Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of Renacet tablets (calcium acetate). This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted from the list of excipients in error. The affected products are:
- Renacet 475 mg film-coated tablets (batch number: 2122403, 2122404, 2122405, 2122407, 2122408, 2122409, 2122410)
- Renacet 950 mg film-coated tablets (batch number: 2222418, 2222419, 2222420, 2222421, 2222422, 2222439, 2222440, 2222441, 2222442, 2222443, 2222444, 2222445, 2222446, 2222447)
The product is indicated for hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis.
Healthcare Professionals are advised that 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-renacet-475-mg-and-950-mg-tablets-calcium-acetate-renacare-nephromed-gmbh-el-25-a15
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Apr 8, 2025
Issued at HKT 17:15
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