Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 500 mg
Southern Cross Pharma Pty Ltd
Levetiracetam
Tablet, film coated
Excipient Ingredients: maize starch; povidone; purified talc; colloidal anhydrous silica; magnesium stearate; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
60 tablets
(S4) Prescription Only Medicine
Use in epiletpic 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 genralisation, 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). Add-on therapy in the treatment of Primary Generalised Tonic Clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).
Visual Identification: yellow oblong tablet, with central score on both faces, one side marked "Lev 500"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2010-04-28
________________________________________________________________________________ C:Products/Levetir/CMI 8 February 2012 Page 1 of 4 Levetiracetam SCP tablets _levetiracetam tablets_ CONSUMER MEDICINE INFORMATION _ _ What is in this leaflet This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medication against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again . What Levetiracetam SCP is used for Levetiracetam SCP is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Levetiracetam SCP belongs to a group of medicines called antiepileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Levetiracetam SCP may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe Levetiracetam SCP in addition to your current therapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LEVETIRACETAM SCP HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Levetiracetam SCP is addictive. This medicine is available only with a doctor's prescription. The safety and effectiveness of Levetiracetam SCP have not been established in patients less than 4 years of age. Before you take Levetiracetam SCP _When you must not take it _ DO NOT TAKE LEVETIRACETAM SCP IF YOU HAVE AN ALLERGY TO: any of the ingredients listed at the end of this leaflet Symptoms of an allergic reaction to Levetiracetam SCP may include: shortness of breath, wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body Read the complete document
AUSTRALIAN PRODUCT INFORMATION LEVETIRACETAM SCP (LEVETIRACETAM) TABLETS _ _ 1. NAME OF THE MEDICINE Levetiracetam 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The product, Levetiracetam SCP tablets, contains levetiracetam as the active ingredient, available in strengths of 250 mg, 500 mg, 750 mg and 1000 mg. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets - oblong, film coated • 250 mg -blue, marked Lev 250 on one side with central score on both faces; • 500 mg - yellow, marked Lev 500 on one side with central score on both faces; • 750 mg * orange, marked Lev 750 on one side with central score on both faces; • 1,000 mg -white, marked Lev 1000 on one side with central score on both faces. * Not currently marketed in Australia 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS FILM COATED TABLETS. • 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). • Add-on therapy in the treatment of Primary Generalised Tonic Clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). 4.2. DOSE AND METHOD OF ADMINISTRATION The film coated tablets must be taken orally, swallowed with liquid. MONOTHERAPY: 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. ADULTS (> 18 YEARS OF AGE) AND ADOLESCENTS (AGED 12 TO 17 YEARS OF AGE) WEIGHING 50 KG Read the complete document