1. Name of the medicinal product
Tegretol® 100mg/5ml Liquid

2. Qualitative and quantitative composition
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide. The liquid contains 100mg carbamazepine Ph.Eur. in each 5ml.

3. Pharmaceutical form
Tegretol Liquid is a white oral suspension.

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 Liquid is given orally, usually in two or three divided doses.

Tegretol Liquid (the liquid should be shaken before use) may be taken during, after or between meals.

Since a given dose of Tegretol Liquid will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses of the liquid and to increase them slowly so as to avoid adverse effects on the central nervous system such as dizziness and lethargy.

When switching a patient from tablets to liquid the same overall dose may be used but in smaller, more frequent, doses.

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 to 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 in several divided doses.

Age up to 1 year:
 100 to 200mg daily (5-10ml liquid per day).
 
1-5 years:
 200 to 400mg daily (10-20ml liquid