ALLERGODIL COLL FL 6ML 0.05%

ALLERGODIL 0.5 MG/ML COLLIRIO, SOLUTION

active ingredients

Azelastina Hydrochloride 0.05% (0,5 mg/ml). Each drop contains 0.015 mg of azelastina hydrochloride. Excipient with known effects: 1 ml contains 0.125 mg of benzalconium chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride, disodium edetate, ipromellosa, liquid sorbitol (crystallized), sodium hydroxide, water for injectable preparations.

Therapeutic indications

Treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children from 4 years on. Treatment of symptoms of non seasonal allergic conjunctivitis (perennials) in adults and children from 12 years on.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Seasonal allergic conjunctivities: The usual dose in adults and children from 4 years on is of a drop per eye, twice a day that can be increased, if necessary, up to four times a day. If the exposure to allergens is anticipated, ALLERGODIL Collirio should be administered in profile before exposure. Non seasonal allergic conjunctivitis (perennials): The usual dose in adults and children from 12 years on is of a drop per eye twice a day, which can be increased, if necessary, up to four times a day. Since safety and effectiveness have been demonstrated in clinical studies for periods of up to 6 weeks, the duration of each treatment must be limited to a maximum period of 6 weeks.

Conservation

This medicine does not require any special precaution for conservation.

Warnings

ALLERGODIL Collirio is not indicated for the treatment of eye infections. For further warnings see paragraph 4.5 and 4.6. ALLERGODIL Collirio contains the preservative benzalconio chloride. Chloride benzalconium can cause irritation to the eyes, especially in case of dry eyes or cornea alterations. Use with soft contact lenses should be avoided. Remove contact lenses before applying the eye drops and wait at least 15 minutes before returning them. It is known to fade soft contact lenses.

Interactions

Specific studies have not been conducted to evaluate the interactions with ALLERGODIL Collirio. Interaction studies have been conducted with high doses of azelastina by mouth, although they have no relevance to ALLERGODIL Collirio, since, after administration of eye drops, the systemic levels of the drug are located in the range of picograms.

Effects

Evaluation of unwanted effects is based on the following frequencies: Very common (≥ 1/10); Common (≥ 1/100 a Disorder of the immune system: Very rare: allergic reactions (such as rash and itching). Diseases of the nervous system Not common: bitter taste. Pathologies of the eye Town: light and gentle irritation to the eyes. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Specific reactions after eye overdose are not known and ocular administration is not expected to be overdose reactions. There is no experience with the administration of toxic doses of azelastina hydrochloride in man. In case of overdose or poisoning, disturbances at the central nervous system should be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.

Fertility

The effects on fertility in man have not been studied.

Pregnancy

There is no sufficient information available to establish the safety of azelastina in human pregnancy. At high doses by mouth azelastina has shown to induce adverse reactions (fetal death, delay of growth and skeletal malformations) in the laboratory animal. The local eyepiece application will lead to a minimal systemic exposure (in the range of picograms). However, the use of ALLERGODIL Collirio during pregnancy must be done with precaution.

Food

Azelastina is excreted in milk in low quantity. For this reason, ALLERGODIL Collirio is not recommended during lactation.

Source: Farmadati