Class 4 Medicines Defect Notification: RenaCare NephroMed GmbH, EL(25)A15

Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15

RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted from the list of excipients in error.

DMRC Number: DMRC 35184448

Company name: RenaCare NephroMed GmbH

Details of the affected batches: 

Renacet 475 mg, film-coated tablets- PL: 36032/0001, SNOMED code: 18613411000001100, GTIN: 4027052102120

Renacet 950 mg, film-coated tablets- PL: 36032/0002, SNOMED code: 18613911000001108, GTIN: 4027052102229

Brief description of problem:

RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000 which is included in Renacet tablets. Macrogol 6000 has always been included in Renacet Tablets but has been omitted from the list of excipients in error.

The batches listed as ‘not yet distributed’ have also been manufactured and packed with macrogol 6000. 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 the notification.

Advice to Healthcare Professionals:

There has not been a change to the formulation of Renacet Tablets, prescribers should continue to provide these tablets to patients.

In very rare cases there are patients who are allergic to polyethylene glycols, with the possibility of minor allergic type reactions seen in patients who consume these ingredients orally. There have been very few reported adverse events associated with Renacet Tablets and the risk to patient health is minimal regarding this omission.

Macrogols are used in a range of pharmaceutical products as an excipient and at much higher doses, Macrogol is approved as a laxative in the UK at much higher quantities than are present in Renacet Tablets. This dose is far in excess of the dose consumed by patients who take Renacet as regular treatment.

Advice to Patients:

Patients should continue to take tablets from these batches as prescribed by your healthcare professional. If you are taking Renacet Tablets and have an allergy to Macrogol or to polyethylene glycol please notify your prescribing doctor.

In very rare cases oral macrogol or polyethylene glycols may cause allergic reactions. If you develop skin reactions including hives and itching, wheezing, a new cough, or nausea and vomiting please inform your doctor as soon as possible.

Any suspected adverse reactions should also be reported online via the Yellow Card scheme or via the Yellow card app available from the Apple App Store or Google Play Store.

Company contacts for further information:

For medical information enquiries please telephone 01159 124 253 or email medinfo@stanningleypharma.co.uk

For stock control enquiries telephone 01159 124 253 or email medinfo@stanningleypharma.co.uk

To access the full recall: Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15