Femoston

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Femoston (Femaston)

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Femaston are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Femoston and what is it used for
• 2. Important information before taking Femoston
• 3. How to take Femoston
• 4. Possible side effects
• 5. How to store Femoston
• 6. Contents of the pack and other information

1. What is Femoston and what is it used for

Femoston is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen called estradiol and a progestogen called dydrogesterone.
Femoston is indicated for use in women who have symptoms of estrogen deficiency and who have been post-menopausal for at least 6 months.

Femoston is used for the following purpose:

Treatment of post-menopausal symptoms

During menopause, the amount of estrogen produced by the body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest. Femoston alleviates symptoms in post-menopausal women.
Femoston is prescribed if these symptoms significantly interfere with daily life.

Prevention of osteoporosis

In some post-menopausal women, bone fragility (osteoporosis) may occur. You should discuss all available treatment options with your doctor.
If you have an increased risk of fractures due to osteoporosis and cannot take other medicines, Femoston may be used to prevent osteoporosis in post-menopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

Taking HRT involves risks that need to be considered when deciding to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or after ovarian surgery) is limited. In the case of premature menopause, the risk of taking HRT may be different. You should consult your doctor.
Before starting (or re-starting) HRT, your doctor should conduct a medical history, including a family history. Your doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston, you should visit your doctor for regular check-ups (at least once a year). During these check-ups, you should discuss the benefits and risks of continuing to take Femoston with your doctor.
You should have regular breast screening tests as recommended by your doctor.
DO NOT TAKE FEMOSTONif you have or have had any of the following conditions or symptoms. If you are unsure about any of the following conditions or symptoms before taking Femoston, you should consult your doctor.

When not to take Femoston

• if you have been diagnosed with, have had, or your doctor suspects you have breast cancer;
• if you have or your doctor suspects you have a tumor that is estrogen-dependent, such as endometrial cancer (cancer of the endometrium);
• if you have or your doctor suspects you have a tumor that is progestogen-dependent, such as a brain tumor (meningioma);
• if you have unexplained vaginal bleeding;
• if you have untreated endometrial hyperplasia(thickening of the lining of the uterus);
• if you have or have had blood clots in the veins(thrombosis), such as deep vein thrombosis or pulmonary embolism;
• if you have a blood clotting disorder(such as protein C, protein S, or antithrombin deficiency);
• if you have or have recently had a disease caused by blood clots in the arteries, such as heart attack, stroke, or coronary artery disease;
• if you have or have had liver disease, and your liver 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 should stop taking it and consult your doctor immediately.

Warnings and precautions

Before starting treatment, you should tell your doctor if you have ever had any of the following problems, as they may recur or worsen while taking Femoston. If you have ever had any of the following problems, you should have more frequent medical check-ups:

• uterine fibroids;
• endometriosis (a condition in which tissue similar to the lining of the uterus is found outside the uterus) or a history of endometrial hyperplasia;
• risk factors for blood clots (see "Blood clots in the veins (thrombosis)");
• increased risk of estrogen-dependent cancer (such as a family history of breast cancer);
• high blood pressure;
• liver disease, such as benign liver tumors;
• diabetes;
• gallstones;
• migraine or severe headaches;
• systemic lupus erythematosus (an immune system disease that affects many organs);
• epilepsy;
• asthma;
• otosclerosis (a condition that affects the bones of the middle ear and can cause hearing loss);
• very high levels of triglycerides in the blood;
• fluid retention due to heart or kidney problems.

You should stop taking Femoston and consult your doctor immediately

if you experience any of the following symptoms while taking HRT:

• any of the conditions listed in "When not to take Femoston";
• yellowing of the skin or whites of the eyes (jaundice) - this may be a sign of liver disease;
• a significant increase in blood pressure (symptoms may include headaches, fatigue, dizziness);
• migraine headaches that occur for the first time;
• pregnancy;
• symptoms of blood clots, such as painful swelling and redness of the legs, sudden chest pain, difficulty breathing; For more information, see "Blood clots in the veins (thrombosis)".

Warning:Femoston does not have a contraceptive effect. If it has been less than 12 months since your last menstrual period and you are under 50 years old, you may need to use additional contraception to prevent pregnancy. You should consult your doctor.

HRT and cancer

Taking HRT that only contains estrogen increases the risk of endometrial hyperplasia(thickening of the lining of the uterus) and endometrial cancer(cancer of the endometrium).
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

While taking Femoston, you will experience monthly bleeding (so-called withdrawal bleeding). However, if you experience unexpected bleeding or spotting that:

• lasts longer than the first 6 months of treatment,
• starts after 6 months of taking Femoston,
• continues after stopping Femoston, you should consult your doctor as soon as possible.

