VISIOFEN COLL 30FL 0.25MG/ML

VISIOFEN 0.25 MG/ML COLLIRIA, MONODOSE CONTENT

active ingredients

A ml solution contains 0.25 mg of ketotifen corresponding to 0.345 mg of ketotifene hydrogen smoked. Each 0.4 ml single-dose container contains 0.1 mg of ketotifene (such as smoked hydrogen). Each drop contains about 6.95 micrograms of ketotifene (such as smoked hydrogen). For the full list of excipients, see paragraph 6.1.

Excellent

Glicerol (E422); Hydroxide sodium (E524) (for pH adjustment); Water for injectable solution.

Therapeutic indications

Syntomatic treatment of seasonal allergic conjunctivitis.

Contraindications

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

Population

Population. Adults, elders and children (from 3 years of age): a drop of Visiofen in the joint sack twice a day. The contents of a single-dose container is sufficient for administration in both eyes. Pediatric population: The safety and effectiveness of Visiofen in children under 3 years of age have not been established. Method of administration: Eye use. The content remains sterile until the original closure is broken. To avoid contamination do not touch the eye or other surfaces with the tip of the container.

Conservation

Do not store at temperature above 25°C. Do not refrigerate or freeze. Store the container in the aluminum envelope.

Warnings

No special warning.

Interactions

If Visiofen is used in conjunction with other eye medicines, at least 5 minutes must be taken between the application of the two medicines. The administration of oral pharmaceutical forms of ketotifen can enhance the effects of depressive drugs on SNC, antihistamines and alcohol. Although these phenomena have not been observed with collieries containing ketotifen, the possibility of such effects cannot be excluded.

Effects

Adverse reactions from clinical trials (Table 1) are listed according to the classification for systems and organs according to MedDRA. Within the classification for systems and organs, adverse reactions are classified according to the frequency, with the most frequent reactions at the beginning. Within each frequency grouping, adverse reactions are presented in descending order of gravity. In addition, the corresponding frequency category for each adverse reaction to the drug is based on the following convention (MedDRA): very common (≥1/10); common (≥1/100 to Table 1. Averse reactions.

Classification for systems and organs	Frequency	Action against
Immune system disorders	Not common	Hypersensitivity
Diseases of the nervous system	Not common	Cefa
Pathologies of the eye	Town	Eye irritation, eye pain, pointed keratite, episode erosion of the corneal epithelium.
	Not common	Offused vision (during instillation), eye dryness, eyelid disorder, conjunctivitis, photophobia, conjunctive hemorrhage.
Gastrointestinal diseases	Not common	Dry mouth
Pathologies of skin and subcutaneous tissue	Not common	Skin rash, eczema, hives
Systemic pathologies and conditions for administration	Not common	Sleep

Adverse reactions from post-marketing experience (not known frequency). The following post-marketing events with ketotifen-based colliery were also observed: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, swelling of the eyes, itching and edema of the eyelids), systemic allergic reactions, including swelling / edema of the face (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions, such as as asthma and eczema; 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 address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

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

Pregnancy

: There is no adequate data on the use of colliary ketotifen in pregnancy. Animal studies with toxic oral doses for the mother showed an increase in pre- and postnatal mortality, but did not show teratogenic effects. Systemic levels after eye administration are much lower than after oral use. It must be used caution in prescribing the medicine to pregnant women.

Food

: Although the data of animal studies after oral administration demonstrate excretion in breast milk, it is unlikely that the topical administration in the woman can produce detectable quantities in breast milk. Visiofen can be used during breastfeeding.

Fertility

: There is no data available on the effect of hydrogen ketotifen smoked on human fertility.

Source: Farmadati