Trileptal 300 mg 50 tablets

Trade name:

Trileptal 600 mg 50 Film-coated Tablets

Composition:

Each film-coated tablet contains 600 mg of oxcarbazepine.

Indications:

Trileptal is indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures.

Trileptal is indicated for use as monotherapy or adjunctive therapy in adults and in children of 6 years of age and above.

Dosage and method of administration:

In mono- and adjunctive therapy, treatment with Trileptal is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. 

Trieptal can be taken with or without food.

Adults. Monotherapy:

Trileptal should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.

Therapeutic effects are seen at doses between 600 mg/day and 2,400 mg/day.

Patients with renal impairment 

In patients with impaired renal function (creatinine clearance less than 30 ml/min)

Trileptal therapy should be initiated at half the usual starting dose (300 mg/day) and increased, in at least weekly intervals, to achieve the desired clinical response.

Pediatric population:

In mono- and adjunctive therapy, Trileptal should be initiated with a dose of 8-10 mg/kg/day given in 2 divided doses.

Maintenance dose:

In adjunctive therapy trials, a maintenance dose of 30-46 mg/kg/day, achieved over two weeks, Is shown to be effective and well tolerated in children.

Therapeutic effects were seen at a median maintenance dose of approximately 30 mg/kg/day.

Maximum recommended dose:

Clinically indicated, the dose may be increased by a maximum of 10 mg/kg/ day at approximately weekly intervals from the starting dose, to a maximum dose of 46 mg/kg/day, to achieve the desired clinical response.

Contraindications:

Hypersensitivity to the active substance, to eslicarbazepine or to any of the excipients listed in the leaflet.

Trileptal is not recommended in children aged less than 6 years.

Special warnings and precautions:

Hypersensitivity

Side Effects:

Anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Trileptal.

Rare: severe skin reactions.

Hypersensitivity reactions, including multi-organ hypersensitivity reactions: Such reactions can affect the skin, liver, blood and lymphatic system or other organs, either individually or together in the 2 contexts of a systemic reaction.

Fertility, pregnancy:

Trileptal may result in a failure of the therapeutic effect of oral contraceptive medicines containing ethinylestradiol (EE) and levonorgestrel (LNG). 

Pregnancy

In the treated population, an increase in malformations has been noted with polytherapy, particularly in polytherapy including valproate.

Moreover, effective anti-epileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.

Storage Method: 

Do not store above 30 °C

Keep out of the reach and sight of children

Package:

A carton box contains 3 blisters, 10 tablets in each one.