DEXA-RHINASPRAY DUO
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-04-2023
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Active ingredient:
TRAMAZOLINE HYDROCHLORIDE DEXAMETHASONE ISONICOTINATE
Available from:
Boehringer Ingelheim Limited
Dosage:
120/20 Microgram
Pharmaceutical form:
Nasal Spray Suspension
Authorization date:
1999-03-04
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Dexa-Rhinaspray Duo 120 micrograms/20 micrograms, Nasal Spray, Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tramazoline hydrochloride 120 micrograms/metered dose and dexamethasone isonicotinate 20 micrograms/metered
dose.
Also contains 150 micrograms/ml benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
A white, homogenous suspension.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of allergic rhinitis.
4.2 Posology and method of administration
Adults (including the elderly)
1 metered dose into each nostril up to six times in 24 hours, although 2 or 3 applications a day are usually sufficient.
Children
5-12 years: 1 metered dose into each nostril up to twice daily.
Under 5 years: Not recommended.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Each course of treatment should not exceed 14 days.
No specific information on the use of this product in the elderly is available. No adverse reactions specific to this age
group have been reported with tramazoline and dexamethasone.
Administration
For detailed information on instructio
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