Consumer medicine information

Mydriacyl Eye Drops

Tropicamide

BRAND INFORMATION

Brand name

Mydriacyl

Active ingredient

Tropicamide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Mydriacyl Eye Drops.

What is in this leaflet?

Read this leaflet carefully before you start to use Mydriacyl Eye Drops.

This leaflet answers some common questions about Mydriacyl Eye Drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.

You can also download the most up to date leaflet from
TGA eBusiness Services

The updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Mydriacyl against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Mydriacyl is used for

Mydriacyl is used alone or in combination with other eye drops/ medicines to enlarge (dilate) the pupil and to prevent the eye from focusing. Your doctor may use Mydriacyl prior to either a surgical procedure or examination of the eye.

Mydriacyl Eye Drops contain the active ingredient tropicamide, which belongs to a class of medicines known as "anticholinergics".

Ask your doctor if you have any questions about why Mydriacyl has been prescribed for you.

Your doctor may have prescribed it for another reason.

Use in children

Mydriacyl is not for use in children. The safety and effectiveness of Mydriacyl in children has not been established.

Before you use Mydriacyl

When you must not use it

Do not use Mydriacyl Eye Drops if:

  • You are allergic to tropicamide or to any of the ingredients in Mydriacyl Eye Drops listed at the end of this leaflet under "Product description".
    Some of the symptoms of an allergic reaction may include:
    - Shortness of breath
    - Wheezing or difficulty breathing
    - Swelling of the face, lips, tongue or other parts of the body
    - Rash, itching or hives on the skin.
  • You are taking any other medicines.

Do not use this medicine if you have been previously diagnosed with angle-closure glaucoma or with a narrow angle between the iris and cornea.

Do not use Mydriacyl Eye Drops if:

  • the safety seal around the closure and neck area is broken
  • the bottle/packaging shows signs of tampering
  • the expiry date on the bottle/ carton has passed.
    If you use this medicine after the expiry date has passed, it may not work.

Before you start to use it

Tell your doctor if:

  • you have had an allergy to any other medicines or any other substances such as foods, preservatives or dyes
  • you are pregnant or intend to become pregnant.
    Your doctor will discuss the risks and benefits of using Mydriacyl Eye Drops when pregnant.
  • you are breastfeeding or intend to breastfeed.
    Your doctor will discuss the risks and benefits of using Mydriacyl Eye Drops when breastfeeding.

If you have not told your doctor about any of the above, tell him/ her before you use Mydriacyl Eye Drops.

Using or taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy at a pharmacy, supermarket or health food shop without a doctor's prescription. This is particularly important if you are currently using any other type of eye drops.

Tell your doctor if you are using any of the following:

  • Amantadine (Symmetrel) used to treat Parkinson's disease or type A influenza
  • Antihistamines used to treat the symptoms of allergy
  • Phenothiazine medicines used to treat major mental illnesses
  • Tricyclic antidepressants used to treat depression
  • Carbachol, pilocarpine or other cholinesterase inhibitors used to treat glaucoma.

Some medicines may be affected by Mydriacyl or may affect how well it works. You may need different amounts of your medicines, or you may need to take or use different medicines.

If you are unsure if you are using these medicines ask your doctor or pharmacist.

Your doctor or pharmacist will be able to tell you what to do when using Mydriacyl Eye Drops with other medicines.

How to use Mydriacyl

Your doctor will decide on the strength and dose of Mydriacyl Eye Drops dependent on the procedure they will perform.

How much is used

Mydriacyl 1%
The usual dose of Mydriacyl is one or two drops in the affected eye(s), repeated in five minutes.

Your doctor may use additional drops if necessary.

Mydriacyl 0.5%
The usual dose of Mydriacyl is one or two drops, 15 to 20 minutes prior to eye examination.

There might be a slight burning feeling in the eye(s) shortly after using Mydriacyl. If this persists, or is very uncomfortable, tell your doctor.

If you are wearing soft contact lenses, you will be asked to remove them prior to instillation of the drops by your doctor.

The preservative in Mydriacyl Eye Drops, benzalkonium chloride, may be deposited in soft contact lenses.

You may put your soft contact lenses back into your eyes 15 minutes after your procedure.

How to use it

Your doctor will administer Mydriacyl prior to your surgery or eye examination.

If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

If used, eye ointments should be administered last.

Things to be careful of

Do not drive or operate any machinery whilst your pupils are dilated.

If you experience any sensitivity to light after using Mydriacyl, you should protect your eyes from bright light.

If you use too much (overdose)

If too many drops are accidentally put in your eye(s), immediately rinse your eye(s) with warm water.

If anyone accidentally swallows Mydriacyl Eye Drops, immediately telephone your doctor or Poisons Information Centre on 13 11 26 for advice or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning

Some of the symptoms of an overdose include:

  • Flushed or dry skin
  • Dry mouth
  • Rapid pulse
  • Reduced sweating
  • Constipation
  • Difficulty passing urine.

Side Effects

Tell your doctor as soon as possible if you do not feel well while he/ she is giving you Mydriacyl.

