FEMOSTON CONTI 1 MG5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DYDROGESTERONE; ESTRADIOL AS HEMIHYDRATE

Available from:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC code:

G03FB08

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DYDROGESTERONE 5 MG; ESTRADIOL AS HEMIHYDRATE 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ABBOTT BIOLOGICAL B.V., THE NETHERLANDS

Therapeutic area:

DYDROGESTERONE AND ESTROGEN

Therapeutic indications:

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women at least 12 months since last menses.Prevention of osteoporosis in postmenopausal women at high risk of future fractures. Femoston contini 1/5 should only be used in patients who are intolerant of other products, approved for the prevention of osteoporosis or for whom these products are contra-indicated.Femoston is indicated for women with an intact uterus

Authorization date:

2020-06-30

Patient Information leaflet

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

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
FEMOSTON CONTI 1MG/ 5MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 1 mg estradiol (as hemihydrate) and 5 mg
dydrogesterone.
Excipient with known effect: lactose monohydrate 114.7 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex tablets marked 379 on one side (7mm)
Salmon coloured 1/5 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.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures. Femoston conti 1/5
should only be used in patients who are intolerant of other products,
approved for the prevention of
osteoporosis or for whom these products are contra-indicated.
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 1mg/ 5mg film-coated tablets are 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 1mg/ 5mg film-coated tablets 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 1mg/
5mg film-coated tablets
depending on the time since menopause and severity of symptoms. Women
experiencing a natural
menopause should commence treatment with Femoston-conti 1mg/ 5mg
film-coated tablets 12 months
after their last natural menstrual bleed. For surgically induced
menopause, treatment may star