GovWire

MDR number

MDR 133-04/23

Company name

Omega Pharma Ltd

Product name

Beconase Hayfever Nasal Spray, PL 02855/0064

SNOMED Code

2945411000001101

Brief description of the 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:

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 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 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.

Further information

For medical information, stock control queries and Patient Information Leaflet (PIL) requests, please contact: UKLOcustomerservice@perrigo.com

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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