15 months.
Do not use in patients with a known hypersensitivity to any component of the preparation.
Should not be used in neonates except where, on expert evaluation, the need is considered to be compelling.
Do not use in patients with confirmed or suspected narrow-angle glaucoma as an acute attack may be precipitated.
None known.
Hydrochloric acid
Purified water
Solution-drops
Local Effects
Local irritation may result following the use of this product. The frequency of this effect occurring is dependant on the concentration instilled.
Increased intraocular pressure may occur in predisposed patients.
Allergic reactions may rarely occur, manifesting as diffusely red eyes with lacrimation and stringy white mucus discharge.
Systemic Effects
Systemic cyclopentolate toxicity is dose-related and is uncommon following administration of 1% solution and would not be expected to occur following instillation of 0.5% solution. Children are, however, more susceptible to such reactions than adults. Toxicity is usually transient and is manifest mainly by CNS disturbances. Any CNS disturbances are characterised by signs and symptoms of cerebellar dysfunction and visual and tactile hallucinations.
Peripheral effects typical of anti-cholinergics, such as flushing or dryness of the skin and mucous membranes, have not been observed with topical cyclopentolate in children or adults. Temperature, pulse and blood pressure are not normally affected.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
As a topical mydriatic and cycloplegic.
Cyclopentolate hydrochloride is a synthetic tertiary amine, antimuscarinic compound with actions similar to atropine.
As a group, the synthetic tertiary amine antimuscarinic compounds are well absorbed following oral administration. Cyclopentolate may be absorbed systemically either by transcorneal absorption, direct topical absorption through the skin or by absorption from the nasal or naso lacrimal system.
January 2015
Bausch & Lomb UK Limited
Bausch & Lomb House
106 London Road
Kingston-Upon-Thames
Surrey, UK
KT2 6TN
In a place protected from light, at a temperature not exceeding 25 °C. Do not freeze.
Shelf life of the drug Cyclomed2 года. После вскрытия флакона — 1 мес.Do not use after the expiration date indicated on the package.
5 ml each in a plastic dropper bottle with a screw cap. Each dropper bottle is placed in a cardboard pack.
5 ml each in a dark glass bottle, closed with a rubber stopper, compressed with an aluminum cap with a safety plastic cap. One glass bottle with a sterile dropper, packed in a PE bag, is placed in a cardboard box.
PL 03468/0070
Cyclopentolate
Recovery of accommodation occurs within 24 hours.
Use with caution in very young children and other patients at special risk, such as debilitated or aged patients.
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.)
May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.
Local, instilling 1-2 drops into the conjunctival sac.
For examination of the fundus — 1 drop 1-3 times every 10 minutes.
In the study of refraction in children and adolescents-1-2 drops 2-3 times after 15-20 minutes.
Each Minims unit should be discarded after a single use.
Administrative dataDate of first Authorisation: 17 June 1987
Renewal of Authorisation: 17 June 1992
