Femoston 1/5 conti tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

estradiol (estradiol hemihydrate), dydrogesterone

Available from:

ABBOTT Biologicals B.V.

ATC code:

G03FA14

INN (International Name):

estradiol (estradiol hemihydrate), dydrogesterone

Dosage:

1mg+ 5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/1x28/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-01-24

Summary of Product characteristics

Abbott
Confidential
Information
This information is
confidential
Estradiol - Dydrogesterone
SOLID 1000323709
SUMMARY OF PRODUCT CHARACTERISTICS ESTRADIOL / DYDROGESTERONE
Date of Previous Approval: 15 Jan 2013
Date of Approval: 15 Jan 2016
1
NAME OF THE MEDICINAL PRODUCT
Femoston
®
1/5 conti, 1mg/5mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femoston
®
1/5 conti, 1mg/5mg film-coated tablets
28 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and 5
mg dydrogesterone.
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex tablets marked 379 on one side.
Salmon-coloured 1/5 mg tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women
at least 12 months since last menses.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are
intolerant
of,
or
contraindicated
for,
other
medicinal
products
approved
for
the
prevention
of
osteoporosis.
The experience in treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Femoston
®
1/5 conti, Continuous combined.
For oral use.
The oestrogen and the progestogen are given every day without
interruption.
One tablet to be taken daily for a 28 day cycle.
Femoston
®
1/5 conti should be taken continuously without a break between packs.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose
for the shortest duration should be used.
Continuous combined treatment may be started with Femoston
®
1/5 conti depending on time since
menopause and severity of symptoms.
Depending on the clinical response, the dosage can subsequently be
adjusted.
Patients changing from another continuous sequential or cyclical
preparation should complete the 28
day cycle and then change to Femoston
®
1/5 conti.
Patients changing from a continuous combined preparation may start
therapy at any time. If a dose
has been forgotten, it should be taken as soon as possible. If mor