Femoston tablets are used for the following indications:
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.
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.
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.
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.
The most common adverse reactions in patients receiving estradiol / dydrogesterone therapy in clinical trials were headache, abdominal pain, breast pain / tenderness, and back pain.
Preparation interaction studies have not been conducted.
Store in its original packaging at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life is 3 years.
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