ZADITEN Eye drops, solution Ref.[7795] Active ingredients: Ketotifen

This medicine contains 2.6 micrograms benzalkonium chloride in each drop.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

Benzalkonium chloride may also cause eye irritation, especially in dry eyes or disorders of the cornea.

If Zaditen is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

The use of oral dosage forms of ketotifen may potentiate the effect of CNS depressants, antihistamines and alcohol. Although this has not been observed with Zaditen eye drops, the possibility of such effects cannot be excluded.

Pregnancy

There are no adequate data from the use of ketotifen eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre-and postnatal mortality, but no teratogenicity. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women.

Breast-feeding

Although animal data following oral administration show excretion into breast milk, topical administration to human is unlikely to produce detectable quantities in breast milk. Zaditen eye drops can be used during lactation.

Fertility

There are no data available on the effect of ketotifen fumarate on fertility in humans.

Any patient who experiences blurred vision or somnolence should not drive or operate machines.

Adverse reactions are ranked under heading of frequency, using the following convention: 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), not known (cannot be estimated from the available data).

Immune system disorders

Uncommon: Hypersensitivity

Nervous system disorders

Uncommon: Headache

Eye disorders

Common: Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion.

Uncommon: Vision blurred (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.

Gastrointestinal disorders

Uncommon: Dry mouth

Skin and subcutaneous tissue disorders

Uncommon: Rash, eczema, urticarial

General disorders and administration site conditions

Uncommon: Somnolence

Adverse drug reactions from post-marketing experience (Frequency not known): The following post marketing events have also been observed: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 676 4971, Fax: +353 1 676 2517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

Not applicable.