AZELASTINE

Seasonal allergic conjunctivitis The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Azelastine should be administered prophylactically, prior to the exposure.

Non-seasonal (perennial) allergic conjunctivitis:

The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks.

Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.

The assessment of undesirable effects is based on the following frequencies:

Very common (≥ 1/10) Common (≥1/100 to < 1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Very rare: Allergic reactions (such as rash and pruritus).

Nervous system disorders Uncommon:

Bitter taste Eye disorders Common: Mild, transient irritation in the eye Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Azelastine is not intended for treatment of eye infections. 5 and

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