Ketoftil*oft Gel 10g 0,5mg/g

NAME
KETOFTIL

PHARMACOTHERAPEUTIC CATEGORY
Decongestants and antiallergics.

ACTIVE PRINCIPLES
Eye drops, 100 ml contain 0.069 g ketotifen fumarate, equivalent to 0.05 g of ketotifen. Eye gel, 100 g contain ketotifen fumarate 0.069 g, equivalent to 0.05 g of ketotifen.

EXCIPIENTS
Eye drops (in multi-dose pack): sorbitol; benzalkonium chloride; TS-Polysaccharide; water for injections. Eye drops, solution: TS-Polysaccharide; sorbitol; water for injections. Ophthalmic gel: hydroxyethylcellulose; sorbitol; benzalkonium chloride; water for injections.

INDICATIONS
Acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature (spring, atopic and others).

CONTRAINDICATIONS / SECONDARY EFFECT
Individual hypersensitivity to one of the components of the product or strictly correlated substances from a chemical point of view. Generally contraindicated in pregnancy.

DOSAGE
Eye drops, solution: 1 drop into the conjunctival sac 2 or more times a day, according to medical prescription. Ophthalmic gel: 1 drop into the conjunctival sac 2 times per day.

STORAGE
No special storage precautions.

WARNINGS
The product, in its various pharmaceutical forms, can cause a slight and fleeting burning sensation at the time of application. The 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 eye drops and ophthalmic gel is incompatible with the use of soft contact lenses.

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 negative effects of ketotifen on gestation and fetus, its administration in pregnant women, particularly in the first trimester, should be limited to cases of actual need. There are no known overdose reactions.