Active Ingredients
A single-dose container of 0.5 ml of solution contains 125 mcg of ketotifen (as hydrogen fumarate), equivalent to 250 mcg/ml.
Excipients
Glycerol (E422), sodium hydroxide, purified water.
Indications
Symptomatic treatment of seasonal allergic conjunctivitis.
Contraindications/side effects
Hypersensitivity to the active substance ketotifen or to any of the excipients.
Dosage
Adults, elderly and children (over 3 years): one drop of eye drops in the conjunctival sac twice a day. The contents of a single-dose container are sufficient for administration to both eyes. The contents and container remain sterile until the original closure is opened. To avoid the risk of contamination, do not touch any surface with the tip of the container.
Storage
Store at a temperature not exceeding 25 degrees C.
Warnings
No special precautions.
Interactions
If you are using other ocular medications, leave at least 5 minutes between one application and the next. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines, and alcohol. Although these phenomena have not been observed with the drug, the possibility of such effects cannot be excluded.
Undesirable Effects
The following undesirable effects have been reported at the recommended dose. The frequencies listed below are defined using the following convention: very common (>=1/10), common (from >=1/100 to <1/10), uncommon (from >=1/1,000 to <1/100), rare (from >=1/10,000 to <1/1,000). Eye disorders. Common: eye irritation, eye pain, punctate keratitis; uncommon: blurred vision (during instillation), dry eye, eyelid disorders, conjunctivitis, photophobia, conjunctival haemorrhages. Nervous system disorders. Uncommon: headache. General disorders and administration site conditions. Uncommon: somnolence. Skin and subcutaneous tissue disorders. Uncommon: rash, eczema, urticaria. Gastrointestinal disorders. Uncommon: dry mouth. Immune system disorders. Uncommon: hypersensitivity.
Pregnancy and breastfeeding
No clinical data are available on use during pregnancy. Animal studies with oral toxic doses have shown an increase in pre- and postnatal mortality, but have not shown teratogenic effects. Systemic levels of ketotifen after ophthalmic application are much lower than those achieved after oral administration. However, caution should be exercised when prescribing the medicine to pregnant women. Although data from animal studies following oral administration demonstrate excretion of the active ingredient in breast milk, it is unlikely that topical administration to women would produce detectable quantities of the active ingredient in breast milk. Mothers using the product can therefore breastfeed.
Product Code:FRCM046870
Richiedi info sul prodotto
