Therapeutic indications
Epilepsy:
Adults and adolescents aged 13 years and above
• Adjunctive or monotherapy treatment of partial seizures and generalized seizures, including tonic-clonic seizures.
• Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given as an adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaout syndrome.
Children and adolescents aged 2 to 12 years
• Adjunctive treatment of partial seizures and generalized seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.
• Monotherapy of typical absence seizures.
Bipolar disorder:
Adults aged 18 years and above
• Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).
Lamotrigine is not indicated for the acute treatment of manic or depressive episodes.
Lamotrigine tablets should be swallowed whole. If the tablets require halving ( to take half the dose or to facilitate ease of swallowing), the halves should also be swallowed whole and not be chewed or crushed. Use a tablet cutter to halve tablets. Alternatively, keeping the score-line side facing upwards, hold both the upper and lower sides of the tablet, on either side of the score-line, using the thumb and index finger of both hands (Fig. A) and halve the tablet by pressing down and away from the score-line so that the tablet opens at the score-line side. Do not hold on to the shoulder (end) of the tablet, on either side of the score-line (Fig. B), when halving since this may cause the tablet to crumble.
If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.
For doses not realisable/practicable with this medicinal product, other strengths of this medicinal product or other pharmaceutical forms and products are available.
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