QUETIAPINE SG quetiapine (as fumarate) 200 mg film-coated tablet blister pack

Active ingredient:

quetiapine fumarate, Quantity: 230.31 mg (Equivalent: quetiapine, Qty 200 mg)

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; lactose monohydrate; hypromellose; povidone; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; magnesium stearate; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

20, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Quetiapine is indicated for: Bipolar disorder -Adults- Maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes.Treatment of depressive episodes associated with bipolar disorder (see dosage and administration). Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate. Children/adolescents aged 10 to 17 years - Monotherapy treatment of acute mania associated with bipolar I disorder. Schizophrenia - Adults and adolescents aged 13 to 17 years -Treatment of schizophrenia

Product summary:

Visual Identification: White coloured, round, biconvex, film coated tablet, engraved with 'Q' on one face and '200' on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-12-12