Minims Cyclopentolate Hydrochloride 1%, Eye drops solution

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.

Hypersensitivity to cyclopentolate or to any of the excipients listed in section 6.1.

Use in patients with narrow-angle glaucoma or those with a tendency towards glaucoma e.g., patients with a shallow anterior chamber (see section 4.4).

Use in children with organic brain syndromes, including congenital or neuro-developmental abnormalities, particularly those predisposing to epileptic seizures

Tachycardia and cardiac symptoms are sometimes observed therefore the product should only be used with caution in patients with cardiovascular disease (e.g. tachycardias, heart failure).

Caution should be observed when cyclopentolate is administered to patients with epilepsy, ataxia, dementia, rhinitis sicca, gastrointestinal obstruction, toxic megacolon, myasthenia gravis, and obstructive urinary tract disorders.

Recovery of accommodation occurs within 24 hours (see section 4.7 and 5.1).

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).

Caution is advised in case of open-angle glaucoma. Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly if therapy is likely to be intense or protracted (see section 4.3).

Paediatric population

Extreme caution is advised for use in individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Atropine-like effects have been reported as side effects. The product should be used with caution in infants under the age of 1 year due to the increased risk of systemic toxicity.

Consider withholding feeding for four (4) hours after examination. Observe infants closely for at least 30 minutes.

Convulsions in children have also been reported in association with the use of cyclopentolate (see section 4.8).

Necrotic colitis in premature children

Particular caution should be observed for use in children because cases of necrotic colitis have been reported following administration of cyclopentolate eye drops in premature babies (see section 4.8). Early symptoms may include, but are not limited to, bradycardia, vomiting, food intolerance, increased stomach residues, abdominal distension, and bloody stools. In such a case, immediate medical evaluation is needed.

Since systemic cyclopentolate effects cannot be excluded even with topical application, the anticholinergic effects of other pharmaceuticals with anticholinergic activity could be increased (including but not limited to: antihistamines, butyrophenones, phenothiazines, tricyclic and tetracyclic antidepressants, amantadine, quinidine, disopyramide, oxybutynin).

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

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

Pregnancy

There are no or limited amount of data from the use of cyclopentolate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity.

As a precautionary measure, it is preferable to avoid the use of cyclopentolate eye drops during pregnancy.

Breast-feeding

It is not known how much cyclopentolate passes into breast milk. Infants can be very sensitive to anticholinergics. Therefore, the preparation should not be used during breastfeeding.

Cyclopentolate has major influence on the ability to drive and use machines. Cyclopentolate may cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear

Adverse reactions are listed in the table in frequency categories under MedDRA system/organ classes. The frequency of adverse reactions is defined using the following convention:

Very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

a. Cases of abdominal distension have been reported in infants.

b. Necrotising colitis has been reported in preterm infants.

c. Convulsions and seizures have been reported in children.

d. Abnormal behaviour, psychotic disorders, cardiopulmonary failure and rash have been reported in the paediatric population.

Systemic cyclopentolate toxicity is dose-related and would be less likely to occur following administration of 0.5% solution than following instillation of 1% solution.

Children are, however, more susceptible to such reactions than adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Symptoms

In isolated cases, ocular topical application of eye drops containing cyclopentolate can lead to central nervous system disorders and general systemic manifestations, especially in children.

a) Central nervous manifestations: abnormal behaviour (restlessness, incoherent speech, disorientation), hallucinations, memory loss, gait disturbance, seizures, somnolence.

b) General systemic manifestations: dry mouth, flushing, tachycardia, increase in temperature, urinary blockage.

Treatment

Treatment is supportive and symptomatic.

Pharmacotherapeutic group: Ophtalmologicals, mydriatics and cycloplegics, Anticholinergics

ATC code: SO1FA04

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 25° C. 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.