Ketoftil Single-Dose Eye Drops are used in the treatment of acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature (spring, atopic and others).
Indications
Acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature (spring, atopic and others).
Composition
Active ingredients
Ketoftil 0.5 mg/ml eye drops, solution. 1 ml contains 0.69 mg of ketotifen fumarate, equivalent to 0.5 mg of ketotifen. Ketoftil 0.5 mg/g ophthalmic gel. 1 g contains 0.69 mg of ketotifen fumarate, equivalent to 0.5 mg of ketotifen. Excipient with known effect: The multidose bottle and eye gel contain benzalkonium chloride. For a full list of excipients, see section 6.1.
Excipients
Ketoftil 0.5 mg/ml eye drops, solution (multidose bottle): Sorbitol, benzalkonium chloride, TS-Polysaccharide and water for injections. Ketoftil 0.5 mg/ml eye drops, solution (single-dose containers): TS-Polysaccharide, sorbitol and water for injections. Ketoftil 0.5 mg/g ophthalmic gel: Hydroxyethylcellulose, sorbitol, benzalkonium chloride and water for injections.
Directions for use and Dosage
Ketoftil 0.5 mg/ml eye drops, solution: 1 drop in the conjunctival sac 2 or more times a day, as prescribed by your doctor. Ketoftil 0.5 mg/g ophthalmic gel: 1 drop in the conjunctival sac 2 times a day.
Warnings
Ketoftil eye drops, solution (multi-dose container) and Ketoftil gel: The Ketoftil multi-dose eye drops and Ketoftil gel formulations contain benzalkonium chloride as a preservative which may be deposited on soft contact lenses; Therefore, Ketoftil should not be used if the patient wears these types of lenses. Lenses must be removed before application and a 15-minute wait must be made before reinsertion. Products containing benzalkonium chloride as a preservative may discolor soft contact lenses. Benzalkonium chloride can cause eye irritation, dry eye, and alteration of the corneal film and surface. Use with caution in patients with dry eye and corneal damage. Patients should be monitored in case of prolonged use. Ketoftil, in its various pharmaceutical forms, may 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 blurring of vision upon application. Ketoftil eye drops, solution and gel: No special warnings.
Contraindications
Hypersensitivity to ketotifen or to any of the product's excipients or chemically closely related substances. Generally contraindicated in pregnancy (see section 4.6).
Undesirable effects
Adverse reactions from clinical studies (Table 1) are listed according to the MedDRA system organ class. Within each system organ class, adverse reactions are presented 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 disorders. 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. Skin and subcutaneous tissue disorders. Uncommon: rash, eczema, urticaria. General disorders and administration site conditions. Uncommon: somnolence. 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, itching of the eyelids and oedema)
- systemic allergic reactions including facial swelling/oedema (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 after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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.
Overdose
Ketoftil multidose No cases of overdose have been reported. Oral administration of this medicine is not recommended. Oral ingestion of the contents of the 10 ml multidose bottle or tube is equivalent to 5 mg of ketotifen (the recommended daily dose for children over 3 years of age is 2 mg). Clinical results have not indicated serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen. Ketoftil single-dose No cases of overdose have been reported. Oral ingestion of the contents of the single-dose container is equivalent to 0.25 mg of ketotifen (the recommended daily dose for children over 3 years of age is 2 mg). Clinical results have not indicated serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.
Pregnancy and breastfeeding
There are no data available on the use of ketotifen 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 this medicine to pregnant women. Breastfeeding: Although data from animal studies following oral administration demonstrate excretion of the active ingredient in breast milk, topical administration to women is unlikely to produce detectable quantities of the active ingredient in breast milk. Ketoftil can be used during breastfeeding. Fertility: No data are available on the effects of ketotifen fumarate on fertility in humans.
Format
25 Vials 0.5 ml
Product Code:FRCM045991
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