Ketophtil 0.05% 10 ml eye drops solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

Hypersensitivity to ketotifen or to any of the excipients of the product or closely chemically related substances. Generally contraindicated during pregnancy (see section 4.6).

WARNINGS AND PRECAUTIONS FOR USE

Ketoftil eye drops, solution (multi-dose container) and Ketoftil gel: The formulations of Ketoftil multidose eye drops and Ketoftil gel contain benzalkonium chloride as a preservative which can deposit on soft contact lenses; therefore Ketoftil should not be used if the patient wears this type of lenses. The lenses must be removed before application and you must wait 15 minutes before putting them back on. Products containing benzalkonium chloride as a preservative may discolor soft contact lenses. Benzalkonium chloride can cause ocular irritation, dry eye, alteration of the corneal film and surface. To be used with caution in patients with dry eye and corneal compromise. Patients should be monitored during prolonged use. Ketoftil, in its various pharmaceutical forms, can cause a slight and fleeting burning sensation upon application. Ketoftil ophthalmic gel, due to the nature of its excipients, may cause a slight and transient visual blurring upon application. Ketophtil eye drops, solution and gel: No particular warnings.

INTERACTIONS

If Ketoftil is used concomitantly with other ocular medications, it is necessary to allow at least 5 minutes between applications. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with Ketoftil, the possibility of such effects cannot be excluded.

SIDE EFFECTS

Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class. Within each system organ class, adverse reactions are reported in order of frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Adverse reactions. Immune system disorders. Uncommon: hypersensitivity. Nervous system disorders. Uncommon: headache. Eye pathologies. Common: eye irritation, eye pain, punctate keratitis, punctate erosion of the corneal epithelium; Uncommon: blurred vision, (during instillation), dry eye, eyelid disorders, conjunctivitis, photophobia, conjunctival haemorrhage. Gastrointestinal disorders. Uncommon: dry mouth. Pathologies of the skin and subcutaneous tissue. Uncommon: rash, eczema, urticaria. Systemic pathologies and conditions relating to the administration site. Uncommon: drowsiness. Adverse reactions from post-marketing experience (frequency not known) The following post-marketing adverse reactions have also been observed: • hypersensitivity reactions including local allergic reactions (predominantly contact dermatitis, swelling of the eye area, eyelid pruritus and edema) • systemic allergic reactions including facial swelling/edema (in some cases associated with contact dermatitis) • exacerbations of pre-existing allergic conditions such as asthma and eczema. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.