Class 4 Medicines Defect Information: Beconase Hayfever Nasal Spray (Omega Pharma Ltd)
Class 4 Medicines Defect Information: Beconase Hayfever Nasal Spray (Omega Pharma Ltd)
Drug alert number: EL (23)A/15
Date issued: 26 April 2023
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Product name:Beconase Hayfever Nasal Spray, PL 02855/0064 (Omega Pharma Ltd)
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.
View full alert here.
Further Information
For medical information, stock control queries and Patient Information Leaflet (PIL) requests, please contact: UKLOcustomerservice@perrigo.com