All medicines can have side effects. Sometimes they are serious, however most of the time they are not. You may need to seek medical treatment if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor if you notice any of the following effects in the eye(s) and the eye area and they worry you:

  • Momentary burning or stinging of the eye
  • Sore eye and blurred vision
  • Sensitivity to light
  • Increased pressure in the eye
  • Blurry vision
  • Eye pain
  • Eye irritation
  • Red eye
  • Dilated pupil (prolonged effect).

Occasionally, some people notice unwanted effects in other areas of the body as a result of using Mydriacyl Eye Drops. These effects may include:

  • Mental and behavioural disturbances
  • Dryness of the mouth
  • Dryness of the skin (and/or rash)
  • Nausea or vomiting
  • Headache
  • Constipation and abdominal pain
  • Flushing
  • Need to urinate more often than usual
  • Fast or irregular heartbeat, also called palpitations
  • Dizziness
  • Fainting
  • Low blood pressure.

Let your doctor know if you observe any unwanted effects after using Mydriacyl, even if they do not appear in the lists above.

Other side effects not listed above may also occur in some patients.

After using Mydriacyl

Storage

Mydriacyl will be stored by your doctor or pharmacist at the recommended temperature of below 25° C. Mydriacyl should not be stored in a refrigerator (between 2° to 8° C).

Do not freeze. Protect from light.

The lid of the bottle should be tightly closed.

Mydriacyl Eye Drops should be discarded 4 weeks after first opening the bottle.

Product description

What it looks like

Mydriacyl is a colourless liquid that comes in a 15 mL dropper bottle.

Ingredients

Mydriacyl contains the active ingredient, tropicamide.

It is available as either tropicamide 5 mg in 1 mL (0.5%) or tropicamide 10 mg in mL (1.0%).

Mydriacyl also contains:

  • Benzalkonium chloride used as a preservative
  • Sodium chloride
  • Disodium edetate
  • Hydrochloric acid and/or sodium hydroxide to adjust pH
  • Water-purified.

Supplier

Mydriacyl is supplied in Australia by:

Alcon Laboratories (Australia) Pty Ltd
ABN 88 000 740 830
15 Talavera Road
Macquarie Park NSW 2113
Australia Toll Free: 1800 224 153.

Australian registration numbers

Mydriacyl 0.5%: Aust R No. 25356

Mydriacyl 1.0%: Aust R No. 25357

Date of preparation

This leaflet was prepared in April 2020.

Internal reference: myd200420c

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Mydriacyl

Active ingredient

Tropicamide

Schedule

S4

 

1 Name of Medicine

Tropicamide 0.5% Eye Drops.
Tropicamide 1.0% Eye Drops.

6.7 Physicochemical Properties

Chemical structure.

Structure of tropicamide and enantiomer.
Empirical formula: C17H20N2O2.
Chemical name: (2RS) N-ethyl-3- hydroxy-2-phenyl-N- (pyrid-4-ylmethyl) propionamide.

CAS number.

CAS Registry Number: 1508-75-4.

2 Qualitative and Quantitative Composition

Mydriacyl Eye Drops contain either 5 mg/mL (0.5%) or 10 mg/mL (1.0%) tropicamide.
The solution is preserved with benzalkonium chloride (0.01%).
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops.
Mydriacyl Eye Drops is a sterile, multi-dose ophthalmic solution for topical administration in the eye, available in two strengths.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Tropicamide is an anticholinergic drug with a similar pharmacological action to that of atropine. It blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation resulting in mydriasis. At higher concentrations (1%), tropicamide also paralyses accommodation (cycloplegia). These preparations have a more rapid onset and shorter duration of effect than atropine. Mydriasis is produced within 15-30 minutes and the duration of activity is approximately 3-8 hours. Complete recovery in some individuals may require 24 hours. Cycloplegia is maximal within about 30 minutes and is short-lasting, with complete recovery of accommodation normally within 6 hours.

Clinical trials.

No data are available.

5.2 Pharmacokinetic Properties

Tropicamide, administered topically to the eye, does not bind to tissues as firmly as does atropine. The wash 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.

5.3 Preclinical Safety Data

Genotoxicity.

No long-term studies have been conducted in animals to determine the mutagenic potential of ophthalmic tropicamide.

Carcinogenicity.

No long-term studies have been conducted in animals to determine the carcinogenic potential of ophthalmic tropicamide.

4 Clinical Particulars

4.1 Therapeutic Indications

Mydriacyl Eye Drops are used to produce mydriasis and cycloplegia for diagnostic purposes.

4.3 Contraindications

Mydriacyl should not be used:
in patients with glaucoma or with a narrow anterior chamber angle;
in individuals known to be hypersensitive to any component of the preparation (see Section 6.1. List of Excipients).

