FEMOSTON 110 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DYDROGESTERONE; ESTRADIOL; ESTRADIOL

Available from:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC code:

G03FB08

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DYDROGESTERONE 10 MG; ESTRADIOL 1 MG; ESTRADIOL 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ABBOTT HEALTHCARE PRODUCTS B.V., NETHERLANDS

Therapeutic area:

DYDROGESTERONE AND ESTROGEN

Therapeutic indications:

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in menopausal women at least 6 months since last menses.Prevention of osteoporosis in postmenopausal women at high risk of future fractures. Femoston 1/10 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 uterusExperience with treatment of women older than 65 years is limited.

Authorization date:

2019-01-21

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 1/10 MG
FILM-COATED TABLETS
THE ACTIVE INGREDIENTS AND THEIR QUANTITIES:
Each film-coated tablet containing estradiol only:
Estradiol 1 mg
Each film-coated tablet containing a combination of estradiol
and dydrogesterone:
Estradiol 1 mg
Dydrogesterone 10 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 1/10 mg is a Hormone Replacement Therapy )HRT(.
It contains two types of female hormones, an estrogen called
estradiol and a progestogen called dydrogesterone. Femoston
1/10 mg is suitable for postmenopausal women with at least
6 months since their last natural period.
Femoston 1/10 mg is intended for:
• RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During menopause, the amount of estrogen produced by a
woman’s body decreases. This can cause symptoms such as
a feeling of warmth in the face, neck and chest )”hot flashes“(.
Femoston 1/10 mg alleviates these symptoms after cessation
of menstruation. You will only be prescribed Femoston 1/10
mg if your symptoms hinder your daily life routine.
• PREVENTION OF OSTEOPOROSIS
Some postmenopausal women may develop bone depletion
)osteoporosis(. You should discuss all available treatments
with your doctor. If you are at an increased risk of fractures
due to osteoporosis, and other medicines are not suitable for
you, you can use Femoston 1/10 mg to prevent osteoporosis.
The treatment with Femoston 1/10 mg is intended for women
with a norm

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Femoston 1/10 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Blister of 28 tablets: 14 white tablets contain 1 mg estradiol and 14
grey tablets contain 1 mg
estradiol and 10 mg dydrogesterone.
Also contains: lactose monohydrate 119.1 mg (white film-coated
tablets) and 110.2 mg (grey film-
coated tablets).
For the full list of excipients see 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Estradiol film coated tablet 1 mg: Round, biconvex, white film-coated
tablets with
inscription '379'
on one side.
Estradiol/dydrogesterone film coated tablet 1/10mg: Round, biconvex,
grey film-
coated tablets with inscription '379' on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
postmenopausal women at least 6 months since last menses.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures.
Femoston 1/10 mg 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
(See also section 4.4).
Femoston is indicated for women with an intact uterus.
Experience with treatment of women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Femoston 1/10 mg is indicated for the treatment of symptoms and not
for prevention.
Femoston 1/10 mg is taken orally daily according to a continuous
sequential regimen, as
described below.
For each cycle of 28 days for the first 14 days one white tablet with
estradiol is taken once a day and
for the following 14 days one grey tablet with estradiol and
dydrogesterone is taken once a day, as
indicated on the calendar pack for 28 days.
After a cycle of 28 days on the 29
th
day a new cycle of 28 days begins. The treatment cycles
therefore follow one another without a break.
For the treatment of estrogen deficiency in postmenopausal women as an
initial and maintenance
dose the lowest effective dose should be used and the duration of
treatment per