VELMETIA XR 50/500 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride 500 mg modified release tablet bottle

Active ingredient:

metformin hydrochloride, Quantity: 500 mg; sitagliptin phosphate monohydrate, Quantity: 64.25 mg (Equivalent: sitagliptin, Qty 50 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Metformin hydrochloride,sitagliptin phosphate monohydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; propyl gallate; kaolin; povidone; colloidal anhydrous silica; macrogol 3350; microcrystalline cellulose; sodium stearylfumarate; Carnauba Wax; titanium dioxide; hyprolose; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

14 tablets - starter pack, 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VELMETIA XR (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].

Product summary:

Visual Identification: Light blue, bi-convex oval, film coated tablet, debossed "78" on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-11-19