OXYCODONE MR APOTEX oxycodone hydrochloride 30mg modified release tablets blister pack

Active ingredient:

oxycodone hydrochloride, Quantity: 30 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: colloidal anhydrous silica; hyprolose; iron oxide red; titanium dioxide; lactose; hypromellose; ethylcellulose; magnesium stearate; macrogol 8000; iron oxide black; iron oxide yellow

Administration route:

Oral

Units in package:

28, 20, 60

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

OXYCODONE MR APOTEX modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. OXYCODONE MR APOTEX is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. OXYCODONE MR APOTEX is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Light brown, round, biconvex film-coated tablet, engraved 'APO' on one side, 'OCD' over '30' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-11-21