Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language.
Femoston (femoston)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and фемостон are the same brand names of the same medicine written in Polish and Bulgarian.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
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
What you need to know 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 oestrogen deficiency and who have been amenorrhoeic for at least 6 months.
Femoston is used for the following purposes:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogen 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 impair daily life.
Prevention of osteoporosis
Some postmenopausal women may develop brittle bones (osteoporosis). Discuss all available treatment options with your doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women who have an increased risk of fractures due to osteoporosis and who 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. The risks associated with HRT in cases of premature menopause may differ. Please consult your doctor.
Before starting (or restarting) HRT, your doctor should take a detailed medical history, including family medical 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 have 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 as recommended by your doctor.

DO NOT take Femoston if any of the following symptoms or medical conditions are present or have occurred previously. 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 a tumour whose growth is dependent on estrogens, e.g. endometrial cancer (endometrium cancer);
if you currently have or your doctor suspects 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 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 currently have or have previously 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 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, you must stop taking the medicine immediately and consult your doctor.

Warnings and precautions
Before starting treatment, inform your doctor if you have ever experienced any of the following conditions, as they may recur or worsen during treatment with Femoston. If any of the following conditions have occurred in the past, you should have more frequent medical check-ups:

uterine fibroids;
presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal thickening of the endometrium (endometrial hyperplasia);
presence of risk factors for venous thrombosis (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 membrane and impairing hearing (otosclerosis);
very high levels of blood fats (triglycerides);
fluid retention due to heart or kidney disorders;
hereditary or acquired angioedema.

You must 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) – 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);
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 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 necessary to prevent pregnancy. Please consult your doctor.

HRT and cancer

Excessive 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 bleeding (so-called withdrawal bleeding). However, if, in addition to monthly bleeding, you experience unexpected bleeding or spotting that:

persists for longer than the first 6 months of treatment;
begins after 6 months of starting Femoston;
continues after stopping Femoston,
you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking combined estrogen-progestogen HRT or estrogen-only H6 months
In the case of women aged 50 to 54 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 the case of 50-year-old women 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 the case of 50-year-old women who start a 5-year course of combined estrogen-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
In the case of 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 the case of 50-year-old women 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 the case of 50-year-old women who start a 10-year course of combined estrogen-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,
- changes around the nipple area,
- any visible or palpable lumps.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of 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).

Effects of HRT on the heart and circulatory system

Blood clots in the veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women using HRT than in those not using 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 venous thrombosis 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 thrombosis in the legs, lungs, or other organs in any close relatives,
systemic lupus erythematosus diagnosed in you,
cancer diagnosed in you.

Symptoms of venous thrombosis: see "Stop taking Femoston and contact your doctor immediately".

Comparative data
In women aged 50–60 who do not use HRT, venous thrombosis is expected to occur in 4 to 7 out of 1,000 over 5 years.
In women aged 50–60 who use combined estrogen-progestogen HRT for more than 5 years, it will occur in 9 to 12 out of 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 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 increases with age.

Comparison
In women aged 50 to 60 who do not use HRT, stroke is expected to occur 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, it will occur in 11 out of 1,000 women (i.e. 3 additional cases).

Meningioma
The use of Femoston is associated with the development of a usually benign tumour 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 menstrual period.

Femoston and other medicines
Some medicines may affect the action of Femoston, potentially 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),
HIV (AIDS) treatments (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 antiepileptic drug lamotrigine, which may increase seizure frequency;
combination treatment regimens for hepatitis C virus (HCV) infection using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section 4.4) 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 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 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.

Tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including over-the-counter medicines, herbal remedies, or other natural health products (e.g. dietary supplements). Your doctor will provide appropriate advice.

Blood tests
Before 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 menstrual period.

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

Driving and operating machinery
No studies on the effects of Femoston on driving and operating machinery have been conducted. Such effects are unlikely.

Femoston contains monohydrate lactose
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking Femoston.

