Antiallergic eye drops in single-dose vials for seasonal allergic conjunctivitis.
Indications
Visiofen 0.25 mg/ml in single-dose containers is an eye drop for the symptomatic treatment of seasonal allergic conjunctivitis.
Ingredients
Active ingredients: one ml of solution contains 0.25 mg of ketotifen (as hydrogen fumarate).
Each 0.4 ml single-dose container contains 0.1 mg of ketotifen (as hydrogen fumarate).
Excipients: glycerol (E422), sodium hydroxide (E524) (for pH adjustment), water for injections.
How to use and Dosage
Adults, elderly and children (from 3 years of age): one drop of Visiofen in the conjunctival sac twice a day.
The contents of a single-dose container are sufficient for administration to both eyes.
Paediatric population: The safety and efficacy of Visiofen in children under 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.
Warnings
Keep out of the sight and reach of children.
Do not take alcoholic beverages at the same time.
May cause allergic reactions. may affect the ability to drive and use machines.
Interactions
If Visiofen is used concomitantly with other ocular medications, at least 5 minutes should elapse between the application of the two medications.
The 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 eye drops containing ketotifen, the possibility of such effects cannot be excluded.
Undesirable effects
Adverse reactions from clinical studies are listed according to MedDRA system organ class.
Within the system organ class, adverse reactions are classified according to frequency, with the most frequent reactions being: very rare (<1/100); ... frequent at the beginning.
Furthermore, the corresponding frequency category for each adverse drug reaction is based on the following convention (MedDRA): 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 (frequency cannot be estimated from the available data).
Immune system disorders
Uncommon: Hypersensitivity
Nervous system disorders
Uncommon: Headache
Eye disorders
Common: Eye irritation, eye pain, punctate keratitis, punctate erosion of the corneal epithelium.
Uncommon: Blurred vision (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.
Gastrointestinal disorders
Uncommon: Dry mouth
Skin and subcutaneous tissue disorders
Uncommon: Rash, eczema, urticaria
General disorders and related conditions at the site of administration
Uncommon: Somnolence
Adverse reactions from post-marketing experience (frequency not known).
The following post-marketing events have also been observed with ketotifen eye drops: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, swelling of the eyes, itching and oedema of the eyelids), systemic allergic reactions, including swelling/oedema of the face (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions, such as asthma and eczema.
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, equivalent to 5% of a recommended daily oral dose for a 3-year-old child. years.
Clinical results have shown no serious signs or symptoms of overdose after oral ingestion of a dose of up to 20 mg of ketotifen.
Pregnancy and breastfeeding
Pregnancy
There are no adequate data on the use of ketotifen eye drops during pregnancy.
Animal studies with maternally 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 exercised when prescribing the medicine to pregnant women.
Breastfeeding
Although data from animal studies after oral administration demonstrate excretion in breast milk, it is unlikely that topical administration to women will 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.
Storage
Do not store above 25°C.
Do not refrigerate or freeze.
Keep single-dose containers in the foil pouch.
Do not use for more than 4 weeks after opening the foil pouch.
Format
30 single-dose containers of 0.4 ml
Product Code:FRCM173117
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