HRT increases with age.

Comparative data
Among women aged 50–60 who do not use HRT, stroke is expected in an average of 8 out of 1,000 women over 5 years. Among women aged 50–60 who use HRT for more than 5 years, 11 cases per 1,000 women will occur (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.

Children
Femoston mite is indicated only for women with symptoms of estrogen deficiency who have not had a menstrual period for at least 6 months.

Femoston mite and other medicines
Some medicines may affect the action of Femoston mite, potentially causing irregular bleeding. These include:

The following medicines may reduce the effectiveness of Femoston mite, possibly causing bleeding or spotting:

• antiepileptic drugs (epilepsy) (such as: phenobarbital, carbamazepine, phenytoin)
• tuberculosis medications (such as: rifampicin, rifabutin)
• HIV (AIDS) medications (such as: nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal remedies containing St. John's wort (Hypericum perforatum)

HRT may affect the action of other medicines:

• the antiepileptic drug lamotrigine, which may increase the frequency of seizures
• combination therapy for hepatitis C virus (HCV) infection (e.g. with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir combination therapy) may increase liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT liver enzyme activity may occur when Femoston is used concurrently with such combination HCV treatments.

During treatment with Femoston mite, dangerously high blood levels of the following drugs may occur:

• tacrolimus, cyclosporine – used, for example, after organ transplantation
• fentanyl – a painkiller
• theophylline – used in asthma and other breathing problems.

Therefore, careful monitoring of drug levels may be necessary for a period of time, and dose reduction of the affected drug may be required.
Inform 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 medicinal products (e.g. dietary supplements). Your doctor will provide appropriate advice.

Blood tests
Before a planned blood test, inform your doctor or laboratory staff that you are taking Femoston mite, as this medicine may affect the results of certain laboratory tests.

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

Pregnancy and breastfeeding
Femoston mite is indicated only for women with symptoms of estrogen deficiency who have not had a menstrual period for at least 6 months.

• If pregnancy is confirmed, stop taking Femoston mite and contact your doctor.

Driving and using machines
No studies have been conducted on the effects of Femoston mite on driving and operating machinery. Such effects are unlikely.

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

3. How to use Femoston mite

This medicine should always be taken exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
When to start taking Femoston mite
Do not start treatment with Femoston mite until at least 6 months have passed since your last natural menstrual period.
Treatment with Femoston mite may be started on any day if:

• the patient is not currently using any other hormone replacement therapy (HRT)
• the patient is switching from another HRT product used in a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily that contains both an oestrogen and a progestagen.

Treatment with Femoston mite may be started the day after the completion of a 28-day menstrual cycle if:

• the patient is switching from HRT used in a "cyclical" or "sequential" regimen. This regimen involves taking a tablet or applying a patch containing oestrogen during the first part of the cycle, followed by taking a tablet or applying a patch containing both oestrogen and progestagen for the next 14 days.

Taking Femoston mite

• Swallow the tablet with water.
• Tablets may be taken with or without food.
• Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in the body and also helps you remember to take it.
• Take 1 tablet every day without interruption between packs. The days of the week are marked on the blister pack to help you 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 the leaflet and on the sachet included in the package).

Dosage

• Your doctor will choose the lowest effective dose to be used for the shortest necessary duration to treat your symptoms. Consult your doctor if the dose seems too strong or too weak for you.
• When Femoston mite is used to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone mass.
• Take one white tablet daily for the first 14 days, followed by one grey tablet daily for the next 14 days. The 28-day treatment schedule is indicated on the calendar printed on the packaging.

Planned surgery

• If you are planning to have surgery, inform your surgeon that you are taking Femoston mite. It may be necessary to stop taking Femoston mite approximately 4 to 6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (venous thromboembolism)"). Ask your doctor when you can resume taking Femoston mite.

If you take more Femoston mite than you should
If you (or someone else) take too many Femoston mite tablets, it is unlikely to cause harmful effects. Symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually necessary, but if in doubt, consult your doctor.

If you forget to take Femoston mite
Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been taken, take the next tablet at the usual time and do not take the missed tablet. Do not take a double dose to make up for a forgotten tablet. Breakthrough bleeding or spotting may occur if a dose is missed.

Stopping Femoston mite
Do not stop taking Femoston mite without consulting your doctor.

• If you have any further questions about the use of 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 diseases have been reported more frequently in women using hormone replacement therapy (HRT) compared to women not using HRT:

• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer of the endometrium)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart disease
• stroke
• probable memory loss if HRT is initiated after the age of 65.

For more information on the above adverse effects, see section 2.
The following adverse effects may occur during treatment with Femoston mite:

Very common (may affect more than 1 in 10 women):

• headache
• abdominal pain
• back pain
• breast tenderness or pain

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

• vaginal thrush (a fungal infection of the vagina caused by Candida albicans)
• depression, nervousness
• migraine. If migraine-type headaches occur for the first time, treatment with Femoston mite should be discontinued and you should contact your doctor immediately
• dizziness
• nausea, vomiting, flatulence (bloating)
• skin allergic reactions (such as rash, severe 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 the ankles, feet or fingers (peripheral oedema)
• weight gain

Uncommon (may affect up to 1 in 100 women):

• proliferative changes in the pelvis (e.g. fibroids) may increase in size
• hypersensitivity reactions, such as shortness of breath (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhoea or hypotension
• change in libido
• blood clots causing embolism in blood vessels of the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling of weakness or general malaise and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Fem游戏副本

5. How to store Femoston mite

Keep this medicine out of sight and reach of children.
No special storage conditions are required.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Femoston mite contains

• The active substances are: estradiol (as estradiol hemihydrate) and dydrogesterone
• each white tablet contains 1 mg of estradiol
• each grey tablet contains 1 mg of estradiol and 10 mg of dydrogesterone
• Other ingredients: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate
• Coating (white tablets): titanium dioxide (E 171), hypromellose, polyethylene glycol
• Coating (grey tablets): titanium dioxide (E 171), black iron oxide (E 172), polyvinyl alcohol, polyethylene glycol, talc

What Femoston mite looks like and contents of the pack

• The coated tablets are round, biconvex, with "379" embossed on one side. Each blister contains 28 tablets.
• Femoston mite contains tablets in two colours. Each pack contains 14 white tablets (for the first 14 days of the cycle) and 14 grey tablets (for the following 14 days of the cycle).
• The tablets are packed in PVC/Al blisters in a cardboard box.
• The pack contains 28 coated tablets.
• A cardboard pocket is included with the pack, in which the blister should be placed.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin, D01YE64
Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The 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 France, country of export: 3400935264350
Parallel Import Authorisation Number: 431/24

Translation of the weekday symbols located next to each tablet in the immediate packaging:
LUN – Monday
MAR – Tuesday
MER – Wednesday
JEU – Thursday
VEN – Friday
SAM – Saturday
DIM – Sunday