CYCLOGYL* is used to produce mydriasis and cycloplegia.

Adults and elderly:
Instill 1 or 2 drops of 1%, solution in the eye which may be repeated in 5 to 10 minutes. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days.

Pediatrics:
Children:
Instill 1 or 2 drops of 1%, solution in the eye which may be repeated in 5 to 10 minutes later by a second application of 1% solution if necessary.

Small Infants:
A single instillation of 1 drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutesn following instillation. Individuals with heavily pigmented irides may require higher strengths.
The lowest concentration and number of drops necessary to produce the desired effect should always be used. If any medicine misses the eye, wash away immediately.

Elderly population
Elderly patients may be a higher risk for undiagnosed glaucoma as well as CYCLOGYL* induced psychotic reactions and behavioural disturbances (See Section 4.4).

Hepatic and renal impairment
No formal studies have been conducted in patients with renal or hepatic impairment.

Method of Administration
For ocular use only.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
Nasolacrimal occlusion or gently closing the eyelid after administration is
recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

- Use with caution in patients, especially children, who have previously had a severe systemic reaction to atropine.
- CYCLOGYL* Eye Drops may cause increased intraocular pressure. The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients.
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 (see Section 4.8).
- CYCLOGYL* induced psychotic reactions and behavioral disturbances and other CNS disturbances may occur in patients with increased susceptibility to anticholinergic drugs (see Section 4.8). Use with caution in children and elderly patients, but reactions may occur at any age.
- Because of the risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.
- Patients may experience sensitivity to light and should protect eyes in bright illumination. (see Section 4.8)
- CYCLOGYL* Eye Drops contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of CYCLOGYL* Eye Drops and wait 15 minutes before reinsertion.

Paediatric Population
- Use with extreme caution, if at all, in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage. (see section 4.2).
- Premature and small infants, young children, or children with Down syndrome, spastic paralysis or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary and gastrointestinal toxicity from systemic absorption of CYCLOGYL* (see
Section 4.8).
- Seizures and acute psychosis induced by CYCLOGYL* are especially prominent in children (see Section 4.8). CYCLOGYL* should be used with caution in children with known epilepsy.
- Fair-skinned children with blue eyes may exhibit an increased response and/or increased susceptibility to adverse reactions.
- Observe infants closely for at least 30 minutes following instillation.
- Feeding intolerance may follow ophthalmic use of this product in infants (see Section 4.8). It is recommended that feeding be withheld for 4 hours after examination.
- Parents should be warned not to get this preparation in their child's mouth or on their child’s cheeks and to wash their hands and the child's hands or cheeks following administration.

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

Fertility
Studies have not been performed to evaluate the effects of topical ocular administration of cyclopentolate hydrochloride CYCLOGYL* Eye Drops on fertility (See Section 5.3).

Pregnancy
There are no or limited amount of data from the use of CYCLOGYL* Eye Drops in pregnant women. CYCLOGYL* should be administered to a pregnant woman only if clearly needed.

Breast-feeding
It is not known whether cyclopentolate/metabolites are excreted into human milk. A risk to the suckling child cannot be excluded. Caution should be exercised when cyclopentolate hydrochloride is administered to a nursing woman.

CYCLOGYL* may cause drowsiness, blurred vision and sensitivity to light. Patients receiving CYCLOGYL* Eye Drops should be advised not to drive or engage in other hazardous activities unless vision is clear.

Tabulated List of Adverse Reaction
The following adverse reactions have been identified from post-marketing surveillance following  administration of CYCLOGYL* Eye Drops. Frequency cannot be estimated from the available data. Within each SOC, undesirable effects are presented in decreasing order of seriousness.

Description of selected adverse re actions
This drug produces reactions similar to those of other anticholinergic drugs. The central nervous system manifestations such as ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people are possible. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe reactions are manifested by hypotension with rapid progressive respiratory depression.

CYCLOGYL* Eye Drops may increase intraocular pressure and provoke glaucoma attacks in patients predisposed to acute angle closure in particular geriatric patients (see Section 4.4).

The onset of CYCLOGYL* toxicity occurs within 20 to 30 minutes of drug instillation, and although usually transient (subsiding in 4 to 6 hours), the symptoms can last 12 to 24 hours.

Paediatric population
Increased risk for systemic toxicity has been observed in premature and small infants, young children, or children with Down syndrome, spastic paralysis or brain damage with this class of drug (see Section 4.4).
Use of CYCLOGYL* Eye Drops has been associated with psychotic reactions and behavior changes in pediatric patients. Central nervous system reactions manifest similar to those listed above. Seizures and acute psychosis induced by CYCLOGYL* are especially prominent in children.
Feeding intolerance may follow ophthalmic use of the product in infants (see Section 4.4).
A local or generalized allergic-type response to CYCLOGYL* consisting of a urticarial rash has been described in children.
--To reports any side effect(s):
           Saudi Arabia:
--The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
        Other GCC States:
-- Please contact the relevant competent authority.

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.
Excessive dosage may produce exaggerated symptoms as noted in ADVERSE REACTIONS.

When administration of the drug product is discontinued, the patient usually recovers spontaneously. In case of severe manifestations of toxicity the antidote of choice is physostigmine salicylate.

Pharmacotherapeutic group: Ophthalmicologicals, mydriatics and cycloplegics, anticholinergic agents ATC code: S 01 FA 04
This anticholinergic preparation blocks the responses 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 than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.

Absorption
Following topical ocular administration, CYCLOGYL* is absorbed into the eye as well as the systemic circulation. Following topical administration of 2 drops of 1% CYCLOGYL* to the eye of patients undergoing cataract surgery, aqueous humor drug concentrations during surgery (55 to 125 minutes postdose) ranged from 1410 to 25,361 nM. The corresponding plasma drug concentrations over this same interval ranged from 1.03 to 7.55 nM. In healthy female volunteers administered 1 drop of 1% CYCLOGYL* to each eye, a mean maximum plasma drug concentration of 2.06 ± 0.86 nM was achieved within 1 hour. In another study, plasma CYCLOGYL* concentrations were determined following two 30-microliter unilateral doses of 1% CYCLOGYL* administered 5 minutes apart. Peak plasma drug concentrations ranged from 3.3 to 15.5 ng/mL (mean: 8.3 ± 4.1 ng/mL) and were achieved within 5 to 15 minutes following the second dose.

Distribution
Aside from the aqueous humor data reported above for cataract patients, the ocular and systemic distribution of CYCLOGYL* has not been reported.

Biotransformation
The metabolic pathways of CYCLOGYL* have not been reported in the literature.

Elimination
The elimination mechanisms of CYCLOGYL* have not been reported in the literature.

Linearity/non-linearity
The dose proportionality of CYCLOGYL* has not been reported in the literature.
The maximum pupillary dilation in female volunteers administered 1% CYCLOGYL* bilaterally occurred at 30 minutes postdose, when plasma concentrations were approaching their maximum values.

Nonclinical data with CYCLOGYL* reveal no special hazard for humans based on conventional studies of single- and repeated-dose toxicity.

Benzalkonium chloride
Boric acid
Disodium edetate
Potassium chloride
Hydrochloric acid 0.1 N and/or sodium carbonate monohydrate
Purified water

None known.

Store below 30°C.
Do not use this medicine after the expiry date which is stated on the packaging.
Discard 4 weeks after first opening.
Keep this medicine out of the sight and reach of children.

15 ml fill size in LDPE DROPTAINER.

No special requirements.