TEGRETOL 200MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CARBAMAZEPINE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CARBAMAZEPINE

Unit dalam pakej:

50Tablet Tablets

Dikeluarkan oleh:

NOVARTIS FARMA S.P.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TEGRETOL TABLETS/CR TABLETS/
SYRUP ®
carbamazepine
(200mg, 400mg, 100mg/5mL)
1
WHAT IS IN THIS LEAFLET
1.
What Tegretol is used for
2.
How Tegretol works
3.
Before you use Tegretol
4.
How to use Tegretol
5.
While you are using Tegretol
6.
Side effects
7.
Storage and Disposal of Tegretol
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT TEGRETOL IS USED FOR
Tegretol belongs to a group of
medicines called antiepileptics
(medicine for seizures). Due to its
mode of action it can be used for other
diseases too.
Tegretol is used to treat certain types
of seizures (epilepsy). It is also used
to treat some neurological diseases
(such as a painful condition of the
face called ‘trigeminal neuralgia’),
certain psychiatric conditions (such as
a disorder known as mania, episodes
of bipolar mood disorders and a
certain type of depression) as well as
alcohol-withdrawal syndrome. It must
not be used for common aches or
pains.
HOW TEGRETOL WORKS
Epilepsy is a disorder characterized by
two or more seizures (fits). Seizures
occur when messages from the brain
to the muscles are not properly passed
on by the nerve pathways in the body.
Tegretol helps to control the passing-
on of these messages. Tegretol also
regulates nerve functions for the other
diseases mentioned above.
BEFORE YOU USE TEGRETOL
You may only take Tegretol after a
full medical examination.
The risk of serious skin reactions in
patients of Han Chinese or Thai origin
associated with carbamazepine or
chemically related compounds may be
predicted by testing a blood sample of
these patients. Your doctor should be
able to advise if a blood test is
necessary before taking Tegretol.
_ _
_- When you must not use it _

If you are allergic
(hypersensitive) to
carbamazepine or to any of the
other ingredients of Tegretol
listed at the end of this leaflet.

If you have severe heart disease.

If you have had a serious blood
illness
in the past.

If y

Ciri produk

Novartis
Business Use Only
Page 2 of 24
Malaysian Package Leaflet
13-Jan-2023
Tegretol
TEGRETOL
®
Antiepileptic, neurotropic, and psychotropic agent
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
TABLETS
: 200 mg carbamazepine.
CR
TABLETS
(modified-release
film-coated
tablets,
divisible):
200
mg
and
400
mg
carbamazepine.
ORAL SUSPENSION
: 5 mL (= 1 measure) contain 100 mg carbamazepine.
ACTIVE SUBSTANCE
Carbamazepine.
Certain dosage strengths and dosage forms may not be available in all
countries.
DESCRIPTION
TEGRETOL 200 MG TABLETS
White, round, flat, with bevelled edges. One side bears the imprint
“CG”, the other “GK” and
a score.
TEGRETOL CR 200 MG TABLETS
Beige-orange, oval, slightly biconvex coated tablets with a score on
each side. One side bears
the imprint “H/C”, the other “C/G”.
TEGRETOL CR 400 MG TABLETS
Brownish-orange, oval, slightly biconvex coated tablets with a score
on each side. One side
bears the imprint “ENE/ENE”, the other “CG/CG”.
TEGRETOL SYRUP
Viscous suspension, white, caramel flavored.
INDICATIONS

Epilepsy
–
Complex or simple partial seizures (with or without loss of
consciousness) with or
without secondary generalization.
–
Generalized tonic-clonic seizures. Mixed forms of seizures.
Tegretol is suitable for both monotherapy and combination therapy.
Tegretol is usually not effective in absences (petit mal) and
myoclonic seizures (see section
WARNINGS AND PRECAUTIONS).

Acute mania and maintenance treatment of bipolar affective disorders
to prevent or
attenuate recurrence.

Alcohol-withdrawal syndrome.

Idiopathic trigeminal neuralgia and trigeminal neuralgia due to
multiple sclerosis (either
typical or atypical). Idiopathic glossopharyngeal neuralgia.
Novartis
Business Use Only
Page 3 of 24
Malaysian Package Leaflet
13-Jan-2023
Tegretol
DOSAGE REGIMEN AND ADMINISTRATION
EPILEPSY
When possible, Tegretol should be prescribed as monotherapy.
Treatment should be initiated with a low daily dosage, to be slowly
increased until an optimal
effect is obt