Azel-Drop Allergy, eye drops, solution, 6 ml

Azel-Drop Alergia is a drug in the form of eye drops containing azelastine hydrochloride . Used in the prevention and treatment of symptoms of allergic, seasonal conjunctivitis in adults and children over 4 years of age and symptomatic treatment of perennial allergic conjunctivitis in adults and adolescents over 12 years of age.

Azelastine hydrochloride is a specific, potent and long-acting H1 receptor antagonist with antiallergic properties. Additionally, when applied topically to the eye, it has anti-inflammatory effects.

In-vivo (preclinical) and in-vitro studies have shown that azelastine inhibits the synthesis or release of chemical mediators (e.g. leukotrienes, histamine, PAF and serotonin) that participate in the early and late phase of the allergic reaction.

After ocular administration of azelastine hydrochloride (one drop in each eye 4 times daily), the maximum concentration of azelastine hydrochloride in blood was very low (equal to or less than the lower limit of quantification).

Azel-Drop Allergy has anti-allergic and anti-inflammatory effects.

Azel-Drop Allergy eye drops are indicated for the treatment and prevention of symptoms of allergic, seasonal conjunctivitis in adults and children under 4 years of age and for the treatment of symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and adolescents over 12 years of age.

The active substance is azelastine hydrochloride. 1 ml contains 0.5 mg of azelastine hydrochloride. One drop contains 0.015 mg of azelastine hydrochloride.

The other ingredients are: benzalkonium chloride; liquid sorbitol 70% (non-crystallising); hypromellose; disodium edetate; sodium hydroxide (to adjust pH); water for injections.

Seasonal allergic conjunctivitis

• In adults and children aged 4 years and over, the most common dose is one drop in each eye twice daily.
• If necessary, the dose may be increased to one drop, administered 4 times daily.
• Azel-Drop Allergy can be administered prophylactically before anticipated exposure to an allergen.

Non-seasonal (perennial) allergic conjunctivitis

• The usual dose for adults and adolescents aged 12 years and over is one drop in each eye twice daily.
• If necessary, the dose may be increased to one drop 4 times daily.
• Clinical studies have confirmed the efficacy and safety of the product during treatment lasting a maximum of 6 weeks, therefore one treatment cycle should be limited to 6 weeks.

Note on self-medication

Treatment of seasonal conjunctivitis for a period longer than 6 weeks should only be performed under medical supervision. It is recommended to contact a doctor if the symptoms of the disease worsen or the patient’s health does not improve within 48 hours.

How to use:

1. Unscrew the cap.
2. Tilt your head back slightly and gently pull down your lower eyelid.
3. Carefully apply 1 drop to the inner part of the lower eyelid.
4. Be careful not to touch your eye or skin with the dropper tip.
5. Let go of the lower eyelid and gently press the corner of the eye towards the nose.
6. Blink your eye slowly a few times to spread the drop across the surface of the eyeball.

Hypersensitivity to the active substance or any of the excipients.

The Azel-Drop Allergy package contains 6 ml of solution and a leaflet.