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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 09-Nov-2020 09:59:24

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks
  • GP Practices 1

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, KOLANTICON GEL 200ML (PL 17509/0084), INTRAPHARM LABORATORIES LIMITED

Broadcast content:

Intrapharm Laboratories Ltd has informed us that there is a difference in dosage instructions between the carton and label. The Patient Information Leaflet (PIL) and bottle label contain the correct instructions. 

The carton instructions for dosing read as follows:

‘Dosage: For Oral use. Two to four 6ml spoonfuls every four hours as required….’

The correct instructions should be:

‘Dosage: For Oral use. ‘Two to four 5ml spoonfuls every four hours as required….’ 

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. 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.

Advice for healthcare professionals

• When dispensing or providing this product, please 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. However, 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.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.


Additional information: NHS England and NHS Improvement Regional Offices: Please cascade this alert to Community Pharmacies yet to be registered with CAS.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/51

Attachments:
Cascade to:
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency