“Composition
Active ingredients
Each ml of solution contains 1 mg of azelastine hydrochloride. One spray (0.14 ml) contains 0.14 mg of azelastine hydrochloride, which corresponds to 0.13 mg of azelastine.
Excipients
Hypromellose 2910, disodium edetate, anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride, purified water.
Method of administration and dosage
Local route of administration – nasal mucosa.
One spray (0.14 ml) in each nostril twice a day (0.56 mg of azelastine hydrochloride).
No special studies have been conducted in the elderly. Children aged 6 years and older – one spray (0.14 ml) in each nostril twice a day (0.56 mg of azelastine hydrochloride).
Azelastine hydrochloride should not be administered to children under 6 years of age due to lack of safety and efficacy data.
Method of administration: Nasal. Precautions to be taken into account before using or administering the medicinal product: Spray with head upright.
Before first use, press the pump mechanism several times (3-4 times) until a uniform spray is produced.
If azelastine is not used for 6 days or more, the pump mechanism should be reactivated by pressing and releasing a sufficient number of times to produce a fine mist.
After use, clean the dispenser nozzle and close the protective cap.
Warnings
Use the spray with head upright.
Contraindications
Children under 6 years of age. Hypersensitivity to the active substance or to any of the excipients.
Storage
Do not refrigerate or freeze. Do not store at temperatures above 25°C.
Storage conditions after first opening the product.”
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