Prosdrop Adverse Reactions

Summary of the safety profile: The majority of adverse reactions relate to the ocular system. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see Precautions). Other ocular adverse events are generally transient and occur on dose administration.
Tabulated list of adverse reactions: Adverse reactions are categorized by frequency as follows: 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 (frequency cannot be estimated from the available data). (See Table 2.)

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Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Description of selected adverse reactions: No information is provided.
Paediatric population: In two short-term clinical trials (≤12 weeks), involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified. The short-term safety profiles in the different paediatric subsets were also similar (see Pharmacology: Pharmacodynamics under Actions). Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia.
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.