Breast cancer

Data confirms that taking combined estrogen-progestogen HRT or estrogen-only HRT 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. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT lasted more than 5 years.
Comparison
In women aged 50-54 who do not take HRT, breast cancer will be diagnosed in approximately 13-17 out of 1000 women over a 5-year period.
In women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 out of 1000 patients (i.e., 0-3 additional cases).
In women aged 50 who start 5-year combined estrogen-progestogen HRT, the number of cases will be 21 out of 1000 patients (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer will be diagnosed in approximately 27 out of 1000 women over a 10-year period.
In women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 out of 1000 patients (i.e., 7 additional cases).
In women aged 50 who start 10-year combined estrogen-progestogen HRT, the number of cases will be 48 out of 1000 patients (i.e., 21 additional cases).

• You should have regular breast examinations. You should consult your doctor if you notice any changes, such as:
• indentation of the breast skin,
• changes in the nipple area,
• any visible or palpable lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that only contains estrogen or combined estrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed over a 5-year period in approximately 2 out of 2000 women. In women who have taken HRT for 5 years, it will occur in approximately 3 out of 2000 women (i.e., approximately 1 additional case).

Effect of HRT on the heart and blood vessels

Blood clots in the veins (thrombosis)

The risk of blood clots in the veinsis 1.3-3 times higher in women taking HRT than in those not taking HRT, especially during the first year of treatment.
The formation of blood clots can have serious consequences. If they travel to the lungs, they can cause chest pain, shortness of breath, fainting, or even death.
The risk of blood clots in the veins increases with age and if you have any of the following conditions. You should inform your doctor if you have any of the following:

• you are unable to walk for a long period due to a serious operation, injury, or illness (see also section 3 "Planned surgery"),
• you are significantly overweight (BMI >30 kg/m2),
• you have any blood clotting problems that require long-term treatment with anticoagulant medicines,
• any of your close relatives have had blood clots in the veins of the legs or lungs,
• you have systemic lupus erythematosus,
• you have had cancer.

Symptoms of blood clots, see "You should stop taking Femoston and consult your doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, over a 5-year period, blood clots in the veins will occur in approximately 4-7 out of 1000 women.
In women aged 50-60 who take combined estrogen-progestogen HRT for more than 5 years, 9-12 cases will occur out of 1000 women (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.
In women over 60 years old taking combined estrogen-progestogen HRT, there is a slightly increased risk of heart disease compared to those not taking HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in women taking HRT than in those not taking HRT.
The number of additional stroke cases due to HRT increases with age.
Comparison
In women aged 50-60 who do not take HRT, over a 5-year period, stroke will occur in approximately 8 out of 1000 women. In women aged 50-60 who take HRT for more than 5 years, 11 cases will occur out of 1000 women (i.e., 3 additional cases).

Other conditions

HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT at an age above 65. You should consult your doctor.

Children

Femoston is indicated only for women with symptoms of estrogen deficiency, who have been post-menopausal for at least 6 months.

Femoston and other medicines

Certain medicines may affect the action of Femoston. This may cause irregular bleeding. These include:

• medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin),
• medicines for tuberculosis (such as rifampicin, rifabutin),
• medicines used to treat HIV (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir),
• herbal medicines containing St. John's Wort (Hypericum perforatum).

While taking Femoston, you may experience high levels of the following medicines in your blood:

• tacrolimus, cyclosporin - used, for example, after organ transplantation,
• fentanyl - a pain reliever,
• theophylline - used in asthma and other breathing problems.

Therefore, it may be necessary to monitor the levels of these medicines closely and adjust the dose accordingly.
You should tell your doctor or pharmacist about all other medicines you are currently taking, including those available without a prescription, herbal medicines, or other natural products (e.g., dietary supplements).

Blood tests

Before a blood test, you should inform your doctor or laboratory staff that you are taking Femoston, as this medicine may affect the results of some 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, who have been post-menopausal for at least 6 months.

• If pregnancy is suspected, you should stop taking Femoston and consult your doctor.

Driving and using machines

No studies have been conducted on the effect of Femoston on driving or using machines. Such an effect is unlikely.

Femoston contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking Femoston.

3. How to take Femoston

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

When to start taking Femoston

You should not start 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 taking hormone replacement therapy,
• you are switching from another HRT product to a continuous combined HRT product. This method involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

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

• you are switching from a cyclic or sequential HRT product. This method involves taking a tablet or applying a patch that contains estrogen for the first part of the cycle, followed by a tablet or patch that contains both estrogen and progestogen for the next 14 days.

How to take Femoston

• Swallow the tablet with water.
• The tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This will help keep a constant level of the medicine in your body. It will also help you remember to take the tablet.
• You should take 1 tablet every day, without interruption between packs. The blister pack is marked with the days of the week to help you remember when to take the tablet.

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. You should consult your doctor if you think the dose is too strong or too weak.
• If you are taking Femoston to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone density.
• You should take 1 brick-red tablet every day for the first 14 days, followed by 1 yellow tablet every day for the remaining 14 days. The 28-day treatment cycle is indicated on the calendar pack.

