البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 1000 mg
Dr Reddys Laboratories Australia Pty Ltd
Levetiracetam
Tablet, film coated
Excipient Ingredients: povidone; titanium dioxide; purified talc; magnesium stearate; hypromellose; silicon dioxide; macrogol 400; sodium starch glycollate type A; maize starch
Oral
60 tablets
(S4) Prescription Only Medicine
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 Generalized Tonic Clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).
Visual Identification: White to off-white, oval shaped, film coated tablets debossed with breakline separating '1000' and 'MG' on one side and '1017' on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-05-27
Levecetam 1 LEVECETAM (LEVETIRACETAM) TABLETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LEVECETAM? Levecetam contains the active ingredient Levetiracetam. Levecetam is used to 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 For more information, see Section 1. Why am I using Levecetam? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LEVECETAM? Do not use if you have ever had an allergic reaction to levecetam or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Levecetam? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Levecetam and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE LEVECETAM? • The film coated tablets must be taken orally, swallowed with liquid and may be taken with or without food. • The daily dose is administered in two equally divided doses. More instructions can be found in Section 4. How do I use Levecetam? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LEVECETAM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly (if relevant). DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how this medicine affects you. Children should be careful doing things like riding bicycles or climbing trees. DRINKING ALCO اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION LEVECETAM (LEVETIRACETAM) TABLETS 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in Levecetam 250, 500, 1000/ tablets is levetiracetam 250 mg, 500 mg or 1000 mg. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Levecetam 250 levetiracetam 250 mg are blue coloured, oval shaped, film-coated tablets debossed with breakline separating ‘250’ and ‘MG’ on one side and ‘1014’ on other side. Levecetam 500 levetiracetam 500 mg are yellow coloured, oval shaped, film-coated tablets debossed with breakline separating ‘500’ and ‘MG’ on one side and ‘1015’ on other side. Levecetam 1000 levetiracetam 1000 mg are white to off white, oval shaped, film-coated tablets debossed with breakline separating ‘1000’ and ‘MG’ on one side and ‘1017’ on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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 Generalized Tonic Clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). 4.2 D OSE AND METHOD OF ADMINISTRATION The film coated tablets must be taken orally, swallowed with liquid and may be taken with or without food. The daily dose is administered in two equally divided doses. 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 depend اقرأ الوثيقة كاملة