Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 45: Request to Reclassify a Product from P to GSL - 12-sachet pack of Calpol Six Plus Sugar Free Suspension

Deadline for response:

8 November 2007

Background: Calpol® Six Plus Sugar Free Suspension is already available and marketed as a GSL medicine with a pack size of 10 x 5 ml sachets. This application proposes an increase in pack size from 10 x 5 ml sachets to 12 x 5 ml sachets, still as a GSL medicine. The increased pack size will have identical indications, paracetamol strength (250 mg / 5ml), dosage regimen and formulation to the currently registered pack size.

The key rationale behind this application is to increase convenience to parents as a 12 pack size better complements the dosing regimen. Calpol Six Plus Sugar Free Suspension is primarily designed for use in children aged 6 to 12 years.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
ARM 45: REQUEST TO RECLASSIFY A PRODUCT FROM P TO GSL - 12-SACHET PACK OF CALPOL SIX PLUS SUGAR FREE SUSPENSION

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on Consultation ARM 45.

In fact although this is labelled as a reclassification of Calpol Six Plus Sugar Free Suspension from P to GSL, it is rather more simple than that.

The application is to change the pack size of this product from a 10 x 5ml sachet carton, which is already marketed as a GSL product, to a 12 x 5ml sachet carton.  The rational is that the current dose recommendations for 6-12 year olds is 5 to 10 ml (500-1000mg paracetamol) repeated every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours, with a maximum duration of 3 days.  This would amount to 12 sachets which means that 2 cartons must be purchased for the lower dose and 3 cartons for the higher dose.  This proposal would mean that one carton would contain a complete course at the lower dose and two would provide the higher dose level.

Although this product contains paracetamol which is toxic in overdose, the safety profile of Calpol is excellent despite the fact that up to 250,000 children aged 6-12 years use the product annually.  In addition, this product is an unlikely choice for intentional overdosage and has only rarely been reported as being associated with accidental overdosage.  It is also unlikely, given the rational, that this change would result in more Calpol being purchased or used than under present pack sizes.

The College is therefore happy to support this request.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[8 November 2007]