Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Levetiracetam
Clonmel Healthcare Ltd
N03AX14
Levetiracetam
500 milligram(s)
Film-coated tablet
levetiracetam
Marketed
2021-02-12
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Levetiracetam Clonmel 250 mg film-coated tablets Levetiracetam Clonmel 500 mg film-coated tablets Levetiracetam Clonmel 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 Clonmel is and what it is used for 2. What you need to know before you take Levetiracetam Clonmel 3. How to take Levetiracetam Clonmel 4. Possible side effects 5. How to store Levetiracetam Clonmel 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM CLONMEL IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Clonmel 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 the 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 thereafter 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 seizures (short, shock-like jerks of a muscle or group of muscles) in adults a Läs hela dokumentet
Health Products Regulatory Authority 09 November 2021 CRN00CJ41 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levetiracetam Clonmel 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg levetiracetam. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, oval shaped film coated tablets with a score line on one side with dimensions 16.5 x 7.7 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam Clonmel is 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 Clonmel is 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 seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic -clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Partial onset seizures_ The recommended dosing for monotherapy (from 16 years of age) and adjunctive therapy is the same; as outlined below. _All indications_ _Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more_ The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. However, a lower initial dose of 250 mg twice daily may be given based on physician assessment of seizure reduction versus potential side effects. This can be increased to 500 mg twice daily after two weeks. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 250 mg Läs hela dokumentet