Consumer medicine information

Minims Pilocarpine

Pilocarpine nitrate

BRAND INFORMATION

Brand name

Minims Pilocarpine Eye Drops

Active ingredient

Pilocarpine nitrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Pilocarpine.

SUMMARY CMI

Minims® Pilocarpine

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 Pilocarpine?

Minims Pilocarpine contains the active ingredient pilocarpine nitrate. Minims Pilocarpine is commonly used at the end of an eye examination to return the size of the pupil back to normal. It is also used to decrease pressure in the eye, by allowing more fluid to flow out from within the eye, and help control glaucoma (a condition in which the pressure of fluid in the eye may be high).
For more information, see Section 1. Why am I using Minims Pilocarpine? in the full CMI.

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

  • Do not use if you are allergic to any medicine containing pilocarpine or to any of the ingredients listed at the end of this leaflet. Do not use if you have an inflammation in the eye(s), pupillary block glaucoma (a condition that prevents normal flow of fluid through the pupil), have or have had detached retina or conditions that predispose to detachment of the retina. Do not use while wearing soft contact lenses. 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 Pilocarpine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Minims Pilocarpine 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 Pilocarpine?

Your doctor will normally instil the drops into your eyes for you. The usual dose is one or two drops 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 Pilocarpine? in the full CMI.

5. What should I know while using Minims Pilocarpine?

Things you should do
  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Minims Pilocarpine.
  • Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.
Things you should not do
  • Do not stop using Minims Pilocarpine before first talking to your doctor. If you stop using your eye drops, your eye pressure may rise again and damage to your eye may occur.
  • 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.
Things to be careful of
  • Be careful before you drive, use any machines or perform tasks at night or in poor light until you know how Minims Pilocarpine affects you. It may cause blurred vision for a short time and difficulty adapting to the dark. Allow enough time to regain clear vision before performing such activities.
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 Pilocarpine? 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. Less serious side effects include: blurred vision, burning, stinging, redness or watering of the eyes, local irritation or feeling of having something in the eye, poor night vision, short sightedness, headache or browache. Serious side effects include: increased sweating, muscle tremors, nausea and/or vomiting, diarrhea, watering of the mouth, trouble breathing or wheezing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

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® Pilocarpine

Active ingredient: Pilocarpine nitrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Minims Pilocarpine. 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 Pilocarpine.

Where to find information in this leaflet:

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

1. Why am I using Minims Pilocarpine?

Minims Pilocarpine contains the active ingredient pilocarpine nitrate. Minims Pilocarpine belongs to a family of medicines called parasympathomimetics.

Minims Pilocarpine is commonly used at the end of an eye examination to return the size of the pupil back to normal. It is also used to decrease pressure in the eye, by allowing more fluid to flow out from within the eye, and help control glaucoma (a condition in which the pressure of fluid in the eye may be high).

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

Warnings

Do not use Minims Pilocarpine if:

  • You are allergic to any medicine containing pilocarpine.
  • You are allergic to 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 a condition known as iritis, an inflammation of the coloured part of the eye.
  • You have a condition known as uveitis, a serious inflammation of the eye.
  • You have a certain type of glaucoma called "pupillary block glaucoma", a condition that prevents normal flow of fluid through the pupil.
  • You have iridocyclitis, a condition that makes parts of the eyes swollen and inflamed.
  • You have certain forms of secondary glaucoma (a type of glaucoma that happens due to another eye problem or health condition).
  • You have or have had detached retina (back part of the eye) or conditions that predispose to detachment of the retina.
  • You are wearing soft contact lenses. Remove them before instilling Minims Pilocarpine into your eye(s).

Check with your doctor if:

  • You have had an allergy to any other medicines, foods, preservatives or dyes.
  • You have inflamed eye(s) or damaged or scratched cornea.
  • You have or have had breathing difficulties or lung problems or predisposition to lung problems (e.g. asthma).
  • You have or have had heart problems.
  • You have stomach ulcer.
  • You have urinary tract obstruction.
  • You have Parkinson's disease.
  • You are to have eye surgery.
  • A child who has primary congenital glaucoma (a rare form of childhood glaucoma) has been prescribed with Minims Pilocarpine.

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.

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

  • Atropine and related medicines
  • Cyclopentolate
  • Belladonna alkaloids
  • Other medicines or eye drops for glaucoma.

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 Pilocarpine.

4. How do I use Minims Pilocarpine?

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to use

  • Use Minims Pilocarpine 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 of Minims Pilocarpine is one or two drops instilled into the eye(s).

How to use Minims Pilocarpine

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

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

In most cases, your doctor will instil the eye drops. However, if you are required to instil the drops, follow the steps below:

  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 (or one minute, 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 soft contact lenses.

If you use too much Minims Pilocarpine

If you accidentally put more drops in your eyes than advised by your doctor, immediately rinse your eye(s) with warm water.

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

If you think that an infant or young age child may have swallowed any or all of the contents of the container of Minims Pilocarpine, you should immediately:

  • phone the Poisons Information Centre
    (in Australia phone 13 11 26), or
  • contact your doctor.

