Patient Information Leaflet

Warning! Keep this 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
Estradiol, Estradiol + Dydrogesterone
Femoston and Femoston 2/10 are different trade names for the same medicine.
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, please 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 another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 of 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 to relieve symptoms occurring after menopause. Femoston 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.
In cases of increased risk of fractures due to osteoporosis, and when the patient cannot take other medicines, Femoston may be used to prevent osteoporosis in postmenopausal women.

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 in treating women with premature menopause (due to ovarian dysfunction or surgical removal of ovaries) is limited. In cases of premature menopause, the risks associated with HRT may differ. Consult your doctor.
Before starting (or re-introducing) HRT, your doctor should take a full medical history, including family history. Your doctor may decide to perform additional tests, including breast examination and/or gynecological examination, if considered 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 according to your doctor's recommendations.
DO NOT take Femoston if any of the following symptoms or medical conditions are present or have occurred in the past. If you have any doubts about the conditions listed below before taking Femoston, you should contact 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 the presence of a tumour whose growth is dependent on oestrogens, e.g. endometrial cancer (cancer of the endometrium)
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 (usually a benign tumour of the tissue layer 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 (venous thrombosis), 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 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 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 uterus
presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal thickening of the lining of the womb (endometrial hyperplasia)
presence of risk factors for blood clots (see "Blood clots in the veins (thrombosis)")
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 ear drum and impairing 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 and contact your doctor immediately if you notice any of the following symptoms while taking 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 symptoms of liver disease
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, combined with breathing difficulties – these may be symptoms of angioedema
significant increase in blood pressure (symptoms may include: headache, fatigue, dizziness)
migraine-type headaches occurring for the first time
pregnancy
symptoms indicating blood clots, 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 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 oestrogen-only HRT increases the risk of abnormal thickening of the lining of the womb (endometrial hyperplasia) and endometrial cancer. The progestogen contained in Femoston protects against this additional risk.
Unexpected bleeding
While taking Femoston, you will experience monthly bleeding (so-called withdrawal bleeding). However, if in addition to monthly bleeding, unexpected bleeding occurs or spotting (blood stains) appears, which:

lasts 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), either oestrogen-progestogen combination or oestrogen-only, 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 over time, but the risk 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 out of 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 use HRT, breast cancer will be diagnosed in an average of 27 out of 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 – much less common than breast cancer. Using oestrogen-only HRT or combined oestrogen-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 to 54 years who do not use HRT, ovarian cancer will be diagnosed in approximately 2 out of 2,000 women over a 5-year period. Among women who have used HRT for 5 years, it will occur in approximately 3 out of 2,000 women (i.e. about 1 additional case).
Effects of HRT on the heart and circulation
Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is 1.3 to 3 times higher in women using HRT than in those not using it, 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 conditions apply to you. Inform your doctor if any of the following situations apply to you:

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 problems requiring long-term anticoagulant treatment
any close relative has ever had blood clots in the legs, lungs or other organs
you have systemic lupus erythematosus
you have cancer.

Symptoms of blood clots are described under "Stop taking Femoston and contact your doctor immediately".
Comparison
Among women aged 50–60 years who do not use HRT, venous blood clots are expected to occur in 4 to 7 out of 1,000 women over 5 years.
Among women aged 50–60 years who use oestrogen-progestogen HRT for over 5 years, 9 to 12 cases per 1,000 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 oestrogen-progestogen HRT, there is a slightly higher 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 years who do not use HRT, stroke is expected to occur in an average of 8 out of 1,000 women over 5 years. Among women aged 50 to 60 years who use HRT for over 5 years, 11 cases per 1,000 women will occur (i.e. 3 additional cases).
Meningioma
Use of Femoston is associated with the development of a usually benign tumour of the tissue layer 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, worsening headaches, memory loss, seizures, or weakness in arms or legs, you should inform your doctor immediately.
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 is indicated only for women with symptoms of deficiency of female sex hormones (oestrogens) in whom at least 6 months have passed since the last menstrual period.
Femoston and other medicines
Some medicines may affect the action of Femoston. This may cause irregular bleeding. The following medicines are involved:
The following medicines may reduce the effectiveness of Femoston, which may lead to bleeding or spotting:

