Package leaflet: Information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please 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, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Femoston mite is and what it is used for
Important information before taking Femoston mite
How to take Femoston mite
Possible side effects
How to store Femoston mite
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 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 women after menopause may develop brittle bones (osteoporosis). All available treatment options should be discussed with the doctor.
Femoston mite may be used for the prevention of osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and who cannot take other medications.

2. Important information before taking 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 the 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, including family history. The doctor may decide to perform additional tests, including breast and/or gynecological examination, if considered necessary.
After starting Femoston mite, you should visit your doctor regularly (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 have any doubts about the conditions listed below before taking Femoston mite, you should 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 currently have or your doctor suspects an estrogen-dependent tumour, e.g. endometrial cancer (cancer of the endometrium)
if you currently have or your doctor suspects a tumour dependent on progestogens
if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the membrane covering the brain and spinal cord)
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 previously 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 currently have or have recently had an arterial blood clot-related disease, e.g. heart attack, stroke or angina
if you have liver disease and liver function test results 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 while taking 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 any of the following conditions have occurred in the past, more frequent medical check-ups may be necessary:

uterine fibroids
endometriosis (presence of endometrial tissue outside the uterus) or previous abnormal thickening of the endometrium (endometrial hyperplasia)
risk factors for blood clots (see “Blood clots in the veins (thrombosis)”)
increased risk of estrogen-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
an autoimmune disease affecting multiple organs (systemic lupus erythematosus)
epilepsy
asthma
hearing impairment due to bone overgrowth in the middle ear (otosclerosis)
very high levels of blood fats (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 notice 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 indicate liver disease
swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives combined with breathing difficulties – may indicate angioedema
a significant increase in blood pressure (symptoms may include: headache, fatigue, dizziness)
new-onset migraine 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 act as a contraceptive. 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 (endometrial cancer)
Using HRT with estrogen alone 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 withdrawal bleeding. However, if unexpected bleeding or spotting occurs in addition to the monthly bleed, and:

continues beyond the first 6 months of treatment
starts after 6 months of treatment
continues after stopping Femoston mite

you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking combined estrogen-progestogen HRT or estrogen-only H0RT 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 50–54 not using HRT, breast cancer will be diagnosed in an average of 13 to 17 per 1,000 women over 5 years.
Among women aged 50 starting 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 starting 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 50–59 not using HRT, breast cancer will be diagnosed in an average of 27 per 1,000 women over 10 years.
Among women aged 50 starting 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 starting 10-year combined estrogen-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).

You should examine your breasts regularly. 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 – much rarer than breast cancer. Using estrogen-only HRT or combined estrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50–54 not using HRT, ovarian cancer will be diagnosed in about 2 per 2,000 women over 5 years. Among women who have used HRT for 5 years, it will occur in about 3 per 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 non-users, especially during the first year of use.
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 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 close relatives
systemic lupus erythematosus
cancer

Symptoms of blood clots: see “You should stop taking Femoston mite and contact your doctor immediately”.

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

Coronary heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. Women over 60 using combined estrogen-progestogen HRT have a significantly higher risk of heart disease compared to non-users.

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

Comparative data
Among women aged 50–60 not using HRT, stroke is expected in an average of 8 per 1,000 women over 5 years. Among women aged 50–60 using HRT for more than 5 years, there will be 11 cases per 1,000 women (i.e. 3 additional cases).

Meningioma
Use of Femoston mite is associated with the development of usually benign tumours of the membrane covering the brain and spinal cord (meningioma). If meningioma is diagnosed, your doctor will stop treatment with Femoston mite (see section “When not to take Femoston mite”). If you notice any symptoms such as vision 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 arms or legs, inform your doctor immediately.

Other conditions
HRT does not prevent memory loss. Evidence suggests an 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 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:

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

HRT may affect the action of other medicines:

the antiepileptic drug lamotrigine, which may increase seizure frequency
combination treatment regimens for hepatitis C virus (HCV) infection (e.g. ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir) may increase liver function test parameters in blood (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether elevated AlAT activity may occur when Femoston is used concurrently with such HCV combination therapies.

During treatment with 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 in asthma and other breathing problems

Therefore, careful monitoring of drug levels may be necessary for a period, and dose reduction of the affected medicine may be required.

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 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 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.
Femoston mite is not indicated during breastfeeding.

Driving and using machines
No studies on the effect of Femoston mite on driving and operating machinery have been conducted. 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 used exactly as your doctor has told you. If you are unsure,
please consult your doctor or pharmacist.
When to start using Femoston mite

Do not start treatment with Femoston mite before 6 months have passed since your last
natural menstrual period.

Treatment with Femoston mite can be started on any day if:

the patient is not currently using any hormone replacement therapy (HRT), or
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 estrogen and progestagen.

Treatment with Femoston mite can be started the day after completing 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 your body and also helps you remember to take it.
Take 1 tablet every day without interruption between packs. The blister pack is marked with days of the week to help you remember when to take your tablet (the translation of the day-of-the-week symbols located next to each tablet on the primary packaging can be found at the end of this leaflet and on the sachet included in the package).

Dosage

Your doctor will prescribe the lowest effective dose for the shortest duration necessary 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 cycle 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 "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 serious harm. Possible 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 you are unsure, 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 your usual time without taking 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 first consulting your doctor.

If you have any further questions about the use of this medicine, please 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 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
possible memory loss if HRT is started 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 (feeling sick), vomiting, flatulence (wind)
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 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 Femoston mite should be discontinued and you should contact your doctor immediately
gallbladder disease
breast swelling (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). This may cause difficulty in breathing
purplish spots and patches on the skin (purpura)

Other adverse effects reported during HRT use, including Femoston mite, with unknown frequency:

benign or malignant estrogen-dependent tumours, such as cancer of the lining of the womb (endometrial cancer), ovarian cancer (see section 2 for more information)
increase in size of tumours that may be progestogen-dependent (such as meningioma)
condition involving destruction of red blood cells (haemolytic anaemia)
autoimmune disease affecting multiple organs (systemic lupus erythematosus)
worsening of epileptic seizures (epilepsy)
involuntary muscle spasms (chorea)
blood clots in arteries (arterial thrombosis)
pancreatitis, in women with pre-existing high levels of certain blood fats (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)
leg cramps
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 edema), inability to wear contact lenses (contact lens intolerance)
increased total concentration of thyroid hormones

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse 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 adverse effects helps provide more information on the safety of this medicine.

5. How to store Femoston mite

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

6. Contents of the pack and other information

What Femoston mite contains

The active substances are: estradiol (in the form of 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 are: lactose monohydrate, 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 sachet 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 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Austria, country of export: 1-23189
Parallel import authorisation number: 112/25
Translation of the weekday symbols printed next to each tablet in the immediate packaging:
MO - Monday
DI - Tuesday
MI - Wednesday
DO - Thursday
FR - Friday
SA - Saturday
SO - Sunday