EUSTAMYL COLL 25FL 0.5ML 0.05%

EUSTAMYL 0.5 MG/ML COLLIRIUM, DEVELOPMENT

active ingredients

EUSTAMYL 0.5 mg/ml colliary, 100 ml solution contain: ketotifene smoked 0.069 g, equal to 0.05 g ketotifene.

Excellent

EUSTAMYL 0.5 mg/ml colliery, solution (in multidose packaging): glycerol; benzalconio chloride; water for injectable preparations. EUSTAMYL 0.5 mg/ml colliary, solution (in monodose packaging): hydroxyethylcellulose; sorbitol; 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. Generally contraindicated in pregnancy (see paragraph 4.6).

Population

Population EUSTAMYL 0.5 mg/ml colliary, solution: 1 drop in the joint bag 2 or more times a day, according to prescription. Method of administration a) multidose bottle: to open, press the closing capsule and simultaneously unscrew. After use close by screwing thoroughly. b) single-dose bottle: 1) separates from the strip; 2) opens; 3) is used; 4) throws, even if it remains content. Monodose bottles do not contain antimicrobial preservatives to preserve their sterility during use and therefore, once the container is opened, the product contained in it must be used immediately; what should possibly advance must be thrown.

Conservation

Store at temperature not exceeding 30°C.

Warnings

EUSTAMYL can determine at the time of application a light and fleeting burning. Multi-dose container The formulation of EUSTAMYL colliery, solution contains benzalconio chloride 0.01 gr per 100 ml equivalent to 0.001 gr/5 ml as preservative, which can cause eye irritation and is known to alter the color of the contact lenses soft. Careful monitoring is required in case of frequent or prolonged use of EUSTAMYL in patients with eye dryness or under conditions where cornea is compromised. As contact lenses can absorb the chloride benzalconio, these must be removed before the application of EUSTAMYL but can be reapplied after 15 minutes All the colliars containing benzalconio chloride as preservative can discolor the contact lenses soft. Single-dose container No special warning.

Interactions

If you are making use of other eye medicines, you should have at least 5 minutes between one application and the other. Oral administration of ketotifen can enhance the effects of depressive drugs on SNC, antihistamines and alcohol. Although these phenomena have not been observed with EUSTAMYL the possibility of such effects cannot be excluded.

Effects

Reactions from drugs from clinical trials (table 1) are listed according to MedDRA classification by organ and system classes. Within each organic systemic class, adverse reactions from drugs are classified by frequency with the most frequent for first. Within each frequency group, adverse reactions are presented in decreasing order of gravity. 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 a Immune system disorders Not common: Hypersensitivity Diseases of the nervous system Not Municipality: Cefalea Pathologies of the eye Municipalities: Eye irritation, Eye Pain, Bet Keratite, Corneal Epithelium Bet erosion Not common: Offused vision (during instillation), Dry eye, Palpebral disorders, Conjunctivitis, Fotophobia, Conjunctiviral bleeding Rari: Burning yeast, Local irritation with Hyperemia and Blefarite Gastrointestinal diseases Not common: Dry mouth Pathologies of skin and subcutaneous tissue Not Common: Rash, Eczema, Orticaria Systemic pathologies and conditions for administration Not Municipality: Sonnolenza Reactions adverse from drugs from post marketing experience (frequency not known). • hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, swelling of the eyes, itching of the eyelid and edema). • systemic allergic reactions including face/edema swelling (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as 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/web/guest/content/segnalazioni-reazioni-avverse”.

Overdosing

Multi-dose container No overdose cases have been reported. Oral intake of this medicine is not recommended. The oral ingestion of the content of the 10 ml multidose bottle is equivalent to 5 mg of 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. Single-dose container 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

No adequate data on the use of EUSTAMYL colliery during pregnancy. 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 the medicine to pregnant women.

Food

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. EUSTAMYL colliery can be used during lactation.

Fertility

There are no data on the effect of ketotifen smoked on fertility in man.

Source: Farmadati