Tegretol Oral Suspension 2%

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

CARBAMAZEPINE

Beschikbaar vanaf:

NOVARTIS (SINGAPORE) PTE LTD

ATC-code:

N03AF01

Dosering:

2 g/100 ml

farmaceutische vorm:

SUSPENSION

Samenstelling:

CARBAMAZEPINE 2 g/100 ml

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

Delpharm Huningue S.A.S.

Autorisatie-status:

ACTIVE

Autorisatie datum:

1988-04-28

Bijsluiter

TEGRETOL


Antiepileptic, neurotropic, and psychotropic agent 
DESCRIPTION ANDCOMPOSITION  
PHARMACEUTICAL FORMS 
TABLETS
: 100 mg, 200 mg and 400 mg carbamazepine. 
CR TABLETS
 (modified-release film-coated tablets,
divisible): 200 mg and 400 mg 
carbamazepine. 
CHEWABLE TABLETS
 (scored): 100 mg carbamazepine. 
SYRUP
: 5 mL (= 1 measure) contain 100 mg carbamazepine. 
SUPPOSITORIES
: 125 mg and 250 mg carbamazepine. 
ACTIVE SUBSTANCE 
Carbamazepine. 
Certain dosage strengths and dosage forms may not
be available in all countries. 
ACTIVE MOIETY 
Carbamazepine. 
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. 
  Painful diabetic neuropathy. 
  Diabetes insipidus centralis. Polyuria and polydipsia of
neurohormonal origin. 
Novartis   Page 
2 
Singapore-Specific Package Leaflet 
20 Dec 2013 
Tegretol 

DOSAGE AND ADMINISTRATION 
METHOD OF ADMINISTRATION 
The tablets and the syrup (to be shaken before use) may be taken
during, after, or between 
meals. Tablets should be taken with a little liquid, and
possible remnants of the chewable 
tablets should be washed down with a little liquid. 
The CR tablets (either whole or, if so prescribed, only half a
tablet) sho

Productkenmerken

Tegretol Jan 2023.SIN
Page 1 of 26
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.
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.
•
Painful diabetic neuropathy.
•
Diabetes insipidus centralis. Polyuria and polydipsia of neurohormonal
origin.
Tegretol Jan 2023.SIN
Page 2 of 26
DOSAGE REGIMEN AND ADMINISTRATION
METHOD OF ADMINISTRATION
The tablets and the oral suspension (to be shaken before use) may be
taken during, after, or
between meals. Tablets should be taken with a little liquid.
The CR tablets (either whole or, if so prescribed, only half a tablet)
should be swallowed
unchewed with a little liquid. The oral suspension (one measure = 5 mL
= 100 mg; half a
measure = 2.5 mL = 50 mg) is particularly suitable for patients who
have difficulty in swallowing
tablets or need initial careful adjustment of the dosage.
As a result of slow, controlled release of the active substance from
the CR tablets, these are
designed to be taken in a twice-daily dosage regimen.
Since a given dose of Tegretol oral suspension wi