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

5. What should I know while using Minims Pilocarpine?

Things you should do

  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Minims Pilocarpine.
  • Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.

Things you should not do

  • Do not stop using Minims Pilocarpine before first talking to your doctor. If you stop using your eye drops, your eye pressure may rise again and damage to your eye may occur.
  • 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 operate any machines until you know how Minims Pilocarpine affects you.

Minims Pilocarpine may cause blurred vision for a short period of time when it is instilled into the eye. Allow sufficient time to regain clear vision before driving or using machines.

Driving or performing tasks at night and in poor light

Be careful at night and in poor light until you know how Minims Pilocarpine affects you.

Minims Pilocarpine may cause difficulty adapting to the dark. Caution is advised with driving or performing hazardous tasks in poor light.

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, if it is out of date or if the packaging is torn or shows signs of tampering, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date printed on the pack.

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.

Side effects

Less serious side effectsWhat to do
  • blurred vision and/or problems seeing clearly
  • pain, burning, stinging, itching, redness or watering of the eyes
  • local irritation or feeling of having something in the eye
  • poor night vision
  • short sightedness
  • headache or browache.
Speak to your doctor if you have any of these less serious side effects and they worry you.
Serious side effectsWhat to do
  • increased sweating
  • muscle tremors
  • nausea and/or vomiting
  • diarrhea
  • trouble breathing or wheezing
  • watering of the mouth
  • shortness of breath
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.
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.

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 Pilocarpine contains

Active ingredient
(main ingredient)		Pilocarpine nitrate (2% w/v)
Other ingredients
(inactive ingredients)		Purified water

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

The eye drops do not contain any preservatives.

What Minims Pilocarpine looks like

Minims Pilocarpine (AUST R 32280) comes in single dose units (polypropylene tubes) containing 0.5mL of a clear, colourless sterile ophthalmic solution. Each tube is wrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units.

Who distributes Minims Pilocarpine

In Australia, Minims Pilocarpine 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 April 2025.

Published by MIMS June 2025

BRAND INFORMATION

Brand name

Minims Pilocarpine Eye Drops

Active ingredient

Pilocarpine nitrate

Schedule

S4

 

1 Name of Medicine

Pilocarpine nitrate.

2 Qualitative and Quantitative Composition

Minims Pilocarpine Nitrate Eye Drops contains pilocarpine nitrate 2% (20 mg/mL). No preservatives are included 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 Pilocarpine Nitrate Eye Drops are single use, clear, colourless sterile ophthalmic solutions. No preservatives are included in the formulation.

4 Clinical Particulars

4.1 Therapeutic Indications

Chronic glaucoma and a miotic for reversing the effects of the weaker mydriatics and in emergency treatment of glaucoma.

4.2 Dose and Method of Administration

For topical ophthalmic use only. Not for injection into the eye.
Miotics are normally administered at the end of an ophthalmological examination while mydriatics are given at the beginning.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following instillation of drops. It is especially advisable when administering pilocarpine to children.

Adults (including the elderly) and children.

Miosis.

To induce miosis 1 or 2 drops should be used.

Glaucoma.

In cases of emergency treatment of acute narrow angle glaucoma, 1 drop should be used every 5 minutes until miosis is achieved.
Each Minims unit should be discharged after a single use.

4.3 Contraindications

Miotics are contraindicated in conditions where pupillary constriction is undesirable such as acute iritis, pupillary block glaucoma, acute uveitis, anterior uveitis, iridocyclitis, acute iritis and some forms of secondary glaucoma.
Hypersensitivity to pilocarpine nitrate.
Retinal detachment; past history of retinal detachment or conditions that predispose to retinal detachment.
Use of soft contact lenses when administering pilocarpine eye drops (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Administration.

For topical ophthalmic use only. Not for injection into the eye.

Systemic absorption.

Systemic reactions rarely occur when treating chronic simple glaucoma at normal doses. However, in the treatment of acute closed angle glaucoma the possibility of systemic reactions must be considered because of the higher doses given (more frequent administration).
Systemic absorption in adults may be reduced by nasolacrimal occlusion or closing the eyelids for 2 minutes after the instillation of the drops (this blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa).
In pediatric patients lacrimal punctum should be occluded for one minute with a finger to limit systemic exposure.
Pilocarpine ophthalmic solution should be used with caution on an inflamed eye as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
Caution is particularly advised in patients with acute heart failure, bradycardia, coronary artery disease, bronchial asthma and other chronic respiratory diseases, peptic ulceration, hypertension, urinary tract obstruction, Parkinson's disease and corneal abrasions.

Primary congenital glaucoma.

Caution is advised when using pilocarpine ophthalmic solution in pediatric patients with primary congenital glaucoma for control of intraocular pressure (IOP) as cases of paradoxical increase in IOP have been reported.

Pre-existing retinal disease.

Retinal detachments have been caused in susceptible individuals and those with pre-existing retinal disease; therefore, fundus examination is advised in all patients prior to the initiation of therapy.

Poor illumination.

