Safety Alerts & Recalls
What does this mean?
This recall for Topamax 200 mg tablets was issued at the wholesale and pharmacy level only. The MHRA and companies involved have determined that there is no specific evidence to suggest that the medicines are not safe for patient use. People who have these medicines should continue to take their medication as directed. If you use Topamax and are concerned, you should follow up with your doctor or pharmacist.
Recall Topamax: Safety Warnings Not Included in Patient Information Leaflet
P.I.E. Pharma Limited is recalling unused stock from a single batch of Topamax 200 mg tablets because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency.
The safety warning which should have been included in the PILs for Topamax under the section titled "Before taking your medicine" or "Take special care with Topamax" states: "A small number of people being treated with anti-epileptics such as Topamax have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor."
Topamax contains the active ingredient topiramate. Please note, other companies may distribute this medicine, but this recall only applies to a single batch of Topamax from P.I.E. Pharma Limited.
For more information and a complete list of recalled batch numbers, please visit: more information here