Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and over.
Indications
Pollival eye drops are a treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children aged 12 years and over.
Composition
Active substances
Azelastine hydrochloride 0.05% (0.50 mg/ml). One drop of approximately 30 mcl contains 0.015 mg of Azelastine hydrochloride.
Excipients
Disodium edetate, Hypromellose, Sorbitol, Sodium hydroxide (for pH adjustment), Water for injections.
Directions for use and Dosage
Seasonal allergic conjunctivitis: The usual dose in adults and children aged 4 years and over is one drop in each eye twice a day (morning and evening), which can be increased, if necessary, to four times a day.
If exposure to the allergen is expected, Pollival can be administered prophylactically, before exposure. Non-seasonal (perennial) allergic conjunctivitis: The usual dose in adults and children aged 12 years and over is one drop in each eye twice daily (morning and evening), which may be increased, if necessary, to four times daily.
Since safety and efficacy have been demonstrated in clinical trials for a period of 6 weeks, the duration of each treatment cycle 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.
It should be emphasized that use for longer periods of time may be associated with increased risk of allergic reactions. Treatment for 6 weeks should be done under medical supervision even in case of seasonal conjunctivitis.
Warnings
Pollival is not indicated for the treatment of eye infections.
Pollival should not be used while wearing soft contact lenses.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Interactions
No interaction studies have been performed with Pollival.
Interaction studies have been performed with oral formulations of Azelastine at high doses, however, they are not relevant for Pollival since the systemic levels, after administration of the eye drops, are in the order of picograms.
Undesirable effects
The evaluation of undesirable effects follows the following frequencies:
Very common: (≥ 1/10);
Common: (> 1/100, < 1/10);
Uncommon: (> 1/1,000, < 1/100);
Rare: (> 1/10,000, < 1/1,000);
Very rare: (< 1/10,000);
Not known: frequency cannot be estimated from the available data. Immune system disorders.
Very rare: Allergic reactions (such as rash and itching).
Nervous system disorders.
Uncommon: bitter taste.
Eye disorders.
Common: mild, transient eye irritation.
Pregnancy and breastfeeding
Azelastine hydrochloride 0.05% (0.50 mg/ml). One drop of approximately 30 mcl contains 0.015 mg of azelastine hydrochloride.
Storage
Do not store above 25°C.
Do not use this medicine if you notice that the seal on the package is broken before first opening.
Format
10 ml bottle
Product Code:FRCM166652
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