INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CROMOHEXAL® NASAL SPRAY

CROP1

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CROMOHEXAL® NASAL SPRAY

COMPOSITION:
Each mL contains:
  sodium cromoglycate dihydrate equivalent to
  sodium cromoglycate 20 mg
  benzalkonium chloride 0,01% m/v.

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

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