Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets, EL (23)A/42

Source: MHRA / Gov.uk 8.12.23

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

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets, EL (23)A/42

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