SILUMBRA suvorexant 15mg tablet blister pack

Active ingredient:

suvorexant, Quantity: 15 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

suvorexant

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; lactose monohydrate; copovidone; titanium dioxide; hypromellose; triacetin

Administration route:

Oral

Units in package:

3 tablets, 10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SILUMBRA is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. Following initiation of treatment, continuation should be re-evaluated after 3 months [see Pharmacodynamic Properties, Clinical trials and Adverse Effects (Undesirable Effects) for clinical trial durations].

Product summary:

Visual Identification: White, oval, biconvex, film coated tablet, marked with MSD logo and 325 on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2016-11-16