Boehringer Ingelheim Pty Ltd has advised HPS Pharmacies of a safety alert for:
Product: SIFROL (pramipexole HCl) tablets
Dose: 0.125 mg, 0.25 mg, 1 mg
Aust R: 67238, 66484, 66485
Batch numbers: All batches
Expiry date: All expiry dates
The Consumer Medicine Information (CMI) leaflet inserted into the packet, and in general distribution for SIFROL (pramipexole HCl) tablets contains incomplete dosing advice in the “How to take Sifrol” section under the sub-heading “How much to take”.
The revised CMI for SIFROL tablets shows a revision date of September 2012 at the end of the document and is available for download from medicines.org.au.
Boehringer Ingelheim expect to have SIFROL tablets with the correct CMI insert available within the month, at which time existing supplies will be recalled.
SIFROL tablets are safe to be used and not subject to recall at this time. SIFROL ER tablets (pramipexole HCl extended release formulation) are not affected by this notice.
Please retain this notice in a prominent position until the recall notice is issued, including other related business units.
Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies or Boehringer Ingelheim on 1800 226 315.
Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.