MHRA Class 4 Medicines Defect Information: Ponstan 250mg Capsules & 500mg Tablets (Chemidex Pharma Ltd)

Class 4 Medicines Defect Information: Ponstan 250mg Capsules & 500mg Tablets (Chemidex Pharma Ltd)

Drug alert number: EL (24)A/340

Date issued: 27 August 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Ponstan 250mg Capsules & 500mg Tablets (Chemidex Pharma Ltd)

Company name: Chemidex Pharma Ltd

Product name: Ponstan 250mg Capsules, PL 17736/0006

SNOMED Code: 1862111000001104

Product name: Ponstan Forte 500mg Tablets, PL 17736/0007

SNOMED Code: 1867211000001108

Brief description of the problem

Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables above for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, dated March 2020 and January 2021 respectively. The latest PIL, authorised in February 2023 includes updated information related to the use of the product during pregnancy, which is not mentioned in the out of date PILs.

Advice for healthcare professionals

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing these products. When product from batches included in the tables are supplied or dispensed, please ensure that patients are aware of the missing information.

The electronic versions of the SmPC are up to date and can be accessed via the following links:

Ponstan Capsules 250mg – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

Ponstan Forte Tablets 500mg – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

View full alert here.

Advice for patients

Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is a warning in the patient information leaflet (PIL) which accompanies the medicine, for the patient to contact their doctor in case of pregnancy. The updated PIL can be accessed via the following link:

Ponstan Capsules 250mg – Patient Information Leaflet (PIL) – (emc) (medicines.org.uk)

Ponstan Forte Tablets 500mg – Patient Information Leaflet (PIL) – (emc) (medicines.org.uk)

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. 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 medical information enquiries please email essentialpharmaUK@EU.ProPharmaGroup.com, or telephone +44 (0)1423 850700.

For stock control enquiries please email commercial@essentialpharmagroup.com.