Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Lamotrigine
Lexon Pharmaceuticals (Ireland) Limited
N03AX; N03AX09
Lamotrigine
50 milligram(s)
Chewable/dispersible tablet
Other antiepileptics; lamotrigine
2017-05-19
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 What Lamictal is and what it is used for What you need to know before you take Lamictal How to take Lamictal Possible side effects How to store Lamictal Contents of the pack and other information 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 its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamictal works in the brain to have this effect. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMICTAL DO NOT TAKE Lue koko asiakirja
Health Products Regulatory Authority 10 February 2022 CRN00CSP3 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamictal 50 mg chewable/dispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lamictal 50 mg chewable/dispersible tablet contains 50 mg lamotrigine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable/dispersible tablet. _Product imported from Germany_ White to off-white multi-faceted, super-elliptical, tablets with a blackcurrant odour, marked GSCX7 on one side and 50 on the other. The tablets may be slightly mottled. 4 CLINICAL PARTICULARS As per PA1077/061/008 5 PHARMACOLOGICAL PROPERTIES As per PA1077/061/008 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Calcium carbonate Hyprolose Aluminium magnesium silicate Poly(O-carboxymethyl) starch, sodium salt Povidone K30 Sodium saccharine Magnesium stearate (Ph. Eur.) Blackcurrant flavour 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market 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 tablets. Health Products Regulatory Authority 10 February 2022 CRN00CSP3 Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 MARKETING AUTHORISATION HOLDER Unit 18, Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3 Harcourt Centre Harcourt Road Dublin 2 Ireland 8 MARKETING AUTHORISATION NUMBER PPA1097/007/004 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA23176/003/004 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 th May 2017 10 DATE OF REVISION OF THE TEXT October 2021 Lue koko asiakirja