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

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