Composition and Presentation:

Plastic bottle of 30 ml contains 0.1% azelastine.

Indications:

Azelastine Nasal Spray, is an antihistamine which in addition to its histamine H (1)-receptor - blocking activity, appears to inhibit the release of inflammatory mediators from mast cells. Azelastine is indicated for the treatment of the symptoms of perennial and seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 12 years and older.

Contraindications:

Azelastine Nasal Spray is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components.

Side Effects:

The most frequently sides-effects are bitter taste ,drowsiness or fatigue. Less frequently effects include headache, nausea, , nasal burning and dry mouth and nose.

Drugs and Interaction:

- Concurrent use of Azelastine with alcohol or other CNS depressants should be avoided .
- Patients should be advised against the concurrent use of Azelastine with other antihistamines without consulting a physician.

Warnings:

- Caution should be used when Azelastine is administered during pregnancy or lactation.
- Safety and efficacy of Azelastine in pediatric patients below the age of 12 years have not been established.
- Caution should be exercised when driving a car or operating potentially dangerous machinery.
- Avoid spraying in the eyes.

Overdose:

Acute overdose is unlikely to result in clinically significant adverse events, other than increased somnolence.

Dosage:

Adults and children 12 years and older: Two sprays per nostril twice dail.
Bottles of product should be discarded after 3 months after the first use.

Storage:

Store at 20°-25°C. Protect from freezing.