Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 1000 mg
Lupin Australia Pty Limited
Levetiracetam
Tablet, film coated
Excipient Ingredients: maize starch; colloidal anhydrous silica; croscarmellose sodium; povidone; microcrystalline cellulose; purified talc; magnesium stearate; titanium dioxide; macrogol 6000; polyvinyl alcohol; macrogol 3350
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: Levetiracetam tablets 1000 mg are white to off white, oblong-shaped, biconvex film-coated tablets, debossed with '1000' on one side and score line on the side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-07-27
1 LEVETIRACETAM -LAPL TABLETS 250 MG, 500 MG AND 1000 MG. Levetiracetam. (Lupin Australia Pty. Ltd.) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Levetiracetam-LAPL Tablets 250 mg, 500 mg and 1000 mg. 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 Levetiracetam-LAPL Tablets 250 mg, 500 mg and 1000 mg against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LEVETIRACETAM-LAPL TABLETS 250 MG, 500 MG AND 1000 MG IS USED FOR Levetiracetam-LAPL Tablets 250 mg, 500 mg and 1000 mg is used to control epilepsy. 2 Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Levetiracetam 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-LAPL Tablets may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe Levetiracetam-LAPL Tablets in addition to your current therapy. Ask your doctor if you have any questions about why Levetiracetam-LAPL Tablets has been prescribed for you. There is no evidence that Levetiracetam-LAPL Tablets is addictive. This medicine is available only with a doctor's prescription. The safety and effectiveness of Levetiracetam-LAPL Tablets has not been established in patients less than 4 years of age. BEFORE YOU TAKE LEVETIRACETAM-LAPL TABLETS 250 MG, 500 MG AND 1000 MG. WHEN YOU MUST NOT TAKE IT DO NOT TAKE LEVETIRACETAM-LAPL TABLETS IF YOU HAVE AN ALLERGY TO: • any of the ingredients listed at the end of this leaflet Symptoms of an allergic reaction to Levetiracet Přečtěte si celý dokument
Levetiracetam-LAPL Tablets ______________________________________________________________________________ ______________________________________________________________________________ _ Page 1 of 37 LEVETIRACETAM-LAPL TABLETS (LUPIN AUSTRALIA PTY. LTD) NAME OF THE MEDICINE Levetiracetam-LAPL Tablets 250 mg, 500 mg and 1000 mg. DESCRIPTION Chemical name: (S)-alpha-ethyl-2-oxo-1-pyrrolidine acetamide. Levetiracetam is a pure enantiomer. It is a white to off white powder with a faint odour and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 mg/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. Molecular formula: C 8 H 14 N 2 O 2 Molecular Weight: 170.21 CAS: 102767-28-2. Levetiracetam: Chemical structure. Levetiracetam-LAPL Tablets ______________________________________________________________________________ ______________________________________________________________________________ _ Page 2 of 37 Levetiracetam-LAPL tablets contain Levetiracetam, and the inactive ingredients starch-maize, silica-colloidal anhydrous, Croscarmellose sodium, cellulose microcrystalline, magnesium stearate, Povidone, Talc-purified. Tablets are film-coated & the film coating for each strength is different, as follows: 250mg – Opadry blue contains polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 6000 & 3350, and Indigo carmine CI73015 500mg – Opadry yellow contains polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 6000 & 3350, iron oxide yellow (CI77492) 1000mg – Opadry white contains polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 6000 & 3350. PHARMACOLOGY MECHANISM OF ACTION The precise mechanism of action by which Levetiracetam induces seizure protection still remains to be fully elucidated, but appears to be unrelated to the mechanisms of current antiepileptic drugs. _In vitro _and _in vivo _experiments suggest that Levetiracetam d Přečtěte si celý dokument