Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products, EL(24)A/34

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification.

DMRC Number: DMRC 31246876

Company name: Sandoz Limited

Product descriptions: 

Omeprazole 10mg gastro-resistant capsules, PL 04416/0651 SNOMED Code 3753411000001102

Omeprazole 20mg gastro-resistant capsules, PL 04416/0652 SNOMED Code 3753611000001104

Mezzopram 10mg dispersible gastro-resistant tablets, PL 04416/1077 SNOMED Code 18503211000001105

Mezzopram 20mg dispersible gastro-resistant tablets, PL 04416/1078 SNOMED Code 18503311000001102

Mezzopram 40mg dispersible gastro-resistant tablets, PL 04416/1079 SNOMED Code 18503411000001109

Omeprazole 40mg powder for solution for infusion vials, PL 04416/0701 SNOMED Code 31685111000001103

Brief description of problem:

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification. The product information does not include a warning/precaution for severe cutaneous adverse reactions (SCAR) in section 4.4, and adverse events of drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) in section 4.8 of the SmPC.

Advice to Healthcare Professionals:

There is no risk to product quality or safety of the medicines because of this missing information. Therefore the affected batches are not being recalled. Due to supply considerations, batches listed as not yet distributed will not be repackaged with the updated PIL prior to distribution. The specified ‘Not yet distributed’ batches are scheduled to be distributed in the future to avoid any supply considerations

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing. If any of the above products are supplied and/or dispensed, please ensure that patients are aware of the missing information as highlighted above. It is important that any patients who notice relevant symptoms (see information in the ‘Advice for Patients’ section) should seek immediate medical advice. The following is a link to the updated SmPC:

Omeprazole 10mg gastro-resistant capsules (PL 04416/0651):  Omeprazole 10mg Capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Omeprazole 20mg gastro-resistant capsules (PL 04416/0652):  Omeprazole 20mg Capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Mezzopram 10mg dispersible gastro-resistant tablets (PL 04416/1077):  Mezzopram 10 mg Dispersible Gastro-resistant Tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Mezzopram 20mg dispersible gastro-resistant tablets (PL 04416/1078):  Mezzopram 20 mg Dispersible Gastro-resistant Tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Mezzopram 40mg dispersible gastro-resistant tablets (PL 04416/1079):  Mezzopram 40 mg Dispersible Gastro-resistant Tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Omeprazole 40mg powder for solution for infusion vials (PL 04416/0701):  Omeprazole 40 mg Powder for Solution for Infusion - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Advice to Patients:

Omeprazole can very rarely cause certain conditions that result in skin reactions like widespread rashes, peeling skin, scaly skin, bumps, blisters, or redness. These conditions can also cause other symptoms like fever and swollen lymph nodes, which you can feel as lumps under the skin. These conditions are known as ‘drug reaction with eosinophilia and systemic symptoms’ (DRESS) and ‘acute generalized exanthematous pustulosis’ (AGEP), and they occur in about 1 out of every 10,000 to 1,000 patients taking omeprazole. Information about these conditions is missing from the Patient Information Leaflet that comes with your medicine. This does not change or affect the quality of the product, you can safely continue your treatment. Should you experience any skin reactions during or after treatment, or if you have any other unusual symptoms such as high temperature, lumps or feeling unwell please contact your healthcare professional as soon as possible.

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 their 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, please email sandozgb@EU.propharmagroup.com, or telephone: +44 1276 698 101

For stock control queries, please email sales.sandoz-gb@sandoz.com, or telephone: +44 1276 698607

To access the full recall: Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products, EL(24)A/34