Consumer medicine information

Minims Atropine Eye Drops

Atropine sulfate monohydrate

BRAND INFORMATION

Brand name

Minims Atropine Eye Drops

Active ingredient

Atropine sulfate monohydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

SUMMARY CMI

Minims® Atropine

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Minims Atropine?

Minims Atropine contains the active ingredient atropine sulfate monohydrate. Minims Atropine is used to temporarily dilate (enlarge) the pupil of the eye and to stop the movement of the muscles that change the shape of the lens. It is usually used at the beginning of an eye examination so that your doctor can examine your eye(s).

For more information, see Section 1. Why am I using Minims Atropine? in the full CMI.

2. What should I know before I use Minims Atropine?

Do not use if you have ever had an allergic reaction to atropine or any of the ingredients listed at the end of the CMI. Do not use if you have or suspect you have angle closure glaucoma (high pressure in the eye). Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Minims Atropine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Minims Atropine and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Minims Atropine?

  • Your doctor will normally instil the drops into your eyes for you.
  • The usual dose is one drop instilled into the eye.

If your doctor instructs you to instil the drops, more instructions can be found in Section 4. How do I use Minims Atropine? in the full CMI.

5. What should I know while using Minims Atropine?

Things you should do
  • If you have any irritation, pain, swelling, excessive tear production or light-sensitivity while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes. Stop using the eye drops and contact your doctor.
Things you should not do
  • Do not use this medicine to treat any other complaints unless your doctor tells you to.
  • Do not give this medicine to anyone else, even if you think they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Minims Atropine affects you. It may cause blurred vision for a short time when it is instilled into the eye. Allow enough time to regain clear vision before driving or using machines.
Looking after your medicine
  • Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

For more information, see Section 5. What should I know while using Minims Atropine? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.

Side effects rarely occur when atropine is used in the eye. Serious side effects that require urgent medical attention include: symptoms of narrow angle glaucoma, symptoms of an allergic reaction and signs that something harmful is affecting your whole body, like feeling really sick, weak, confused, having a fast heartbeat, or trouble breathing (symptoms of systemic toxicity).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Minims® Atropine

Active ingredient: Atropine sulfate monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Minims Atropine. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Minims Atropine.

Where to find information in this leaflet:

1. Why am I using Minims Atropine?
2. What should I know before I use Minims Atropine?
3. What if I am taking other medicines?
4. How do I use Minims Atropine?
5. What should I know while using Minims Atropine?
6. Are there any side effects?
7. Product details

1. Why am I using Minims Atropine?

Minims Atropine contains the active ingredient atropine sulfate monohydrate. Minims Atropine belongs to a class of medicines called antimuscarinic agents.

Minims Atropine is used to temporarily dilate (enlarge) the pupil of the eye and to stop the movement of the muscles that change the shape of the lens. It is usually used at the beginning of an eye examination so that your doctor can examine your eye(s).

2. What should I know before I use Minims Atropine?

Warnings

Do not use Minims Atropine if:

  • You are allergic to atropine, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • You have or suspect you have angle closure glaucoma (high pressure in the eye). Atropine can increase the pressure in the eye.

Check with your doctor if:

  • You have had an allergy to any other medicines, foods, preservatives or dyes.
  • You have any other medical conditions, especially:
    - glaucoma (high pressure in the eye)
    - Down's syndrome or albinism (a condition where there is no or very little colour in the hair, skin and eyes)
    - keratoconus (a condition where the clear surface on the front of the eye [cornea] becomes thin and cone shaped)
    - synechiae (abnormal sticking) between the iris and lens
  • The weather or room temperature is hot.
  • You are aged 65 years or older.
  • You take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

This medicine has been developed for use in the eye only. It should not be swallowed or injected.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children

Check with your doctor before using Minims Atropine in children. Children may be more likely to experience side effects to atropine.

