CROMOHEXAL® NASAL SPRAY
(and dosage form):
Each mL contains:
sodium cromoglycate dihydrate equivalent to
benzalkonium chloride 0,01% m/v.
A/16 ear nose and throat preparations
Sodium cromoglycate is an anti-allergic agent that acts mainly by inhibiting release of inflammatory mediators.
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.
Clear, colourless aqueous solution, free from foreign particles.
Cromohexal nasal spray is available in a metered dose container holding 15 mL.
Store below 25°C. Protect from light.
NAME AND BUSINESS ADDRESS OF APPLICANT
Hexal Pharma (SA) (PTY) Ltd.
46 Mahogany Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT
Updated on this site: June 2005
Source: Pharmaceutical Industry
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