Shortage of TEMGESIC® [buprenorphine 200 microgram (as hydrochloride)] sublingual tablets, 50 tablet pack, AUST R [34091] and alternative supply arrangement under Section 19A of the Therapeutic Goods

Patient Letter - TEMGESIC buprenorphine hydrochloride 0.2mg sublingual tablet (Germany).pd

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Echo Therapeutics, the supplier of TEMGESIC® [buprenorphine 200 microgram (as hydrochloride)] sublingual tablets, 50 tablet pack, AUST R [34091], wishes to notify you of an alternative and temporary supply arrangement for TEMGESIC®.

For a short term, TEMGESIC buprenorphine hydrochloride 0.2 mg sublingual tablet (Germany) will be supplied. This alternative product is registered and marketed in Germany and therefore all labelling is in German. This product is NOT registered in Australia but is identical in active ingredient, strength, and formulation.

In addition to the packaging being in German rather than English, the way to remove a tablet is also different. Please note the following instructions on how to remove a tablet from the German Temgesic’s lidding foil.

Please disregard the CMI/patient leaflet for TEMGESIC sublingual tablet (Germany) contained within the pack and refer to the Australian Consumer Medicines Information available from the Echo Therapeutics’ website.

The German product has an overlabel sticker affixed as shown below.

Adverse Event Reporting

Reporting any suspected adverse event is important for the continued monitoring of the safety of all medicines. Any adverse events which are experienced with TEMGESIC sublingual tablet (Germany) should be reported to Echo Therapeutics on 1300 848 328 or by email drugsafety@echotherapeutics.net . Alternatively, this information can be reported directly to the TGA.

For additional information, please contact your Doctor or Pharmacist.