Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
levetiracetam
Actavis Group PTC ehf
N03AX14
levetiracetam
Antiepileptics,
Epilepsy
Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis Group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, 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.
Revision: 18
Authorised
2011-12-04
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM ACTAVIS GROUP 100 MG/ML ORAL SOLUTION 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 Actavis Group is and what it is used for 2. What you need to know before you take Levetiracetam Actavis Group 3. How to take Levetiracetam Actavis Group 4. Possible side effects 5. How to store Levetiracetam Actavis Group 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM ACTAVIS GROUP IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Actavis Group 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 and adolescents from 12 years of age with Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 . NAME OF THE MEDICINAL PRODUCT Levetiracetam Actavis Group 100 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 mg levetiracetam. Excipients with known effect: Each ml contains 1.50 mg of methyl parahydroxybenzoate (E218), 0.15 mg of propyl parahydroxybenzoate (E216), 290 mg of maltitol liquid (E965), 3,26 mg propylene glycol (E 1520) and 0.25 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, faint yellowish-brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam Actavis Group 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 Actavis Group 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. 3 Depending upon the clinical response and tolerability, the daily dose can be inc Aqra d-dokument sħiħ