VIVIDRIN EYES * COLL6ML0.5MG / ML
Therapeutic indications
Treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and over. Treatment of symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children aged 12 years and older.
Dosage and method of use
Dosage. 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 up to four times a day if necessary. If subsequent exposure to allergens is known in advance, Vividrin Occhi should be administered prophylactically, prior to 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.Note for self-medication:The patient should be informed that the treatment of seasonal allergic conjunctivitis for more than 6 weeks should only be carried out under the supervision of a physician. It is recommended that you contact your doctor if your symptoms worsen or do not improve after 48 hours.Method of administration:Ophthalmic use. The eye drops should be applied into the conjunctival sac by slightly tilting the head back. The eye drops should always be used avoiding contact of the bottle tip with the eye or skin.
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, Reporting of suspected adverse reactions: Reporting of suspected adverse reactions occurring after authorization of the medicinal product 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: www.aifa.gov.it/content/segnalazioni-reazioni- adverse.
Special warnings
Vividrin Occhi is not indicated for the treatment of eye infections. This medicinal product contains 0.0035 mg of benzalkonium chloride per drop, equivalent to 0.125 mg / ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Patients should be advised to remove contact lenses before using this medicine and to wait at least 15 minutes before reapplying. Benzalkonium chloride has been indicated as a cause of eye irritation, dry eye, film and corneal surface alteration. To be used with caution in patients with dry eye and corneal compromise. Patients should be monitored for prolonged use.
Pregnancy and breastfeeding
Pregnancy:There is insufficient information available to establish the safety of azelastine during human pregnancy. At high oral doses azelastine has been shown to induce adverse effects (fetal death, growth retardation and skeletal malformation) in laboratory animals. Local ocular application will lead to minimal systemic exposure (in the range of picograms). However, caution should be exercised when using Vividrin Eyes during pregnancy.Feeding time:Azelastine is excreted in breast milk in low quantities. For this reason, Vividrin Occhi is not recommended while breastfeeding.Fertility:In animal studies at higher than therapeutic oral doses of azelastine, the fertility index decreased (see section 5.3).
Expiration and retention
Do not store above 25 ° C. Keep the bottle in the original package to protect the medicine from light.
Interactions with other drugs
No specific interaction studies have been conducted with azelastine hydrochloride. Interaction studies have been conducted with high doses of oral azelastine, although they are of no relevance to Vividrin Eyes, as systemic levels of the drug are in the picogram range after administration of the eye drops.
Overdose
No specific reactions are known after ocular overdose and, with the ocular route of administration, no overdose reactions are expected. There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In the event of overdose or intoxication, central nervous system disorders are to be expected based on the results in experimental animals. Treatment of these disorders must be symptomatic. There is no known antidote.
Active principles
Each ml of solution contains 0.5 mg of azelastine hydrochloride. One drop contains 0.015 mg of azelastine hydrochloride. Excipients with known effect: 1 ml of eye drops contains 0.125 mg of benzalkonium chloride. For the full list of excipients, see section 6.1.
Excipients
Benzalkonium chloride; Disodium edetate; Hypromellose; Liquid sorbitol 70% (not crystallizable); Sodium hydroxide (for pH adjustment); Water for injections.