Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Lamotrigine
GlaxoSmithKline (Ireland) Limited
N03AX; N03AX09
Lamotrigine
5 milligram(s)
Chewable/dispersible tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; lamotrigine
Marketed
1994-05-16
Reason for Update: Type IAIN – PRAC recommendation Market: IE Agency Approval Date: 25/10/2023 – Type IA – Implementation date Text Date: 18/09/2023 Text Issue and Draft No.: Issue 24 Draft 1 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LAMICTAL 5 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 25 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 50 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 100 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 200 MG CHEWABLE/DISPERSIBLE TABLETS lamotrigine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT LAMICTAL IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMICTAL 3 HOW TO TAKE LAMICTAL 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE LAMICTAL 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT LAMICTAL IS AND WHAT IT IS USED FOR Lamictal belongs to a group of medicines called _anti-epileptics_ . It is used to treat two conditions — EPILEPSY and BIPOLAR DISORDER . LAMICTAL TREATS EPILEPSY by blocking the signals in the brain that trigger epileptic seizures (fits). • For adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines, to treat epilepsy. Lamictal can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome. • For children aged between 2 and 12 years, Lamictal can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures. LAMICTAL ALSO TREATS BIPOLAR DISORDER. Peopl Lue koko asiakirja
Health Products Regulatory Authority 16 January 2024 CRN00DYM7 Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamictal 5 mg chewable/dispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lamictal 5 mg chewable/dispersible tablet contains 5 mg lamotrigine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable/dispersible tablet. White to off‑white, elongated, biconvex tablet s (major axis 8.0 mm; minor axis 4.0 mm) with a blackcurrant odour, marked GS CL2 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_ - Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic‑clonic seizures. - 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_ - Adjunctive treatment of partial seizures and generalised seizures, including tonic‑clonic seizures and the seizures associated with Lennox‑Gastaut syndrome. - Monotherapy oftypical 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). Lamictal is not indicated for the acute treatment of manic or depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lamictal chewable/dispersible 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. Do not attempt to administer partial quantities of the chewable/dispersible tablets. 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 t Lue koko asiakirja