Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Femoston
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Please read this leaflet 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. This medicine 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, pharmacist, or nurse. See section 4.

Table of contents

What Femoston is and what it is 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 Femoston is and what it is 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 in female sex hormones (oestrogens) and in whom at least 6 months have passed since their last menstrual period.

Femoston is used for the following purposes:

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 helps relieve symptoms occurring after menopause.
Femoston is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
In some women after menopause, bone fragility (osteoporosis) may occur. All available treatment options should be discussed with your doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and who cannot take other medications.

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.
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Experience in 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 should take a detailed medical history, including family history. Your doctor may decide to perform additional tests, including breast examination and/or gynaecological examination, if deemed necessary.
After starting Femoston, you should attend regular check-ups with your doctor (at least once a year). During these visits, you and your doctor should discuss together the benefits and risks of continuing Femoston treatment.
You should undergo regular breast screening examinations as recommended by your doctor.
DO NOT take Femoston if any of the following symptoms or medical conditions exist or have occurred in the past. If you are uncertain about any of the conditions listed below, consult your doctor before taking Femoston.
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 the presence of a tumour whose growth is dependent on oestrogens, e.g. cancer of the lining of the womb (endometrial cancer);
if you currently have or your doctor suspects the presence of a tumour whose growth is dependent on progestogens;
if you have meningioma or have ever been diagnosed with meningioma (a usually benign tumour of the membrane between the brain and the skull);
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 (thrombosis), e.g. in the legs (deep vein thrombosis), or in the 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 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 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 while taking 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 you have ever had any of the conditions listed below, you should have more frequent medical check-ups:

fibroids of the womb;
presence of the lining of the womb outside the womb (endometriosis) or a history of abnormal thickening of the lining of the womb (endometrial hyperplasia);
risk factors for developing blood clots (see "Blood clots in the veins (thrombosis)");

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increased risk of oestrogen-dependent cancer (e.g. history of breast cancer in close relatives such as mother, sister, 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;
a disease damaging the inner ear membrane and impairing hearing (otosclerosis);
very high levels of fats in the blood (triglycerides);
fluid retention due to heart or kidney disorders;
hereditary or acquired angioedema.

You should stop taking Femoston 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";
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 difficulty breathing – these may be symptoms of angioedema;
a significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness);
migraine headaches occurring for the first time;
pregnancy;
symptoms of blood clots such as: painful swelling and redness in the legs, sudden chest pain, difficulty breathing; see "Blood clots in the veins (thrombosis)" for more information.

Note: Femoston 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
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Using HRT with oestrogen alone increases the risk of abnormal thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer).
The progestogen contained in Femoston protects against this additional risk.
Unexpected bleeding
While taking Femoston, you will experience a monthly bleed (so-called withdrawal bleed). However, if in addition to these monthly bleeds, unexpected bleeding or spotting occurs, and:

continues beyond 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), either as oestrogen-progestogen combination or oestrogen alone, 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 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 take HRT, breast cancer will be diagnosed in an average of 13 to 17 per 1,000 women over a 5-year period.
Among women aged 50 who start a 5-year course 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 a 5-year course 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 to 59 years who do not take HRT, breast cancer will be diagnosed in an average of 27 per 1,000 women over a 10-year period.
Among women aged 50 who start a 10-year course 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 a 10-year course 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 rarer than breast cancer. Taking HRT, whether oestrogen-only or combined oestrogen-progestogen, 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 years who do not take HRT, ovarian cancer will be diagnosed in about 2 per 2,000 women over a 5-year period. Among women who have taken HRT for 5 years, it will occur in about 3 per 2,000 women (i.e. about 1 additional case).
Effect of HRT on the heart and circulatory system
Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is 1.3 to 3 times higher in women taking HRT than in those not taking 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 developing 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"),
you are significantly overweight (BMI >30 kg/m²),
you have any blood clotting disorders requiring long-term treatment with anticoagulant medicines,
any close relatives have ever had blood clots in the legs, lungs or other organs,
you have systemic lupus erythematosus,
you have cancer.

