Imigran FD Tablet 50mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SUMATRIPTAN SUCCINATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

SUMATRIPTAN SUCCINATE

Unit dalam pakej:

2Tablet Tablets

Dikeluarkan oleh:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
IMIGRAN
® FD TABLET 50 MG
Sumatriptan (50 mg)
WHAT IS IN THIS LEAFLET
1.
What IMIGRAN FD is used
for
2.
How IMIGRAN FD works
3.
Before you use IMIGRAN FD
4.
How to use IMIGRAN FD
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
IMIGRAN FD
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IMIGRAN FD IS USED
FOR
Imigran FD tablets are used to
relieve migraine attacks,
including the acute treatment of
migraine attacks associated with
the menstrual period in women.
Imigran FD tablets should only
be used when you first
experience signs and symptoms
of a migraine attack, not to try
and prevent an attack from
occurring.
HOW IMIGRAN FD WORKS
Each Imigran capsule-shaped
tablet contains a single dose of
sumatriptan, which belongs to a
group of medicines called
triptans
_(also known as 5-HT1 _
_receptor agonists). _
Migraine symptoms may be
caused by the temporary
widening of blood vessels in the
head. Imigran is believed to
reduce the widening of these
blood vessels. This in turn helps
to take away the headache and
relieve other symptoms of a
migraine attack, such as feeling
or being sick (nausea or
vomiting) and sensitivity to light
and sound.
BEFORE YOU USE IMIGRAN FD
-
_When you must not use it _
_ _
Do not use your medicine:
If you are hypersensitive
(allergic) to sumatriptan or to
any of the ingredients of Imigran
FD.
-
_Before you start to use it _
_ _
If you answer ‘Yes’ to any of
the following questions tell your
doctor about this before using
your medicine as it may not be
suitable for you.
•
Are you pregnant or trying to
become pregnant?
•
Are you breast-feeding? − to
minimise infant exposure,
mothers should not breastfeed
for 12 hours after using
Imigran FD.
•
Is this headache any different
from your usual migraine
attacks?
•
Have you been told that you
are allergic to Imigran FD,
sumatriptan, or any of the
other ingredients in Imigran
FD?
•
Are you taking any medicines
for you

Ciri produk

CONFIDENTIAL
IMIGRAN
® FDT
SUMATRIPTAN FAST DISINTEGRATING TABLETS _(FDT) _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 50 of sumatriptan base as the succinate salt.
PHARMACEUTICAL FORM
Fast disintegrating tablets are triangular in shape.
_IMIGRAN_ FDT 50 mg are pink film coated and debossed with 'GS 1YM' on
one face and
'50' on the other.
CLINICAL PARTICULARS
INDICATIONS
_IMIGRAN _FDT_ _are indicated for the acute relief of migraine attacks
with or without aura,
including the acute treatment of migraine attacks associated with the
menstrual period in
women.
DOSAGE AND ADMINISTRATION
_IMIGRAN_ should not be used prophylactically. The recommended dose of
_IMIGRAN _
should not be exceeded.
It is advisable that _IMIGRAN_ be given as early as possible after the
onset of a migraine
headache. It is equally effective at whatever stage of the attack it
is administered.

POPULATIONS
ADULTS
The recommended dose of oral _IMIGRAN _FDT is asingle 50 mg tablet.
Some patients
may require 100 mg.
If a patient does not respond to the first dose of _IMIGRAN_, a second
dose should not be
taken for the same attack. _IMIGRAN _FDT may be taken for subsequent
attacks.
If the patient has responded to the first dose, but the symptoms recur
a second dose may
be given , provided that there is a minimum interval of two hours
between doses and not
more than 300 mg is taken in any 24-hour period.
CONFIDENTIAL
The tablets should be swallowed whole with water. Patients with
swallowing difficulties
may choose to disperse a tablet in a small amount of water before
administration.
_IMIGRAN _FDT dispersed in water have a bitter taste.
CHILDREN AND ADOLESCENTS (UNDER 18 YEARS OF AGE)
_IMIGRAN _FDT have not been studied in adolescents or children (_see
Clinical Studies_).
ELDERLY (OVER 65 YEARS OF AGE)
Experience of the use of standard sumatriptan tablets in patients aged
over 65 years is
limited. The pharmacokinetics do not differ significantly from a
younger population, but
until further clinical data are available, the use of _