DUPHASTON TABLET 10MG

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

DYDROGESTERONE

Beszerezhető a:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (nemzetközi neve):

DYDROGESTERONE

db csomag:

20Tablet Tablets

Gyártó:

Abbott Biologicals B.V.

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DUPHASTON® TABLET
Dydrogesterone (10mg)
1
WHAT IS IN THIS LEAFLET
1. What Duphaston® is used for
2. How Duphaston® works
3. Before you use Duphaston®
4. How to use Duphaston®
5. While you are using it
6. Side effects
7. Storage and disposal of
Duphaston®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT DUPHASTON®
IS USED FOR
Duphaston® is used
for problems you
may get when your body does not
produce enough progesterone:
•
painful periods
•
endometriosis, where tissue
from the lining of the womb
grows outside the womb.
•
unusual menstrual bleeding
•
periods that have stopped
before the menopause
•
pre-menstrual syndrome
(PMS)
•
irregular periods
•
to reduce the risk of
miscarriage (threatened and
recurrent)
•
infertility due to low levels
of progesterone.
•
as part of Assisted
Reproductive Technology
(ART) treatment
Duphaston® is also used to treat
the
symptoms of menopause in women
with intact womb.
HOW DUPHASTON® WORKS
The body normally balances the
amount of the natural hormone
progesterone with estrogen (the other
major female hormone). If your body
does not produce enough
progesterone, Duphaston® makes up
for this and restores the balance.
BEFORE YOU USE DUPHASTON®
_- When you must not use it_
Do not take Duphaston® if:
•
if you are allergic
(hypersensitive) to
dydrogesterone or to any of
the other ingredients of
Duphaston®.
•
You have, or might have a
tumour that is made worse
by progesterone - such as a
brain tumour called a
‘meningioma’
•
You have vaginal bleeding
and the cause is not known.
If you are not sure, talk to your doctor
or pharmacist before taking it.
Duphaston® is not recommended for
use in children below age 18 due to
insufficient safety information
_ _
_- Before you start to use it _
Talk to your doctor or pharmacist
before taking Duphaston® if you
suffer from any medical conditions
or illnesses, in particular if you have:
•
depression
•
liver

Termékjellemzők

1.
NAME OF THE MEDICINAL PRODUCT
Duphaston 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg dydrogesterone.
Excipient(s) with known effect: Each tablet contains 111.1 mg Lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A round, biconvex, scored, white film-coated tablet, one side with
inscription ‘155’ on either side of the
score (size 7 mm).
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROGESTERONE DEFICIENCIES
•
Treatment of dysmenorrhoea
•
Treatment of endometriosis
•
Treatment of secondary amenorrhoea
•
Treatment of irregular cycles
•
Treatment of dysfunctional uterine bleeding
•
Treatment of pre-menstrual syndrome
•
Treatment of threatened abortion, associated with proven progesterone
deficiency
•
Treatment of habitual abortion, associated with proven progesterone
deficiency
•
Treatment of infertility due to luteal insufficiency
•
Luteal support as part of an Assisted Reproductive Technology (ART)
treatment
HORMONE REPLACEMENT THERAPY
To counteract the effects of unopposed estrogen on the endometrium in
hormone replacement therapy for
women with disorders due to the natural or surgical induced menopause
with an intact uterus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Always take Duphaston exactly as your doctor has prescribed. If you
have any questions, contact your
doctor or pharmacist.
If you forget to take your tablet(s), do not take a double dose to
compensate for it. If you require further
information, please ask your doctor or pharmacist for advice.
For hormone replacement therapy:
■
In combination with continuous oestrogen therapy, take one tablet
daily for 14 consecutive days of a 28
day cycle.
■
In combination with cyclical oestrogen therapy, take one tablet daily
during the last 12 to 14 days of
oestrogen therapy.
■
For doctors: If endometrial biopsies or ul