1. Name of the medicinal product
Tegretol® Prolonged Release 200mg and 400mg Tablets

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

Each coated tablet contains 200mg or 400mg carbamazepine Ph.Eur.

3. Pharmaceutical form
Prolonged Release Tablet.

The 200mg tablets are beige-orange, oval, slightly biconvex, coated tablets with a score on each side. One side bears the imprint “H/C”, the other “C/G”.

The 400mg tablets are brownish-orange, oval, slightly biconvex coated tablets with a score on each side. One side bears the imprint “ENE/ENE”, the other “C/G”.

4. Clinical particulars
4.1 Therapeutic indications
Epilepsy - generalised tonic-clonic and partial seizures. Tegretol Prolonged Release is indicated in newly diagnosed patients with epilepsy and in those patients who are uncontrolled or unable to tolerate their current anti-convulsant therapy.

Note: Carbamazepine 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 psychoses in patients unresponsive to lithium therapy.

4.2 Posology and method of administration
Tegretol Prolonged Release is given orally, generally in the same total daily dose as conventional Tegretol dosage forms but usually in two divided doses. In a few patients when changing from other oral dosage forms of Tegretol to Tegretol Prolonged Release the total daily dose may need to be increased, particularly when it is used in polytherapy. When starting treatment with Tegretol Prolonged Release in monotherapy, 100-200mg once or twice daily is recommended. This may be followed by a slow increase in dosage until the best response is obtained, often 800-1200mg daily. In some instances, 1600mg or even 2000mg daily may be necessary.

Tegretol Prolonged Release (either the whole or half divisible tablet as prescribed), should not be chewed but should be swallowed with a little liquid, before, during or between meals. The divisible tablet presentation enables flexibility of dosing to be achieved.

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.

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 5 years:

5-10 years:

10-15 years:

>15 years of age:
 Tegretol Prolonged Release Tablets are not recommended

400-600mg daily

600-1000mg

800 to 1200mg daily (same as adult dose).
 
 Maximum recommended dose

Up to 6 years of age: 35mg/kg/day

6-15 years of age: 1000mg/day

>15 years of age: 1200mg/day.

Wherever possible, Tegretol Prolonged Release should be used as the sole drug anti-epileptic agent but if used in polytherapy, the same incremental dosage pattern is advised.

When Tegretol is added to existing antiepileptic therapy, this should be done gradually while maintaining or, if necessary, adapting the dosage of the other antiepileptic(s) (see 4.5 Interaction with other Medicaments and other forms of Interaction).

Trigeminal neuralgia:

Slowly raise the initial dosage of 200-400mg daily until freedom from pain is achieved (normally at 200mg 3-4 times daily). In the majority of patients a dosage of 200mg 3 or 4 times a day is sufficient to maintain a pain free state. In some instances, doses of 1600mg Tegretol daily may be needed. However, once the pain is in remission, the dosage should be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.

Elderly:

Dosage in Trigeminal neuralgia

Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Tegretol should be selected with caution in elderly patients.

In elderly patients, an initial dose of 100mg twice daily is recommended. The initial dosage of 100mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.

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

Initial starting dose of 400mg daily, in divided doses, increasing gradual