PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Femoston (Femoston 2/10)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston and Femoston 2/10 are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the 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. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Femoston and what is it used for
Important information before taking Femoston
How to take Femoston
Possible side effects
How to store Femoston
Contents of the pack and other information

1. What is Femoston and what is it used for

Femoston 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 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.

Femoston is used for the following purposes:
Treatment of symptoms occurring after menopause.
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 relieves symptoms experienced by postmenopausal women. Femoston is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some women after menopause may develop brittle bones (osteoporosis). Please discuss all available treatment options with your doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and for whom other medicinal treatments are not suitable.

2. Important information before using Femoston

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 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 should take a full medical history, including family medical history. Your doctor may decide to perform additional tests, including breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston, 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 Femoston treatment.
Regular breast screening should be performed according to your doctor's recommendations.

DO NOT take Femoston 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 before taking Femoston, consult your doctor.

When not to take Femoston

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 tumor whose growth is dependent on estrogens, e.g., endometrial cancer (endometrium cancer)
if you currently have or your doctor suspects a tumor whose growth is dependent on progestogens
if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumor of the membrane between the brain and skull)
if you have vaginal bleeding of unknown cause
if you have untreated abnormal thickening of the uterine lining (endometrial hyperplasia)
if you currently have or have had blood clots in the veins (thrombosis), 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 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 (listed in section 6).

If any of the above conditions occur for the first time during treatment with Femoston, 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. If any of the following conditions apply to you, more frequent medical check-ups may be necessary:

uterine fibroids
endometriosis (presence of uterine lining tissue outside the uterus) or history of abnormal thickening of the uterine lining (endometrial hyperplasia)
risk factors for blood clots (see "Blood clots in blood vessels (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 tumors
diabetes
gallstones
migraine or severe headaches
autoimmune disease affecting multiple organs (systemic lupus erythematosus)
epilepsy
asthma
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.

Stop taking Femoston 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"
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, possibly with difficulty breathing – may indicate angioedema
significantly increased blood pressure (symptoms may include: headaches, fatigue, dizziness)
new-onset migraine headaches
pregnancy
symptoms of blood clots, such as: painful swelling and redness in the legs, sudden chest pain, difficulty breathing. See "Blood clots in veins (thrombosis)" for more information.

Note: Femoston 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

Excessive thickening of the uterine lining (endometrial hyperplasia) and uterine cancer (endometrial cancer)
Using HRT with estrogen alone increases the risk of abnormal thickening of the uterine lining (endometrial hyperplasia) and uterine cancer (endometrial cancer).
The progestogen contained in Femoston protects against this additional risk.

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

persists longer than the first 6 months of treatment
starts after 6 months of taking Femoston
continues after stopping Femoston

you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking hormone replacement therapy (HRT) in the form of estrogen-progestogen combination or estrogen alone increases the risk of developing 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 to 54 years 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-progestogen 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-progestogen HRT, the number of cases will be 48 per 1000 women (i.e., 21 additional cases).

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. Using HRT containing only estrogens or a combination of estrogens and progestogens 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 2000 women over 5 years. Among women who have used HRT for 5 years, it will occur in about 3 out of 2000 women (i.e., about 1 additional case).

Effects of HRT on the heart and circulatory system

Blood clots in veins (thrombosis)
The risk of developing blood clots in veins is 1.3 to 3 times higher in women using HRT than in those not using it, especially during the first year of treatment.
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. Inform your doctor if you have any of the following:

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)
any blood clotting disorders requiring long-term anticoagulant treatment
history of venous blood clots in legs, lungs or other organs in close relatives
systemic lupus erythematosus
cancer.

Symptoms of blood clots are described under "Stop taking Femoston and contact your doctor immediately".

Comparative data
Among women aged 50–60 who do not use HRT, 4 to 7 out of 1000 are expected to develop venous blood clots within 5 years.
Among women aged 50–60 who use estrogen-progestogen HRT for over 5 years, 9 to 12 cases per 1000 women will occur (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 combined estrogen-progestogen 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 than in those not using it. The number of additional stroke cases due to HRT use increases with age.

Comparison
Among women aged 50 to 60 who do not use HRT, stroke is expected in an average of 8 per 1000 women over 5 years. Among women aged 50 to 60 who use HRT for over 5 years, 11 cases per 1000 women will occur (i.e., 3 additional cases).

Meningioma
Using Femoston is associated with the development of a usually benign tumor of the membrane between the brain and skull (meningioma). If meningioma is diagnosed, your doctor will discontinue treatment with Femoston (see section "When not to take Femoston"). 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 is indicated only for women with symptoms of estrogen deficiency who have had at least 6 months since their last menstrual period.

