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

Medicines Healthcare Products Regulatory Agency

April 26
12:55 2023

MDR number

MDR 133-04/23

Company name

Omega Pharma Ltd

Product name

Beconase Hayfever Nasal Spray, PL 02855/0064

SNOMED Code

2945411000001101

Batch No Expiry Date Pack Size First Distributed
2014041A 04-2023 1 5/4/2021
2014065A 04-2023 1 15/4/2021
2014066A 04-2023 1 16/5/2021
2044014A 10-2023 1 2/6/2021
2044067A 11-2023 1 17/6/2021
2044067B 11-2023 1 21/6/2021
2044068A 11-2023 1 25/6/2021
2044069A 11-2023 1 19/7/2021
2116123A 04-2024 1 14/10/2021
2116124A 04-2024 1 16/12/2021
2116125A 04-2024 1 26/1/2022
2116126A 05-2024 1 22/2/2022
2145069A 12-2024 1 17/3/2022
2145070A 12-2024 1 29/3/2022
2148073A 12-2024 1 5/4/2022
2148074A 12-2024 1 10/4/2022
2150075A 01-2025 1 26/4/2022
2140122A 10-2024 1 3/5/2022
2150076A 01-2025 1 5/5/2022
2140119A 10-2024 1 12/5/2022
2140120A 10-2024 1 5/13/2022
2140121A 10-2024 1 9/6/2022
2213041A 04-2025 1 4/7/2022
2213042A 04-2025 1 19/7/2022
2213043A 04-2025 1 17/8/2022
2213044A 04-2025 1 7/11/2022
2213045A 04-2025 1 23/12/2022
2239053A 11-2025 1 26/1/2023
2239054A 11-2025 1 8/2/2023
2242070A 12-2025 1 15/2/2023
2242071A 12-2025 1 7/3/2023
2247008A 12-2025 1 7/3/2023
2248058A 12-2025 1 7/3/2023
2247075A 12-2025 1 20/3/2023
2247076A 12-2025 1 21/3/2023
2248057A 12-2025 1 21/3/2023
2247076B 12-2025 1 22/3/2023
2301078A 01-2026 1 30/3/2023
2301084A 01-2026 1 30/3/2023
2301083A 01-2026 1 30/3/2023
2301080A 01-2026 1 3/4/2023
2313009A 03-2026 1 Not yet distributed
2313010A 03-2026 1 Not yet distributed
2313011A 03-2026 1 Not yet distributed
2313012A 04-2026 1 Not yet distributed
2313013A 04-2026 1 Not yet distributed
2313014A 04-2026 1 Not yet distributed
2313015A 04-2026 1 Not yet distributed

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:

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 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

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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

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