MYDRIACYL Eye drops, solution Ref.[9462] Active ingredients: Tropicamide

Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy.

Tropicamide-induced psychotic reactions and behavioral disturbances may occur in patients with increased susceptibility to anticholinergic drugs (See Section 4.8 Undesirable effects).

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

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 can thus by digital pressure for at least two minutes after instillation of the drops.

Mydriacyl contain benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of Mydriacyl and wait at least 15 minutes before reinsertion.

Not for intravenous injection, life threatening adverse reactions have been reported to occur if this preparation is administered intravenously.

Pediatric Population

Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children.

Excessive use in children may produce systemic toxic symptoms. Use with extreme caution in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage.

Parents should be warned of the oral toxicity of this preparation for children and advised to wash their own hands and the child’s hands after use.

The effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, antipsychotics, phenothiazines and tricyclic anti-depressants.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Fertility

There is no adequate information on whether this drug may affect fertility in human males or females.

Pregnancy

There is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.

Lactation

It is unknown whether tropicamide/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Mydriacyl therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Tropicamide eye drops have a moderate influence on the ability to drive and use machines.

Tropicamide may cause drowsiness, blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.

The following adverse reactions have been reported following use of tropicamide topical ophthalmic preparations. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.

Nervous system disorders

Not known (cannot be estimated from the available data): dizziness, headache

Eye disorders

Not known (cannot be estimated from the available data): vision blurred, photophobia, eye pain, eye irritation, ocular hyperaemia

Vascular disorders

Not known (cannot be estimated from the available data): syncope, hypotension

Gastrointestinal disorders

Not known (cannot be estimated from the available data): nausea

Skin and subcutaneous issue disorders

Not known (cannot be estimated from the available data): rash

General disorders and administration site conditions

Not known (cannot be estimated from the available data): drug effect prolonged (mydriasis)

Cycloplegic drugs may increase intraocular pressure and can precipitate angle-closure glaucoma in predisposed patients (See section 4.3 Contraindications and section 4.4 Special warnings and precautions for use).

Psychotic reactions, behavioural disturbances and cardio respiratory collapse have been reported with this class of drug, especially in children (See section 4.4 Special warnings and precautions for use).

Other toxic manifestations of anticholinergic drugs include flushing of the skin, dryness of the mouth, dryness of mucous membranes, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrhythmias, decrease secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary urgency, difficulty and retention and decreased nasal, bronchial and lachrymal secretions.

Local: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.

Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.

Paediatric Population

Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children (See Section 4.4 Special warnings and precautions for use).

An increased risk for systemic toxicity has been observed in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage with cycloplegic drugs (See Section 4.4 Special warnings and precautions for use).

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.

None known.