Cyclogyl 1 %/10 mg Solution

For mydriasis and cycloplegia in diagnostic procedures.

ADULTS: One drop followed by a second drop in 5 minutes. In refractions where prolongation of cycloplegia is desirable, one additional drop only is recommended. Although complete recovery usually occurs in 24 hours, 1 or 2 drops of 1 % and 2 % pilocarpine reduces recovery time to 3 to 6 hours in most eyes. Tonometric examination prior to drop instillation is advisable.

CHILDREN: Pre-treatment with CYCLOGYL on the day prior to examination usually is not necessary. One drop is instilled each time at the time of refractions, followed 10 minutes later by a second application if necessary. Do not touch dropper tip to any surface, as this may contaminate the solution. After cap is removed, if tamper evident snap collar is loose, remove before using product. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

• Hypersensitivity to Cyclopentolate hydrochloride or to the inactive pharmaceutical ingredient of CYCLOGYL (see section 2).
• Should not be used in the presence of closed angle glaucoma, or patients with a narrow angle between the iris and the cornea.

Systemic reactions have followed the absorption of anticholinergic eye drops, particularly in children where psychotic reactions and behavioural disturbances and other central nervous system (CNS) disturbances have been encountered. Use with caution in children and elderly patients, but reactions may occur at any age. Because of risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile. Systemic absorption may be minimised by compressing the lacrimal sac for a minute or two during and following instillation of the drops. Use with caution in patients, especially children, who have previously had a severe systemic reaction to atropine. CYCLOGYL may cause increased intraocular pressure and caution must be observed when the drops are used in the elderly and others where an increase may be encountered. The possibility of undiagnosed glaucoma should be considered in some patients, such as the elderly. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy to avoid glaucoma attacks. Patients may experience sensitivity to light. They should wear sunglasses in sunlight and other brightly lit places.

ELDERLY PATIENTS: Geriatric patients are more susceptible to the effects of cyclopentolate and similar drugs (atropine) thus increasing the potential for systemic side effects. Cyclopentolate should be used with caution in the elderly because of possible undiagnosed predisposition to angle closure glaucoma.

PAEDIATRIC PATIENTS: CYCLOGYL 1 % Eye Drops should not be used in small infants as concentrations greater than 0,5 % are not recommended due to the risk of serious systemic side effects. Use with extreme caution, if at all, in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage. These patients are particularly susceptible to central nervous system disturbances, cardiopulmonary and gastrointestinal toxicity from systemic absorption of cyclopentolate. Seizures and acute psychosis induced by cyclopentolate are especially prominent in children. CYCLOGYL should be used with caution in children, with known epilepsy. (See section 4.8) Fair-skinned children with blue eyes may exhibit an increased response and/or increased susceptibility to side effects. Systemic toxicity has been reported in neonates following ocular administration of cyclopentolate. Observe infants closely for at least 30 minutes following instillation. Feeding intolerance (see Section 4.8) and necrotizing enterocolitis (NEC) in preterm infants may follow ophthalmic use of cyclopentolate in neonates and infants. Cases of NEC have been reported in preterm infants following administration; however, causality has not been established. It is recommended that feeding be withheld for four hours after examination in infants. Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration. CYCLOGYL contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of CYCLOGYL and to wait 15 minutes before reinsertion. As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

The effects of CYCLOGYL may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics and tricyclic antidepressants.

Pregnancy: The safety of CYCLOGYL during pregnancy has not been established.

Breast-feeding: It is not known whether CYCLOGYL is distributed into breast milk, however cyclopentolate may be systemically absorbed.

CYCLOGYL has a major influence on the ability to drive and use machines. CYCLOGYL may cause drowsiness, blurred vision and sensitivity to light. Patients receiving CYCLOGYL should be advised not to drive or engage in other hazardous activities unless vision is clear.

Transient stinging may occur when drops are instilled. Hypersensitivity e.g. conjunctivitis may occur. The onset of cyclopentolate toxicity occurs within 20 to 30 minutes after instillation, and although usually transient (subsiding in 4 to 6 hours), the symptoms can last 12 to 24 hours. Symptoms associated with systemic absorption of CYCLOGYL which require medical attention are ataxia, behavioural disturbances, psychotic reactions, confusion, fast or irregular heartbeat, fever, infants, hallucinations, skin rash, slurred speech, swollen stomach in thirst or dryness of mouth, unusual drowsiness, tiredness or weakness, vasodilation (flushing or redness of face). The following symptoms need medical attention only if they continue or are bothersome: blepharo-conjunctivitis, conjunctivitis, hyperaemia, punctate keratitis, synechia, blurred vision, burning of the eye and photophobia. The following side effects have been identified from post-marketing surveillance following administration of CYCLOGYL. Frequency cannot be estimated from the available data. Within each System Organ Class, adverse reactions are presented in order of decreasing seriousness:

System Organ Class MedDRA Preferred Term (v12.1) Immune system disorders hypersensitivity Psychiatric disorders hallucination, confused state, disorientation, agitation, restlessness Nervous system disorders incoherent, retrograde amnesia, dizziness, headache, somnolence Eye disorders photophobia, drug effect prolonged (mydriasis), eye irritation, vision blurred, eye pain Gastrointestinal disorders vomiting, nausea, dry mouth Skin and subcutaneous tissue disorders erythema General disorders and administration site conditions gait disturbance, pyrexia, fatigue A local or generalized allergic-type response to CYCLOGYL consisting of an urticarial rash has been described in children.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201cAdverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Systemic reactions due to overdosage which have been reported are ataxia, incoherent speech, restlessness, hallucinations, disorientation, failure to recognise people and tachycardia. Systemic toxicity may occur following topical use, particularly in children. It is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, convulsions and hallucinations and the loss of neuromuscular coordination. Severe intoxication is characterized by central nervous system depression, coma, circulatory and respiratory failure, and death. Treatment is symptomatic and supportive. In infants and small children the body surface must be kept moist. An ocular overdose of CYCLOGYL can be flushed from the eye(s) with lukewarm water.