Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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 (beclometasone dipropionate 50 micrograms). For details of the affected batch numbers, please refer to the website in MHRA.
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).
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. Omega Pharma Ltd. has confirmed that all future production batches of Beconase Hayfever Nasal Spray will contain the correct PIL.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-omega-pharma-ltd-beconase-hayfever-nasal-spray-el-23-a-slash-15
In Hong Kong, Beconase Aqueous Nasal Spray 0.05% (HK-28384) is a pharmaceutical product registered by GlaxoSmithKline Limited (GSK). The product is a pharmacy-only medicine. As confirmed with GSK, the affected batches have not been imported into Hong Kong.
Ends/Thursday, Apr 27, 2023
Issued at HKT 18:00
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