Miosis causes difficulty in dark adaptation. Caution is therefore necessary when driving at night or performing hazardous tasks in poor illumination. (See Section 4.8 Adverse Effects (Undesirable Effects)).

Long-term treatment.

Patients with chronic glaucoma on long-term pilocarpine therapy should have regular monitoring of intraocular pressure and visual fields.
If possible, treatment with long acting miotics should be discontinued before surgery on the eye as there is an increased risk of hyphaemia.
Pilocarpine induces spasm of the ciliate muscle which may last up to two hours. Topical miotics may precipitate bronchospasm in susceptible patients.

Use of soft contact lenses.

Miotics should not be used by patients wearing soft contact lenses.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Belladonna alkaloids or cyclopentolate used ophthalmically may interfere with the miotic effects of pilocarpine and may have their own mydriatic effects reduced. This latter effect may be used to therapeutic advantage.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Safety for use in pregnancy has not been established, therefore, use only when considered essential by the physician.
 Safety for use in lactation has not been established, therefore, use only when considered essential by the physician.

4.7 Effects on Ability to Drive and Use Machines

Pilocarpine may cause transient blurring of vision on instillation. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.
Pilocarpine may also cause difficulty with dark adaptation and caution is necessary with driving or performing hazardous tasks in poor illumination.

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.
Following ocular administration pilocarpine is usually better tolerated than the anticholinesterases but in common with other miotics may produce ciliary spasm, ocular pain and irritation, blurred vision, lachrymation, myopia and browache.
Conjunctival vascular block has been reported. Lens opacities have occurred following prolonged use. Treatment with miotics should be stopped if symptoms of systemic toxicity develop.
Systemic adverse effects after the ophthalmic use of pilocarpine are thought to be rare and reports of toxicity appear to involve elderly patients treated for acute angle closure glaucoma prior to surgery and who received 2 to 5 times the usual daily dose of pilocarpine in a few hours.
Adverse effects reported are listed in the CIOMS table (see Table 1). These are listed by system organ class and frequency categories: very common (≥ 10%), common (≥ 1% to ˂ 10%), uncommon (≥ 0.1% to ˂ 1%), rare (≥ 0.01% to ˂ 0.1%), very rare (< 0.01%), not known (cannot be estimated from available data).

4.9 Overdose

Should accidental overdosage in the eye(s) occur, flush eye(s) with water or normal saline. If accidentally ingested, induce emesis or perform gastric lavage. Observe patients for signs of pilocarpine toxicity, i.e. salivation, lacrimation, sweating, nausea, vomiting and diarrhoea. If these occur, therapy with anticholinergics (atropine) may be necessary. Bronchial constriction may occur in asthmatic patients.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pilocarpine is a miotic; its action commences a few minutes after instillation and continues for about six hours. Although not as active as physostigmine, it does have the important advantage that there is an absence of pain and the miotic action is of a shorter duration.
Pilocarpine is a tertiary amine direct acting parasympathomimetic agent with primarily the muscarinic effects of acetylcholine. It is mainly used as a miotic in the treatment of glaucoma and in ophthalmological procedures.
It is much better pharmacologically to reverse mydriasis by using a drug that acts on the same muscle as the mydriatic. If an antimuscarinic has been used which paralyses the sphincter pupillae muscle, then ideally pilocarpine should be used. Pilocarpine is adequate only against the weaker mydriatics such as tropicamide and phenylephrine.
Miotics should return the size of the pupil to normal, have a length of action of the same order but slightly longer than the mydriatic and not cause any local or systemic toxicity.
Pilocarpine acts directly on the muscarinic receptors on the smooth muscle of the sphincter pupillae and its action is independent of a functioning sympathetic nerve supply. Following the use of eye drops, miosis occurs in 10 to 30 minutes and lasts 4 to 8 hours while peak reduction in intraocular pressure occurs in 75 minutes and the reduction usually lasts for 4 to 14 hours.

Glaucoma.

Pilocarpine may be used when miotics are required to reduce intraocular pressure in the treatment of open angle glaucoma and is commonly administered with topical β-blockers or adrenergic agents. Chronic open angle glaucoma is the commonest form and is due to blockage in drainage through the trabecular meshwork. Intraocular pressure increases gradually, and the condition is usually asymptomatic until well advanced and severe damage has occurred. Usually both eyes are affected. Risk factors include old age, diabetes, a family history and myopia.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

No data available.

Metabolism.

No data available.

Excretion.

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

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.) Do not expose to strong light.

6.5 Nature and Contents of Container

Minims Pilocarpine Eye Drops 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 solution.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical name: (3S, 4R)-3-ethyl-4- [(1-methyl- 1H-imidazol-5-yl) methyl]-dihydro-3H- furan-2-one nitrate. Molecular formula: C11H16N2O2HNO3. Molecular weight: 271.3.
Pilocarpine nitrate is a white crystalline powder or colourless crystals, sensitive to light, freely soluble in water, sparingly soluble in alcohol, practically insoluble in ether. It melts at about 174°C with decomposition.

Chemical structure.


CAS number.

148-72-1.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes