Other safety alerts
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| The United Kingdom: Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed MHRA that the Patient Information Leaflet (PIL) within their packs for the pharmacy (P) batches of the following products is incorrect. The affected products are:
Crescent Pharma Ltd products
- Ibuprofen 400mg Tablets (Almus Livery)
- Ibuprofen 400mg Tablets (Crescent Livery)
Flamingo Pharma (UK) Ltd products
- Ibuprofen 400mg Tablets (Flamingo Pharma Livery)
- Ibuprofen 400mg Tablets (TEVA Livery)
Please refer to the website in MHRA for details of the affected batches of the products.
The PIL in the affected batches includes incorrect dosing instructions in Section 3, How to take Ibuprofen. The leaflet incorrectly states that ‘The maximum daily dose should not exceed 6 [six] tablets (2400 mg).’ This dosing regimen should only be given to patients who are under the supervision of their general practitioner or healthcare prescriber and have been prescribed Ibuprofen 400mg Tablets. The outer carton contains the correct P indications and posology. Correct statement is ‘The maximum daily dose should not be more than 3 tablets (1200 mg).’
Healthcare professionals are advised that, when dispensing or providing this product over the counter, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling. Where possible, these packs should be considered to be dispensed against a prescription rather than sold over the counter to safeguard patients from taking a prescription only dose.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-drug-alert-crescent-pharma-ltd-and-flamingo-pharma-uk-ltd-ibuprofen-400mg-tablets-el-20-a-10
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Feb 21, 2020
Issued at HKT 15:00
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