Minims Atropine is not recommended in infants aged less than 3 months.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Atropine may interfere with each other. These medicines may be affected by Minims Atropine or may affect how well it works. These include:

  • Medicines to treat glaucoma
  • A class of medicines called anticholinergic drugs which are commonly used to treat asthma, chronic obstructive pulmonary disease (COPD), stomach and gut problems, incontinence, depression, allergies, Parkinson's disease and mental illness.
  • Medicines used to treat muscle weakness.
  • Potassium citrate and potassium supplements
  • Medicines to treat vomiting and nausea.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Minims Atropine.

4. How do I use Minims Atropine?

Your doctor will normally instil the drops into your eyes for you. If your doctor instructs you to instil the drops, please follow the directions below.

How much to use

  • Use Minims Atropine only when prescribed by your doctor. Your doctor will tell you how often to use the eye drops and how many drops to use each time.
  • The usual dose is one drop instilled into the eye.

How to use Minims Atropine

If you are wearing contact lenses, remove them before putting the drops in your eye.

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are instilling your own drops, then follow these steps to use the eye drops:

  1. Wash your hands well with soap and water.
  2. Shake the container.
  3. Break the seal.
  4. Hold the container upside down in one hand between your thumb and forefinger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the container close to your lower eyelid. Do not let it touch your eye.
  8. Release the required number of drops into the pouch or pocket formed between your eye and eyelid by gently squeezing the container.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This is very important when administering to children. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body.
  11. Repeat steps 4-10 for the other eye if needed.
  12. Throw away any eye drops left in the container.
  13. Wait at least 15 minutes before replacing your contact lenses.

If you use too much Minims Atropine

If you think that you have used too much Minims Atropine, you may need urgent medical attention.

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of atropine.

If you think that you or anyone else may have swallowed Minims Atropine or used too much Minims Atropine, you should immediately:

  • phone the Poisons Information Centre
    (in Australia phone 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Minims Atropine?

Things you should do

  • If you have any irritation, pain, swelling, excessive tear production or light-sensitivity while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes. Stop using the eye drops and contact your doctor.

Things you should not do

  • Do not use this medicine to treat any other complaints unless your doctor tells you to.
  • Do not give this medicine to anyone else, even if you think they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Minims Atropine affects you.

Minims Atropine generally does not cause any problems with your ability to drive a car or use machines. However, it may cause blurred vision for a short time when it is instilled into the eye. Allow enough time to regain clear vision before driving or using machines.

Looking after your medicine

Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

When to discard your medicine

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Getting rid of any unwanted medicine

If your doctor tells you to stop using the eye drops or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Eyes:
  • blurred vision
  • local irritation, stinging or the feeling of having something in the eye
  • red, itchy or watery eyes
  • red, itchy, swollen eyelids or skin
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Symptoms of narrow angle glaucoma, such as:
  • nausea
  • sudden severe eye and head pain
  • blurred or sudden loss of vision
  • red eyes
  • halos around lights.
Symptoms of an allergic reaction, such as:
  • 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.
Symptoms of harmful effects throughout the body (systemic toxicity), such as:
  • dryness of the mouth and skin
  • flushing
  • fever
  • rash
  • thirst
  • fast heart rate
  • irritability
  • hyperactivity
  • poor balance or muscle control
  • confusion
  • drowsiness
  • hallucinations
  • delirium.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Some side effects (for example, an increase in the pressure of the eye) can only be found when your doctor or optometrist does tests from time to time.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects online (in Australia, go to www.tga.gov.au/reporting-problems). By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Minims Atropine contains

Active ingredient
(main ingredient)		atropine sulfate monohydrate (1% w/v)
Other ingredients
(inactive ingredients)
  • Purified water
  • Hydrochloric acid

Do not take this medicine if you are allergic to any of these ingredients.

The eye drops do not contain any preservatives.

