Dan Neville
Question:380 Mr. Neville asked the Minister for Health and Children the position regarding control of the sale of paracetamol products. [26198/01]
Written Answers. - Medicinal Products.
The Medicinal Products (Control of Paracetamol) Regulations, 2001, were made by me on 12 April 2001 and came into force on 1 October 2001. The regulations were made on the recommendations of the National Drugs Advisory Board and its successor, the Irish Medicines Board, and impose further restrictions on the sale of medicinal products containing paracetamol.
In general, the regulations prescribe the maximum pack sizes for products when sold in pharmacies and non-pharmacies and cautionary and warning statements which must appear on all packs, prohibit the sale of paracetamol products in automatic vending machines and in non-pharmacy outlets when a second analgesic component is present, prohibit the sale of multiple packs of paracetamol in the course of a single transaction, and prohibit the sale of paracetamol products unless they are in blister packs or in other such equivalent form of packaging as may be specified in the relevant product authorisations. Exemptions are provided in the case of prescription medicines and medicines intended for export.
The Irish Medicines Board gave particular consideration to the sale of medicinal products containing paracetamol in non-pharmacy outlets and recommended that, "Emergency supplies of paracetamol as single ingredient preparations only should be available in non-pharmacy outlets with the following restrictions: The maximum pack size will be restricted to a total of 12 x 500mg tablets or the equivalent amount of paracetamol, packaged in single unit dose packs for adult use and 60ml (125mg/5ml) for liquid paediatric formulations. Only one pack should be supplied on each occasion of purchase."
Also included in these regulations, on the recommendation of the board, is the requirement that certain information be provided on the labelling of the products so as to inform users of the precautions to be taken in their use. The following statements, therefore, must appear clearly on the packaging of the medicinal product or, if there is no outer packaging, on its immediate packaging: "Contains Paracetamol,""Do not take any other paracetamol-containing products,""Do not exceed the stated dose,""Immediate medical advice should be sought in the event of overdosage, even if you feel well. Please read the enclosed leaflet carefully." in cases where a package leaflet is supplied with the product and the product is intended mainly for use in adults, "Immediate medical advice should be sought in the event of overdosage, even if the child seems well. Please read the enclosed leaflet carefully." in cases where a package leaflet is supplied with the product and the product is intended mainly for use in children not over 12 years of age, "Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage." in cases where no package leaflet is supplied with the product.