Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
Intega Sdn. Bhd.
LEVETIRACETAM
60 Tablets
Rontis Hellas Medical and Pharmaceutical Products S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 INTIRACETAM FILM COATED TABLET Levetiracetam (250mg, 500mg, 1000mg) WHAT IS IN THIS LEAFLET 1. What INTIRACETAM is used for 2. How INTIRACETAM works 3. Before you use INTIRACETAM 4. How to use INTIRACETAM 5. While you are using it 6. Side effects 7. Storage and Disposal of INTIRACETAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT INTIRACETAM IS USED FOR INTIRACETAM is used: • on its own in adults and adolescents from 16 years of age with a certain type of newly diagnosed 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 seizures with or without secondary generalization). INTIRACETAM 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 secondary generalization in adults and children from 4 years of age with epilepsy. - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy - primary generalized tonic-clonic seizures (major fits, including loss of consciousness) in adults and children from 12 years of age with Idiopathic Generalized Epilepsy. HOW INTIRACETAM WORKS INTIRACETAM is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). BEFORE YOU USE INTIRACETAM - _When you must not use it_ Do not take INTIRACETAM • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). _Pregnancy and breastfeeding:_ If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Přečtěte si celý dokument
INTIRACETAM Levetiracetam _ _- INTIRACETAM 250 mg Film-coated Tablets INTIRACETAM 500 mg Film-coated Tablets INTIRACETAM 1000 mg Film-coated Tablets PHARMACEUTICAL FORM AND STRENGTH _Levetiracetam, 250 mg, film-coated tablets _ Each film-coated tablet contains 250 mg of levetiracetam.. Blue color, oval shaped film coated tablets with a break line on one side. _Levetiracetam, 500 mg, film-coated tablets _ Each film-coated tablet contains 500 mg of levetiracetam. Yellow color, oval shaped film coated tablets with a break line on one side. _Levetiracetam, 1000 mg, film-coated tablets _ Each film-coated tablet contains 1000 mg of levetiracetam . White color, oval shaped film coated tablets with a break line on one side. EXCIPIENTS _Levetiracetam, 250 mg, film-coated tablets _ Crospovidone (type B) (E1202), Povidone K30, Silica, colloidal anhydrous (E551), Magnesium stearate (E470b), Hypromellose (E464), Macrogol / PEG 400 (E1521), Titanium dioxide (E171), Talc (E553b), Indigo carmine aluminium lake (E132), Water, purified _Levetiracetam, 500 mg, film-coated tablets _ Crospovidone (type B) (E1202), Povidone K30, Silica, colloidal anhydrous (E551), Magnesium stearate (E470b), Hypromellose (E464), Macrogol / PEG 400 (E1521), Titanium dioxide (E171), Talc (E553b), Iron oxide yellow (E172), Water, purified _Levetiracetam, 1000 mg, film-coated tablets _ Crospovidone (type B) (E1202), Povidone K30, Silica, colloidal anhydrous (E551), Magnesium stearate (E470b), Hypromellose (E464), Macrogol / PEG 400 (E1521), Titanium dioxide (E171), Talc (E553b), Water, purified INDICATIONS Intiracetam 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. Intiracetam is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy. • in the treatment of myoclonic seizures in adults and adolescents from 12 Přečtěte si celý dokument