OSENI 25/45 25 mg alogliptin (as benzoate) / 45 mg pioglitazone (as hydrochloride) film-coated tablet bottle

Active ingredient:

pioglitazone hydrochloride, Quantity: 49.59 mg (Equivalent: pioglitazone, Qty 45 mg); alogliptin benzoate, Quantity: 34 mg (Equivalent: alogliptin, Qty 25 mg)

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Alogliptin benzoate,Pioglitazone hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; hyprolose; iron oxide red; lactose monohydrate; purified talc; mannitol; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; Shellac; ethanol absolute; iron oxide black; 1-butanol

Administration route:

Oral

Units in package:

90, 100, 14 (sample pack), 30, 56, 28, 7 (sample pack), 10 (sample pack), 60, 98

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OSENI is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and pioglitazone is appropriate,- when treatment with metformin or pioglitazone alone does not provide adequate control; or,- in combination with metformin when dual therapy does not provide adequate control.,OSENI can also be used to replace separate tablets of alogliptin and pioglitazone in patients already being treated with this combination.

Product summary:

Visual Identification: Red, round, biconvex, film-coated tablets with A/P and 25/45 printed on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-02-10