CIPLA LEVETIRACETAM levetiracetam 250 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

levetiracetam, Quantity: 250 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; maize starch; colloidal anhydrous silica; povidone; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 400; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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), 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).

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2015-10-19