Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Strandhaven Ltd t／a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Strandhaven Ltd t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the following batches of Clarithromycin film-coated tablets:
- Clarithromycin 250mg film-coated tablets (batch number: ET207E2001, ET207E3001, ET207E3002, ET207E3003)
- Clarithromycin 500mg film-coated tablets (batch number: ET208E1001, ET208E1002, ET208E1003, ET208E1004, ET208E1005, ET208E2001, ET208E2002, ET208E2003, ET208E2005, ET208E2004, ET208E2006, ET208E2007, ET208E2008, ET208E2009, ET208E2010, ET208E2011, ET208E2012, ET208E2013, ET208E2014, ET208E2015, ET208E2016, ET208E2017, ET208E2018, ET208E2019, ET208E2020, ET208E2021, ET208E2022, ET208E3001, ET208E3002, ET208E3003, ET208E3004, ET208E3005, ET208E3006, ET208E3007, ET208E3008, ET208E3009, ET208E3010, ET208E3011, ET208E3012, ET208E3013, ET208E3014, ET208E3015, ET208E3016, ET208E3017, ET208E3018, ET208E3019, ET208E3020)
The PIL does not include the most up to date safety information as described below. The information missing from the PILs is included below:
2. What you need to know before you take Clarithromycin
Do not take Clarithromycin tablets, and tell your doctor if:
- you are taking a medicine containing lomitapide
- you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia)
It is important to tell your doctor or pharmacist if you are taking any of the following medicines:
- Warfarin or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban (used to thin your blood)
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. If it is not possible to provide an updated PIL, please advise patients of the missing information and discuss with them whether the medicine is suitable for them.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-strandhaven-ltd-t-slash-a-somex-pharma-clarithromycin-250mg-and-500mg-film-coated-tablets-el-23-a-slash-42
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Dec 7, 2023
Issued at HKT 16:00
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