国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lamotrigine
GlaxoSmithKline Pharmaceuticals S.A.
N03AX09
lamotrigine
5mg
tablets chewable/dispersible
(28/2x14/) in blister
Prescription
Registered
2016-07-27
Reason for update: 2015-12-17 UKIE-TII-WS158-GDS 42-alopecia Text Date: 09 March 2016 MHRA Approval: 8 March 2016 Text Issue and Draft No.: Issue 10 Draft 3 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LAMICTAL ® 2 MG, 5 MG, 25 MG AND 100 MG CHEWABLE/DISPERSIBLE TABLETS LAMOTRIGINE LAMICTAL ® 2 MG, 5 MG, 25 MG AND 100 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 B EFORE 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 OTHER FORMATS To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: PRODUCT NAME LAMICTAL 2 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 5 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 25 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL 100 MG CHEWABLE/DISPERSIBLE TABLETS Reference number 00003/0375 This is a service provided by the Royal National Institute of Blind People. 1 WHAT LAMICTAL IS AND WHAT IT IS USED FOR Reason for update: 2015-12-17 UKIE-TII-WS158-GDS 42-alopecia Text Date: 09 March 2016 MHRA Approval: 8 March 2016 Text Issue and Draft No.: Issue 10 Draft 3 2 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 epile 阅读完整的文件
Reason for update: TII-WS158-GDS 42-alopecia Agency approval date: 8 March 2016 Text Date: 22 March 2016 SPC Issue 19 Draft 1 1 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 tablets (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 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). 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. Reason for update: TII-WS158-GDS 42-alopecia Agency approval date: 8 March 2016 Text Date: 22 March 2016 SPC Issue 19 Draft 1 2 If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients 阅读完整的文件