MINIMS CYCLOPENTOLATE HYDROCHLORIDE

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. 5% solution to each eye repeated after 10 minutes if necessary. Children should be observed for 45 minutes after instillation.

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). System organ class Adverse reaction Eye disorders Not known Eye irritation, accommodation disorder, eye pain, ocular hyperaemia, vision blurred, increased intraocular pressure, conjunctivitis Gastrointestinal disorders Not known Abdominal distension a, constipation, dry mouth, nausea, vomiting, necrotising colitis b Immune system disorders Rare Allergic reaction Not known Hypersensitivity (both local and systemic hypersensitivity reactions) Nervous system disorders Not known Gait disturbance, dizziness, convulsions c, seizures c, cerebellar dysfunction, somnolence Psychiatric disorders Not known Hallucination, abnormal behaviour d, psychotic disorder d, Cardiac disorders Not known Arrhythmia, bradycardia, cardiopulmonary failure d, palpitations, tachycardia Vascular disorders Not known Flushing Skin and subcutaneous tissue disorders Not known Dry skin, rash d Renal and urinary disorders Not known Urinary retention a.

Cases of abdominal distension have been reported in infants. b. Necrotising colitis has been reported in preterm infants. c. Convulsions and seizures have been reported in children. d. Abnormal behaviour, psychotic disorders, cardiopulmonary failure and rash have been reported in the paediatric population.

5% solution than following instillation of 1% solution. Children are, however, more susceptible to such reactions than adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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.

1). 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. 3). 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. 8). 8). 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.

1. 4). Use in children with organic brain syndromes, including congenital or neuro-developmental abnormalities, particularly those predisposing to epileptic seizures