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

The following medicines may reduce the effectiveness of Femoston, leading to bleeding or spotting:

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

HRT may affect the action of other drugs:

the antiepileptic drug lamotrigine, which may increase 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 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, 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 any planned blood test, inform your doctor or laboratory staff that you are taking Femoston, as this medicine may affect the results of certain laboratory tests.

Femoston with food and drink
Femoston may be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only for women with symptoms of estrogen deficiency who have had at least 6 months since their last menstrual period.

If pregnancy occurs, stop taking Femoston and contact your doctor. Femoston is not indicated during breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of Femoston on driving and operating machinery. Such an effect is unlikely.

Femoston 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

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 taking Femoston

Do not start treatment with Femoston until at least 6 months have passed since your last natural menstrual period.

Treatment with Femoston may 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 that contains both an oestrogen and a progestagen.

Treatment with Femoston may be started the day after completing a 28-day cycle of a menstrual-type regimen if:

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

How to take Femoston

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 one tablet every day without breaks between packs. The days of the week are marked on the blister pack to help you remember when to take each tablet (the translation of the day symbols located next to each tablet on the immediate packaging can be found at the end of this leaflet and on the sachet included in the package).

Dosage

Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. If the dose seems too strong or too weak, discuss this with your doctor.
If Femoston is being taken to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone mass.
Take one brick-red tablet daily for the first 14 days, followed by one yellow tablet 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. It may be necessary to stop taking Femoston 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 Femoston after surgery.

If you take more Femoston than you should

If you (or someone else) take too many Femoston tablets, it is unlikely to cause serious harm. 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 concerned, consult your doctor.

If you forget to take Femoston

Take the missed tablet as soon as you remember. 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 and do not take a double dose to make up for the missed dose. Breakthrough bleeding or spotting may occur.

Stopping Femoston

Do not stop taking Femoston unless your doctor advises you to do so.

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 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 legs or lungs (venous thromboembolism, pulmonary embolism)
heart disease
stroke
probable 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:
Very common (may occur in more than 1 in 10 women):

headache
abdominal pain
back pain
breast tenderness or pain.

Common (may occur in 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 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
vaginal discharge
feeling of weakness, fatigue, and general malaise
swelling of ankles, feet, or fingers (peripheral oedema)
weight gain.

Uncommon (may occur in 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 blockages in blood vessels of the 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 should be discontinued and you should contact your doctor immediately
gallbladder disease
breast swelling (breast oedema)
premenstrual syndrome
weight loss.

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

heart attack
swelling of tissues in the face and neck area causing breathing difficulties (angioedema)
purplish skin spots and rashes (purpura).

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

benign or malignant tumours which may be oestrogen-dependent, such as cancer of the lining of the womb (cancer of the endometrium), ovarian cancer (for more information see section 2)
growth of tumours which may be progestogen-dependent (such as meningioma)
a disease involving destruction of red blood cells (haemolytic anaemia)
an immune system (autoimmune) disease which may affect multiple organs (systemic lupus erythematosus)
increased frequency of epileptic seizures (epilepsy)
involuntary muscle spasms (chorea)
arterial blood clots (arterial thrombosis)
pancreatitis in women with previously 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 breast changes)
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 not listed in this leaflet, 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 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

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

6. Contents of the pack and other information

What Femoston contains

The active substances are: estradiol (in the form of estradiol hemihydrate) and dydrogesterone
each brick-red tablet contains 2 mg of estradiol (as estradiol hemihydrate);
each yellow tablet contains 2 mg of estradiol (as estradiol hemihydrate) and 10 mg of dydrogesterone
Other ingredients: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Coating: Opadry OY-6957 (pink tablets): hypromellose, talc, polyethylene glycol 400, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172). Coating: Opadry OY-02B2264 (yellow tablets): hypromellose, talc, polyethylene glycol 400, titanium dioxide (E 171), yellow iron oxide (E 172).

What Femoston looks like and contents of the pack

The coated tablets are round, biconvex, with "379" embossed on one side. Each pack contains 28 tablets.
Femoston contains tablets of two different colours. Each blister contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the following 14 days of the cycle).
The tablets are packed in PVC/Al blisters, in a cardboard carton.
The pack contains 28 coated tablets.

A cardboard sachet is included in the pack, into which the blister should be placed.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
THERAMEX IRELAND LIMITED
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1
Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Marketing Authorisation numbers in Romania, country of export:
15178/2023/01
15178/2023/02
Parallel Import Authorisation number: 193/20
Translation of the symbols for days of the week printed next to each tablet in the immediate packaging:
Luni – Monday
Mar – Tuesday
Mie – Wednesday
Joi – Thursday
Vin – Friday
Sâm – Saturday
Dum – Sunday