1. Name of the medicinal product
Tegretol® 100mg, 200mg and 400mg Tablets

2. Qualitative and quantitative composition
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.

Each tablet contains 100mg / 200mg / 400mg carbamazepine Ph.Eur.

3. Pharmaceutical form

100mg Tablets :
 The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side impressed “GEIGY”, the other “B/W” and a score.
 
200mg Tablets :
 The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side impressed “CG”, the other “G/K” and a score.
 
400mg Tablets :
 The tablets are white, flat, rod-shaped tablets with bevelled edges. One side bears the imprint "CG/CG", the other "LR/LR" and both sides are scored.
 
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy - generalised tonic-clonic and partial seizures.

Note: Tegretol is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences.

The paroxysmal pain of trigeminal neuralgia.

For the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy.

4.2 Posology and method of administration
Tegretol is given orally, usually in two or three divided doses. Tegretol may be taken during, after or between meals, with a little liquid e.g. a glass of water.

Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome (See information on genetic testings and cutaneous reactions in section 4.4).

Epilepsy:

The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and precautions).

Adults: It is advised that with all formulations of Tegretol, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient.

Tegretol should be taken in a number of divided doses although initially 100-200mg once or twice daily is recommended. This may be followed by a slow increase until the best response is obtained, often 800-1200mg daily. In some instances, 1600mg or even 2000mg daily may be necessary.

Elderly: Due to the potential for drug interactions, the dosage of Tegretol should be selected with caution in elderly patients.

Children and adolescents: It is advised that with all formulations of Tegretol, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient.

Usual dosage 10-20mg/kg bodyweight daily taken in several divided doses.

Tegretol tablets are not recommended for very young children.

5-10 years:
 400 to 600mg daily (2-3 x 200mg tablets per day, to be taken in divided doses).
 
10-15 years:
 600 to 1000mg daily (3-5 x 200mg tablets per day, to be ta