Ketotil 0.05% 10 g ophthalmic gel

Ketotil 0.05% 10 g ophthalmic gel is an ocular antihistamine specifically formulated for the treatment of acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature , such as spring, atopic and other origins. Thanks to its active ingredient, ketotifen , Ketotil works effectively in reducing the typical symptoms of ocular allergies, including itching, redness, irritation and ocular inflammation . The ophthalmic gel formulation allows for uniform and prolonged distribution of the active ingredient on the ocular surface, offering rapid and long-lasting relief from ocular discomfort and itching .

Ketotil 0.05% ophthalmic gel contains hydroxyethylcellulose and sorbitol , which help maintain eye hydration and improve comfort during application. The presence of benzalkonium chloride as a preservative ensures the stability of the product, but it is important to remove soft contact lenses before use to avoid possible interactions. The 10 g format is practical and ideal for prolonged use, ensuring effective coverage of ocular allergy symptoms. Ketotil is indicated for those suffering from eye allergies , red eyes and ocular inflammation , offering a targeted and reliable solution for the treatment of ocular allergy symptoms .

ACTIVE INGREDIENTS

Active ingredients contained in Ketotil 0.05% 10 g ophthalmic gel - What is the active ingredient of Ketotil 0.05% 10 g ophthalmic gel?

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% 10g ophthalmic gel - What does Ketotil 0.05% 10g ophthalmic gel 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% 10 g ophthalmic gel - Why is Ketotil 0.05% 10 g ophthalmic gel 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% 10 g ophthalmic gel - When should Ketotil 0.05% 10 g ophthalmic gel 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% 10 g ophthalmic gel - How to take Ketotil 0.05% 10 g ophthalmic gel?

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% 10 g ophthalmic gel - How to store Ketotil 0.05% 10 g ophthalmic gel?

None.

WARNINGS

Warnings Ketotil 0.05% 10 g ophthalmic gel - About Ketotil 0.05% 10 g ophthalmic gel it is important to know that:

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% 10 g ophthalmic gel - Which medicines or foods can modify the effect of Ketotil 0.05% 10 g ophthalmic gel?

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% 10g ophthalmic gel can cause side effects - What are the side effects of Ketotil 0.05% 10g ophthalmic gel?

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% 10g ophthalmic gel - What are the risks of Ketotil 0.05% 10g ophthalmic gel 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% 10 g eye gel.

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% 10 g eye gel before driving or using machines - Does Ketotil 0.05% 10 g eye gel 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.