Minims Cyclopentolate Hydrochloride 0.5%

Minims Cyclopentolate Hydrochloride 0.5%

Solution-drops

As a topical mydriatic and cycloplegic.

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.

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.

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 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.

Treatment is supportive.

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.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Hydrochloric acid

Purified water

None known.

15 months.

Keep out of reach of children.

Do not use after the expiration date indicated on the package.

Each Minims unit should be discarded after a single use.

Bausch & Lomb UK Limited

Bausch & Lomb House

106 London Road

Kingston-Upon-Thames

Surrey, UK

KT2 6TN

PL 03468/0070

Date of first Authorisation: 17 June 1987

Renewal of Authorisation: 17 June 1992

January 2015