Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 250 mg
Alphapharm Pty Ltd
Levetiracetam
Tablet, film coated
Excipient Ingredients: magnesium stearate; maize starch; colloidal anhydrous silica; povidone; croscarmellose sodium; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 400
Oral
60
(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), and,Add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).
Visual Identification: Light blue, capsule shaped, biconvex film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2016-11-21
KEVTAM _levetiracetam_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KEVTAM. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking KEVTAM against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT KEVTAM IS USED FOR KEVTAM levetiracetam is used to treat epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. This medicine 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. KEVTAM may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed this medicine in addition to your current therapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that this medicine is addictive This medicine is available only with a doctor's prescription. The safety and effectiveness of KEVTAM has not been established in patients less than 4 years of age. BEFORE YOU TAKE KEVTAM _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE KEVTAM 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 parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING OR IF THE TABLETS DO NOT LOOK QUITE RIGHT. If it has expire Soma hati kamili
AUSTRALIAN PRODUCT INFORMATION KEVTAM 250 KEVTAM 500 KEVTAM 1000 _Levetiracetam film-coated tablets _ 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam 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 g/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. Each KEVTAM 250 film-coated tablet contains 250 mg of levetiracetam. Each KEVTAM 500 film-coated tablet contains 500 mg levetiracetam. Each KEVTAM 1000 film-coated tablet contains 1000 mg levetiracetam. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Film-coated tablets. KEVTAM 250: Light blue, capsule shaped, biconvex film coated tablets plain on both sides. KEVTAM 500: Yellow, capsule shaped, biconvex film coated tablets plain on both sides. KEVTAM 1000: White, capsule shaped, biconvex film coated tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KEVTAM 250, KEVTAM 500 and KEVTAM 1000 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 generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE). Kevtam 250, Kevtam 500 and Kevtam 1000 – AUSTRALIAN PRODUCT INFORMATION _2 _ 4.2 DOSE AND METHOD OF ADMINISTRATION Levetiracetam therapy can be initiated with either intravenous or oral admin Soma hati kamili