INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
CYCLOGYL® 1% ophthalmic solution

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

CYCLOGYL^® 1% ophthalmic solution

COMPOSITION:
Cyclopentolate hydrochloride 10 mg per mL
Preserved with benzalkonium chloride 0,01%.

PHARMACOLOGICAL CLASSIFICATION:
A..15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
CYCLOGYL^® 1% ophthalmic solution is an anticholinergic preparation that blocks the response of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration that atropine.

INDICATIONS:
For mydriasis and cycloplegia in diagnostic procedures.

CONTRA-INDICATIONS:
Should not be used in the presence of closed-angle glaucoma, or patients with a narrow angle between the iris and the cornea.

WARNINGS:
Systemic reactions have followed the absorption of anticholinergic eye drops, particularly in children where psychotic reactions and behavioural disturbances have been encountered.
Systemic absorption may be minimised by compressing the lacrimal sac for a minute or two during and following instillation of the drops.

DOSAGE AND DIRECTIONS FOR USE:
Adults: One drop followed by a second drop in 5 minutes. Although complete recovery usually occurs in 24 hours, 1 or 2 drops of 1% or 2% of pilocarpine reduces recovery time to 3 to 6 hours in most eyes.

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.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Transient stinging may occur when drops are instilled. Hypersensitivity e.g. conjunctivitis may occur. The intraocular pressure may increase and caution must be observed when the drops are used in the elderly and others where an increase may be encountered.
Tonometric examination prior to drop instillation is advisable. In refractions where prolongation of cycloplegia is desirable, one additional drop only is recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic reactions due to overdosage which have been reported are ataxia, incoherent speech, restlessness, hallucinations, disorientation, failure to recognise people and tachycardia.

CONDITION OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
A clear, colourless liquid.

PRESENTATION:
Drop-Tainer^® dispenser containing 15 mL.

STORAGE DIRECTIONS:
Keep in a cool place below 25°C. Keep out of reach of children.

REFERENCE NUMBER:
H.1147 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd.
Surrey Avenue
RANDBURG, 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 May 1976

0990VL                34304-D                343043
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