Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Levetiracetam
Wockhardt UK Limited
N03AX; N03AX14
Levetiracetam
100 milligram(s)/millilitre
Oral solution
Product subject to prescription which may be renewed (B)
Other antiepileptics; levetiracetam
Not marketed
2011-06-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM WOCKHARDT 100 MG/ML ORAL SOLUTION 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. 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 effect please tell your doctor or pharmacist. This includes possible side effects not listed in this leaflet. See section 4 Levetiracetam Wockhardt 100 mg/ml Oral Solution is referred to as Levetiracetam Oral Solution throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Levetiracetam Oral Solution is and what it is used for 2. What you need to know before you take Levetiracetam Oral Solution 3. How to take Levetiracetam Oral Solution 4. Possible side effects 5. How to store Levetiracetam Oral Solution 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM ORAL SOLUTION IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Oral Solution 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 musc Przeczytaj cały dokument
Health Products Regulatory Authority 10 January 2020 CRN009G4G Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levetiracetam Wockhardt 100 mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 100 mg levetiracetam. Excipients with known effect: Each ml also contains liquid maltitol 269.4 mg (approximately 106 mg of maltitol), methyl parahydroxybenzoate (E218) 1.4 mg and propyl parahydroxybenzoate (E216) 0.2 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear to slightly yellow oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam 100mg/ml Oral Solution, 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 100mg/ml Oral Solution, 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. 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 1500 mg twice daily. _Add-on therapy 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 inc Przeczytaj cały dokument