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.

What is in this leaflet

This leaflet answers some common questions about Minims Pilocarpine, including how to use the eye drops.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Pilocarpine 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 the medicine. You may need to read it again.

What Minims Pilocarpine is used for

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 lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure.

Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye.

There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.

Although Minims Pilocarpine helps control your glaucoma it does not cure it.

For more information about glaucoma, contact the Glaucoma Foundation of Australia on 1800 500 880.

Minims Pilocarpine is used, either alone or in combination with other eye drops/medicines, to lower raised pressure within your eye(s).

Minims Pilocarpine lowers the pressure in the eye(s) by allowing more fluid to flow out from within your eye(s).

It belongs to a family of medicines called parasympathomimetics.

Ask your doctor if you have any questions about why this medicine has been prescribed to you. Your doctor may have prescribed it for another reason.

Before you use Minims Pilocarpine

When you must not use it

Do not use Minims Pilocarpine if you have an allergy to:

  • any medicine containing Pilocarpine
  • any of the ingredients listed at the end of this leaflet.

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.

Do not use Minims Pilocarpine if you have any of the following medical conditions:

  • a condition known as iritis, an inflammation of the coloured part of the eye
  • a condition known as uveitis, a serious inflammation of the eye
  • if you have a certain type of glaucoma called "pupillary block glaucoma", a condition that prevents normal flow of fluid through the pupil
  • you have or have had a detached retina (back part of the eye).

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. You can put your soft contact lenses in your eyes 15 minutes after using Minims Pilocarpine.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have had an allergy to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will discuss with you the risks and benefits involved.

Tell your doctor if you have or have had any of the following medical conditions:

  • breathing difficulties or lung problems eg. Asthma.

If you have not told your doctor about any of the above, tell him/her before you start using Minims Pilocarpine.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any 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 include:

  • atropine and related medicines
  • cyclopentolate
  • Other medicines or eye drops for glaucoma.

These medicines may be affected by Minims Pilocarpine or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor and pharmacist will have more information on medicines to be careful with or avoid while using this medicine.

How to 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 on the label, 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 it

In most cases, your doctor will instil the eye drops. However, should you be required to instil the drops, follow the steps below.

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

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

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/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 one or two drops into the pouch/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 15 minutes before inserting your soft contact lenses.

You may feel a slight burning sensation in the eye shortly after using the eye drops. If this persists, or is very uncomfortable, contact your doctor or pharmacist.

How long to use it

Continue using your medicine for as long as your doctor tells you.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble using the eye drops, ask your pharmacist for some hints.

If you use too much (overdose)

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 child may have swallowed any or all of the contents of the container of Minims Pilocarpine, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

While you are using Minims Pilocarpine

Things you must do

If you are to have eye surgery tell your doctor you are using Minims Pilocarpine. Your doctor may advise you to stop your treatment with Minims Pilocarpine.

If you wear contact lenses, remove them before using Minims Pilocarpine. You can put contact lenses back in your eyes 15 minutes after using the eye drops.

If you become or plan to become pregnant while using this medicine, tell your doctor immediately.

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 must 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 driving or operating machinery until you know how Minims Pilocarpine affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause transient blurred vision at the time of application and sufficient time should be allowed to regain clear vision before driving or operating hazardous machinery.

Be careful at night and in poor light until you know how Minims Pilocarpine affects you. This medicine may cause difficulty adapting to the dark. Caution is advised with driving or performing hazardous tasks in poor light.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Pilocarpine.

This medicine helps most people with high eye pressure and glaucoma, but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • blurred vision and/or problems seeing clearly
  • 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.

The above list includes the more common side effects of your medicine.

It is possible that Minims Pilocarpine eye drops may be absorbed into other parts of your body.

Tell your doctor immediately or visit Accident and Emergency at your nearest hospital if you notice any of the following:

  • increased sweating
  • muscle tremors
  • nausea and/or vomiting
  • diarrhoea
  • trouble breathing or wheezing
  • watering of the mouth.

The above list includes more serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Minims Pilocarpine

Storage

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.

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

Disposal

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining containers.

Product description

What it looks like

Minims Pilocarpine comes in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Pilocarpine contains 2%w/v of Pilocarpine Nitrate as the active ingredient.

It also contains:

  • Water - Purified

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia Minims Pilocarpine is supplied by:

Bausch and Lomb (Australia) Pty Ltd
Chatswood, NSW 2067
Phone: 1800 251 150

Minims Pilocarpine 2%
AUST R 32280

In New Zealand, Minims Pilocarpine Eye Drops is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Toll free number: 0508375394

Date of preparation

This leaflet was prepared in February 2018

Published by MIMS May 2018

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