3. How to use Femoston

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should
consult your doctor or pharmacist.
When to start using Femoston
Do not start treatment with Femoston before 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),
you are switching from another HRT product used in a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily containing both oestrogen and progestogen.

Treatment with Femoston may be started the day after completion of a 28-day menstrual cycle pack if:

you are switching from HRT used in a "cyclical" or "sequential" regimen. This regimen involves taking or applying a tablet or patch containing oestrogen alone during the first part of the cycle, followed by taking a tablet or applying a patch containing both oestrogen and progestogen 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 blister pack is marked with days of the week to help you remember when to take each tablet (the translation of the day-of-the-week symbols 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).

How much to take

Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. Consult your doctor if the dose seems too strong or too weak for you.
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 treatment cycle is clearly indicated on the blister 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 "Venous thromboembolism (blood clots in the veins)"). Ask your doctor when you can resume taking Femoston.

If you take more Femoston than you should
If you (or someone else) take too many Femoston tablets, it is unlikely to cause harmful effects.
Possible symptoms include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding. No additional treatment is usually required, but if you are unsure, seek medical advice.

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

Stopping Femoston
Do not stop taking Femoston without consulting your doctor.

If you have any further questions about the use of 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 hormone replacement therapy (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 legs or lungs (venous thromboembolic disease, pulmonary embolism),
heart disease,
stroke,
possible memory loss if HRT is initiated 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 affect more than 1 in 10 women):

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

Common (may affect up to 1 in 10 women):

vaginal thrush (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 (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;
hot flushes;
feeling of weakness, fatigue, and general malaise;
swelling of ankles, feet, or fingers (peripheral edema);
weight gain.

Uncommon (may affect up to 0.1% of women, i.e. 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, diarrhea, or hypotension;
change in libido;
blood clots causing embolism 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, Femoston should be discontinued immediately and you should contact your doctor without delay;
gallbladder disease;
breast swelling (edema);
premenstrual syndrome;
weight loss.

Rare (may affect up to 0.01% of women, i.e. up to 1 in 1000 women):

heart attack;
swelling of tissues in the face and neck area causing breathing difficulties (angioedema);
purple skin spots and lesions (vasculitic purpura).

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

benign or malignant tumors that may be estrogen-dependent, such as cancer of the uterine lining (cancer of the endometrium), ovarian cancer (for more information see section 2);
increased size of tumors that may be progestagen-dependent (e.g. meningioma);
a disease involving destruction of red blood cells (hemolytic anemia);
autoimmune disease (immunological), which may attack multiple organs (systemic lupus erythematosus);
worsening of epileptic seizures (epilepsy);
involuntary muscle spasms (chorea);
arterial blood clots (arterial thrombosis);
pancreatitis in women with previously elevated levels of certain blood fats (hypertriglyceridemia);
various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy mask" (chloasma), painful red skin nodules (nodular erythema), 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 (hypertriglyceridemia);
changes in the cornea of the eye (corneal edema), inability to wear contact lenses (contact lens intolerance);
increased total concentration of thyroid hormones.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
Phone: +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 this medicine out of the sight and reach of children.
No special storage conditions 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 should 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 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), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, polyethylene glycol 400, talc;
- yellow tablets: titanium dioxide (E 171), iron oxide yellow (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).
The tablets are packed in PVC/Al blisters.
The pack contains either 28 coated tablets or 84 coated tablets.

A cardboard sachet is included with the pack, in which the blister should be placed.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1, D01YE64
Ireland
Manufacturer:
Abbott Biologicals BV
C.J. van Houtenlaan 36, 1381 CP Weesp, 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 Bulgaria, country of export: 9700102
Parallel Import Authorisation Number: 366/25
Translation of the symbols for days of the week printed next to each tablet on the immediate packaging:
ПОН - Monday
ВТ - Tuesday
СР - Wednesday
ЧЕТ - Thursday
ПЕТ - Friday
СЪБ - Saturday
НЕД - Sunday