Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.
Contains: Cyclopentolate Hydrochloride BP 0.5% and 1.0% w/v.
Main Indications, Dosage and Administration: topical mydriatic and cycloplegic. Adults (including the elderly): Instil dropwise into eye according to the recommended dosage. One or two drops as required. Maximum effect is induced in 30 - 60 minutes after instillation. For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient. For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 - 2 drops are instilled every 6 - 8 hours. Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides, therefore, the strength of cyclopentolate used should be adjusted accordingly. Children: < 3 months: Not recommended. 3 months - 12 years: 1 drop of a 1% solution to each eye. 12 years - adult: 1 drop of 0.5% solution to each eye repeated after 10 minutes if necessary. Children should be observed for 45 minutes after instillation.
Contraindications, Precautions and Warnings: Hypersensitivity to cyclopentolate or to any of the excipients listed in section 6.1 of the SmPC. Use in patients with narrow-angle glaucoma or those with a tendency towards glaucoma e.g., patients with a shallow anterior chamber (see section 4.4 of the SmPC). Use in children with organic brain syndromes, including congenital or neuro-developmental abnormalities, particularly those predisposing to epileptic seizures. Tachycardia and cardiac symptoms are sometimes observed therefore the product should only be used with caution in patients with cardiovascular disease (e.g. tachycardias, heart failure). Caution should be observed when cyclopentolate is administered to patients with epilepsy, ataxia, dementia, rhinitis sicca, gastrointestinal obstruction, toxic megacolon, myasthenia gravis, and obstructive urinary tract disorders. Recovery of accommodation occurs within 24 hours (see section 4.7 and 5.1 of the SmPC). Caution is also advised in hyperaemia as increased systemic absorption may occur. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children). Caution is advised in case of open-angle glaucoma. Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly if therapy is likely to be intense or protracted (see section 4.3 of the SmPC). Paediatric population: Extreme caution is advised for use in individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Atropine-like effects have been reported as side effects. The product should be used with caution in infants under the age of 1 year due to the increased risk of systemic toxicity. Consider withholding feeding for four (4) hours after examination. Observe infants closely for at least 30 minutes. Convulsions in children have also been reported in association with the use of cyclopentolate (see section 4.8 of the SmPC). Necrotic colitis in premature children: Particular caution should observed for use in children because cases of necrotic colitis have been reported following administration of cyclopentolate eye drops in premature babies (see section 4.8 of the SmPC). Early symptoms may include, but are not limited to, bradycardia, vomiting, food intolerance, increased stomach residues, abdominal distension, and bloody stools. In such a case, immediate medical evaluation is needed.
Fertility, Pregnancy and Lactation: The safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician. For more information see section 4.6 of the SmPC.
Effects on ability to drive and use machines Cyclopentolate has major influence on the ability to drive and use machines and may cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.
Undesirable effects: Eye disorders: Not known: Eye irritation, accommodation disorder, eye pain, ocular hyperaemia, vision blurred, increased intraolcular pressure, conjunctivitis. Gastrointestinal disorders: Not known: Abdominal distension, constipation, dry mouth, nausea, vomiting, necrotising colitis. Immune system disorders: Rare: Allergic reaction. Not known: Hypersensitivity (both local and systemic hypersensitivity reactions). Nervous system disorders: Not known: Dizziness, seizures, cerebellar dysfunction, somnolence. Psychiatric disorders: Not known: Hallucination, psychotic disorder. Cardiac disorders: Not Known: Arrhythmia, bradycardia, cardiopulmonary failure, palpitations, tachycardia. Vascular disorders: Not Known: Flushing. Skin and subcutaneous tissue disorders: Not Known: Dry skin, rash. Renal and urinary disorders: Not Known: Urinary retention.
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. For more information see section 4.8 of the SmPC.
Legal Category: POM.
Minims Cyclopentolate Hydrochloride 0.5%: UK PL No: PL 03468/0070 Basic NHS Price: £ 12.58
Minims Cyclopentolate Hydrochloride 1.0%: UK PL No: PL 03468/0071 Basic NHS Price: £12.87
Marketing Authorisation Holder: Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
Date of Revision: April 2024
Exemption Level: 1
Evocative Code: CYC 0.5, CYC 1.0
PIP Code: 018-0562, 018-0558
United Kingdom (UK)
