Consumer medicine information

Minims Atropine 1% 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 1% Eye Drops.

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.

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

4.9 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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSATRSUM.gif 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

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MINATRST.gif