Summary of the safety profile
In clinical trials, the most frequently reported adverse reactions were blurred vision occurring in 11% of patients and eyelid margin crusting occurring in 7.79% of patients.
The following adverse reactions have been reported during clinical trials with Carbomer 2mg/g, 3mg/g and are classified according to 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), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Classification | Adverse reactions |
Eye disorders | Very common: vision blurred Common: ocular discomfort, eyelid margin crusting, eye irritation Uncommon: periorbital oedema, conjunctival oedema, eye pain, eye pruritus, ocular hyperaemia, lacrimation increased |
Skin and subcutaneous tissue disorders | Uncommon: dermatitis contact |
Additional adverse reactions identified from post-marketing surveillance include the following.
Frequencies cannot be estimated from the available data.
System Organ Classification | Adverse reactions |
Immune system disorders | Not known: Hypersensitivity |
Reporting of suspected adverse reactions
Reporting of 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 at www.mhra.gov.uk/yellowcard