Active ingredients: Ketotifene (Ketotifene fumarate)
KETOFTIL® "0.05% eye drops, solution"
Ketoftil package inserts are available for pack sizes:- KETOFTIL® "0.05% eye drops, solution"
- KETOFTIL® “0.05% eye drops, solution” 25 single-dose containers of 0.5 ml
- KETOFTIL® 0.05% ophthalmic gel
Indications Why is Ketoftil used? What is it for?
Pharmacotherapeutic category
Ocular antihistamine-antiallergic.
Indications
Acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature (spring, atopic and others).
Contraindications When Ketoftil should not be used
Hypersensitivity to ketotifen or to any of the excipients of the product or closely related substances from a chemical point of view.
Generally contraindicated in pregnancy (see Special Warnings and Precautions for Use).
Precautions for use What you need to know before taking Ketoftil
The KETOFTIL eye drops can cause, at the time of application, a slight and fleeting sense of burning.
The formulation of Ketoftil multidose eye drops contains benzalkonium chloride as a preservative that could deposit on soft contact lenses; therefore Ketoftil should not be used if the patient wears this type of lens.
The lenses must be removed before applying the eye drops and it is necessary to wait 15 minutes before putting them back on.
Any eye drops containing benzalkonium chloride as a preservative may discolor soft contact lenses.
Benzalkonium chloride can cause eye irritation.
KETOFTIL, in its various pharmaceutical forms, can cause a slight and fleeting burning sensation at the time of application.
Interactions Which drugs or foods can modify the effect of Ketoftil
Tell your doctor if you have recently taken any other medicines, even those without a prescription.
If Ketoftil is used concomitantly with other eye medications, it is necessary to allow at least 5 minutes between one application and another.
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 ruled out. Although Ketotifen does present interactions with tranquilizers. , hypnotics and alcohol, the low plasma concentrations obtainable by ocular administration make such phenomena unlikely.
Warnings It is important to know that:
Pregnancy
Ask your doctor for advice before taking any medicine No data are available on the use of ketotifen in pregnancy. Studies in animals with toxic oral doses have shown an increase in pre- and postnatal mortality, but have not shown teratogenic effects. Systemic levels of ketotifen after ophthalmic application they are much lower than those achieved after oral administration. Although animal studies have not shown any negative effects of ketotifen on gestation and fetus, its administration to pregnant women, particularly in the first trimester, should be limited to cases of actual need.
Feeding time
Although data from animal studies following oral administration demonstrate excretion of the active substance in breast milk, topical administration in women is unlikely to produce detectable amounts of the active substance in breast milk. Ketoftil can be used during lactation.
Fertility
There are no data on the effects of ketotifen fumarate on fertility in humans.
Effects on ability to drive and use machines
In sensitive subjects, the KETOFTIL eye drops, at the beginning of the treatment, could reduce the ability to react.
If a patient has blurred vision or drowsiness, he should not drive and use machines.
Important information about some of the ingredients
The formulation of Ketoftil multidose eye drops contains benzalkonium chloride
May cause eye irritation.
Avoid contact with soft contact lenses.
Dosage and method of use How to use Ketoftil: Dosage
Remove contact lenses before application and wait at least 15 minutes before reapplying.
The bleaching action against soft contact lenses is known.
Keep this medicine out of the reach of children
Dosage
1 drop in the conjunctival sac 2 or more times a day according to medical prescription.
How to use
To open, press the cap and unscrew at the same time. After use, close it by screwing it down tightly.
Overdose What to do if you have taken too much Ketoftil
No cases of overdose have been reported.
The oral intake of the contents of the 10 ml multidose bottle is equivalent to 5 mg of ketotifen (the recommended daily dose for children over 3 years of age is 2 mg).
Clinical results indicated no serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.
Side Effects What are the side effects of Ketoftil
The following side effects have been reported:
Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100), rare (≥ 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), Frequency not known (cannot be estimated from the available data).
Disorders of the immune system
Uncommon: hypersensitivity
Nervous system disorders
Uncommon: headache
Eye disorders
Common: eye irritation, eye pain, punctate keratitis, punctate erosion of 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
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) and exacerbations of pre-existing allergic conditions such as asthma and eczema.
The patient is invited to inform the doctor or pharmacist of any undesirable effect, even if not described in this leaflet.
Expiry and Retention
Expiration and retention
See the expiry date indicated on the package: this date is intended for the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
The product should not be used more than 30 days after first opening the container.
Composition and pharmaceutical form
Composition
100 ml contain: Ketotifen fumarate g 0.069, equal to 0.05 g of Ketotifen.
Excipients: Sorbitol; Benzalkonium chloride; TS-Polysaccharide; Water for injections.
Pharmaceutical form and content
Eye drops, solution. Bottle of 10 ml of 0.05% solution.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
KETOFTIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
KETOFTIL 0.05% eye drops, solution
100 ml contain:
ketotifen fumarate 0.069 g, equivalent to 0.05 g of ketotifen.
KETOFTIL eye gel
100 g contain:
ketotifen fumarate 0.069 g, equivalent to 0.05 g of ketotifen.
03.0 PHARMACEUTICAL FORM
Eye drops, solution - Eye gel
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Acute and chronic allergic conjunctivitis and keratoconjunctivitis (spring, atopic and other)
04.2 Posology and method of administration
KETOFTIL 0.05% eye drops, solution: 1 drop in the conjunctival sac 2 or more times a day, according to medical prescription.
