MYDRILATE 1.0% Eye drops Ref.[7206] Active ingredients: Cyclopentolate

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.

Caution should be observed when drugs of this group are administered to patients with prostatic enlargement, coronary insufficiency or cardiac failure, or ataxia. Atropine-like effects have been reported as side-effects.

Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity.

Patients should be warned of the oral toxicity of this preparation, and advised to wash their hands after use. If accidentally swallowed, patients should be advised to seek medical attention.

Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.

To reduce systemic absorption the lacrimal sac should be compressed at the medial canthus by digital pressure for at least two minutes after instillation of the drops.

Paediatric population

Use of mydriatic agents has been associated in preterm infants with feed intolerance, abdominal distention, increased gastric aspirate and rare cases of necrotising enterocolitis.

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

The effects of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with antimuscarinic properties such as some antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine.

There is insufficient evidence as to drug safety in pregnancy and lactation. This product should not be used during pregnancy unless it is considered essential by a physician.

May cause blurred vision, difficulty in focusing and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities (including climbing ladders and scaffolding) unless vision is clear. Complete recovery from the effects of Mydrilate Eye Drops may take up to 24 hours.

Frequencies are defined according to the following convention: very common (≥1/100), common ≥1/100 to 1/10, uncommon ≥1/1,000 to <1/100, rare (≥11/10,000 to <1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Notes:

General

¹ Following prolonged administration
² Secondary to pupillary dilation

Paediatric population

^a Abnormal behaviour, psychotic disorders, cardiopulmonary failure and skin rashes have been reported in the paediatric population.
^b Convulsions and partial seizures have been reported in children, although the cases reported to date have been low in number or isolated.
^c Cases of abdominal distension have been reported in infants.
^d Necrotising enterocolitis has been reported in preterm infants.

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.

None stated.