Drug Advisory

HPS Pharmacies wish to advise that Indivior Pty Ltd, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect alert for:

Suboxone® Film
Buprenorphine/Naloxone 2mg/0.5mg
ARTG 163443

This product defect alert has been initiated following reports of more than one film being contained in a single sachet of Suboxone® Film 2mg/0.5mg. The potential consequences of a patient taking an additional film would include increased side effects such as somnolence and euphoria. Although the overall incidence of this defect is very low, reports have occurred in relation to multiple batches.

Healthcare professionals administering this medication should inspect the contents of each sachet in a directly supervised setting immediately prior to administration. Any additional film present in the sachet should be discarded in accordance with the requirements for Schedule 8 medications and the remaining full single film given to the patient as prescribed. Any take-away doses should be managed on a case-by-case basis. Although this issue has only been reported in the 2mg presentation, the same precautions should be instituted when administering the 8mg product.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Indivior on 1800 835 901.

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