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

UPDATED 8th DECEMBER WITH AMENDED EXPIRY DATES (IN BOLD)

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 description: Clarithromycin 250mg film-coated tablets, PL 15764/0039

SNOMED Code: 17522411000001102

Details of the affected batch:

Active Pharmaceutical Ingredient: Clarithromycin

Product description: Clarithromycin 500mg film-coated tablets, PL 15764/0040

SNOMED Code: 17522611000001104

Details of the affected batch:

 

Active Pharmaceutical Ingredient: Clarithromycin

Brief description of 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 to 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 to 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

Company contacts for 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.

To access the full recall:

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