VIVIDRIN COLL6ML0,5MG/ML

VIVIDRIN OCCHI 0.5 MG/ML COLLIRIO, DEOLUTION

active ingredients

Each ml of solution contains 0.5 mg of azelastina hydrochloride. One drop contains 0.015 mg of azelastina hydrochloride. Excipients with known effects: 1 ml of eye drops contains 0.125 mg of benzalconium chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride; Detonate disode; Ipromellosa; Liquid Sorbitol 70% (not crystallized); Hydroxide sodium (for pH adjustment); Water for injectable preparations.

Therapeutic indications

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

Posology. Seasonal allergic conjunctivitis: The usual dosage in adults and children from 4 years on is of a drop per eye, twice a day, which can be increased, if necessary, up to four times a day. If you were aware in advance of a subsequent exposure to allergens, Vividrin Occhi must be administered prophylactically before exposure. Non-seasonal allergic conjunctivitis (perennial): The usual dosage in adults and children from 12 years on is of one 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. Note for self-medication: The patient must be informed that the treatment of seasonal allergic conjunctivitis for more than 6 weeks must be carried out only under the supervision of a doctor. It is recommended to contact your doctor if symptoms worsen or do not improve after 48 hours. Method of administration: Ophthalmic use. The eye drops must be applied in the joint sack by slightly bending the head backwards. The eye drops must be used always avoiding the contact of the tip of the bottle with the eye or with the skin.

Conservation

Do not store at temperature above 25°C. Store the bottle in the original packaging to protect the medicine from light.

Warnings

Vividrin Eyes is not indicated for the treatment of eye infections. This medicine contains 0.0035 mg of benzalconio chloride per drop, equivalent to 0.125 mg/ml. The benzalconio chloride can be absorbed by soft contact lenses and can lead to change of their color. Patients should be informed to remove contact lenses before using this medicine and wait at least 15 minutes before reapplying them. The benzalconio chloride was indicated as a cause of irritation to the eyes, dry eye, alteration of the film and the corneal surface. To be used with caution in patients with dry eye and impairment of cornea. Patients should be monitored in case of prolonged use.

Interactions

Specific interaction studies have not been conducted with azelastina hydrochloride. Interaction studies have been conducted with high doses of azelastina by mouth, although they are not relevant to Vividrin Occhi, since, after administration of the colliery, 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, 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Specific reactions after eye overdose are not known and, with the way of ocular administration, no overdose reactions are expected. 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 experimental animals. Treatment of these disorders must be symptomatic. There is no known antidote.

Pregnancy:

There is no sufficient information available to establish the safety of azelastina during human pregnancy. At high oral doses azelastina has shown to induce adverse effects (fetal death, growth delay and skeletal malformation) in laboratory animals. The local eyepiece application will lead to minimal systemic exposure (in the range of picograms). However, caution must be exercised in the use of Vividrin Eyes in pregnancy.

Nursing:

Azelastina is excreted in breast milk in low quantity. For this reason, Vividrin Eyes is not recommended during breastfeeding.

Fertility:

In animal studies at oral doses of azelatin higher than therapeutic ones, the fertility index decreased (see paragraph 5.3).

Source: Farmadati