Planned surgery

• If you are scheduled for surgery, you should inform your surgeon that you are taking Femoston. It may be necessary to stop taking Femoston about 4-6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (thrombosis)"). You should ask your doctor when you can restart Femoston.

Overdose

If you (or someone else) have taken too many Femoston tablets, it is unlikely to cause serious harm. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding. No additional treatment is necessary, but if you are concerned, you should consult your doctor.

Missed dose

You should take the missed tablet as soon as possible. If it is more than 12 hours since the tablet was due, you should take the next tablet at the scheduled time without taking the missed tablet. Do not take a double dose to make up for the missed dose. You may experience bleeding or spotting.

Stopping treatment

You should not stop taking Femoston without consulting your doctor.

If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Femoston can cause side effects, although not everybody gets them.
The following conditions have been reported more frequently in women taking HRT compared to those not taking HRT:

• breast cancer,
• endometrial hyperplasia or cancer (thickening or cancer of the endometrium),
• ovarian cancer,
• blood clots in the veins of the legs or lungs (venous thromboembolism),
• heart disease,
• stroke,
• possible memory loss, if HRT is started at an age above 65.

For more information on these side effects, see section 2.
The following side effects may occur while taking Femoston:

Very common (may affect more than 1 in 10 people):

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

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

• vaginal thrush (infection with Candida albicans);
• depression, nervousness;
• migraine. If you experience migraine headaches for the first time, you should stop taking Femoston and consult your doctor immediately;
• dizziness;
• nausea (feeling sick), vomiting, bloating (wind);\li>
• skin allergic reactions (such as rash, severe itching, hives);
• bleeding disturbances, such as irregular bleeding or spotting, painful periods, heavy or light bleeding;
• pelvic pain;
• discharge;
• feeling weak, tired, and unwell;
• swelling of the ankles, feet, or fingers (peripheral edema);
• weight gain.

Uncommon (may affect up to 1 in 100 people):

• growth of uterine fibroids;
• allergic reactions, such as asthma (allergic asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure;
• changes in libido;
• blood clots that cause blockages in the blood vessels (thromboembolism);
• liver disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or whites of the eyes, you should stop taking Femoston and consult your doctor immediately;
• gallbladder disease;
• breast swelling;
• premenstrual syndrome;
• weight loss.

Rare (may affect up to 1 in 1000 people):

• heart attack;
• swelling of the face and neck, making it difficult to breathe (angioedema);
• purple spots or patches on the skin (purpura).

Other side effects have been reported with HRT, including Femoston, with an unknown frequency:

• benign or malignant tumors that may be estrogen-dependent, such as endometrial cancer (cancer of the endometrium) or ovarian cancer (for more information, see section 2);
• tumors that may be progestogen-dependent, such as meningioma;
• a condition in which red blood cells are broken down (hemolytic anemia);
• an immune system disease that affects many organs (systemic lupus erythematosus);
• seizures (epilepsy) may worsen;
• involuntary muscle contractions (chorea);
• blood clots in the arteries (arterial thrombosis);
• pancreatitis (inflammation of the pancreas), especially in women with high levels of triglycerides in the blood;
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma), painful red lumps on the skin (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme);
• leg cramps;
• urinary incontinence;
• painful or lumpy breasts (fibrocystic breast changes);
• cervical erosion;
• worsening of porphyria (a rare blood disorder);
• high levels of triglycerides in the blood (hypertriglyceridemia);
• changes in the cornea (corneal edema), inability to wear contact lenses (intolerance to contact lenses);
• increased levels of thyroid hormones.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Ministry of Health, via their website or by phone/fax.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Femoston

The medicine should be kept out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are lactose monohydrate, hypromellose, cornstarch, colloidal silicon dioxide, magnesium stearate. Coating: brick-red tablets - Opadry OY-6957 pink: titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, macrogol 400, talc; yellow tablets - Opadry OY-02B22764 yellow: titanium dioxide (E 171), iron oxide yellow (E 172), hypromellose, macrogol 400, talc.

What Femoston looks like and contents of the pack

• The tablets are round, biconvex, and marked with "379" on one side. Each pack contains 28 tablets.
• Femoston contains tablets in two colors. Each pack contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the remaining 14 days of the cycle).
• The tablets are packaged in PVC/Al blisters.
• The pack contains 28 or 84 film-coated tablets.

A cardboard wallet is included with the packaging, which should be used to store the blister pack.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

BGP Products LTD
63 Agiou Dimitriou Street
174 56 Alimos
Athens
Greece

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
Netherlands

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export: 8565/06-02-2007
10643/18/08-02-2019

Parallel import authorization number: 292/15

Translation of day symbols on the packaging:

ΔΕΥ

• Monday ΤΡΙ
• Tuesday ΤΕΤ
• Wednesday ΠΕΜ - Thursday ΠΑΡ
• Friday ΣΑΒ
• Saturday ΚΥΡ
• Sunday

Date of approval of the leaflet: 02.02.2022
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