KETOFALL

Posology Adults, elderly and children (age 3 and older): one drop of Ketofall into the conjunctival sac twice a day. The contents of a single-dose container are sufficient for one administration into both eyes. Paediatric population The safety and efficacy of Ketofall in children below the age of 3 years have not been established.

Method of administration Ocular use. The contents remain sterile until the original closure is broken. To avoid contamination do not touch the eye or any other surface with the tip of the container.

Adverse drug reactions from clinical trials (table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.

In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (MedDRA): 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).

Table 1 Adverse reactions System Organ Class Frequency Adverse Reaction Immune system disorders Uncommon Hypersensitivity Nervous system disorders Uncommon Headache Common Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion Eye disorders 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 reactions from post marketing experience (frequency not known).

The following post marketing events have also been observed with ketotifen eye drops: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritus 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.

No special warning.

1.