KETAZED

25 mg/ml, eye drops solution into the conjunctival sac twice a day. 25 mg/ml, eye drops solution in children aged from birth to 3 years have not yet been established. Method of administration 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 reactions Nervous system disorders Uncommon: Headache Eye disorders Common: Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion.

Uncommon:

Blurred vision (during instillation), dry eyes, eyelid disorder, conjunctivitis, photophobia, conjunctival bleeding.

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 during post-marketing: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema of the face (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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

No special warnings or precautions for use.

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