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Public Alert 017/2018 – Alert On Withdrawal Of Medicines With Modified Or Prolonged Release Paracetamol By Portugal Internal Health Authority

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Portuguese Authority for Medicines (INFARMED) on the 9th march, 2018 announced the suspension and withdrawal of medicines containing modified or prolonged-release paracetamol, following a safety assessment conducted by the European Medicines Agency (EMA) which concluded that these medicines carry more risks than their supposed benefits to the patients.

Modified-release and prolonged-release paracetamol medications are designed to release paracetamol slowly over a longer period of time into the blood stream while having the advantage of being taken at less frequent intervals than the immediate release products.

The details of the drugs containing paracetamol that are affected by the suspension/withdrawal are as follows:-

  1. Panadol Prolong 665mg
  2. Diliband Retard 75mg + 650mg
  3. Tramadol + Paracetamol KrKa 75mg + 650mg
  4. Tramadol + Paracetamol Verum Pharma LP 75mg + 650mg

NAFDAC implores members of the public to avoid sale and use of these products if in their possession and submit to the nearest NAFDAC office.

Consumers are encouraged to report all adverse events resulting from the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via Pharmacovigilance@nafdac.gov.ng

NAFDAC…………..Safeguarding the health of the nation!!!

Signed Management