Femoston combi-pack film-coated tablets 2 mg/10 mg blister 28 pcs.

The active substance is estradiol (one tablet contains micronized estradiol hemihydrate, which is equivalent to 2 mg of estradiol).

Excipients: Opadry OY-6957 pink (hypromellose (HPMC 2910), polyethylene glycol 400, talc, red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171)).

• diagnosed in the past, present or suspected breast cancer;
• established or suspected estrogen-sensitive tumors (e.g. endometrial cancer);
• vaginal bleeding of unclear origin;
• untreated endometrial hyperplasia;
• active venous thromboembolism in history (deep vein thrombosis, pulmonary embolism);
• the presence of thrombophilic disorders (for example, protein C, protein S, or antithrombin deficiency);
• acute or recent thromboembolic arterial disease (e.g. angina pectoris, myocardial infarction);
• acute liver disease or a history of liver disease in which liver function tests have not returned to normal;
• known hypersensitivity to the active substances or to any of the excipients of the drug;
• porphyria.

The drug is administered orally daily according to a continuous sequential regimen as described below.

Treatment begins with taking one tablet containing 1 mg or 2 mg of estradiol once a day, daily for the first 14 days of a 28-day cycle.

After that, for the next 14 days, 1 tablet containing 1 mg or 2 mg of estradiol and 10 mg of dydrogesterone, once a day, as indicated on the 28-day calendar pack.

After the end of the 28-day cycle, on the 29th day, you should immediately start a new 28-day cycle.

The treatment cycles follow each other and are continuous.

For the treatment of estrogen deficiency in postmenopausal women, the lowest effective dose should be used as initial and maintenance doses, and the duration of the treatment period should be as short as possible.

In general, sequential combination treatment should begin with the drug “Femoston“ estradiol 1 mg + estradiol / dydrogesterone 1 mg / 10 mg.

The dose should be individualized based on clinical response.

In women not using hormone replacement therapy or in women switching from continuous combined hormone replacement therapy, treatment can be started on any convenient day. In women switching from cyclic or continuous sequential hormone replacement therapy, treatment should be started immediately on the day after the end of the previous cycle.

If a tablet is missed, it is recommended to continue with the next tablet without taking the missed tablet. If a tablet is missed, the likelihood of breakthrough bleeding or spotting may increase.

The drug can be taken regardless of meals.

Experience in treating women over 65 years of age is limited.

Pregnant women

This drug is not indicated for use during pregnancy. If pregnancy occurs during treatment with this drug, the drug should be discontinued immediately. There are no adequate data on the use of estradiol/dydrogesterone in pregnant women.

The drug is not indicated for use during breastfeeding.

The drug is not indicated for use in women of childbearing age.

Children

There is no appropriateness of using this drug for this category of patients.

Drivers

The drug has no or negligible influence on the ability to drive or operate other mechanisms.

Both estradiol and dydrogesterone are substances of low toxicity. Symptoms of overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, and withdrawal bleeding. It is unlikely that any specific or symptomatic treatment will be required in case of overdose.

The information described above also applies to overdose in children.

The most common adverse reactions in patients treated with estradiol/dydrogesterone in clinical trials were headache, abdominal pain, breast pain/tenderness, and back pain.

Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.

Shelf life – 3 years.