MYDRILATE

5 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. Deeply pigmented eyes may require the use of a 1 % solution.

NB: Maximum effect is reached after 30-60 minutes, Children 6-16 years:

One drop of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination Children under 6 years: One or two drops of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.

5 % solution instilled into the eye up to 4 times daily or as required. Deeply pigmented eyes may require the use of a 1 % solution.

Children:

At the discretion of the physician Do not use during the first three months of life due to possible association between the cycloplegia produced and the development of amblyopia and also the increased risks of systemic toxicity in neonates.

Cycloplegia following administration is quick in onset and short-lived. Maximal cycloplegia is achieved within 15 - 45 minutes of instillation and lasts on average about 20 minutes. Recovery normally takes place in about 4 hours, but very occasionally some effect persists for up to 24 hours.

5 % solution. Complete recovery from the mydriatic effect generally occurs spontaneously in not more than 20 hours. No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported

Frequencies are defined according to 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).

System organ class Adverse reactions Frequency Psychiatric disorders abnormal behavioura, psychotic disordersa not known Nervous system disorders dizziness, convulsionsb, partial seizuresb not known Eye disorders eye pain, increased intraocular pressure, eye oedema1, eye irritation (stinging)1, ocular hyperaemia1, conjunctivitis1, photophobia2 not known Cardiac disorders bradycardia, tachycardia, palpitations, arrhythmia, cardiopulmonary failurea not known Vascular disorders flushing not known Gastrointestinal disorders dry mouth, vomiting, gastrointestinal hypomotility and constipation, abdominal distensionc, necrotising enterocolitisd not known Skin and subcutaneous disorders dry skin, skin rasha not known Renal and urinary disorders urinary urgency, urinary retention, dysuria not known General disorders and administration site conditions gait disturbance not known 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

8).

3. g. patients with a shallow anterior chamber. (ii) Hypersensitivity to cyclopentolate hydrochloride, benzalkonium chloride or any other components of the formulation. (iii) This preparation contains benzalkonium chloride and should not be used whilst soft contact lenses are being worn.

(iv) Use in patients with paralytic ileus. (v) Use in children with organic brain syndromes, including congenital or neuro- developmental abnormalities, particularly those predisposing to epileptic seizures.