ZADITEN

Posology Adults, elderly and children (age 3 and older): one drop of Zaditen into the conjunctival sac twice a day. Paediatric population The safety and efficacy of Zaditen in children aged from birth to 3 years have not yet been established.

Method of administration The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip.

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, urticaria 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 the Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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