Femoston mite

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Femoston mite
1 mg (white), 1 mg + 10 mg (grey), film-coated tablets
Estradiol, Estradiol + Dydrogesterone
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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. This medicine may harm another person, 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 of the leaflet

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 deficiency of female sex hormones (oestrogens) and in whom at least 6 months have passed since the last menstruation.

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 women after menopause may develop brittle bones (osteoporosis). Discuss all available treatment options with your doctor.
In cases of increased risk of fractures due to osteoporosis, and when the patient cannot take other medications, Femoston mite may be used to prevent osteoporosis in postmenopausal women.

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 with treating women with premature menopause (due to ovarian dysfunction or after surgical removal of ovaries) is limited. The risks associated with HRT in cases of premature menopause 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 examination and/or gynaecological examination, if deemed necessary.
After starting 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.
Regular breast screening should be performed according to your doctor's recommendations.

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

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 currently have or your doctor suspects a tumour whose growth is dependent on oestrogens, e.g. endometrial cancer (endometrium cancer)
• if you currently 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 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 (such as protein C, protein S or antithrombin deficiency)
• if you currently have or have 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 test results have not returned to normal
• if you have the 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 while taking Femoston mite, stop taking it 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, more frequent medical check-ups are recommended:

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

You should stop taking Femoston mite and contact your doctor immediately if you experience any of the following symptoms while on HRT:

• any of the conditions listed under "When not to take Femoston mite"
• yellowing of the skin or whites of the eyes (jaundice) – may be signs of liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, combined with breathing difficulties – may be symptoms of angioedema
• significantly increased blood pressure (symptoms may include: headaches, fatigue, dizziness)
• new onset of migraine-type headaches
• 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 contraceptive effects. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, additional contraception may be needed to prevent pregnancy. Consult your doctor.

HRT and cancer

Abnormal thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer)
Taking oestrogen-only HRT increases the risk of abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. The progestogen component 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 bleeds, unexpected bleeding or spotting occurs that:

• persists beyond 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 combined oestrogen-progestogen HRT or oestrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long HRT is used. 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 50–54 years not taking 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 5 years of oestrogen-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 5 years of oestrogen-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50–59 not taking 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 10 years of oestrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. 7 additional cases).
Among women aged 50 who start 10 years of oestrogen-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 less common than breast cancer. Taking oestrogen-only HRT or combined oestrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer increases with age. For example, among women aged 50–54 not taking HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over 5 years. Among women who have taken 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

Blood clots in the veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women taking HRT than in those not taking it, especially during the first year of treatment.
Venous thrombosis can have serious consequences. If clots travel to the lungs, they may cause chest pain, shortness of breath, fainting or even death.
The risk of venous thrombosis increases with age and if any of the following 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 thrombosis in legs, lungs or other organs in any close relative
• systemic lupus erythematosus
• cancer.

Symptoms of venous thrombosis: see "Stop taking Femoston mite and contact your doctor immediately".

Comparative data
Among women aged 50–60 not taking HRT, 4 to 7 out of 1,000 are expected to develop venous thrombosis over 5 years.
Among women aged 50–60 taking combined oestrogen-progestogen HRT for over 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 taking combined oestrogen-progestogen HRT, the risk of heart disease is significantly higher than in women not taking HRT.

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

Comparative data
Among women aged 50–60 not taking HRT, stroke is expected in an average of 8 out of 1,000 women over 5 years. Among women aged 50–60 taking HRT for over 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 increased risk of memory loss in women who start HRT after age 65. Consult your doctor.

Children
Femoston mite is indicated only for women with symptoms of oestrogen 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. The following medicines may reduce the effectiveness of Femoston mite, leading to bleeding or spotting:

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

HRT may affect the action of other medicines:

• the antiepileptic lamotrigine, potentially increasing seizure frequency
• combination therapy for hepatitis C virus (HCV) infection (e.g. ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir) may increase liver function test parameters (elevated liver enzyme AlAT activity) in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston mite contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT activity may occur when taking Femoston mite concurrently with such HCV combination therapies.

