البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levetiracetam
Lupin Healthcare (UK
N03AX14
Levetiracetam
1gram
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 8901107021290
450 mm 225 mm PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM-LUPIN 250MG FILM-COATED TABLETS LEVETIRACETAM-LUPIN 500 MG FILM-COATED TABLETS LEVETIRACETAM-LUPIN 750 MG FILM-COATED TABLETS LEVETIRACETAM-LUPIN 1000 MG FILM-COATED TABLETS LEVETIRACETAM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 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 Levetiracetam-Lupin is and what it is used for 2. What you need to know before you take Levetiracetam-Lupin 3. How to take Levetiracetam-Lupin 4. Possible side effects 5. How to store Levetiracetam-Lupin 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM-LUPIN IS AND WHAT IT IS USED FOR Levetiracetam-Lupin contains the active substance levetiracetam, which is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam-Lupin is used: · on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could then extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits. · as an add-on to other antiepileptic medicines to treat: - partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age; - myoclonic se اقرأ الوثيقة كاملة
OBJECT 1 LEVETIRACETAM-LUPIN FILM-COATED TABLETS Summary of Product Characteristics Updated 08-Jan-2018 | Lupin Healthcare (UK) Ltd 1. Name of the medicinal product Levetiracetam-Lupin 250 mg film-coated tablets Levetiracetam-Lupin 500 mg film-coated tablets Levetiracetam-Lupin 750 mg film-coated tablets Levetiracetam-Lupin 1000 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 250 mg levetiracetam. Each film-coated tablet contains 500 mg levetiracetam. Each film-coated tablet contains 750 mg levetiracetam. Each film-coated tablet contains 1000 mg levetiracetam. Excipients with known effect (750mg only) Each film-coated tablet contains 0.13 mg E110 sunset yellow FCF aluminium lake (E110). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Blue, oblong shaped, biconvex film coated tablet debossed with “250” on one side and score line on the other side. The tablets can be divided into equal doses. Yellow, oblong shaped, biconvex film coated tablet debossed with “500” on one side and score line on the other side. The tablets can be divided into equal doses. Peach coloured, oblong shaped, biconvex film coated tablet debossed with “750” on one side and score line on the other side. The tablets can be divided into equal doses. White to off white, oblong shaped, biconvex film coated tablet debossed with “1000” on one side and score line on one side. The tablets can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Levetiracetam tablets are indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam tablets are indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy. • in the treatment of myoclonic seizu اقرأ الوثيقة كاملة