Название документа

tablets Femoston are applied at the following indications:

  • replacement hormonal therapy (RHT) for elimination of the symptoms caused by deficiency of estrogen at women during the menopauzny period not earlier than in 6 months from the moment of the last periods;
  • prevention of osteoporosis at women during the post-menopausal period at high risk of changes (this medicament should be used to patients only in case of intolerance or existence of contraindications to use of other medicines for prevention of osteoporosis).

Structure

Active ingredients: oestradiol; didrogesteron;

1 tablet contains

oestradiol of the gemigidrat micronized that is equivalent oestradiol of 1 mg or 2 mg of the didrogesteron micronized 10 mg;

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

Film covering: Opadry® AI gray 85F27664 (polyethyleneglycol 3350, talc (E 553b), polyvinyl alcohol, ferrous oxide black (E172), the titan dioxide (E 171)) - for the tablets containing 1 mg of oestradiol and 10 mg of a didrogesteron;

Opadry® OY-02B22764 yellow (a gipromelloz (HPMC 2910), polyethyleneglycol 400, talc, ferrous oxide yellow (E172), the titan dioxide (E 171)) - for the tablets containing 2 mg of oestradiol and 10 mg of a didrogesteron.

Contraindication

  • breast cancer diagnosed in the past, available or suspected;
  • established or suspected estrogenchuvstvitelny tumors (for example endometrial cancer);
  • vaginal bleedings of not clear genesis;
  • not treated hyperplasia of endometrium;
  • an active venous thrombembolia in the anamnesis (deep vein thrombosis, a thrombembolia of pulmonary arteries);
  • existence of trombofilichesky frustration (for example deficiency of a protein With, a protein of S or antithrombin);
  • acute or recently postponed thromboembolic disease of arteries (for example stenocardia, a myocardial infarction);
  • an acute disease of a liver or a disease of a liver in the anamnesis at which indicators of function of a liver were not normalized;
  • known hypersensitivity to active ingredients or to any of medicine excipients;
  • porphyria.

Route of administration

Drug is used inside daily according to the continuous consecutive mode as it is described below.

Treatment begins

with reception of one tablet containing 1 mg or 2 mg of oestradiol of 1 times a day, daily during the first 14 days of a 28-day cycle.

after that during the next 14 days on 1 tablet containing 1 mg or 2 mg of oestradiol and 10 mg of a didrogesteron, 1 time a day as it is specified on 28-day calendar packing.

, for 29 day, should begin with

After the termination of a 28-day cycle a new 28-day cycle at once.

Cycles of treatment follow

one after another and are continuous.

For treatment of deficiency of estrogen at women during the post-menopausal period as the initial and supporting doses should accept the lowest effective dose, and duration of the period of treatment has to be as it is possible short.

generally should begin the consecutive combined treatment with

with medicine "Femoston ® ", oestradiol of 1 mg + oestradiol / didrogesterona 1 mg / 10 mg.

Dose should be selected individually, depending on the clinical answer.

At the women who are not performing replacement hormonal therapy or at the women passing from the continuous combined replacement hormonal therapy, treatment it is possible to begin in any convenient day. At women who pass from cyclic or continuous consecutive replacement hormonal therapy the treatment should be begun from the next day after the termination of the previous cycle at once.

If reception of a tablet is missed by

, it is recommended to continue on reception of the following tablet, without taking the passed pill. In case of the admission of reception of a tablet the probability of breakthrough bleeding or bloody discharges can increase.

can take the Drug irrespective of meal.

Experience of treatment of women is more senior than 65 years is limited.

Pregnant

This medicine is not shown to

Feature of application

by

for application during pregnancy. If pregnancy occurred during treatment by this medicine, intake of medicine should be stopped immediately. Women do not have sufficient data concerning use of oestradiol / didrogesterona during pregnancy.

Children

does not have expediency of use of this medicine for this category of patients.

Drivers

Drug does not influence or has insignificant impact on ability to drive the car or to work with other mechanisms.

Overdose

As oestradiol, and didrogesteron are substances with hypotoxicity. At overdose there can be such symptoms as nausea, vomiting, sensitivity of mammary glands, dizziness, an abdominal pain, drowsiness/fatigue and bleeding of cancellation. It is improbable that at overdose any specific or symptomatic treatment will be required.

information Described above also concerns overdose at children.

Side effects

Most frequent side reactions at patients to whom performed therapy by oestradiol / didrogesteronom at conduct of clinical trials were a headache, an abdominal pain, pain/sensitivity of mammary glands and a back pain.

Interaction

Researches of medicinal interactions were not conducted by

.

Storage conditions

to Store

in original packing at a temperature not above 30 °C, out of children's reach.

Expiration date - 3 years.

Characteristics
Active ingredients Didrogesteron, Oestradiol
Amount of active ingredient 1 mg + 10 mg
Applicant Abbott
Code of automatic telephone exchange G03FB08 Didrogesteron is also oestrogenic
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status Original
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer B.V. ABBOTT BIOLOGICALZ.
Quantity in packing 56 tablets (2 blisters on 28 pieces)
Release form tablets for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 30 °C
Trade name Femoston

Reviews Femoston of the tab. of p/o 1mg/10mg No. 56

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Femoston of the tab. of p/o 1mg/10mg No. 56

  • Product Code: 180023
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