The Medicines and Health products Regulatory Agency (MHRA) has issued a Class IV medicines defect notice for Kolanticon Gel 200ml of Intrapharm Laboratories Ltd.
The drug manufacturer has informed the MHRA that there is a difference in dosage instructions between the carton and label of the product with the license number- PL 17509/0084.
The patient information leaflet (PIL) and bottle label contain the correct instructions.
The carton instructions for dosing printed as: “Dosage: For Oral use. Two to four 6ml spoonfuls every four hours as required….”
The correct instruction should be: “Dosage: For Oral use. Two to four 5ml spoonfuls every four hours as required….”
|Batch number||Expiry date||Pack size||First distributed|
|AA0620||31/12/2021||200ml||04 Sep 2020|
“It was confirmed that the carton with the incorrect dosage instructions had been used to pack only one batch, AA0620. This batch is not being recalled based on a medical risk assessment and consideration that if the maximum daily dosage is taken then an additional 24ml may get consumed in 24 hours,” MHRA has said in its alert.
“A further consideration is that the standard dosing measurement for a medicine spoon is 5ml; there is no 6ml medicine spoon available. The assessment concluded low risk to patient safety or overdose as a consequence of this dosage instruction error.”
Community pharmacists have been advised to check the marketing authorisation holder and the batch number and ensure that patients are aware of the correct dosing instructions as stated in the PIL and on the bottle label.
In the event that the maximum recommended daily dose is exceeded, the adverse effects expected are likely to be non-serious and may include dry mouth, blurred vision and urinary retention.
The drug is rapidly cleared by the kidneys and has a half-life of 1.8 hours, so any potential adverse effects are quickly reversed on discontinuation.