What Minims Atropine looks like

Minims Atropine comes in single dose units (tubes) containing 0.5mL of a clear, colourless solution. Each tube is wrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units (AUST R 32256).

Who distributes Minims Atropine

In Australia, Minims Atropine is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067
Phone: 1800 251 150

This leaflet was prepared in January 2025.

Published by MIMS March 2025

BRAND INFORMATION

Brand name

Minims Atropine Eye Drops

Active ingredient

Atropine sulfate monohydrate

Schedule

S4

 

1 Name of Medicine

Atropine sulfate monohydrate.

2 Qualitative and Quantitative Composition

Minims Atropine Eye Drops contain atropine sulfate monohydrate 1% w/v. No preservatives are contained in the formulation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A single-use eye drops, solution.
Minims Atropine Eye Drops are clear, colourless sterile eye drops. No preservatives are contained in the formulation.

4 Clinical Particulars

4.1 Therapeutic Indications

Minims Atropine Eye Drops are indicated to produce mydriasis and cycloplegia.

4.2 Dose and Method of Administration

Adults (including the elderly).

One drop to be instilled into the eye, or as required.
Systemic absorption of atropine 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 the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Each Minims Atropine Eye Drops unit should be discarded after a single use.

4.3 Contraindications

Minims Atropine Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation.
Minims Atropine Eye Drops are contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Minims Atropine Eye Drops are for topical ophthalmic use only. The solution should not be injected.
Due to the risk of precipitating an acute attack, atropine eye drops should not be used in cases of confirmed narrow-angle glaucoma or where latent narrow angle glaucoma is suspected. If in doubt, it is recommended that an alternative preparation be used.
Atropine eye drops should not be used in the following situations unless the clinical benefit outweighs the risk: keratoconus (atropine may produce fixed dilated pupil), synechiae between the iris and lens.
Due to the risk of provoking hyperpyrexia, atropine eye drops should be used with caution, especially in children, when the ambient temperature is high.
Persons with Down's syndrome appear to have an increased susceptibility to the actions of atropine, whereas those with albinism may be resistant.
Systemic absorption of atropine 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 the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

Use in the elderly.

Minims Atropine Eye Drops should be used with caution in elderly patients as they may be more susceptible to the effects of atropine thus increasing the potential for systemic side effects.

Paediatric use.

Children may be more susceptible to the adverse effects of atropine. Therefore, atropine eye drops should be used with caution in this population. An increased susceptibility to atropine has been reported in infants and young children and in children with blonde hair, blue eyes, Down's syndrome, spastic paralysis, or brain damage; therefore, atropine should be used with great caution in these patients.
Atropine eye drops are not recommended in infants aged less than 3 months due to the possible association between induced cycloplegia and the development of amblyopia.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although negligible atropine passes into the bloodstream after ocular instillation, drug interactions are nevertheless possible.
The interactions observed with atropine administered by any route should therefore be taken into account.

Anticholinergics.

If significant systemic absorption of ophthalmic atropine occurs, concurrent use of other anticholinergics or medications with anticholinergic activity (e.g. amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants) may result in potentiated anticholinergic effects.

Antiglaucoma agents.

(Cholinergic, long acting, ophthalmic.) Concurrent use with atropine may antagonise the antiglaucoma and miotic actions of ophthalmic long acting cholinergic antiglaucoma agents. Concurrent use with atropine may also antagonise the antiaccommodative convergence effects of these medications when they are used for the treatment of strabismus.

Antimyasthenics, potassium citrate, potassium supplements.

If significant systemic absorption of ophthalmic atropine occurs, concurrent use may increase the chance of toxicity and/or side effects of these systemic medications because of the anticholinergic induced slowing of gastrointestinal motility.

Carbachol, physostigmine or pilocarpine.

Concurrent use with atropine may interfere with the antiglaucoma action of carbachol, physostigmine or pilocarpine. Also, concurrent use may counteract the mydriatic effect of atropine; however, this counteraction may be used to therapeutic advantage.

