Eye drop leaflets omit phosphate concentration, MHRA warns

Rayner Pharmaceuticals Ltd have informed the MHRA that some batches of Dropodex 0.1% w/v eye drops, do not include the concentration of phosphates in the product information leaflets as is required.

The MHRA was told that the patient information leaflet (PIL) and summary of product characteristics (SmPC) were not updated in the affected batches in accordance with the ‘Annex to European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use’, which require the concentration of phosphates to be included.

The batches listed as ‘not yet distributed’ (see below) have also been manufactured and packed without the phosphate concentration included in the PIL.

The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients. Therefore, these batches will not be repackaged and continue to be distributed.

The information that was omitted from these batches will be updated accordingly for new manufactured batches in the product information.

Section 2 of the Dropodex PIL will be updated to include the following statement: ‘This medicinal product contains 1.01 mg phosphates in each 0.4 mL dose which is equivalent to 2.52 mg/mL phosphates (from 9.5 mg/mL disodium phosphate dodecahydrate).’

Section 4 of the Dropodex PIL, ‘very rare side effects’ will be amended to include: ‘If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.’

To align with changes in the PIL, the SmPC will include the following statement in Section 4.4: ‘This medicinal product contains 1.01 mg phosphates in each 0.4 mL dose which is equivalent to 2.52 mg/mL phosphates (from 9.5 mg/mL disodium phosphate dodecahydrate).’

Patients should continue to use the product as instructed by their healthcare professional. The information missing from the PIL and SmPC relates only to the concentration of phosphates in the eye drops. The quality of the eye drops is not impacted by the missing information.

Healthcare professionals are advised to use this medicinal product with caution in patients presenting with compromised cornea and in instances where the patient is receiving polypharmacy with other phosphate-containing eye medications.

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.