Minims Tropicamide 1% w/v, Eye drops solution

As a topical mydriatic and cycloplegic.

Adults, Elderly and Children

1 drop followed by a second drop after an interval of 5 minutes. A further 1 drop may be instilled after 30 minutes, if required.

Use in Children:

Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required. Do not use in concentrations greater than 0.5% in small infants (See section 4.4 Special warnings and precautions for use, section 4.8 Undesirable effects and section 4.9 Overdose)

Do not use in patients with a known hypersensitivity to tropicamide.

Tropicamide is contraindicated in narrow angle glaucoma and in eyes where the filtration angle is narrow, as an acute attack of angle closure glaucoma may be precipitated.

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

Tropicamide-induced psychotic reactions and behavioural 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.

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 drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children).

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.

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

Paediatric 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.

There is no evidence as to the drug's safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. This product should only be used in pregnancy if considered essential by the physician.

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.

Cycloplegic drugs may increase intraocular pressure and can precipitate angleclosure 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.

An ocular overdose of Tropicamide Eye Drops can be flushed from the eye(s) with lukewarm water.

Systemic toxicity may occur following topical use, particularly in children, it is manifested by flushing and dryness of the skin, (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular coordination.

Treatment is symptomatic and supportive, (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.

Tropicamide is a parasympatholytic agent, which acts by blocking the action of the parasympathetic nervous system. As acetylcholine is the neuro-humoral transmitter at the receptor site of the parasympathetic nervous system, tropicamide competes with acetylcholine for uptake at the receptor sites, thereby blocking its action. The results are mydriasis, due to unopposed action of the dilator pupillae, and cycloplegia.

No data on the pharmacokinetics of topical tropicamide are available.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sodium hydroxide

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.