País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levetiracetam
Desitin Pharma Ltd
N03AX14
Levetiracetam
250mg
Oral granules
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 4031649002212
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESITREND 250 MG COATED GRANULES IN SACHET DESITREND 500 MG COATED GRANULES IN SACHET DESITREND 1000 MG COATED GRANULES IN SACHET 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 Desitrend is and what it is used for 2. What you need to know before you take Desitrend 3. How to take Desitrend 4. Possible side effects 5. How to store Desitrend 6. Contents of the pack and other information 1. WHAT DESITREND IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Desitrend 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 generalization in adults, adolescents, children and infants from one month of age; • myoclonic seizures (short, shock-like jerks of a muscle group or muscles) in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy; • primary generalised Leer el documento completo
OBJECT 1 DESITREND 250MG Summary of Product Characteristics Updated 16-Jan-2017 | Desitin Pharma Ltd 1. Name of the medicinal product Desitrend 250 mg coated granules in sachet 2. Qualitative and quantitative composition _Desitrend 250 mg coated granules in sachet_ Each sachet contains 250 mg levetiracetam. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Coated granules in sachet Sachets with white or almost white, round, coated granules (diameter approx. 2 mm). 4. Clinical particulars 4.1 Therapeutic indications Desitrend 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. Desitrend 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 _Monotherapy for adults and adolescents from 16 years of age_ The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1,500 mg twice daily. _Add-on therapy for 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. 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 500 mg twice daily increases or decreases every two to Leer el documento completo