FEMOSTON CONTI 0.5 MG2.5 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DYDROGESTERONE; ESTRADIOL AS HEMIHYDRATE

متاح من:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC رمز:

G03FB08

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

DYDROGESTERONE 2.5 MG; ESTRADIOL AS HEMIHYDRATE 0.5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ABBOTT BIOLOGICAL B.V., THE NETHERLANDS

المجال العلاجي:

DYDROGESTERONE AND ESTROGEN

الخصائص العلاجية:

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women at least 12 months since last menses.Femoston is indicated for women with an intact uterus

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
FEMOSTON-CONTI 0.5 MG/2.5 MG
FILM-COATED TABLETS
ACTIVE SUBSTANCES AND THEIR QUANTITY:
Each film-coated tablet contains a combination of estradiol and
dydrogesterone:
Estradiol 0.5 mg
Dydrogesterone 2.5 mg
FEMOSTON-CONTI 1 MG/5 MG
FILM-COATED TABLETS
ACTIVE SUBSTANCES AND THEIR QUANTITY:
Each film-coated tablet contains a combination of estradiol and
dydrogesterone:
Estradiol 1 mg
Dydrogesterone 5 mg
For a list of inactive and allergenic ingredients in the medicine –
please
see section 6 )”Further information“(.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if it seems to you that their medical condition
is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
FEMOSTON-CONTI 0.5 MG/2.5 MG
Hormone replacement therapy )HRT( for estrogen deficiency symptoms
in postmenopausal women, who are at least 12 months after their last
menstrual period.
Intended for women with a normal uterus.
Experience in treating women over the age of 65 is limited.
FEMOSTON-CONTI 1 MG/5 MG
Hormone replacement therapy )HRT( for estrogen deficiency symptoms
in postmenopausal women, who are at least 12 months after their last
menstrual period.
Prevention of osteoporosis in postmenopausal women who are at
increased risk for fractures, in which other medicines for prevention
of
osteoporosis are contraindicated or are not tolerated by them.
Intended for women with a normal uterus.
Experience in treating women over the age of 65 is limited.
THERAPEUTIC GROUP: Sex hormones, progestogens and estrogens, for
continuous therapy.
2. BEFORE USING THE MEDICINE
DO NOT USE FEMOSTON-CONTI IF:
• You have or have had BREAST CANCER, or if there is a suspicion
t

خصائص المنتج

1. NAME OF THE MEDICINAL PRODUCT
FEMOSTON-CONTI 0.5 MG/2.5 MG FILM-COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 0.5 mg 17β-estradiol (as hemihydrate) and
2.5 mg dydrogesterone.
Excipient with known effect: lactose monohydrate 117.4 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
A round, biconvex, marked 379 on one side.
(7mm).
Yellow 0.5/2.5 mg tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
postmenopausal women at least
12 months since last menses.
Femoston is indicated for women with an intact uterus.
Experience in treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Femoston-conti 0.5 mg/2.5 mg is a continuous combined HRT for oral
use.
The oestrogen and the progestogen are given every day without
interruption.
The dosage is one tablet per day for a 28 day cycle.
Femoston-conti 0.5 mg/2.5 mg 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 (see also section 4.4) should be used.
Femoston is indicated for the treatment of symptoms and not for
prevention.
In case of no improvement of symptoms within 3 months, treatment
should be stopped.
Continuous combined treatment may be started with Femoston-conti 0.5
mg/2.5 mg depending on the
time since menopause and severity of symptoms. Women experiencing a
natural menopause should
commence treatment with Femoston-conti 0.5 mg/2.5 mg not earlier than
at least 12 months after their
last natural menstrual bleed. For surgically induced menopause,
treatment may start immediately.
Depending on the clinical response, the dosage can subsequently be
adjusted.
Patients changing from a continuous sequential or cyclical preparation
should complete the 28 day cycle
and then change to Femoston-conti 0.5 mg/2.5 mg.
Patients changing from another