APO-OXYCODONE MR oxycodone hydrochloride 15mg modified release tablets blister pack

Active ingredient:

oxycodone hydrochloride, Quantity: 15 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

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

Administration route:

Oral

Units in package:

28, 60, 20

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

APO-OXYCODONE MR 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. APO-OXYCODONE MR is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. APO-OXYCODONE MR is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Grey, round, biconvex film-coated tablet, engraved 'APO' on one side, 'OCD' over '15' 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