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.

What is in this leaflet

This leaflet answers some common questions about Minims Atropine Sulphate Eye Drops, 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 your using Minims Atropine Sulphate Eye Drops 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 Atropine Sulphate Eye Drops is used for

Minims Atropine Sulphate Eye Drops belongs to a class of medicines called antimuscarinic agents. It is used to dilate (enlarge) the pupil of the eye and to temporarily paralyse the lens so that your doctor can examine your eye(s). It is usually used at the beginning of an eye examination.

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 Atropine Sulphate Eye Drops

When you must not use it

Do not use Minims Atropine Sulphate Eye Drops if you have an allergy to:

  • Any medicine containing atropine
  • 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 Atropine Sulphate Eye Drops if you have or suspect you have angle closure glaucoma (high pressure in the eye). Atropine can increase the pressure in the eye.

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 have or have had any of the following medical conditions:

  • Glaucoma (high pressure in the eye)
  • Down's syndrome or albinism
  • Conditions known as keratoconus or synechiae

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

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

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 Atropine Sulphate Eye Drops may interfere with each other. These include:

  • Medicines to treat glaucoma
  • Some medicines used to treat depression
  • Some antihistamines
  • Some medicines used to treat Parkinson's disease
  • Some medicines used to treat mental illness
  • Medicines used to treat muscle weakness
  • Potassium citrate and potassium supplements

These medicines may be affected by Minims Atropine Sulphate Eye Drops 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 Minims Atropine Sulphate Eye Drops.

How to use Minims Atropine Sulphate Eye Drops

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

If you do not understand the instructions on the label, ask your doctor for help.

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

How much to use

Use Minims Atropine Sulphate Eye Drops 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 it

Your doctor will normally instil the drops into your eyes for you. If you are instilling your own drops, then follow the directions below

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

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

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 (overdose)

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of atropine. If you think that an infant or young child may have swallowed any or all of the contents of the container of Minims Atropine Sulphate Eye Drops, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

While you are using Minims Atropine Sulphate Eye Drops

Things you must 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 must 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.

Things to be careful of

Be careful driving or operating machinery until you know how Minims Atropine Sulphate Eye Drops 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.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Atropine Sulphate Eye Drops.

This medicine helps most people 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
  • Local irritation or stinging or the feeling of having something in the eye

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

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

  • Thirst, dryness of the mouth
  • Rash or flushing of the skin
  • Fever or increased body temperature
  • Behavioural changes. These are more common in children.
  • Slow, fast or irregular heart beat.
  • Shallow breathing

The above list includes very 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 Atropine Sulphate Eye Drops

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 Atropine Sulphate Eye Drops comes in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Atropine Sulphate Eye Drops contains 1.0%w/v of atropine sulfate monohydrate as the active ingredient.

It also contains:

  • Water - Purified
  • Hydrochloric acid

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia Minims Atropine Sulphate Eye Drops is supplied by:

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

Minims Atropine Sulphate Eye Drops 1.0%
AUST R 32256

In New Zealand Minims Atropine Sulphate 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
April 2020

Published by MIMS June 2020

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