Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Lamotrigine
PCO Manufacturing
N03AX; N03AX09
Lamotrigine
100 milligram(s)
Chewable/dispersible tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; lamotrigine
2012-09-14
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER LAMICTAL ® 25 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL ® 50 MG CHEWABLE/DISPERSIBLE TABLETS LAMICTAL ® 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 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. People with bipolar disorder (sometimes called _manic depression_) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). For adults aged 18 years and over, Lamictal can be used on Baca dokumen lengkap
Health Products Regulatory Authority 07 December 2018 CRN008N1N Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamictal 100 mg chewable/dispersible tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lamictal 100 mg chewable/dispersible tablet contains 100 mg lamotrigine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable/dispersible tablet. _Product imported from Spain:_ White to off‑white square tablet with rounded corners with a blackcurrant odour, marked “GSCL7” on one side and “100” on the other. The tablets may be slightly mottled. 4 CLINICAL PARTICULARS As per PA 1077/061/009 5 PHARMACOLOGICAL PROPERTIES As per PA 1077/061/009 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Calcium carbonate Low-substituted hydroxypropyl cellulose Aluminium magnesium silicate Sodium starch glycolate (Type A) Povidone K30 Saccharin sodium Magnesium stearate Blackcurrant flavour 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 07 December 2018 CRN008N1N Page 2 of 2 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the container and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 56 chewable tablets/dispersible contained in an overlabelled outer carton 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements for disposal. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA465/443/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 th September 2012 10 DATE OF REVISION OF THE TEXT December 2018 Baca dokumen lengkap