epilepsy medicines (such as: phenobarbital, carbamazepine, phenytoin)
tuberculosis medicines (such as: rifampicin, rifabutin)
medicines used in HIV infection (AIDS) (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, as this may increase the frequency of seizures
treatment regimens 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 not known whether elevated AlAT liver enzyme activity may occur when Femoston is used concomitantly with such combination HCV treatment regimens.

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.
You should 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 deficiency of female sex hormones (oestrogens) in whom at least 6 months have passed since the last menstrual period.

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

Driving and using machines
No studies on the effect of Femoston on driving and operating machinery have been conducted. Such an effect is unlikely.
Femoston contains monohydrate lactose.
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking Femoston.

3. How to use Femoston

This medicine should always be taken exactly as your doctor has advised. If you are unsure, you should
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:

you are not currently using any hormone replacement therapy (HRT), or
you are 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 menstrual cycle pack if:

you are switching from an HRT regimen used in a "cyclical" or "sequential" regimen. This regimen
involves taking a tablet or applying a patch containing oestrogen during the first part of the cycle, followed by taking a tablet or applying a patch containing both oestrogen and 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 your 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 (see the translation of the day symbols next to each tablet on the immediate packaging, provided 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 dosing schedule is shown on the blister pack (see also the translation of the day symbols next to each tablet on the immediate packaging, provided at the end of this leaflet and on the sachet included in the package).

Planned surgery

If you are scheduled for surgery, inform your surgeon that you are taking Femoston. You may need to stop taking Femoston approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (venous thromboembolism)"). Ask your doctor when you can restart Femoston after surgery.

Accidental overdose of Femoston
If you (or someone else) take more Femoston tablets than prescribed, it is unlikely to cause harm.
Possible symptoms include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. No additional treatment is usually required, 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 was due, take the next tablet at the usual time without taking 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 uterus (endometrial hyperplasia or endometrial cancer)
ovarian cancer
blood clots in the veins of the legs or lungs (venous thromboembolic disease, pulmonary embolism)
heart disease
stroke
probable memory loss if HRT is started at age over 65.

For more information on the above adverse effects, see section 2.
During treatment with Femoston, the following adverse effects may occur:
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 caused by fungi 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 (wind)
allergic skin 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 embolism in blood 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 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 causing breathing difficulties (angioedema)
purple spots and skin lesions (purpura).

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

benign or malignant tumours that may be hormone-dependent, such as endometrial cancer (endometrium cancer), ovarian cancer (for more information see section 2)
increased size of tumours that may be progestogen-dependent (e.g. meningioma)
condition 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)
arterial blood clots (arterial thrombosis)
pancreatitis in women with previously existing elevated levels of certain blood fats (hypertriglyceridaemia)
various skin disorders: skin pigmentation changes, especially on face and neck known as "pregnancy mask" (chloasma), painful red 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 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 181 C, 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 to provide more information on the safety of the medicine.

5. How to store Femoston

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

6. Contents of the pack and other information

What Femoston 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 are: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, 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. Coating (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" engraved on one side. Each blister 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 blisters made of PVC/aluminium foil, placed in a cardboard box. A cardboard sachet is included with the pack, in which the blister should be stored.
Pack sizes contain either 28 or 84 coated tablets.

For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, No. 44C – 7.3 and 7.4
1990-095 Lisbon
Portugal
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
NL – 8121 AA Olst
The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Portugal, country of export: 2587186
Parallel Import Authorisation number: 663/15

Translation of the weekday symbols printed next to each tablet in the immediate packaging:
Seg – Monday
Ter – Tuesday
Qua – Wednesday
Qui – Thursday
Sex – Friday
Sáb – Saturday
Dom – Sunday