Eustamyl 0.05% Nicox eye drops 25x0.5ml

Eustamyl 0.05% Nicox eye drops - Single dose

Eye drops indicated for acute and chronic conjunctivitis and keratoconjunctivitis of an allergic nature

Pharmacotherapeutic group

Ophthalmological, decongestant and antiallergic, other antiallergic.

Active principles

100 ml contain: ketotifen fumarate 0.069 g, equal to 0.05 g of ketotifen.

Excipients

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

Indications

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

Contraindications and side effects

Hypersensitivity 'to ketotifen or to any of the excipients. Generally contraindicated in pregnancy.

Dosage

1 drop in the conjunctival sac 2 or more times a day, according to medical prescription. Method of administration. Multidose bottle: to open, press the cap and unscrew at the same time. After use, close it by screwing it down tightly. Single-dose vial: separates from the strip; opens; it's used; 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 should eventually be left behind must be thrown away.

storage

Store at a temperature not exceeding 30 degrees C.

Warnings

The medicine can 'cause a slight and fleeting burning at the time of application. Multidose container. The formulation of the eye drops o 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. Careful monitoring is required in case of frequent or prolonged use of the drug in patients with dry eyes or in conditions in which the cornea is compromised. Since contact lenses can absorb benzalkonium chloride, they must be removed before applying the drug but can be reapplied after 15 minutes. All eye drops that contain benzalkonium chloride as a preservative can discolor soft contact lenses. Single-dose container. No special warnings.

Interactions

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. Even if these phenomena have not been observed with eye drops, the possibility of such effects cannot be excluded.

Side effects

Adverse drug reactions from clinical trials are listed according to the MedDRA classification for 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 to <1/10); uncommon (> = 1/1000 to <1/100); rare (> = 1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data). Adverse reactions. Disorders of the immune system. 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 disorders, conjunctivitis, photophobia, conjunctival hemorrhages; rare: mild burning, local irritation with hyperemia and blepharitis. Gastrointestinal disorders. Uncommon: dry mouth. Skin and subcutaneous tissue disorders. Uncommon: rash, eczema, urticaria. General disorders and administration site conditions. Uncommon: somnolence. Adverse drug reactions from post marketing experience (frequency not known): hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, itchy eyelid 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 reactions The reporting of suspected 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.

Pregnancy and breastfeeding

Pregnancy. There are no adequate data on the use of 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 and 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 time. Although 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 ingredient in breast milk. The medicine eye drops can 'be used during breastfeeding. Fertility'. There are no data on the effect of ketotifen fumarate on fertility in humans.

Format

Pack of 25 vials of 0.5ml.