Class 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10

Rayner Pharmaceuticals limited have informed the MHRA that the batches listed in this notification do not include the concentration of phosphates in the product information.

DMRC Number: DMRC-38371734

Company name:Rayner Pharmaceuticals Limited

Product description: Dropodex 0.1% w/v Eye Drops, solution - PL: 47069/0003, SNOMED code: 23484611000001104, GTIN: 5060132680100

Details of the affected batches:

Background information: 

Rayner Pharmaceuticals limited have informed MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for the batches listed in this notification were not updated 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’ 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. They are therefore included in this notification.

Information available in the SmPC covers the risk occurrence due to phosphates. However, information on phosphate concentration was missing from the SmPC and PIL, as detailed below.

PIL

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.

SmPC

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).

Advice to Healthcare Professionals: 

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). This information was not previously included in the product information and will be updated accordingly for new manufactured batches in the product information (SmPC and package leaflet) for HCPs as well as patients.

This medicinal product contains phosphates, which may lead to corneal deposits or corneal opacity when topically administered.

This medicinal product should be used with caution in patients presenting with compromised cornea and in instances where the patient is receiving polypharmacy with other phosphate-containing eye medications.

Advice to Patients: 

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. No adverse events have been received for these batches of products. If patients have any questions about this medication, you should speak to your dispensing pharmacy in the first instance.

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 all medical information enquiries and information on this product, please email: medinfo.Rayner@apcerls.com, or telephone +44-800-041-8153

For stock control enquiries please email markclayton@rayner.com, or telephone 01903 258777.

To access the full recall/alert: Class 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10