Tropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated
for topical use for:
Diagnostic purposes for fundoscopy and cycloplegic refraction.
Use in pre- and post-operative states where a short acting mydriatic is required

Adults, Elderly and children:
Fundoscopy:
One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.
Cycloplegic Refraction:
One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30
minutes an additional drop may be instilled to prolong the effect.
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)

Method of administration
• For topical ophthalmic use only.
• After cap is removed, if tamper evident nap collar is loose, remove before using product.
• Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may
reduce the systemic absorption of medicinal products administered via the ocular route and result in a
decrease in systemic adverse reactions.
• If more than one topical ophthalmic product is being used, the products must be administered at least
5 minutes apart. Eye ointments should be administered last.

• 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.
• Tropicamide 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 Tropicamide 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 Tropicamide 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.

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).

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Ext: 2317-2356-2340.
Toll free phone: 19999
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
• Other GCC States:
− Please contact the relevant competent authority

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 co-ordination.
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.

Pharmacotherapeutic group: Tropicamide is a parasympatholytic agent
ATC code: S01FA06
Tropicamide is an anticholinergic which blocks the responses of the sphincter muscle of the iris and
the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). At higher
concentrations (1%), tropicamide also paralyses accommodation. This preparation acts rapidly and
has a relatively short duration of action.

Tropicamide administered topically to the human eye does not bind to tissues as firmly as does
atropine. The wash out time for half recovery of carbachol responsiveness was shown to be less than
15 minutes for non-pigmented iris and 30 minutes for pigmented iris.

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 1N and/or Sodium Hydroxide 1N (to adjust pH)
 Water for Injection

Not applicable

Do not store above 30°C.
Do not use more than 30 days after opening the Alu-Alu pouch.

LDPE minims
Pack sizes: 4 Alu-Alu covered pouches each contains 5 single use units.

Any unused product should be disposed of in accordance with local requirements.