Central nervous system depression producing medications.

If significant absorption of systemic atropine occurs, concurrent use of medications having CNS effects, such as antiemetic agents, phenothiazines, or barbiturates, may result in opisthotonos, convulsions, coma and extrapyramidal symptoms.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been performed in either animals or humans to evaluate the potential fertility impairing effects of atropine.
(Category A)
Atropine sulphate may be systemically absorbed after ocular administration; however, significant effects on the foetus have not been reported. Nevertheless, caution is advised.
 Systemically absorbed atropine sulphate is distributed into breast milk in very small amounts. It may cause adverse effects, such as rapid pulse, fever, or dry skin, in breastfeeding infants of mothers using ophthalmic atropine.

4.7 Effects on Ability to Drive and Use Machines

Minims Atropine Eye Drops may cause transient blurring of vision on instillation. Patients should be advised not to drive or operate hazardous machinery until vision is clear.

4.8 Adverse Effects (Undesirable Effects)

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.
Adverse effects rarely occur with ocular use of atropine, however, the following have been reported:

Ophthalmic.

Blurred vision, local irritation, allergic conjunctivitis or blepharoconjunctivitis, contact dermatitis, eczematous dermatitis, increased intraocular pressure. May precipitate narrow angle glaucoma.

Systemic.

Systemic reactions may occur after ocular instillation of these anticholinergic drugs, particularly in children or elderly patients. Symptoms of systemic toxicity include dryness of the mouth and skin, flushing, fever, rash, thirst, tachycardia, irritability, hyperactivity, ataxia, confusion, somnolence, hallucinations and delirium.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Systemic reactions to topical atropine are unlikely at normal doses. Signs of overdosage are similar to those described as systemic effects (see Section 4.8 Adverse Effects (Undesirable Effects)).
In the event of atropine overdose, treatment is supportive. Supportive therapy may include oxygen and assisted respiration; cool water baths for fever, especially in children; and catheterisation for urinary retention. In infants and small children, the body surface should be kept moist.
Diazepam may be given to control marked excitement and convulsions.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Atropine is a belladonna alkaloid. Atropine sulphate acts in the eye to block the action of acetylcholine, relaxing the cholinergically innervated sphincter muscles of the iris. This results in dilation of the pupil (mydriasis). The cholinergic stimulation of the accommodative ciliary muscle of the lens is also blocked. This results in paralysis of accommodation (cycloplegia).
Atropine sulphate has a slower onset and more prolonged effect than most other anticholinergics. Maximum mydriatic effect occurs around 30 to 40 minutes. Maximum cycloplegia takes several hours. Mydriasis usually lasts 7 to 12 days and cycloplegia persists for 14 days or longer. Onset of effects and duration may be prolonged in heavily pigmented eyes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Atropine is readily absorbed from the gastrointestinal tract; it is also readily absorbed from mucous membranes, the eye, and to some extent through intact skin.

Distribution.

Atropine is rapidly cleared from the blood and is distributed throughout the body. It crosses the blood-brain barrier.

Metabolism.

Atropine is incompletely metabolised in the liver. A half-life of four hours has been reported.

Excretion.

Atropine is excreted in the urine as unchanged drug and metabolites.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid and 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

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.) Protect from light.

6.5 Nature and Contents of Container

Minims Atropine Eye Drops 1% (10 mg/mL) are supplied in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units. Each unit contains approximately 0.5 mL of solution.

6.6 Special Precautions for Disposal

Each Minims Atropine Eye Drops unit should be discarded after a single use.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: Bis[(1R,3r,5S)-8-methyl-8-azabicyclo [3.2.1]oct-3-yl (2RS)-3- hydroxy-2-phenylpropanoate] sulfate monohydrate.
Molecular formula: (C17H23NO3)2.H2SO4.H2O.
Molecular weight: 694.8.

CAS number.

5908-99-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes