Patient Information Leaflet

Warning! Keep this leaflet! The packaging label 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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 relieves symptoms occurring in 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 when there is an increased risk of fractures due to osteoporosis and when the patient cannot take other available treatments.

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 the ovaries) is limited. In cases of premature menopause, the risks associated with HRT may differ. Please consult your doctor.
Before starting (or reinitiating) 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 deemed necessary.
Once you start taking 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 conditions are present or have occurred in the past. If you are unsure about any of the conditions listed below before taking Femoston, you should 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 have or your doctor suspects the presence of a tumour dependent on estrogens, such as cancer of the endometrium (endometrial cancer);
if you have or your doctor suspects the presence of a tumour dependent on progestogens;
if you have meningioma or have ever been diagnosed with meningioma (a usually benign tumour of the tissue layer between the brain and skull);
if you have vaginal bleeding of unknown cause;
if you have untreated abnormal thickening of the endometrium (endometrial hyperplasia);
if you 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, protein S or antithrombin deficiency);
if you 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 while taking Femoston, you must 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:

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. 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 affecting the middle ear and hearing (otosclerosis);
very high levels of fats in the blood (triglycerides);
fluid retention due to heart or kidney problems;
hereditary or acquired angioedema.

You must stop taking Femoston and contact your doctor immediately if you experience 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) – these may be signs 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;
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. For more information, see "Blood clots in the veins (thrombosis)".

Note: Femoston does not have a contraceptive effect. If less than 12 months have passed since your last period and you are under 50 years of age, you may need to use additional contraception to prevent pregnancy. Please consult your doctor.

HRT and cancer

Abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer

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

Unexpected bleeding

While taking Femoston, you will experience monthly withdrawal bleeding. However, if in addition to regular monthly bleeding you experience unexpected bleeding or spotting that:

persists 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) in the form of combined estrogen-progestogen or estrogen alone increases the risk of 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 the risk may persist for 10 years or longer if HRT was used for more than 5 years.

Comparison

In 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.

In women aged 50 who start a 5-year course of estrogen-only HRT, the number of cases will be 16–17 per 1,000 women (i.e. 0 to 3 additional cases).

In women aged 50 who start a 5-year course of estrogen-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).

In women aged 50 to 59 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.

In women aged 50 who start a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. 7 additional cases).

In women aged 50 who start a 10-year course of 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;
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 combined estrogen-progestogen therapy is associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer depends on age. For example, in women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over a 5-year period. In women who have used HRT for 5 years, it will occur in about 3 out of 2,000 women (i.e. about 1 additional case).

Effect of HRT on the heart and circulatory system

Blood clots in the veins (venous thrombosis)

The risk of developing 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 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 to you. 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: see "You must stop taking Femoston and contact your doctor immediately".

Comparative data

In women aged 50–60 who do not use HRT, 4 to 7 out of 1,000 are expected to develop venous blood clots over 5 years.

In women aged 50–60 who use combined estrogen-progestogen HRT for more than 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 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

In women aged 50 to 60 who do not use HRT, stroke is expected in an average of 8 out of 1,000 women over 5 years. In women aged 50 to 60 who use HRT for more than 5 years, there will be 11 cases per 1,000 women (i.e. 3 additional cases).

Meningioma

The use of Femoston is associated with the development of usually benign tumours of the tissue layer between the brain and 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 visual 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 the 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 the age of 65. Please consult your doctor.

Children

Femoston is indicated only for women with symptoms of estrogen deficiency in whom at least 6 months have passed since the last menstruation.

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 medications (such as: phenobarbital, carbamazepine, phenytoin);
tuberculosis medications (such as: rifampicin, rifabutin);
medications used for HIV infection (AIDS) (such as: nevirapine, efavirenz, ritonavir and nelfinavir);
herbal products containing St. John's wort (Hypericum perforatum).

HRT may affect the action of other medicines:

the epilepsy medication lamotrigine, which may increase the frequency of seizures;
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 parameters in blood tests (increased liver enzyme AlAT activity) in women using 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 used concurrently 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 drug 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 health products (e.g. dietary supplements). Your doctor will provide you with 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 can be taken with or without food.

Pregnancy and breastfeeding

Femoston is indicated only for women with symptoms of estrogen deficiency in whom at least 6 months have passed since the last menstruation.

If pregnancy is detected, you must 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 using machines 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 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, you should
ask your doctor or pharmacist.
When to start taking Femoston
You should 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 hormone replacement therapy (HRT),
you are switching from another HRT product used in a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch containing both an oestrogen and a progestagen every day.

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

you are switching from HRT used in a "cyclical" or "sequential" regimen. This regimen involves taking or applying an oestrogen-containing tablet or patch during the first part of the cycle, followed by taking or applying a tablet or patch containing both oestrogen and 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 translation of weekday symbols located next to each tablet on the immediate packaging – provided at the end of this leaflet and on the sachet included in the pack).

How much medicine to take

Your doctor will choose the lowest effective dose to be used for the shortest necessary duration to treat your symptoms. If you feel the dose is too strong or too weak, consult your doctor.
If Femoston is being used 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 weekday symbols located next to each tablet on the immediate packaging – provided at the end of this leaflet and on the sachet included in the pack).

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.

If you take more Femoston than you should
If you (or someone else) take more Femoston tablets than recommended, it is unlikely to cause harmful effects.
Possible symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. No additional treatment is usually required, but if you are concerned, consult your doctor.

If you forget to take 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 your usual time and do not take the missed tablet. Do not take a double dose to make up for a forgotten tablet. Breakthrough bleeding or spotting may occur.

Stopping Femoston
Do not stop taking Femoston without first discussing it with your doctor.

If you have any further questions about the use of this medicine, ask 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 uterine lining (endometrial hyperplasia or cancer of the endometrium);
ovarian cancer;
blood clots in the veins of the legs or lungs (venous thromboembolic disease, pulmonary embolism);
heart 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:
Very common (may occur in more than 1 in 10 users):

headaches;
abdominal pain;
back pain;
breast tenderness or pain.

Common (may occur in up to 1 in 10 users):

vaginal thrush (vaginal infection caused by fungi called Candida albicans);
depression, nervousness;
migraine. If migraine-type headaches occur for the first time, treatment with Femoston should be discontinued and you should contact your doctor immediately;
dizziness;
nausea, vomiting, flatulence (wind);
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;
hot flushes;
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 users):

benign growths in the pelvis (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 blockage 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 stopped and you should contact your doctor immediately;
gallbladder disease;
breast swelling (oedema);
premenstrual syndrome;
weight loss.

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

heart attack;
swelling of tissues in the face and neck causing breathing difficulties (angioedema);
purple skin spots or patches (purpura).
Other adverse effects reported during HRT use, including Femoston, with unknown frequency:
benign or malignant tumours that may be dependent on oestrogen levels, such as cancer of the uterine lining (cancer of the endometrium), ovarian cancer (for more information see section 2);
increase in size of tumours that may be dependent on progestogen levels (such as meningioma);
disease involving destruction of red blood cells (haemolytic anaemia);
autoimmune disease (immunological disease) that may affect multiple organs (systemic lupus erythematosus);
worsening of epileptic seizures (epilepsy);
involuntary muscle spasms (chorea);
blood clots in arterial vessels (arterial thrombosis);
pancreatitis in women with previously existing high levels of certain fats in the blood (hypertriglyceridaemia);
various skin disorders: skin pigmentation, especially on 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 adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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

Keep this 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Femoston contains

The active substances in this medicine 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: monohydrate lactose, 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.
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. Each blister contains 28 tablets.
Femoston contains tablets in 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/Aluminium foil blisters, placed in a cardboard box. A cardboard sachet is included in the package, in which the blister should be stored.
The pack contains 28 or 84 coated tablets. For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Ireland, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin, DO1 YE64, Ireland
Manufacturer:
Abbott Biologicals BV, 8121 AA Olst, The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Irish Marketing Authorisation Number, country of export: PA 22668/014/002
Parallel Import Licence Number: 20/22

Translation of the weekday symbols printed next to each tablet in the immediate packaging:
MON – Monday
TUE – Tuesday
WED – Wednesday
THU – Thursday
FRI – Friday
SAT – Saturday
SUN – Sunday