EUSTAMYL * COLL 25FL 0,5ML 0,05%

EUSTAMYL * COLL 25FL 0,5ML 0,05%

Therapeutic indications

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

Dosage and method of use

DosageEUSTAMYL 0.5 mg / ml eye drops, solution: 1 drop in the conjunctival sac 2 or more times a day, according to medical prescription.Method of administrationa) 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 strip; 2) opens; 3) it is used; 4) it is thrown away, even if some content remains. The single-dose vials do not contain antimicrobial preservatives designed to preserve their sterility during use and therefore, once the container has been opened, the product contained in it must be used immediately; what may be left over must be thrown away.

Contraindications

Hypersensitivity to ketotifen or to any of the excipients. Generally contraindicated in pregnancy (see section 4.6).

Side effects

Adverse drug reactions from clinical trials (table 1) are listed according to MedDRA classification by organ and system classes. Within each system organ class, adverse drug reactions are ranked by frequency with the most frequent first. Within each frequency group, adverse reactions are presented in order of decreasing 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 y

Adverse drug reactions from post marketing experience (frequency not known).

• hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, eyelid itching and edema). • systemic allergic reactions including swelling of the face / edema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse”.

Special warnings

EUSTAMYL can cause a slight and fleeting burning sensation at the time of application.Multidose containerThe formulation of EUSTAMYL eye drops, solution contains benzalkonium chloride 0.01 g per 100 ml equivalent to 0.001 g / 5 ml as a preservative, which can cause eye irritation and is known to alter the color of soft contact lenses. Close monitoring is required in case of frequent or prolonged use of EUSTAMYL in patients with dry eye or in conditions in which the cornea is compromised. As contact lenses can absorb benzalkonium chloride, they must be removed before applying EUSTAMYL but can be reapplied after 15 minutes.All eye drops that contain benzalkonium chloride as a preservative can discolour soft contact lenses.Single-dose containerNo special warnings.

Pregnancy and breastfeeding

PregnancyThere are no adequate data on the use of EUSTAMYL eye drops during pregnancy. Animal studies 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 are much lower than those achieved after oral administration. However, caution should be exercised when prescribing the medicine to pregnant women.Feeding timeAlthough data from animal studies following oral administration demonstrate excretion of the active substance in breast milk, it is unlikely that topical administration in women will produce detectable amounts of the active substance in breast milk. EUSTAMYL eye drops can be used during breastfeeding.FertilityThere are no data on the effect of ketotifen fumarate on human fertility.

Expiration and retention

Store at a temperature not exceeding 30 ° C.

Interactions with other drugs

If you are using other eye medications, you should leave at least 5 minutes between applications. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with EUSTAMYL eye drops, the possibility of such effects cannot be excluded.

Overdose

Multidose containerNo 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 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.Single-dose containerNo cases of overdose have been reported. Oral intake 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 indicated no serious signs or symptoms after the ingestion of a dose of up to 20 mg of ketotifen.

Active principles

EUSTAMYL 0.5 mg / ml eye drops, 100 ml solution contain: ketotifen fumarate 0.069 g, equivalent to 0.05 g of ketotifen.

Excipients

EUSTAMYL 0.5 mg / ml eye drops, solution (in multi-dose pack): glycerol; benzalkonium chloride; water for injections. EUSTAMYL 0.5 mg / ml eye drops, solution (in single-dose packaging): hydroxyethylcellulose; sorbitol; water for injections.