4.8 Undesirable effects
No adverse events have been reported in clinical trials. All adverse events recorded below were identified in post-marketing reports.
The frequency of adverse reactions documented from spontaneous post-marketing reporting is given below and is defined as follows: Not Known (cannot be estimated from available data).
Within each frequency grouping, the undesirable effects are presented in order of decreasing seriousness:
Eye Disorders:
Not known: Eye pain (including stinging), eye irritation (including burning sensation), eye allergy, vision blurred, eye swelling, eye inflammation, eyelid oedema, eye pruritus, eye discharge, foreign body sensation, ocular/conjunctival hyperaemia, eyelid erythema, lacrimation increased.
Immune System disorders:
Not known: Hypersensitivity
4.9 Overdose
Accidental topical ocular overdosage will present no hazard, apart from a potential transient effect on vision (see section 4.7).
6.2 Incompatibilities
Not applicable
6.5 Nature and contents of container
Not all pack sizes may be marketed.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23rd July 2003
Date of first authorisation: 5 November 1981
Date of latest renewal: 23 July 2003
10. DATE OF REVISION OF THE TEXT
16th Dec 2010
