WHO Pharmaceuticals Newsletter 1997, No. 11&12
(1997; 24 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAcetylsalicylic acid and paracetamol - prescription control: United Kingdom
View the documentChlormezanone - marketing authorization withdrawn: Germany
View the documentCounterfeit antimalarial detected: Kenya
View the documentDiphenhydramine - warning statements: United States of America
View the documentGeriatric use - added to labelling: United States of America
View the documentHerbal “Fen-Phen” - warning concerning “natural” anti-obesity alternatives: United States of America
View the documentHIV protease inhibitors - hyperglycaemia: United Kingdom
View the documentIrinotecan - revised data sheet: warning & precautions for use: Japan
View the documentLamotrigine - warning: severe cutaneous reactions: Australia
View the documentLaxatives containing phenolphthalein - recommendation to revoke marketing authorization: Germany
View the documentLevothyroxine sodium - new drug applications to be submitted: United States of America
View the documentLysine amidotrizoate in ionic contrast media - withdrawn: Germany
View the documentMelatonin - prescription control: New Zealand
View the documentMetamizole sodium - prohibited: Nepal
View the documentNSAIDs, including acetylsalicylic acid - proposed risk-based framework: New Zealand
View the documentPaediatric data - labelling to be required for new drugs: United States of America
View the documentParacetamol - restrictive measures: Ireland
View the documentPemoline - withdrawn: hepatotoxicity: United Kingdom
View the documentSodium hydrogen bicarbonate (paediatric) - prohibited: Nepal
View the documentSuxamethonium chloride - warnings: cardiac arrest and hyperkalaemia: United States of America
View the documentTerfenadine - restrictive measures: Ireland
View the documentTerfenadine and terfenadine/pseudoephedrine - warnings concerning interactions: United States of America
View the documentTramadol - not recommended as first choice for moderate pain: Norway
View the documentTramadol - rescheduled: Oman
View the documentTrihexyphenidyl - rescheduled: Oman
View the documentVigabatrin - visual field defects: Australia
View the documentWomen in clinical trials - proposed rule: United States of America
View the documentZafirlukast - possible association with Churg-Strauss syndrome: United States of America
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine
 

Acetylsalicylic acid and paracetamol - prescription control: United Kingdom

United Kingdom. Acetylsalicylic acid and paracetamol have been subjected to prescription control, with exemptions to allow nonprescription sales in limited quantities. The changes will take effect on 16 September 1998 in order to allow stocks of existing packs to be cleared.

Pharmacies will be required not to sell more than 100 tablets or capsules of either acetylsalicylic acid or paracetamol at any one time. Exemptions apply only to tablets and capsules in packs of 32 or less and the following forms/strengths:

. acetylsalicylic acid: maximum strength 325 mg
. paracetamol: 120 mg for children aged under 12 years and 500 mg for adults and children aged 12 years and over.

In both cases, the new restrictions will apply only to non-effervescent tablets and capsules. A blanket exemption from prescription control will cover all other presentations.

For general sale (e.g. supermarkets), new maximum pack sizes of 16 are being introduced for non-effervescent tablets and capsules (reduced from 25) and a maximum pack size of 160 ml for liquid preparations of paracetamol for persons aged 12 and over with a maximum strength of 2.5%, and a maximum pack size of 20 doses of no more than 5 ml for preparations intended for children under 12 years old with a maximum strength of 2.4% (maximum dose 480 mg and maximum daily dose 1,920 mg).

[See also p.00 below and Pharmaceuticals Newsletter Nos. 3&4, March & April 1997]

Reference: The Pharmaceutical Journal Vol. 257, p. 785, 13 September 1997.

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Last updated: May 3, 2013