Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 500 mg
Accord Healthcare Pty Ltd
Levetiracetam
Tablet, film coated
Excipient Ingredients: povidone; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
60 tablets
(S4) Prescription Only Medicine
LEVETIRACETAM VIATRIS tablets are indicated for: ? Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? Add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME) and, ? Add-on therapy in the treatment of primary generalised tonic-clonic seizures (PGTC) in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).
Visual Identification: Yellow coloured, oval biconvex, film coated tablets, debossed " L 65" and breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-04-20
CONSUMER MEDICINE INFORMATION Version 1 2020 Page: 1 of 5 LEVETIRACETAM MYLAN TABLETS 250 MG/500 MG/1000 MG levetiracetam WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LEVETIRACETAM MYLAN tablets. It does not contain all the available information. It does not take the place of talking to your physician or pharmacist. All drugs have risks and benefits. Your physician has weighed the risks of you taking LEVETIRACETAM MYLAN tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS DRUG, ASK YOUR PHYSICIAN OR PHARMACIST. KEEP THIS LEAFLET WITH THE DRUG. You may need to read it again. WHAT LEVETIRACETAM MYLAN TABLETS ARE USED FOR LEVETIRACETAM MYLAN tablets are used to control epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. LEVETIRACETAM MYLAN tablets belong to a group of drugs called antiepileptics. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. LEVETIRACETAM MYLAN tablets may be used alone or in combination with other drugs, to treat your condition. Your physician may have prescribed LEVETIRACETAM MYLAN tablets in addition to your current therapy. ASK YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS LEVETIRACETAM MYLAN TABLETS HAVE BEEN PRESCRIBED FOR YOU. There is no evidence that LEVETIRACETAM MYLAN tablets are addictive. This drug is available only with a physician’s prescription. The safety and effectiveness of LEVETIRACETAM MYLAN tablets has not been established in patients less than 4 years of age. BEFORE YOU TAKE LEVETIRACETAM MYLAN TABLETS WHEN YOU MUST NOT TAKE IT DO NOT TAKE LEVETIRACETAM MYLAN TABLETS IF YOU HAVE AN ALLERGY TO: • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing. • swelling of the face, lips, tongue or other par Olvassa el a teljes dokumentumot
LEVETIRACETAM MYLAN PI v1 AUSTRALIAN PRODUCT INFORMATION LEVETIRACETAM MYLAN 250/500/1000 (LEVETIRACETAM) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The product LEVETIRACETAM MYLAN contain levetiracetam as the active ingredient. LEVETIRACETAM MYLAN are available in three strengths 250 mg, 500 mg, and 1000 mg. For the full list of Excipients, see Section 6.1 List of Excipients 3 PHARMACEUTICAL FORM LEVETIRACETAM MYLAN 250 (AUST R 189885): are white to off white tablets, oval biconvex, film coated tablets, debossed ‘L 64’ and breakline on one side and plain on the other side. LEVETIRACETAM MYLAN 500 (AUST R 189886): are yellow coloured tablets, oval biconvex, film coated tablets, debossed ‘L 65’ and breakline on one side and plain on the other side. LEVETIRACETAM MYLAN 1000 (AUST R 1898877): are white to off white tablets , oval biconvex, film coated tablets, debossed ‘L 67’ and breakline on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS LEVETIRACETAM MYLAN are indicated for • Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. • Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. • Add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME) and, • Add-on therapy in the treatment of primary generalised tonic-clonic seizures (PGTC) in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). 4.2 D OSE AND METHOD OF ADMINISTRATION LEVETIRACETAM MYLAN PI v1 The film coated tablets must be taken orally, swallowed with liquid. The film coated tablets may be taken with or without food. The daily dose is administered in two equally divided doses. MONOTHERAPY: The recommended startin Olvassa el a teljes dokumentumot