Ketoftil 0.05%

Eye drops

Composition:

KETOFTIL 0.05% eye drops, solution 100 ml contain: ketotifen fumarate 0.069 g, equal to 0.05 g of ketotifen. KETOFTIL eye gel 100 g contain: ketotifen fumarate 0.069 g, equivalent to 0.05 g of ketotifen.

Excipients

KETOFTIL 0.05% eye drops, solution (in multidose package): Sorbitol; Benzalkonium chloride; TS-Polysaccharide; Water for injections. KETOFTIL 0.05% eye drops, solution: TS-Polysaccharide; Sorbitol; Water for injections. KETOFTIL 0.05% ophthalmic gel: Hydroxyethylcellulose; Sorbitol; Benzalkonium chloride; Water for injections.

Therapeutic indications

Acute and chronic allergic conjunctivitis and keratoconjunctivitis (spring, atopic and other)

Contraindications

Known individual hypersensitivity to one of the components of the product or closely related substances from a chemical point of view. Generally contraindicated in pregnancy (see section 4.6).

Dosage

KETOFTIL 0.05% eye drops, solution: 1 drop in the conjunctival sac 2 or more times a day, according to medical prescription. KETOFTIL 0.05% ophthalmic gel: 1 drop in the conjunctival sac 2 times a day.

Warnings and Precautions

KETOFTIL, in its various pharmaceutical forms, can cause a slight and fleeting burning sensation at the time of application. KETOFTIL ophthalmic gel, due to the nature of its excipients, can cause a slight and transient blurred vision at the time of application. Due to the presence of benzalkonium chloride, the use of KETOFTIL eye drops and KETOFTIL ophthalmic gel is incompatible with the use of soft contact lenses. Keep this medicine out of the reach of children.

Interactions

Although ketotifen has interactions with tranquilizers, hypnotics and alcohol, the low plasma concentrations obtainable by ocular administration make such phenomena unlikely.

Side effects

In rare cases, mild burning, local irritation with hyperemia and blepharitis have been reported.

Pregnancy and breastfeeding

Although animal studies have not shown any adverse effects of ketotifen on gestation and fetus, its administration to pregnant women, particularly in the first trimester, should be limited to cases of actual need. There are no known overdose reactions.