Symptoms of blood clots, see "Stop taking Femoston and contact your doctor immediately".
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Comparative data
Among women aged 50–60 years who do not take HRT, an average of 4 to 7 per 1,000 can be expected to develop venous blood clots within 5 years.
Among women aged 50–60 years who take oestrogen-progestogen HRT for more than 5 years, there will be 9 to 12 cases per 1,000 women (i.e. 5 additional cases).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
In women over 60 years of age taking combined oestrogen-progestogen HRT, there is a slightly increased tendency to develop heart disease compared to women not taking HRT.
Stroke
The risk of stroke is about 1.5 times higher in women taking HRT than in those not taking it.
The number of additional stroke cases due to HRT use increases with age.
Comparison
Among women aged 50 to 60 years who do not take HRT, stroke is expected to occur in an average of 8 per 1,000 women over 5 years. Among women aged 50 to 60 years who take HRT for more than 5 years, there will be 11 cases per 1,000 women (i.e. 3 additional cases).
Meningioma
Taking Femoston is associated with the development of a usually benign tumour of the membrane between the brain and the skull (meningioma). If meningioma is diagnosed in you, 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, progressively worsening headaches, memory loss, seizures, or weakness in the arms or legs, you should 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 the age of 65. Consult your doctor.
Children
Femoston is indicated only for women with symptoms of oestrogen deficiency who have not had a menstrual period for at least 6 months.
Femoston and other medicines
Some medicines may affect the action of Femoston. This may cause irregular bleeding. The following medicines may reduce the effectiveness of Femoston, leading to bleeding or spotting:

epilepsy medicines (such as: phenobarbital, carbamazepine, phenytoin),
tuberculosis medicines (such as: rifampicin, rifabutin),
medicines used in HIV (AIDS) infection (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 epilepsy medicine lamotrigine, which may increase the frequency of seizures,
combination treatment regimens for hepatitis C virus (HCV) infection using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 4.4), may increase liver function parameters in blood tests (increased liver enzyme AlAT activity) in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether increased AlAT liver enzyme activity may occur when Femoston is taken concurrently with such combination HCV treatment regimens.

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During treatment with Femoston, 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 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 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 oestrogen deficiency who have not had a menstrual period for at least 6 months.
➢ If pregnancy is detected, stop taking Femoston and contact your doctor.
Femoston is not indicated during breastfeeding.
Driving and using machines
No studies have been conducted on the effect of Femoston on driving and operating machinery. Such an effect is unlikely.
Femoston contains lactose monohydrate
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking Femoston.

3. How to use Femoston

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, 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 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 estrogen and a progestagen.

Treatment with Femoston may be started the day after completion of a 28-day cycle pack if:
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the patient is switching from HRT administered in a "cyclical" or "sequential" regimen. This regimen involves taking a tablet or applying a patch containing estrogen 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

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 interruption 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 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.
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 blister pack.

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 resume taking Femoston.

Accidental overdose of Femoston
If you (or someone else) take more tablets than prescribed, it is unlikely to cause 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 in doubt, consult your doctor.

Missed dose of Femoston
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 missed dose. Breakthrough bleeding or spotting may occur.

Stopping Femoston
Do not stop taking Femoston without consulting your doctor.
➢ If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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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,
probable memory loss if HRT is started after the age of 65.

For further information on the above adverse reactions, see section 2.
The following adverse reactions may occur during treatment with Femoston:
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 caused by a fungus called Candida albicans);
depression, nervousness;
migraine. If you experience migraine-type headaches for the first time, stop taking Femoston and 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 periods, 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 affect up to 1 in 100 women):

growth of pelvic masses (e.g. fibroids) may increase;
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 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, stop taking Femoston and 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);
purple spots and rashes on the skin (purpura).

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

benign or malignant tumours that may be influenced by oestrogen levels, such as cancer of the lining of the womb (cancer of the endometrium), ovarian cancer (see section 2 for more information);
increased size of tumours that may be influenced by progestogen levels (e.g. meningioma);
a disease involving destruction of red blood cells (haemolytic anaemia);
autoimmune disease which may affect multiple organs (systemic lupus erythematosus);
worsening of epileptic seizures (epilepsy);
involuntary muscle spasms (chorea);
blood clots in arteries (arterial thrombosis);
pancreatitis in women with previously elevated 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 with 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 reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can also 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 reactions helps provide more information on the safety of this medicine.

5. How to store Femoston

Keep this medicine out of the 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. Such measures help protect the environment.
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6. Contents of the pack and other information

What Femoston contains

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

What Femoston looks like and contents of the pack

The coated tablets are round, biconvex, with "379" embossed on one side.
Femoston contains tablets in two colours. Each pack 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).
Tablets are packed in PVC/Al blisters.
The pack contains either 28 coated tablets or 84 coated tablets.

A cardboard sleeve is included with the pack, in which the blister should be placed.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland
Manufacturer:
Abbott Biologicals BV
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 the Czech Republic, country of export: 54/114/98-C
Parallel Import Licence Number: 14/26
Translation of symbols for days of the week printed next to each tablet in the immediate packaging:
PO - Monday
ÚT - Tuesday
ST - Wednesday
ČT - Thursday
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PÁ - Friday
SO - Saturday
NE - Sunday
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