Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15
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).
MDR Number: MDR 133-04/23
Company name: Omega Pharma Ltd
Product description: Beconase Hayfever Nasal Spray, PL 02855/0064
Details of the affected batches: see Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15
Brief description of problem:
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:
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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 to Healthcare Professionals:
There is no risk to product quality as a result of this issue, and the affected batches are not being recalled. Healthcare professionals are advised to inform patients about the error when dispensing the above batches of the product or in discussion with patients who are taking other medications and to exercise caution when dispensing the above batches of the product. The batches on hold awaiting distribution will be sold and have been included in this notification for information. Omega Pharma Ltd. has confirmed that all future production batches of Beconase Hayfever Nasal Spray will contain the correct PIL.
Advice to 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.
Company contacts for further information:
For medical information, stock control queries and Patient Information Leaflet (PIL) requests, please contact: UKLOcustomerservice@perrigo.com
To access the full recall: Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15