Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets, EL(24)A/48

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Linezolid 600 mg film-coated tablets.

DMRC/MDR Number: DMRC 31944581

Company name: Sandoz Ltd.

Product description: Linezolid 600 mg film-coated tablets, PL 04416/1389 SNOMED Code 31684511000001106

Details of the affected batch: 

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 (SmPC) for Linezolid 600 mg film-coated tablets. The summary of the missing safety information is tabulated in Annex 1 of the recall.

Advice to Healthcare Professionals:

There is no risk to product quality or impact to safety of the medicine listed in this notification because of this missing information, full details in Annex 1.

The missing information from the SmPC is already covered under other sections:

• The missed extension of thrombocytopenia to patients with hepatic impairment under section 4.4 of the SmPC is already included in same section under sub section special population where it is recommended that linezolid should be given to patients with severe hepatic insufficiency only when the perceived benefit outweighs the theoretical risk. Hyponatremia and/ (SIADH) is already listed twice under section 4.8 of the SmPC under metabolism disorders & investigations
• The missed ADR of Hypersensitivity vasculitis missing under section 4.8 of the SmPC SOC skin & subcutaneous tissue disorders is covered under broader topic as a contraindication in section 4.3
• The missed warning under section 4.4 of the SmPC on Impairment of fertility is limited to adult male rats and already covered under section 4.6 of the SmPC “Fertility, pregnancy & lactation”.
• The missed frequency upgrade in section 4.8. are considered of minor impact for patient safety. All ADRs for which frequency has been updated are already listed in the SmPC.

Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current SmPC & PIL on the existing clinical concepts and take this into account when prescribing.

If the medicine listed in this notification is supplied or dispensed, ensure that patients are aware of the information missing from the PIL on warnings prior to taking Linezolid and possible side-effects (see Annex 1, Table 2). It is important to advise patients that if they experience any of the symptoms listed in Table 2, they should seek immediate medical advice.

Sandoz Ltd has confirmed that all future batches of the product will contain the updated PIL

Advice to Patients:

Patients do not need to take any action. The information in Annex 1, Table 2 is missing from the Patient Information Leaflet. The missing information does not change or affect the quality of the product. Therefore, you can safely continue your treatment. However, should you experience any reactions or symptoms matched with the information in Table 2, or you have a history of hyponatraemia, or you take medicines that lower blood sodium levels, please urgently 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 medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

For stock control queries, please contact: sales.sandoz-gb@sandoz.com , Telephone: +44 1276 698607.

To access the full recall: Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets, EL(24)A/48