Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets, EL (23)A/42
Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.
MDR number
MDR 055-11/23
Company name
Strandhaven Ltd t/a Somex Pharma
Product name
Clarithromycin 250mg film-coated tablets, PL 15764/0039
SNOMED Code
17522411000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| ET207E2001 | Nov-25 | 14 | 14/09/2022 |
| ET207E3001 | Jun-26 | 14 | 08/02/2023 |
| ET207E3002 | Aug-26 | 14 | 08/05/2023 |
| ET207E3003 | Dec-26 | 14 | 15/09/2023 |
Active Pharmaceutical Ingredient: Clarithromycin
Product name
Clarithromycin 500mg film-coated tablets, PL 15764/0040
SNOMED Code
17522611000001104
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| ET208E1001 | Dec-24 | 14 | 05/06/2021 |
| ET208E1002 | Dec-24 | 14 | 01/04/2021 |
| ET208E1003 | Dec-24 | 14 | 01/04/2021 |
| ET208E1004 | Dec-24 | 14 | 01/04/2021 |
| ET208E1005 | Dec-24 | 14 | 05/06/2021 |
| ET208E2001 | Dec-25 | 14 | 13/05/2022 |
| ET208E2002 | Dec-25 | 14 | 13/05/2022 |
| ET208E2003 | Dec-25 | 14 | 24/05/2022 |
| ET208E2005 | Jan-26 | 14 | 13/05/2022 |
| ET208E2004 | Jan-26 | 14 | 08/07/2022 |
| ET208E2006 | Jan-26 | 14 | 08/07/2022 |
| ET208E2007 | Apr-26 | 14 | 11/08/2022 |
| ET208E2008 | Apr-26 | 14 | 11/08/2022 |
| ET208E2009 | Apr-26 | 14 | 11/08/2022 |
| ET208E2010 | Jul-26 | 14 | 18/11/2022 |
| ET208E2011 | Jul-26 | 14 | 18/11/2022 |
| ET208E2012 | Jul-26 | 14 | 18/11/2022 |
| ET208E2013 | Aug-26 | 14 | 18/11/2022 |
| ET208E2014 | Aug-26 | 14 | 18/11/2022 |
| ET208E2015 | Aug-26 | 14 | 14/12/2022 |
| ET208E2016 | Sep-26 | 14 | 14/12/2022 |
| ET208E2017 | Sep-26 | 14 | 14/12/2022 |
| ET208E2018 | Sep-26 | 14 | 14/12/2022 |
| ET208E2019 | Oct-26 | 14 | 09/01/2023 |
| ET208E2020 | Oct-26 | 14 | 09/01/2023 |
| ET208E2021 | Nov-26 | 14 | 08/02/2023 |
| ET208E2022 | Nov-26 | 14 | 08/02/2023 |
| ET208E3001 | Dec-26 | 14 | 17/03/2023 |
| ET208E3002 | Dec-26 | 14 | 17/03/2023 |
| ET208E3003 | Jan-27 | 14 | 12/04/2023 |
| ET208E3004 | Jan-27 | 14 | 12/04/2023 |
| ET208E3005 | Jan-27 | 14 | 12/04/2023 |
| ET208E3006 | Feb-27 | 14 | 28/04/2023 |
| ET208E3007 | Feb-27 | 14 | 28/04/2023 |
| ET208E3008 | Mar-27 | 14 | 08/07/2023 |
| ET208E3009 | Mar-27 | 14 | 08/07/2023 |
| ET208E3010 | Mar-27 | 14 | 08/07/2023 |
| ET208E3011 | Mar-27 | 14 | 15/07/2023 |
| ET208E3012 | Mar-27 | 14 | 15/07/2023 |
| ET208E3013 | Apr-27 | 14 | 15/07/2023 |
| ET208E3014 | Apr-27 | 14 | 15/07/2023 |
| ET208E3015 | Apr-27 | 14 | 15/07/2023 |
| ET208E3016 | May-27 | 14 | 15/09/2023 |
| ET208E3017 | May-27 | 14 | 15/09/2023 |
| ET208E3018 | May-27 | 14 | 15/09/2023 |
| ET208E3019 | May-27 | 14 | 15/09/2023 |
| ET208E3020 | May-27 | 14 | 15/09/2023 |
Active Pharmaceutical Ingredient: Clarithromycin
Brief description of the problem
Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets. 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)
Advice for healthcare professionals
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. The current PIL is being updated, therefore Strandhaven Limited t/a Somex Pharma do not immediately have any copies they can provide. 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. Strandhaven Limited t/a Somex Pharma has confirmed that all future batches will contain the correct PIL.
Advice for patients
No action is needed from patients. This issue is about missing information on the Patient Information leaflets (PILs) in specific batches of Clarithromycin 250mg and 500mg film-coated tablets, an antibiotic used to stop the growth of bacteria that cause infections. The medication itself is not affected.
These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care.
If you have concerns about a medicine you may be using, please contact your healthcare professional. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Further Information
For more information, or medical information queries, contact: regulatory@somexpharma.com, tel: 020 8590 9399, choose option 3 or 4.
For stock control queries, contact: accounts@somexpharma.com, tel: 020 8590 9399, choose option 2.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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Updates to this page
Last updated 7 December 2023 + show all updates
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The update includes the availability of the updated PIL and also includes corrections to the batch numbers detailed in the notification which were incorrectly provided by the MAH at the time of issue.
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First published.