While taking Femoston mite, dangerously high blood levels of the following medicines may occur:

• tacrolimus, cyclosporine – used, for example, after organ transplantation
• fentanyl – a painkiller
• theophylline – used for 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 medicine 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 health 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 oestrogen deficiency who have not had a menstrual period for at least 6 months.

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

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

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

3. How to use Femoston mite

This medicine should always be used as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
When to start using Femoston mite

Do not start treatment with Femoston mite before 6 months have passed since the last
natural menstrual period.
Treatment with Femoston mite may be started on any day if:

• the patient is not currently using 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 containing both an estrogen and a progestagen.

Treatment with Femoston mite may be started the day after 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 or applying an estrogen-only tablet or patch during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both estrogen and progestagen.

How to take 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 your tablet.

• Take 1 tablet daily, without interruption between packs. The days of the week are marked on the blister pack to help you remember when to take each tablet (a translation of the day symbols located 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).

How much to take

• Your doctor will prescribe the lowest effective dose 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 once daily for the next 14 days. The 28-day treatment schedule is indicated on the calendar provided in the packaging.

Planned surgery

• If you are scheduled for surgery, inform your surgeon that you are taking Femoston mite. You may need 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 veins (venous thromboembolism)"). Ask your doctor when you can resume taking Femoston mite.

Taking more than the recommended dose of Femoston mite
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.

Missed dose of 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—do not take 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 mite treatment
Do not stop taking Femoston mite without consulting your doctor.

• If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
The following conditions have been reported more frequently in women using 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 thromboembolic disease, pulmonary embolism)
• heart diseases
• 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):

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

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

• vaginal thrush (vaginal infection with a fungus called Candida albicans)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, treatment with Femoston mite should be discontinued immediately and you should contact your doctor without delay
• dizziness
• nausea, vomiting, flatulence (bloating)
• skin allergic reactions (such as rash, severe 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 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 vessels of legs or lungs (venous thromboembolic disease 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 Femoston mite should be discontinued immediately and you should contact your doctor without delay
• gallbladder disorders
• breast swelling (breast oedema)
• premenstrual syndrome
• weight loss

Rare (may affect up to 1 in 1000 women):

• heart attack
• swelling of tissues in the face and neck causing breathing difficulties (angioedema). May cause difficulty in breathing.
• purplish spots and patches on the skin (purpura)

Other adverse effects reported during HRT use, including this medicine Femoston mite, with unknown frequency of occurrence:

• benign or malignant estrogen-dependent tumours, such as cancer of the lining of the womb (cancer of the endometrium), ovarian cancer (for more information see section 2)
• increase in size of tumours that may be progestagen-dependent (such as meningioma)
• disease involving destruction of red blood cells (haemolytic anaemia)
• autoimmune disease attacking multiple organs (systemic lupus erythematosus)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle spasms (chorea)
• arterial blood clots (arterial thrombosis)
• pancreatitis, in women with previously existing high levels of certain fats in the blood (hypertriglyceridaemia)
• various skin disorders: skin pigmentation, especially on the face and neck known as "pregnancy mask" (chloasma), painful red skin nodules (erythema nodosum), rash in the form of red rings or blisters (erythema multiforme)
• cramps in the lower limbs
• urinary incontinence
• painful/lumpy breasts (fibrocystic changes of the breast)
• cervical erosion
• worsening of symptoms of a rare disease affecting blood pigment (porphyria)
• high levels of certain fats in the blood (hypertriglyceridaemia)
• changes in the cornea of the eye (corneal oedema), inability to wear contact lenses (contact lens intolerance)
• increased total concentration of thyroid hormones

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Femoston mite

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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. This helps 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 wallet is included with the pack, in which the blister should be stored.

For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Austria, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House Park Lane
Spencer Dock - D01 YE64 Dublin 1, Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, Netherlands
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorization number in Austria, country of export: 1-23189
Parallel import authorization number: 247/24

Translation of the symbols for days of the week printed next to each tablet in the immediate packaging:
MO – Monday
DI – Tuesday
MI – Wednesday
DO – Thursday
FR – Friday
SA – Saturday
SO – Sunday