Ketotil 0.05% 25×0.5 ml eye drops solution

Ketotil 0.05% 25×0.5 ml eye drops solution is a single-dose eye drop based on ketotifen fumarate , an active ingredient with a strong antihistaminic and mast cell stabilizing action, specifically indicated for the treatment of ocular allergies . This ophthalmic solution is particularly effective in counteracting the typical symptoms of allergic conjunctivitis and keratoconjunctivitis , both in acute and chronic form, such as itching of the eyes , redness , burning and eye irritation . Thanks to the formulation in 0.5 ml single-dose containers , Ketotil guarantees a hygienic and safe application, reducing the risk of contamination and also being ideal for those who need preservative-free eye drops .

Ketotil 0.05% eye drops are the ideal solution for those who suffer from seasonal eye inflammation or for those who are exposed to environmental allergens such as pollen, dust or animal hair. The product acts quickly, alleviating annoying symptoms and improving visual comfort. Its effectiveness also makes it suitable as eye drops for daily use and for the treatment of eye allergies in children (according to medical prescription). The preservative-free formulation is particularly suitable for those with sensitive eyes or who use contact lenses, although it is always recommended to remove the lenses before application.

Ketotil 0.05% 25×0.5 ml eye drops solution represents a reliable and practical choice for the targeted treatment of eye allergies , offering rapid and long-lasting relief from red, itching and burning eyes , improving the quality of life during periods of greater exposure to allergens.

ACTIVE INGREDIENTS

Active ingredients contained in Ketotil 0.05% 25×0.5 ml eye drops solution - What is the active ingredient of Ketotil 0.05% 25×0.5 ml eye drops solution?

Ketoftil 0.5 mg/ml eye drops, solution. 1 ml contains 0.69 mg ketotifen fumarate, equivalent to 0.5 mg ketotifen. Ketoftil 0.5 mg/g eye gel. 1 g contains 0.69 mg ketotifen fumarate, equivalent to 0.5 mg ketotifen. Excipient with known effect The multidose bottle and the eye gel contain benzalkonium chloride. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Ketotil 0.05% 25×0.5 ml eye drops solution - What does Ketotil 0.05% 25×0.5 ml eye drops solution contain?

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 eye gel : Hydroxyethylcellulose, sorbitol, benzalkonium chloride and water for injections.

DIRECTIONS

Therapeutic indications Ketotil 0.05% 25×0.5 ml eye drops solution - Why is Ketotil 0.05% 25×0.5 ml eye drops solution used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Ketotil 0.05% 25×0.5 ml eye drops solution - When should Ketotil 0.05% 25×0.5 ml eye drops solution not be used?

Hypersensitivity to ketotifen or to any of the excipients of the product or closely related chemical substances. Generally contraindicated in pregnancy (see paragraph 4.6).

DOSAGE

Quantity and method of taking Ketotil 0.05% 25×0.5 ml eye drops solution - How to take Ketotil 0.05% 25×0.5 ml eye drops solution?

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.

CONSERVATION

Storage Ketotil 0.05% 25×0.5 ml eye drops solution - How is Ketotil 0.05% 25×0.5 ml eye drops solution stored?

None.

WARNINGS

Warnings Ketotil 0.05% 25×0.5 ml eye drops solution - It is important to know that about Ketotil 0.05% 25×0.5 ml eye drops solution:

Ketoftil eye drops, solution (multi-dose container) and Ketoftil gel: Ketoftil multi-dose eye drops and Ketoftil gel formulations contain benzalkonium chloride as a preservative that may deposit on soft contact lenses; therefore Ketoftil should not be used if the patient wears these types of lenses. Lenses should be removed before application and it is necessary to wait 15 minutes before putting them back. Products containing benzalkonium chloride as a preservative may discolour soft contact lenses. Benzalkonium chloride may cause eye irritation, dry eye, alteration of the corneal film and surface. Use with caution in patients with dry eye and with compromised cornea. 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 slight and transient visual blurring upon application. Ketoftil eye drops, solution and gel: No particular warnings.

INTERACTIONS

Interactions Ketotil 0.05% 25×0.5 ml eye drops solution - Which medicines or foods can modify the effect of Ketotil 0.05% 25×0.5 ml eye drops solution?

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

SIDE EFFECTS

Like all medicines, Ketotil 0.05% 25×0.5 ml eye drops solution can cause side effects - What are the side effects of Ketotil 0.05% 25×0.5 ml eye drops solution?

Adverse reactions from clinical trials (Table 1) are listed according to 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 (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 disorder, 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 (mostly contact dermatitis, swelling of the eye area, eyelid itching 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 that occur 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

Overdose Ketotil 0.05% 25×0.5 ml eye drops solution - What are the risks of Ketotil 0.05% 25×0.5 ml eye drops solution in case of overdose?

Ketoftil multidose No cases of overdose have been reported. Oral intake of this medicine is not recommended. Oral ingestion of the contents of the 10 ml multidose bottle or tube is equivalent to 5 mg 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 ketotifen. Ketoftil monodose No cases of overdose have been reported. Oral intake of the contents of the single-dose container is equivalent to 0.25 mg 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 ketotifen.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Ketotil 0.05% 25×0.5 ml eye drops solution.

Pregnancy: There are no data available on the use of ketotifen during pregnancy. Studies in animals with oral toxic doses have shown an increase in pre- and postnatal mortality, but have not shown any 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 after oral administration demonstrate excretion of the active substance in breast milk, topical administration in women is unlikely to produce detectable quantities of the active substance in breast milk. Ketoftil can be used during breastfeeding. Fertility: There are no data available on the effects of ketotifen fumarate on fertility in humans.

DRIVING AND USE OF MACHINERY

Taking Ketotil 0.05% 25×0.5 ml eye drops solution before driving or using machines - Does Ketotil 0.05% 25×0.5 ml eye drops solution affect driving or using machines?

In sensitive subjects, Ketoftil, at the beginning of treatment, may reduce the ability to react. If the patient experiences blurred vision or drowsiness following the administration of this medicine, he should not drive or operate machinery.