4.4 Special Warnings and Precautions for Use

For topical ophthalmic use only. Not for injection.
Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma and 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 angle of the anterior chamber should be made before use.
Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Parents should be warned of the oral toxicity of this preparation for children and advised to wash their hands and the child's hands after use.
This preparation may also cause CNS disturbances, which may be dangerous in paediatric patients. The possibility of psychotic reactions and behavioural disturbances due to hypersensitivity to anticholinergic drugs should be considered.
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.
Do not use in concentrations greater than 0.5% in small infants.
Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption.
To reduce systemic absorption the lacrimal sac should be compressed at the medial canthus by digital pressure for one minute after instillation of the drops.
In refractions where prolongation of cycloplegia is desirable only one additional drop is recommended.

Use in hepatic impairment.

The safety and efficacy of Mydriacyl in patients with hepatic impairment have not been established.

Use in renal impairment.

The safety and efficacy of Mydriacyl in patients with renal impairment have not been established.

Use in the elderly.

No data available.

Paediatric use.

No controlled clinical studies have been performed in children, thus the safety and efficacy of Mydriacyl use in children has not been established. In rare cases, tropicamide has been known to cause CNS disturbances which may be dangerous in paediatric patients. Psychotic reactions, behavioural disturbances and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

Effects on laboratory tests.

No data available.

Instructions for patients.

Mydriacyl contains the preservative benzalkonium chloride which may cause eye irritation, is known to discolour and may be deposited in soft (hydrophilic) contact lenses. Patients who wear soft contact lenses should remove their lenses prior to instilling Mydriacyl Eye Drops and should not reinsert their lenses until at least 15 minutes after instillation of the eye drops.
Tropicamide may cause drowsiness and blurred vision. Patients are advised not to drive or engage in potentially hazardous activities whilst the pupils are dilated unless vision is clear. Patients may experience sensitivity to light and should protect their eyes in bright illumination when their pupils are dilated. Complete recovery may take up to 24 hours in some individuals.
To prevent contamination, care should be taken not to touch the dropper tip to any surface, including the eye. The bottle should be tightly closed when not in use.
Mydriacyl Eye Drops should be discarded within 28 days of opening.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effects of tropicamide may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics, and tricyclic antidepressants. Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine or ophthalmic cholinesterase inhibitors.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Reproductive studies with tropicamide have not been performed in animals. Therefore, the potential effects on male or female fertility have not been investigated.
(Category B2)
There is no data from the use of tropicamide in pregnant women. There have been no animal reproduction studies conducted or well-controlled studies performed in pregnant women, therefore, Mydriacyl should be used in pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or foetus.
Caution should be exercised when tropicamide is administered to a breastfeeding mother as it is not known whether tropicamide topically administered is excreted in human milk. A risk to the suckling child cannot be excluded.

4.8 Adverse Effects (Undesirable Effects)

Ocular.

An increase in intraocular pressure, especially in patients with angle-closure glaucoma, transient stinging, blurred vision, punctate keratitis and sensitivity to light secondary to pupillary dilation may occur. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.

Systemic.

Systemic toxicity can occur with the use of anti-muscarinic eye drops, particularly in children and the elderly. Symptoms include dryness of the mouth, flushing, nausea, vomiting, giddiness, headache, pallor, staggering, dryness of the skin (a rash may be present in children), bradycardia followed by tachycardia with palpitation and arrhythmias, urinary urgency, difficulty and retention, reduction in the tone and motility of the gastrointestinal tract leading to constipation (abdominal distention may occur in infants).
Psychotic reactions, behavioural disturbances and vasomotor or cardio-respiratory collapse may occur in children.

Post marketing events.

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.

Eye disorders.

Vision blurred, photophobia, eye pain, eye irritation, ocular hyperaemia.

Nervous system disorders.

Dizziness, headache.

Vascular disorders.

Syncope, hypotension.

Gastrointestinal disorders.

Nausea.

Skin and subcutaneous tissue disorders.

Rash.

General disorders and administration site conditions.

Drug effect prolonged (mydriasis).
Cycloplegic drugs may increase intraocular pressure and can precipitate angle closure glaucoma in predisposed patients (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).
Psychotic reactions and behavioural disturbances 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 mucous membranes, tachycardia, decrease secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary retention and decreased nasal, bronchial and lachrymal secretions.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

For refraction, instill one or two drops of 1% solution in eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, one or two drops of 0.5% solution, 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses.
In order to minimise systemic absorption, apply pressure to the tear duct for one minute immediately after administration.
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.

4.7 Effects on 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.

4.9 Overdose

In the event of a topical overdose, flush from the eye with running water.
Systemic toxicity may occur following topical use, particularly in children. Symptoms include 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. Overdose treatment is supportive. In infants and small children the body surface must be kept moist.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, disodium edetate, concentrated hydrochloric acid and/or sodium hydroxide (to adjust pH), benzalkonium chloride, purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years. Discard container 28 days after opening.

6.4 Special Precautions for Storage

Store Mydriacyl Eye Drops below 25°C. Do not refrigerate. Protect from light. Keep tightly closed.

6.5 Nature and Contents of Container

Mydriacyl Eye Drops 0.5% and 1% are presented in 15 mL Drop-Tainer dispensers.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes