Urgent Product Notice

Posted on:

Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15

MDR Number: MDR 133-04/23

Company Name: Omega Pharma Ltd

Product Name: Beconase Hayfever Nasal Spray, PL 02855/0064

SNOMED Code: 2945411000001101 – See Full Batch List

Omega Pharma Ltd. has identified that there is text missing in Section 2 of the Patient Information Leaflet (PIL) in packs of Beconase Hayfever Nasal Spray (P).

The current PIL states: 
Other medicines and beconase hayfever
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines; particularly corticosteroid medicines (including eczema creams, asthma inhalers, tablets, injections, nasal sprays, and eye or nose drops).

This section is missing the following wording:
including medicines obtained without a prescription.
Some medicines may increase the effects of Beconase Hayfever and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Advice for Patients

Patients should be aware that the Patient Information Leaflet (PIL) in certain batches of Beconase Hayfever Nasal Spray does not contain the most up-to-date safety information.

The products themselves are not impacted and are not being recalled.

Your pharmacist or other relevant healthcare professional responsible for your care can provide further information.

The missing information is detailed in bold below:

Other Medicines and Beconase Hayfever

  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines;
  • particularly corticosteroid medicines (including eczema creams, asthma inhalers, tablets, injections, nasal sprays and eye or nose drops).
  • including medicines obtained without a prescription.
  • Some medicines may increase the effects of Beconase Hayfever and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
  • As for all medicines, if you experience any adverse reactions, you should contact your doctor immediately. You can also report suspected adverse reactions via the MHRA Yellow Card scheme.
For further information please visit the Gov website