Femoston Conti 15mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DYDROGESTERONE; ESTRADIOL

Boleh didapati daripada:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

DYDROGESTERONE; ESTRADIOL

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

Abbott Biologicals B.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
FEMOSTON® CONTI 1MG/5MG
FILM-COATED TABLET
Estradiol (1mg), dydrogesterone (5mg) 1
WHAT IS IN THIS LEAFLET
1. What Femoston® Conti is used for
2. How Femoston® Conti works
3. Before you use Femoston® Conti
4. How to use Femoston® Conti
5. While you are using it
6. Side effects
7. Storage and disposal of
Femoston® Conti
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT FEMOSTON® CONTI
IS USED FOR
Femoston® Conti is used
to relief
symptoms due to estrogen deficiency
such as hot flushes in women who
still have a uterus (womb).
Femoston® Conti is also used to
prevent osteoporosis in post-
menopausal women who still have a
uterus.
HOW FEMOSTON® CONTI WORKS
Femoston® Conti 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® CONTI
_- When you must not use it_
Do not take Femoston® Conti:
•
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, 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.
•
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
•
if you have or recently have
had a disease caused by
blood clots in the arteries,
such as a heart attack, or
angina
•
if 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® Conti.
If you

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Femoston 1/5 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
28 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and 5
mg
dydrogesterone. Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
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
Hormonal replacement therapy (HRT) for the relief of symptoms due to
estrogen deficiency in
women with a uterus.
Prevention of postmenopausal osteoporosis in women with a uterus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
The oestrogen and the progestogen are to be taken every day without
interruption. One tablet is to
be taken daily for a 28 day cycle.
Femoston conti 1/5 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 Warnings & Precaution)
should be used.
Continuous combined treatment may be started with Femoston 1/5
depending on the time since
menopause and the severity of the 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 conti 1/5.
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 more than 12 hours have elapsed,
treatment should be continued with the next tablet without taking the
forgotten tablet. The likelihood of
breakthrough bleeding or spotting may be increased.
Femoston conti 1/5 can be taken irrespective of food intake.
Paediatric population:
There is no relevant indication for the use of Femoston conti 1/5 in
the paediatric population
4.3
CONTRAINDICATIONS
•
Known past or suspected br