ALLERGODIL * COLL FL 6ML 0.05%
Therapeutic indications
Treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and over. Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children aged 12 years and older.
Dosage and method of use
Seasonal allergic conjunctivitis: The usual dosage in adults and children aged 4 years and over is one drop per eye, twice a day which can be increased, if necessary, up to four times a day. If exposure to allergens is anticipated, ALLERGODIL Eye Drops should be administered prophylactically before exposure. Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children aged 12 years and over is one drop per eye twice a day, which can be increased up to four times a day if necessary. As safety and efficacy have been demonstrated in clinical studies for periods of up to 6 weeks, the duration of each treatment should be limited to a maximum of 6 weeks.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Side effects
The assessment of undesirable effects is based on the following frequencies: Very common (≥ 1/10); Common (≥ 1/100 to Immune system disorders:Very rare:allergic reactions (such as rash and itching).Nervous system disorders Uncommon: bitter taste.Eye disorders Common: slight and transient eye irritation.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Special warnings
ALLERGODIL Eye drops are not indicated for the treatment of eye infections. For further warnings see sections 4.5 and 4.6. ALLERGODIL Eye drops contains the preservative benzalkonium chloride. Benzalkonium chloride can cause eye irritation, especially in the case of dry eyes or corneal changes. Use with soft contact lenses should be avoided. Remove contact lenses before applying eye drops and wait at least 15 minutes before putting them back on. Soft contact lenses have been known to fade.
Pregnancy and breastfeeding
FertilityEffects on human fertility have not been studied.PregnancyInsufficient information is available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has been shown to induce adverse reactions (fetal death, growth retardation and skeletal malformations) in laboratory animals. Local ocular application will lead to minimal systemic exposure (in the range of picograms). However, the use of ALLERGODIL eye drops during pregnancy should be done with caution.Feeding timeAzelastine is excreted in milk in low quantities. For this reason, ALLERGODIL eye drops are not recommended during lactation.
Expiration and retention
This medicinal product does not require any special storage conditions.
Interactions with other drugs
No specific studies have been conducted to evaluate interactions with ALLERGODIL Eye drops. Interaction studies have been conducted with high doses of azelastineorally, although they have no relevance for ALLERGODIL Eye drops, since, after administration of eye drops, the systemic levels of the drug are located in the range of picograms.
Overdose
No specific reactions are known after ocular overdose and by ocular administration route overdose reactions are not to be expected. There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In case of overdose or intoxication, central nervous system disorders are to be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.
Active principles
Azelastine hydrochloride 0.05% (0.5 mg / ml). Each drop contains 0.015 mg of azelastine hydrochloride. Excipient with known effect: 1 ml contains 0.125 mg of benzalkonium chloride. For the full list of excipients, see section 6.1.
Excipients
Benzalkonium chloride, disodium edetate, hypromellose, liquid (crystallized) sorbitol, sodium hydroxide, water for injections.
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