KETOFTIL OFT GEL 10G 0.5MG/G

KETOFTIL

active ingredients

Ketoftil 0.5 mg/ml colliary, solution. 1 ml contain 0.69 mg of smoked ketotifen, equal to 0.5 mg of ketotifene. Ketoftil 0.5 mg/g ophthalmic gel. 1 g contain 0,69 mg of smoked ketotifene, equal to 0.5 mg of ketotifene. Excipient with known effects The multidose bottle and eye gel contain benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Ketoftil 0.5 mg/ml colliary, solution (multidose fluctuation): Sorbitol, benzalconio chloride, TS- Polisaccaride and water for injectable preparations. Ketoftil 0.5 mg/ml colliary, solution (single containers): TS-Polisaccaride, sorbitol and water for injectable preparations. Ketoftil 0.5 mg/g ophthalmic gel: Hydroxyetylcellulose, sorbitol, benzalconio chloride and water for injectable preparations.

Therapeutic indications

Conjunctivitis and keratoconjunctivitis acute and chronic allergic nature (spring, atopics and others).

Contraindications

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

Population

Ketoftil 0.5 mg/ml colliary, solution: 1 drop in the joint bag 2 or more times a day, according to prescription. Ketoftil 0.5 mg/g ophthalmic gel: 1 drop in the joint sack 2 times a day.

Conservation

None.

Warnings

Ketoftil colliery, solution (multidose container) and Ketoftil gel: The formulations of Ketoftil multidose and Ketoftil gel contain benzalconio chloride as a preservative that can settle on soft contact lenses; therefore Ketoftil should not be used if the patient wears this type of lens. The lenses must be removed before the application and it is necessary to wait 15 minutes before returning them. Products containing benzalconio chloride as preservative can discolor soft contact lenses. Chloride benzalconium can cause eye irritation, dry eye, alteration of film and corneal surface. To be used with caution in patients with dry eye and with impairment of cornea. Patients should be monitored in case of prolonged use. Ketoftil, in its different pharmaceutical forms, can determine at the time of application a slight and fleeting burning. Ketoftil ophthalmic gel, due to the nature of its excipients, can cause at the time of application a slight and transitory visual obfuscation. Ketoftil colliery, solution and gel: No special warning.

Interactions

If Ketoftil is used in conjunction with other eye medicines, it is necessary to take at least 5 minutes between one application and the other. Oral administration of ketotifen can enhance the effects of depressive medicines on SNC, antihistamines and alcohol. Although these phenomena have not been observed with Ketoftil, the possibility of such effects cannot be excluded.

Effects

Adverse reactions from clinical trials (Table 1) are listed according to MedDRA classification for systems and organs. Within each class for systems and organs, adverse reactions are reported in frequency order, with the most frequent reactions first. Within each frequency group, adverse reactions are reported in descending order by severity. 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, adverse reactions. Immune disorders. Not common: hypersensitivity. Nervous system pathologies. Not common: headaches. Pathologies of the eye. Common: eye irritation, eye pain, pointed keratite, episode erosion of the corneal epithelium; Not common: blurred vision, (during instillation), dry eye, eyelids, conjunctivitis, photophobia, conjunctive hemorrhage. Gastrointestinal disease. Not common: dry mouth. Pathologies of skin and subcutaneous tissue. Not common: rash, eczema, hives. Systemic pathologies and conditions for administration. Not common: sleepiness. Reactions adversely affected by post-marketing experience (unknown frequency) The following post-marketing adverse reactions have also been observed: • hypersensitivity reactions including local allergic reactions (prevalence contact dermatitis, swelling of the eye area, eyelid itching and edema) • systemic allergic reactions with including swelling/facial edema (in some cases associated with contact dermatitis) • reacutting of pre-existing allergic conditions such as asthma and eczema. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Ketoftil multidose No overdose cases have been reported. Oral intake of this medicine is not recommended. Oral ingestion of the content of the 10 ml multidose bottle or tube is equivalent to 5 mg of ketotifen (the recommended daily dose for children over 3 years is 2 mg). Clinical results have not indicated severe signs or symptoms after ingestion of a dose of up to 20 mg of ketotifene. Ketoftil monodose No overdose cases have been reported. Oral intake of monodose container content is equivalent to 0.25 mg ketotifene (the recommended daily dose for children over 3 years is 2 mg). Clinical results have not indicated severe signs or symptoms after ingestion of a dose of up to 20 mg of ketotifene.

Pregnancy:

Data on the use of pregnant ketotifen are not available. Animal studies with toxic oral doses showed an increase in pre- and postnatal mortality, but did not show teratogenic effects. Systemic levels of ketotifene after ophthalmic application are much lower than those achieved after oral administration. You should however use caution in prescribing this medicine to pregnant women.

Nursing:

Although the data of animal studies after oral administration demonstrates the excretion of the active ingredient in breast milk, it is unlikely that the topical administration in the woman can produce quantity of active ingredient detectable in breast milk. Ketoftil can be used during nursing.

Fertility:

Data relating to the effects of smoking ketotifen on fertility in humans are not available.

Source: Farmadati