⚠️ Warnings
Use with caution in patients, particularly children, with a history of severe systemic reaction to atropine.
Cyclopentolate Olikla may raise intraocular pressure. In some patients, particularly the elderly, the possibility of undiagnosed glaucoma should be considered. Intraocular pressure should therefore be measured and the depth of the anterior chamber angle assessed before initiating treatment, in order to avoid precipitating a glaucoma attack (see section 4.8).
Severe eye pain may indicate an acute rise in intraocular pressure or corneal damage. In either case, medical consultation is required.
Cyclopentolate-induced psychotic reactions, behavioural disturbances and other central nervous system effects may occur in patients with heightened sensitivity to anticholinergics (see section 4.8).
Use with caution in children and the elderly, although such reactions may occur in any age group and in patients receiving higher doses. These reactions may include, but are not limited to, ataxia, slurred speech, restlessness, agitation, hallucinations, hyperactivity, seizures, disorientation and psychosis.
Owing to the risk of hyperthermia, Cyclopentolate Olikla should be used with caution in patients, particularly children, who may be exposed to elevated ambient temperatures or who are febrile.
Because of its mechanism of action (pupillary dilation and accommodative paralysis), cyclopentolate may cause blurred vision (see section 4.7). Patients may experience photosensitivity, and the eyes should therefore be protected from bright light (see section 4.8). Dark glasses may reduce light sensitivity.
Owing to the potential for cardiovascular effects following systemic absorption, this medicinal product should be used with caution in patients with cardiovascular disease. Tachycardia or dizziness may indicate excessive systemic absorption; if these symptoms occur, use of cyclopentolate should be discontinued.
Cyclopentolate Olikla contains benzalkonium chloride as a preservative.
Contact lenses should be removed prior to instillation and not reinserted for at least 15 minutes. Benzalkonium chloride is known to discolour soft contact lenses.
Benzalkonium chloride has been reported to cause eye irritation and symptoms of dry eye and may affect the tear film and corneal surface. It should be used with caution in patients with dry eye syndrome and in those with potential corneal damage. Patients should be monitored during prolonged treatment.
Paediatric population
Premature neonates, infants and toddlers, young children and children with Down's syndrome, spastic paralysis or brain damage are particularly susceptible to central nervous system disturbances and to cardiopulmonary and gastrointestinal toxicity following systemic absorption of cyclopentolate (see section 4.8). In such children, this medicinal product should be used with the utmost caution and only when strictly necessary (see section 4.2).
Cyclopentolate-induced seizures and acute psychoses occur predominantly in children (see section 4.8). Cyclopentolate should be used with caution in children with diagnosed epilepsy.
Children with fair skin and blue eyes may have a more pronounced response and/or increased susceptibility to adverse reactions.
Children should be closely monitored for at least 30 minutes following administration.
Food intolerance may occur in children following use of this product. Necrotising enterocolitis (NEC) may occur in premature infants. Owing to the pharmacodynamic effect on gastrointestinal motility, it is recommended that no food be given to children for 4 hours after administration.
Parents should be advised that the solution must not come into contact with the child's mouth or cheeks, and that the child's hands and face should be washed after administration.
