Class 4 Medicines Defect Information: Clarithromycin 250mg and 500mg tablets (Strandhaven Ltd t/a Somex Pharma Ltd)

Class 4 Medicines Defect Information: Clarithromycin 250mg and 500mg tablets (Strandhaven Ltd t/a Somex Pharma Ltd)

Drug alert number: EL(23)A/42

Date issued: 06 December 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Clarithromycin 250mg and 500mg tablets (Strandhaven Ltd t/a Somex Pharma Ltd)

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-27
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
Nov-24
14
05/06/2021

ET208E1002
Nov-24
14
01/04/2021

ET208E1003
Dec-25
14
01/04/2021

ET208E1004
Dec-25
14
01/04/2021

ET208E1005
Dec-25
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-25
14
18/11/2022

ET208E2011
Jul-25
14
18/11/2022

ET208E2012
Jul-25
14
18/11/2022

ET208E2013
Aug-25
14
18/11/2022

ET208E2014
Aug-25
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
Jun-27
14
15/09/2023

ET208E3020
Jun-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.

View full alert here.

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 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, 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.

The post Class 4 Medicines Defect Information: Clarithromycin 250mg and 500mg tablets (Strandhaven Ltd t/a Somex Pharma Ltd) appeared first on Community Pharmacy England.