Eye drops indicated for the prevention and the treatment of conjunctivitis, even those not on allergic basis. Ages 4 years and up.
Treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and older. Relieving symptoms of non-seasonal allergic conjunctivitis (perennial) in adults and children aged 12 years and older.
Hypersensitivity 'ascertained to the active substance or to any of the excipients.
The usual dose in adults and children from 4 years onwards and 'one drop per eye, twice the ' you can 'be increased, if necessary up to four times the '. If 'exposure to allergens and ' advance, the drug is administered prophylactically prior 'exposure. non-seasonal allergic conjunctivitis (perennial): the usual dose in adults and children aged 12 years and over, and 'one drop in each eye twice a ', which can 'be increased, if necessary up to four times the '. Since 'Safety and efficacy were demonstrated in clinical trials for up to 6 weeks, the duration of each treatment should be limited to a maximum period of 6 weeks.
And not 'indicated for the treatment of eye infections. The benzalkonium chloride can 'cause eye irritation. L 'use with soft contact lenses must be avoided. Remove contact lenses before applying the eye drops and wait 15 minutes before putting them back. It 'known as fading of soft contact lenses.
No specific studies have been conducted to evaluate interactions with the medicine. Interaction studies were conducted with high oral doses, even if they have no relevance with the drug, because ', after administration of eye drops, systemic levels of the drug are located in the range of picograms.
The evaluation of side effects and '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 (can not be estimated for lack of data). Nervous system disorders. Uncommon: taste bitter. Alterations of the ocular system. Common: light and transient irritation to the eyes. Immune system. Very rare: allergic reactions (such as rash and itching).
There is insufficient information to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (fetal death, late 's growth and skeletal malformations) in ' laboratory animal. Local ocular application will bring 'to a minimal systemic exposure (in the range of picograms). However, l 'use during pregnancy will have ' be made with caution. Azelastine and 'excreted in milk in low quantities '. For this reason, and not 'recommended during lactation.