LAMICTAL TABLET 50MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMOTRIGINE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

LAMOTRIGINE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Delpharm Poznan Spolka Akcyjna

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
LAMICTAL TABLET/DISPERSIBLE TABLET
Lamotrigine (50mg, 100mg, 5mg, 25mg)
WHAT IS IN THIS LEAFLET
1.
What LAMICTAL is used for
2.
How LAMICTAL works
3.
Before you use LAMICTAL
4.
How to use LAMICTAL
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
LAMICTAL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT LAMICTAL IS USED FOR
Lamictal can be used in two
different conditions: Epilepsy
and Bipolar disorder (maniac
depression).
ASK YOUR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT
WHY LAMICTAL HAS BEEN
PRESCRIBED FOR YOU.
Your doctor
may have prescribed it for
another reason.
HOW LAMICTAL WORKS
_Epilepsy_
:
Lamictal is used to treat or
prevent various types of
epilepsy in adults and children.
Lamictal may be used on its own
to treat adults and children over
12 years.
Lamictal can also be used in
combination with other anti-
epileptic medicines in both
adults and children aged 2 years
and over. Sometimes other anti-
epileptic medicines may be
stopped after Lamictal has been
started.
_Bipolar Disorder: _
Lamictal is also used to help
prevent depression in adults over
18 years of age with bipolar
disorder. Lamictal should not be
used to treat bipolar disorder in
children (under 18 years of age).
BEFORE YOU USE LAMICTAL
-
_When you must not use it_
_ _
_ _
Do not take or use Lamictal if
you are hypersensitive (allergic)
to lamotrigine or any of the other
ingredients of Lamictal Tablets.
Lamictal is not recommended
for treatment of epilepsy in
children under 2 years of age.
-
_Before you start to use it_
_ _
_ _
Talk to your doctor or
pharmacist before taking
Lamictal:
•
If you have any kidney
problems
•
If you have ever
developed a rash after
taking lamotrigine orother
medicines for bipolar
disorder or epilepsy
•
If you have ever
developed meningitis
(swelling of the
membranes of the brain
and spinal cord) after
taking lamotrigine
•
If you are already taking
medicine that contains
lam

Ciri produk

CONFIDENTIAL
[GSK logo]
LAMICTAL
LAMOTRIGINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_TABLETS: _
_ _
_LAMICTAL _
50mg
Pale yellowish brown, multifaceted, superelliptical unscored tablet,
branded ‘GSEE1’ on one
side, with ‘50’ on the reverse.
_LAMICTAL _
100mg
Pale yellowish brown, multifaceted, superelliptical unscored tablet,
branded ‘GSEE5’ on one
side, with ‘100’ on the reverse.
_DISPERSIBLE TABLETS: _
_ _
_LAMICTAL _
5mg
White to off-white tablet with odour of blackcurrant. Elongated,
biconvex unscored tablets
branded 'GS CL2' on one side and '5' on the other. The tablets might
be slightly mottled.
_LAMICTAL _
25mg
White to off-white tablet with odour of blackcurrant. Multi-faceted,
superelliptical, unscored.
Branded “GSCL5” on one side and “25” on the other. The tablets
might be slightly mottled.
CLINICAL INFORMATION
INDICATIONS
EPILEPSY
•
ADULTS AND ADOLESCENTS
_ _
_LAMICTAL _
is indicated for use as adjunctive or monotherapy in the treatment of
epilepsy, for
partial seizures and generalised seizures, including tonic-clonic
seizures and the seizures
associated with Lennox-Gastaut Syndrome.
•
CHILDREN (2 TO 12 YEARS OF AGE)
_ _
_LAMICTAL _
is indicated as adjunctive therapy in the treatment of epilepsy, for
partial seizures
and generalised seizures including tonic-clonic seizures and the
seizures associated with
Lennox-Gastaut syndrome (above 3 years of age only).
Initial monotherapy treatment in newly diagnosed paediatric patients
is not recommended.
After epileptic control has been achieved during adjunctive therapy,
concomitant anti-
CONFIDENTIAL
epileptic drugs (AEDs) may be withdrawn and patients continued on
_LAMICTAL _
monotherapy.
If
_LAMICTAL_
2 mg Chewable Dispersible Tablet is not available and the calculated
dose in
children is less than 2.5 mg daily, then
_LAMICTAL_
cannot be used. DO NOT attempt to
administer partial quantities of the dispersible tablets.
BIPOLAR DISORDER
•
ADULTS (18 YEARS OF AGE AND OVER)
_ _
_LAMICTAL _
is indicated for the prevention of mo