a. Summary of the safety profile
The most frequently occurring adverse reaction during clinical trials was vision blurred.
b. Tabulated list of adverse reactions
The following adverse reactions 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. The adverse reactions were obtained from clinical trials and post marketing spontaneous reports.
System Organ Classification
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MedDRA Preferred Term (v.19.0)
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Immune system disorders
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Not known: hypersensitivity
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Nervous system disorders
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Uncommon: headache
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Eye disorders
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Very common: vision blurred
Common: dry eye (residual), eyelid disorder, abnormal sensation in eye, foreign body sensation in eyes, ocular discomfort.
Uncommon: photophobia, hypoaesthesia eye, eye pruritus, eye irritation, ocular hyperaemia.
Not known: erythema of eyelid, eye swelling, eye pain, eye discharge, eyelid margin crusting, lacrimation increased.
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General disorders and administration site conditions
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Uncommon: discomfort (skin)
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Reporting of side effects
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 at: www.mhra.gov.uk/yellowcard