Dear Pharmacist,

Teva Pharmaceuticals Ireland, in agreement with the Health Products Regulatory Authority (HPRA), would like to alert you of the following:

The package leaflet contained within packs of the above referenced batches of products is not in line with the current approved package leaflet and is missing important safety information. Please refer to Appendix I for details of the current approved package leaflet with the omissions highlighted for ease of reference. 

The SmPC and electronic version of the package leaflet (available at www.hpra.ie) are compliant with current approved text.

When dispensing packs from the above referenced batches of products, we kindly request that you make patients aware of the omissions from the package leaflet.

If you have supplied units from the above batches of products to any pharmacy, clinic, or any other healthcare facility we request that you please forward a copy of this notification to them.

We anticipate that compliant packs of all strengths will be available by end of December 2020.

CALL FOR REPORTING

Healthcare professionals are asked to report any suspected adverse events to the Health Products Regulatory Authority, via HPRA Pharmacovigilance, website: www.hpra.ie. When reporting please provide as much information as
possible, including information about medical history, any concomitant medication, onset, treatment dates and product brand name.

Adverse events should also be reported to Teva Pharmaceuticals Ireland by telephone to +44 207 540 7117 or via email to safety.ireland@teva.ie.

COMPANY CONTACT POINT

We apologise for any inconvenience that this incident has caused. If you have any questions, or if you require any further information, please contact Teva Pharmaceuticals Ireland at 1800 201 700 or via info@teva.ie.

Yours Sincerely,

Kevin Woods
Senior Manager Commercial Quality

Date of Preparation November 2020
GEN-IE-NP-00015

Download Letter and Appendix I