Femoston 1mg / 10mg, 28 tablets — Made in Netherlands — Free Delivery

Product description

Femoston tablets are used for the following indications:

• hormone replacement therapy (HRT) to eliminate symptoms caused by estrogen deficiency in women in the menopausal period no earlier than 6 months after the last menstruation;
• prevention of osteoporosis in postmenopausal women with a high risk of fractures (this preparation should be used in patients only in case of intolerance or contraindications to the use of other preparationa for the prevention of osteoporosis).

Compound

Active ingredients: estradiol; dydrogesterone;

1 tablet contains micronized estradiol hemihydrate, which is equivalent to 1 mg estradiol or 2 mg micronized dydrogesterone 10 mg;

Excipients: lactose monohydrate, hypromellose (HPMC 2910), corn starch, colloidal silicon dioxide, magnesium stearate;

Film coating: Opadry® II gray 85F27664 (polyethylene glycol 3350, talc (E 553b), polyvinyl alcohol, black iron oxide (E172), titanium dioxide (E 171)) - for tablets containing 1 mg of estradiol and 10 mg of dydrogesterone;

Opadry® OY-02B22764 yellow (hypromellose (HPMC 2910), polyethylene glycol 400, talc, iron oxide yellow (E172), titanium dioxide (E 171)) - for tablets containing 2 mg estradiol and 10 mg dydrogesterone.

Contraindications

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

Mode of application

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

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

Thereafter, over the next 14 days, 1 tablet containing 1 mg or 2 mg of estradiol and 10 mg of dydrogesterone, 1 time per day, as indicated on the 28-day calendar package.

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

Treatment cycles follow one another and are continuous.

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

In general, sequential combination therapy should be started with Femoston®, estradiol 1 mg + estradiol / dydrogesterone 1 mg / 10 mg.

The dose should be selected individually, depending on the clinical response.

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

If a pill is missed, it is recommended that you continue on the next pill without taking the missed pill. If you skip taking a pill, you may be more likely to have breakthrough bleeding or spotting.

The preparation  can be taken with or without food.

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

Application features

Pregnant

This medication is not indicated for use during pregnancy. If pregnancy occurs during treatment with this preparation, the preparation  should be stopped immediately. There is no sufficient data on the use of estradiol / dydrogesterone in women during pregnancy.

Children

There is no feasibility of using this preparation for this category of patients.

Drivers

The preparation does not affect or has a slight effect on the ability to drive a car or work with other mechanisms.

Overdose

Both estradiol and dydrogesterone are substances of low toxicity. In case of overdose, symptoms such as nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness / fatigue, and withdrawal bleeding may occur. Overdose is unlikely to require any specific or symptomatic treatment.

The information described above also applies to overdose in children.

Side effects

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

Interaction

Preparation interaction studies have not been conducted.

Storage conditions

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

Shelf life is 3 years.