KETOFTIL 0.05% ophthalmic gel: 1 drop in the conjunctival sac 2 times a day.
04.3 Contraindications
Known individual hypersensitivity to one of the components of the product or closely related substances from a chemical point of view.
Generally contraindicated in pregnancy (see section 4.6).
04.4 Special warnings and appropriate precautions for use
KETOFTIL, in its various pharmaceutical forms, can cause a slight and fleeting burning sensation at the time of application. KETOFTIL ophthalmic gel, due to the nature of its excipients, can cause a slight and transient blurred vision at the time of application.
Due to the presence of benzalkonium chloride, the use of KETOFTIL eye drops and KETOFTIL ophthalmic gel is incompatible with the use of soft contact lenses.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Although ketotifen has interactions with tranquilizers, hypnotics and alcohol, the low plasma concentrations obtainable by ocular administration make such phenomena unlikely.
04.6 Pregnancy and lactation
Although animal studies have not shown any negative effects of ketotifen on gestation and fetus, its administration to pregnant women, particularly in the first trimester, should be limited to cases of actual need.
There are no known overdose reactions.
04.7 Effects on ability to drive and use machines
In sensitive subjects, KETOFTIL, at the beginning of the treatment, could reduce the ability to react.
Since Ketoftil ophthalmic gel can cause a slight blurring of vision for a few minutes, after application, we do not recommend driving or using machines during this period.
04.8 Undesirable effects
In rare cases, mild burning, local irritation with hyperemia and blepharitis have been reported.
04.9 Overdose
No symptoms of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
KETOFTIL is a locally active antiallergic and antihistamine drug in all forms of allergic keratoconjunctivitis. Its anti-anaphylactic activity, of a non-steroidal type, is expressed both through an inhibition of the release of the chemical mediators of allergy and local inflammation from mast cells (histamine, SRS-A, etc.), and through an inhibition of the activation of eosinophils by antigens or platelet activating factor (PAF).
The antihistamine effect manifests itself through an inhibition of the effects of histamine on peripheral H1 receptors.
05.2 "Pharmacokinetic properties
Orally (rat) the absorption half-life of ketotifen is 0.5 ± 0.2 hours and the elimination half-life is 8.4 hours. Its elimination occurs for 25% -30% through the renal emunctory. .
Ocular administration (rabbit): with C14-labeled ketotifen fumarate, the maximum concentration in ocular tissues is detected 15 minutes after administration; the maximum level is reached in the corneal epithelium, followed by conjunctiva, cornea, iris, sclera, ciliary body and aqueous humor.
The mean retention time at the conjunctival level is 5.7 hours. The blood concentration for repeated ocular doses was calculated to be approximately 1/70 of the conjunctival one.
05.3 Preclinical safety data
Ketotifen exhibits low acute toxicity. The DL50 is shown in the following table
No toxic effect has been found for repeated oral doses and well above those usable for clinical-therapeutic use.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
KETOFTIL 0.05% eye drops, solution (in multi-dose pack): Sorbitol; Benzalkonium chloride; TS-Polysaccharide; Water for injections.
KETOFTIL 0.05% eye drops, solution: TS-Polysaccharide; Sorbitol; Water for injections.
KETOFTIL 0.05% eye gel: Hydroxyethylcellulose; Sorbitol; Benzalkonium chloride; Water for injections.
06.2 Incompatibility
Not known.
06.3 Period of validity
KETOFTIL 0.05% EYE DROPS, SOLUTION - 10 ml bottle
30 months in intact packaging.
The multidose bottle should not be used more than 30 days after first opening the container.
KETOFTIL 0.05% EYE DROPS, SOLUTION - 25 single-dose containers 0.5 ml
30 months in intact packaging.
The single-dose vials do not contain antimicrobial preservatives designed to preserve their sterility during use and therefore, once the container is opened, the product contained in it must be used immediately; any leftovers must be thrown away.
KETOFTIL 0.05% OPHTHALMIC GEL
36 months in intact packaging.
The product should not be used more than 30 days after first opening the container.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
KETOFTIL 0.05% eye drops, solution (multidose container)
10 ml polyethylene dropper bottle, equipped with a cap with rational and non-instinctive opening.
KETOFTIL 0.05% eye drops, solution (single-dose container)
Box of 25 0.5 ml polyethylene containers. The containers, in cartons of 5 units, are enclosed in polythene-aluminum-polyester sachets.
KETOFTIL 0.05% eye gel
10 g aluminum tube, internally coated with epoxy resins, with ophthalmic tip.
06.6 Instructions for use and handling
Eye drops
a) multidose bottle:
To open, press the cap and unscrew at the same time. After use, close it by screwing it down tightly.
b) single-dose vial:
1) separates from the splint;
2) opens;
3) it is used;
4) you throw it away, even if some content remains.
Eye gel:
To obtain a better dripping, during the application keep the tube perpendicular and not oblique.
07.0 MARKETING AUTHORIZATION HOLDER
FARMIGEA SpA - Via G. B. Oliva 6/8, 56121 - Pisa
08.0 MARKETING AUTHORIZATION NUMBER
KETOFTIL 0.05% eye drops, solution - 10 ml bottle: A.I.C. n. 029278013
KETOFTIL 0.05% eye drops, solution - single-dose container: A.I.C. n. 029278025
KETOFTIL 0.05% ophthalmic gel: A.I.C. n. 029278037
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
24.03.2000 / May 2005
10.0 DATE OF REVISION OF THE TEXT
April 2010
