Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Lamotrigine
Imbat Limited
N03AX; N03AX09
Lamotrigine
5 milligram(s)
Dispersible tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; lamotrigine
Authorised
2011-05-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamictal 5mg dispersible/chewable tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lamictal 5mg dispersible/chewable tablet contains 5mg lamotrigine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dispersible/chewable tablet. _Product imported from Italy :_ White to off-white, elongated, biconvex tablet with a blackcurrant odour, marked ‘GSCL2’ on one side, and ‘5’ on the other. The tablets may be slightly mottled. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy _Adults and adolescents aged 13 years and above_ o Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic - clonic seizures. o Seizures associated with Lennox - Gastaut syndrome. Lamictal is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox - Gastaut syndrome. _Children and adolescents aged 2 to 12 years_ o Adjunctive treatment of partial seizures and generalised seizures, including tonic - clonic seizures and the seizures associated with Lennox - Gastaut syndrome. o Monotherapy of typical absence seizures. Bipolar disorder _Adults aged 18 years and above_ o Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes_ (see section 5.1)._ Lamictal is not indicated for the acute treatment of manic or depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lamictal dispersible/chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water. 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. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Læs hele dokumentet