FEMOSTON 110 TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DYDROGESTERONE; ESTRADIOL; ESTRADIOL

Boleh didapati daripada:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

DYDROGESTERONE; ESTRADIOL; ESTRADIOL

Unit dalam pakej:

84 Tablet Tablets; 28 Tablet Tablets; 28Tablet Tablets

Dikeluarkan oleh:

Abbott Biologicals B.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
FEMOSTON® 1/10 TABLET
Estradiol (1mg), dydrogesterone (10mg)
1
WHAT IS IN THIS LEAFLET
1. What Femoston® is used for
2. How Femoston® works
3. Before you use Femoston®
4. How to use Femoston®
5. While you are using it
6. Side effects
7. Storage and disposal of
Femoston®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT FEMOSTON®
IS USED FOR
Femoston® is used
in
postmenopausal women who still
have a uterus (womb) as hormone
replacement therapy.
This product is not recommended for
women older than 65 years.
HOW FEMOSTON® WORKS
Femoston® acts as a hormone
replacement therapy by providing
two
types of female hormones, an
oestrogen called estradiol and a
progestogen called dydrogesterone.
BEFORE YOU USE FEMOSTON®
_- When you must not use it_
Do not take Femoston®:
•
If you have or have ever had
breast cancer, or if you are
suspected of having it
•
if you have cancer which is
sensitive to oestrogens, such
as cancer of the womb lining
(endometrium), or if you are
suspected of having it.
•
if you have or your doctor
thinks you might have a
tumor that is dependent on
progestogens. An example is
a tumor in the brain
(meningioma).
•
if you have any unexplained
vaginal bleeding
•
if you have excessive
thickening of the womb
lining that is not being
treated
•
if you have or have ever had
a blood clot in a vein such as
in the legs or the lungs
•
if you have a blood clotting
disorder (such as protein C,
protein S, or antithrombin
deficiency)
•
if you have or recently have
had a disease caused by
blood clots in the arteries,
such as a heart attack, or
angina
•
you have or have ever had a
liver disease and your liver
function tests have not
returned to normal
•
if you have porphyria (a
metabolic disorder)
•
if you are allergic
(hypersensitive) to estradiol,
dydrogesterone or to any of
the other ingredients of
Femoston®.
If you are not sure, talk to your doctor
or pharmacist before taking
Femoston

Ciri produk

1.
NAME OF THE MEDICINAL
Femoston 1/10 film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
14 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and
14 tablets, each containing 1
mg 17β- estradiol (as hemihydrate) and 10 mg dydrogesterone.
3.
PHARMACEUTICAL
FORM
Film-coated tablet,
Round, biconvex tablets marked 379 on one side.
White 1 mg tablets and grey 1/10 mg tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy for women with disorders due to natural or
surgically induced
menopause with intact uterus.
Elderly population
The experience in treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
th
One tablet, containing 1mg estradiol, daily during 14 consecutive days
per cycle of 28
days on
one tablet, containing 1mg estradiol and 10mg dydrogesterone, daily
during the remaining 14
days has to be taken immediately after a 28 day cycle, the next
treatment cycle is to be started.
Patients should take one tablet a day orally, according to the
sequence indicated on the package.
Medication is to be continued without interruption.
If the patient is still menstruating, it is recommended to begin
treatment on the first day after onset
of menstruation.
If the patient is menstruating infrequently it is advisable to begin
treatment after 10-14days
monotherapy of progesteogen (“chemical curettage”).
In patients who had their last period more than approximately 12
months ago treatment can be
started at any time. Femoston 1/10 can be taken irrespective of food
intake.
Paediatric population:
There is no relevant indication for the use of Femoston 1/10 in the
paediatric population.
4.3
CONTRAINDICATIONS
•
Known past or suspected breast cancer
•
Known or suspected oestrogen-dependent malignant tumours (e.g.
endometrial cancer)
•
Known or suspected progestogen-dependent neoplasms (e.g meningioma)
•
Undiagnosed genital bleeding
•
Untreated endometrial hyperplasia
•
Previous
or
current
venous
thromboembolism
(de