PHARMACOLOGICAL CLASSIFICATION A/16 ear nose and throat preparations
PHARMACOLOGICAL ACTION Sodium cromoglycate is an anti-allergic agent that acts mainly by inhibiting release of inflammatory mediators.
INDICATIONS Allergic rhinitis.
CONTRA-INDICATIONS Hypersensitivity to sodium cromoglycate or benzalkonium chloride Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE Adults and children: Instill 1 spray into each nostril 4 –6 times daily.
SIDE EFFECTS AND SPECIAL PRECAUTIONS Intranasal use of sodium cromoglycate may cause transient irritation of the nasal mucosa, sneezing and occasionally epistaxis.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT See side-effects and special precautions. Treatment is symptomatic and supportive.
IDENTIFICATION Clear, colourless aqueous solution, free from foreign particles.
PRESENTATION Cromohexal nasal spray is available in a metered dose container holding 15 mL.
STORAGE INSTRUCTIONS Store below 25°C. Protect from light.
REGISTRATION NUMBER 29/16/0383
NAME AND BUSINESS ADDRESS OF APPLICANT Hexal Pharma (SA) (PTY) Ltd.
46 Mahogany Road
Mahogany Ridge
Pinetown
3610
DATE OF PUBLICATION OF THIS PACKAGE INSERT July 1996
CROP1
Updated on this site: June 2005
Source: Pharmaceutical Industry
CROMOHEXAL® NASAL SPRAY