PRUCALOPRIDE MedTAS prucalopride (as succinate) 2 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prucalopride succinate, Quantity: 2.64 mg (Equivalent: prucalopride, Qty 2 mg)

Available from:

MedTAS Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide yellow; iron oxide red; macrogol 3000; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

28 film-coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief. ? Before Prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation. ? If treatment with Prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

Product summary:

Visual Identification: Pink, round biconvex, film coated tablets debossed with P2 on one side and no debossing on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-09-12