The Pharmaceutical Journal
Vol 270 No 7250 p709
24 May 2003

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Consultation letter ARM7 (more Microsoft Word document)
Galpharm Healthcare (www.galpharm.co.uk)

Omeprazole to be a pharmacy medicine

Galpharm Healthcare is seeking pharmacy medicine classification for omeprazole 10mg gastroresistant tablets. The company wants to market the product for the relief of heartburn (reflux-like symptoms) in adults.

In its application to the Medicines and Healthcare products Regulatory Agency, Galpharm says that acid regurgitation and heartburn are conditions that are self-diagnosable and for which the H₂-receptor antagonists ranitidine and famotidine are already available over the counter.

Consultation letter ARM7, issued by the MHRA, says that the proposed dosage of 20mg omeprazole daily until relief is achieved, followed by a reduced dose of 10mg daily for a maximum of four weeks treatment, and the 28-tablet pack size limit the danger of masking serious underlying disease. These proposals are in line with approved regimens for non-prescription omeprazole in Sweden and the United States.

In support of its application, Galpharm proposes to give pharmacists a training document which will explain how to diagnose gastroesophageal reflux disease. It will also explain when patients should be referred to a general practitioner for further investigation. The Committee on Safety of Medicines has agreed these proposals.

According to the MHRA, changing the legal classification of omeprazole 10mg tablets from prescription-only medicine to P medicine poses no safety concerns beyond those set out in the product's summary of product characteristics. It says that single oral doses of up to 400mg have not resulted in any severe symptoms.

"The overall risk-to-benefit to the community of pharmacy availability of omeprazole 10mg tablets is regarded as favourable," the MHRA concludes. "The reclassification does not raise any clinically significant new safety problems and there is no need for further investigation of activity or side effects. Therefore, there is no indirect or direct danger when omeprazole is used correctly."

Comment's on Galpharm's application can be sent to Amanda Lawrence, Room 14-152, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ (e-mail Amanda.Lawrence@MHRA.gsi.gov.uk) until 27 June.