VISIOFEN * COLL 30FL 0.25MG / ML

VISIOFEN * COLL 30FL 0.25MG / ML

Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Dosage and method of use

Dosage.Adults, seniors and children (from 3 years of age): one drop of Visiofen in the conjunctival sac twice a day. The content of a single-dose container is sufficient for one administration in both eyes.Pediatric population: The safety and efficacy of Visiofen in children below 3 years of age have not been established.Method of administration: Ocular use. The contents remain sterile until the original closure is broken. To avoid contamination, do not touch the eye or other surfaces with the tip of the container.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Side effects

Adverse reactions from clinical trials (table 1) are listed by MedDRA system organ class. Within the organ system class, adverse reactions are ranked by frequency, with the most frequent reactions at the beginning. Within each frequency grouping, adverse reactions are presented in order of decreasing severity. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (MedDRA): very common (≥1 / 10); common (≥1 / 100 in Table 1. Adverse reactions.

Adverse reactions from post-marketing experience (frequency not known). The following post-marketing events with ketotifen eye drops have also been observed: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, itching and edema of the eyelids), systemic allergic reactions including swelling / face edema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions, such as asthma and eczema;Reporting of suspected adverse reactions: The reporting of suspected 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 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

No special warnings.

Pregnancy and breastfeeding

Pregnancy: There are no adequate data on the use of ketotifen eye drops in pregnancy. Animal studies with maternal toxic oral doses have shown an increase in pre- and postnatal mortality, but have not shown teratogenic effects. Systemic levels after ocular administration are much lower than after oral use. Caution should be used when prescribing the medicine to pregnant women.Feeding time: Although data from animal studies following oral administration demonstrate excretion into breast milk, topical administration in women is unlikely to produce detectable quantities in breast milk. Visiofen can be used during breastfeeding.Fertility: There are no data available on the effect of ketotifen hydrogen fumarate on human fertility.

Expiration and retention

Do not store above 25 ° C. Do not refrigerate or freeze. Keep the container in the foil bag.

Interactions with other drugs

If Visiofen is used concomitantly with other eye medications, at least 5 minutes should elapse between application of the two medications. Administration of oral pharmaceutical forms of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with ketotifen-containing eye drops, the possibility of such effects cannot be excluded.

Overdose

No cases of overdose have been reported. Oral intake of the contents of a single-dose container is equivalent to 0.1 mg of ketotifen, which is 5% of a recommended daily oral dose for a 3-year-old child. Clinical results showed no severe signs or symptoms of overdose after oral ingestion of a dose of up to 20 mg of ketotifen.

Active principles

One ml of solution contains 0.25 mg of ketotifen corresponding to 0.345 mg of ketotifen hydrogen fumarate. Each single-dose container of 0.4 ml of solution contains 0.1 mg of ketotifen (as hydrogen fumarate). Each drop contains approximately 6.95 micrograms of ketotifen (as hydrogen fumarate). For the full list of excipients, see section 6.1.

Excipients

Glycerol (E422); Sodium hydroxide (E524) (for pH adjustment); Water for solution for injection.