Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Orifarm UK Ltd, Concerta XL 18mg & 36 mg prolonged release tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Orifarm UK Ltd has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the following batches of Concerta (methylphenidate hydrochloride) XL 18mg and 36mg prolonged release tablets. The affected products are:
- Concerta XL 18mg prolonged release tablets (batch number: 3EE35801, 3EE35802, 3EE36101, 3EE35803, 3EE36102, 3FE46100, 3FE46101, 3GE51900)
- Concerta XL 36mg prolonged release tablets (batch number: 3AE07102, 3DE29500, 3FE44101, 3FE44102, 3AE07103, 3DE29201, 3DE29501, 3FE44103, 3FE46800, 3FE46801, 3EE37002, 3GE50002)
A section of the product side effects containing the serious side effects has been added to paragraph 3 in error however this should be part of paragraph 4. All other sections of the PIL are unaffected.
Healthcare professionals are advised to inform patients of this discrepancy when dispensing packs from the specified batches.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-concerta-xl-18mg-and-36-mg-prolonged-release-tablets-el-24-a-slash-07
In Hong Kong, Concerta Extended Release Tab 18mg (HK-60005) and Concerta Extended Release Tab 36mg (HK-60003) are pharmaceutical products registered by Johnson & Johnson (Hong Kong) Ltd. These products are prescription-only medicines. As confirmed with the company, the affected batches have not been imported into Hong Kong.
Ends/Tuesday, Feb 27, 2024
Issued at HKT 15:30
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