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SYNAZE NASAL SPRAY [SIN15256P]
Active ingredients: SYNAZE NASAL SPRAY
Last updated 26 October 2025
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Product Info
SYNAZE NASAL SPRAY
[SIN15256P]
Product information
Active Ingredient and Strength | AZELASTINE HYDROCHLORIDE - 0.1% W/W |
Dosage Form | SPRAY, METERED |
Manufacturer and Country | CIPLA LIMITED - INDIA |
Registration Number | SIN15256P |
Licence Holder | PHARMLINE MARKETING PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R01AD58 |
INDICATIONS
Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 6 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.
DOSAGE AND ADMINISTRATION
Dosage
Adults, adolescents and children (6 years and older)
One spray in each nostril twice daily (morning and evening).
Children below 6 years
SYNAZE nasal spray is not recommended for use in children below 6 years of age as safety and efficacy has not been established in this age group.
Elderly
No dose adjustment is required in this population (see Pharmacokinetics under Special Populations – Age and PRECAUTIONS – Use in the Elderly – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Renal and hepatic impairment
No dose adjustment is required in patients with renal impairment or mild to moderate hepatic impairment (see Pharmacokinetics under Special Populations – Renal Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Caution is required when treating patients with severe hepatic impairment (see Pharmacokinetics under Special Populations – Hepatic Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Duration of treatment
SYNAZE nasal spray is suitable for long-term use. There is no restriction regarding duration of use.
Method of Administration
SYNAZE Nasal Spray is for administration by the nasal route only.
Preparing the spray:
Shake the bottle gently before each use for about 5 seconds. Then, remove the protective cap.
Prior to first use, SYNAZE nasal spray must be primed by pressing down and releasing the pump 6 times until a fine mist appears. If SYNAZE nasal spray has not been used for more than 7 days, reprime by pressing down and releasing the pump a number of times until a fine mist is produced.
Do not prick the nozzle in case spray is not obtained. Clean the actuator with water.
Using the spray:
After blowing the nose, spray the suspension once into each nostril keeping the head tilted downward. After each use, wipe the spray tip and replace the protective cap.
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the excipients.