Adverse reactions are listed in the table in frequency categories under MedDRA system/organ classes. The frequency of adverse reactions is defined using 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), not known (cannot be estimated from the available data).
MedDRA system organ class | Adverse reaction |
Eye disorders | |
Not known | Eye irritation |
Gastrointestinal disorders | |
Not known | Necrotising colitis (in preterm infants) |
Immune system disorders | |
Rare | Allergic reaction |
Not known | Anaphylactic reaction, Anaphylactic shock |
Investigations | |
Not known | Increased intraocular pressure |
Nervous system disorders | |
Not known | Seizures (especially in children) Cerebellar dysfunction |
Psychiatric disorders | |
Not known | Hallucination |
Systemic cyclopentolate toxicity is dose-related and would be less likely to occur following administration of 0.5% solution than following instillation of 1% solution.
Children are, however, more susceptible to such reactions than adults.
Peripheral effects typical of anti-cholinergics, such as flushing or dryness of the skin and mucous membranes, have not been observed with topical cyclopentolate in children or adults. Temperature, pulse and blood pressure are not normally affected.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.