Minims Cyclopentolate Hydrochloride

Clear, colourless, sterile eye drops containing cyclopentolate hydrochloride BP Two strengths are available: Cyclopentolate Hydrochloride BP 0.5% and 1.0% w/v solutions.

Single-use, sterile eye drops.

As a topical mydriatic and cycloplegic.

Adults (including the elderly):

Instil dropwise into eye according to the recommended dosage.

One or two drops as required. Maximum effect is induced in 30 - 60 minutes after instillation.

For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient.

For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 - 2 drops are instilled every 6 - 8 hours.

Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides, therefore, the strength of cyclopentolate used should be adjusted accordingly.

Children

< 3 months: Not recommended

3 months - 12 years: 1 drop of a 1% solution to each eye.

12 years - adult: 1 drop of 0.5% solution to each eye repeated after 10 minutes if necessary.

Children should be observed for 45 minutes after instillation.

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.)

None known.

The safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.

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.

Overdose is rare but symptoms can include those mentioned in Section 4.8 above. 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.

Store below 25ºC. Do not freeze. Protect from light.

A sealed, conical shaped container fitted with a twist and pull-off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.

Each Minims unit should be discarded after a single use.

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

Minims Cyclopentolate Hydrochloride 0.5%: PL 0033/5005R

Minims Cyclopentolate Hydrochloride 1.0%: PL 0033/5006R

Minims Cyclopentolate Hydrochloride 0.5%

Date of first Authorisation: 17 June 1987

Renewal of Authorisation: 13 July 2002

Minims Cyclopentolate Hydrochloride 1.0%

Date of first Authorisation: 17 June 1987

Renewal of Authorisation: 13 July 2002

Minims Cyclopentolate Hydrochloride 0.5%

July 1997.

November 2002

Minims Cyclopentolate Hydrochloride 1.0%

May 1997.

November 2002