ZADITEN OFTABAK * COLL FL 5ML

ZADITEN OFTABAK * COLL FL 5ML

Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Dosage and method of use

DosageAdults, seniors and children (from 3 years): One drop of ZADITEN OFTABAK in the conjunctival sac twice a day.Method of administrationThe patient must be instructed to: - before use, discard the first 5 drops. After the first time, it is no longer necessary to discard the first 5 drops; - wash your hands thoroughly before instillation; - to avoid contamination, do not touch the eye or eyelids or any other surface with the tip of the dropper; - close the eyelids and perform a nasolacrimal occlusion for 1-2 minutes. This will help reduce systemic absorption; - close the bottle after use.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Adverse reactions are ranked under headings of frequency using the following convention: very common: (≥1 / 10), common: (≥1 / 100 toDisorders of the immune systemUncommon: HypersensitivityNervous system disordersUncommon: HeadacheEye disordersCommon: Eye irritation, eye pain, punctate keratitis, punctate erosion of the corneal epithelium. Uncommon: Blurred vision (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.Gastrointestinal disordersUncommon: dry mouthSkin and subcutaneous tissue disordersUncommon: rash, eczema, urticariaGeneral disorders and administration site conditionsUncommon: SomnolenceAdverse reactions from post-marketing experience (frequency not known): The following post-marketing events have been observed: - hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, itching and edema of the eyelids), systemic allergic reactions including swelling / edema of the face ( in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions, such as asthma and eczema; - dizzinessReporting 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

No particular precautions.

Pregnancy and breastfeeding

Pregnancy There are no adequate data on the use of ketotifen eye drops in pregnancy. Animal studies with toxic oral doses have shown an increase in pre- and postnatal mortality, but have not shown teratogenic effects. Systemic levels after ocular administration are much lower than after oral use. Caution should be used when prescribing the medicine to pregnant women. Lactation Although data from animal studies following oral administration demonstrate excretion into breast milk, topical administration in women is unlikely to produce detectable quantities in breast milk. ZADITEN OFTABAK eye drops can be used during breastfeeding. Fertility There are no data available on the effect of ketotifen hydrogen fumarate on fertility.

Expiration and retention

This medicinal product does not require any special storage conditions. For storage conditions after first opening of the medicinal product, see section 6.3.

Interactions with other drugs

If ZADITEN OFTABAK is used concomitantly with other eye medications, at least 5 minutes should elapse between the application of the 2 medications. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with ketotifen-containing eye drops, the possibility of such effects cannot be excluded.

Overdose

No cases of overdose have been reported. Oral intake of the contents of a 5 ml bottle is equivalent to 1.25 mg of ketotifen, which is 60% of a recommended daily oral dose for a 3-year-old child. Clinical results indicated no serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.

Active principles

One ml contains 0.345 mg of ketotifen hydrogen fumarate corresponding to 0.25 mg of ketotifen. For a full list of excipients, see section 6.1.

Excipients

Glycerol Sodium Hydroxide (for pH adjustment) Water for injections