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ATROPT Eye Drops

Atropine sulphate (at-rop-een sul-fay-t) 0.5%, 1%

Consumer Medicine Information

Disclaimer

This document answers some common questions about Atropt Eye Drops.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Atropt against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this document with the medicine.

You may need to read it again.

What is Atropt

The name of your medicine is Atropt Eye Drops.

The active ingredient is called atropine sulphate.

Atropt widens the pupil of the eye and blocks the ability to change the focus of the eye.

Atropt Eye Drops are for use in the eyes only. They should not be taken by mouth.

What is Atropt Eye Drops used for

Atropt Eye Drops are used in eye examinations as well as other circumstances when the pupil is to be widened and/or the accommodation frozen.

Your doctor, however, may have prescribed Atropt Eye Drops for another purpose.

Ask your doctor if you have any questions about why Atropt Eye Drops have been prescribed for you.

If you have any concerns, you should discuss this with your doctor or in his/her absence with your pharmacist.

Atropt Eye Drops are available only on a doctor's prescription.

Before you use Atropt Eye Drops

When you must not use it

Do not use Atropt Eye Drops if you are allergic to:

• Atropine or any of the ingredients listed at the end of this document.

Do not use Atropt Eye Drops if you have angle closure glaucoma or a family history of glaucoma.

Atropt like all medicines, should not be used during pregnancy unless your doctor specifically tells you to (Category A).

Do not use Atropt Eye Drops after the expiry date printed on the pack.

If you use it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not purchase or use Atropt Eye Drops if the packaging is torn or shows signs of tampering.

Before you start to take it.

You must tell your doctor if you are:

• allergic to any other medicines or any foods, dyes or preservatives.
• have glaucoma or a family history of glaucoma
• wearing contact lenses

Taking other medicines

Tell your doctor if you are taking any other medication, including medicines, creams, ointments or lotions that you buy without a prescription from a pharmacy, supermarket or health food shop.

Do not use in children unless specifically directed to by your doctor.

Your doctor or pharmacist has information on medicines to be careful with or avoid while using Atropt.

How to use Atropt Eye Drops

How to use it

Gently pull out the lower eyelid to form a sac. Allow one drop to fall into the sac without touching the eye with the dropper end of the bottle.

To minimise absorption of the drug other than into the eye, apply gentle pressure to the tear duct for approximately one minute immediately after application.

When to use Atropt Eye Drops

Use as directed by your Doctor. Do not use more than the number of drops he/she advises or use them more frequently than directed.

It is important to use Atropt Eye Drops exactly as directed.

If you use less than you should, it may not work as well and your medical condition may not improve.

Using it more frequently than you should may not improve your condition any faster and may cause or increase side effects.

If you forget to use Atropt Eye Drops at the required time.

Use it as soon as you remember and then return to your normal dosing time.

If your next dose is almost due, leave using Atropt Eye Drops until that time.

Do not try to make up for missed doses by using more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If you have trouble remembering when to use Atropt Eye Drops, ask your pharmacist for some hints.

If you accidentally swallow it:

Immediately phone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think you or anyone else may have swallowed Atropt. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

While you are using Atropt Eye Drops

Things you must do:

Tell your doctor if you feel Atropt Eye Drops are not helping your condition.

Tell your doctor if, for any reason, you have not used your Atropt Eye Drops as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Always discuss with your doctor any problems or difficulties during or after using Atropt Eye Drops.

Things you must not do:

Do not give Atropt Eye Drops to anyone else even though their symptoms seem similar to yours.

Do not use Atropt for other conditions unless your doctor tells you. Atropt Eye Drops have been prescribed for you for a specific condition.

If you use it for another condition, it may not work or may make the condition worse.

Do not give Atropt Eye Drops to small children.

Things to be careful of:

The pupil dilation will last for up to 12 days. This can make driving or using machinery difficult and possibly hazardous.

While the pupil is dilated you will experience distorted vision, lack of tolerance to bright light or sunlight and possible distortion of your balance. Special care is needed at these times.

Ask your doctor or pharmacist if you are concerned about the length of time you have used Atropt Eye Drops.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while using Atropt Eye Drops.

Atropt Eye Drops helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Common side effects

The most common side effects of Atropt Eye Drops are:

• temporary blurred vision.
• burning, stinging, redness or watering of the eyes.

There is a possibility of systemic absorption of Atropt Eye Drops.

If this occurs you may experience flushing, dryness of the skin, rapid and irregular pulse, fever, mental aberrations and loss of neuromuscular coordination.

Atropt Eye Drops may cause other side effects, check with your doctor.

Check with your doctor as soon as possible if you have any problems while using Atropt Eye Drops even if you do not think the problems are connected with the medicine or are not listed on this document

Do not be alarmed by the list of side effects or their discussion. You may not experience any of them.

After using Atropt Eye Drops

Storage:

Keep Atropt where children cannot reach it.

A locked cupboard at least one and a half metres above the floor is a good place to store medicines.

Keep Atropt Eye Drops in a cool, dry place where the temperature stays below 25°C and protect from light.

Do not freeze or refrigerate.

Do not store it or any other medicines in a bathroom or near a sink.

Do not leave Atropt Eye Drops in the car or on window sills.

Discard any of the drops still left after 4 weeks from first using them.

Disposal

If your doctor tells you to stop using Atropt Eye Drops, or they pass their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

Atropt Eye Drops are presented in a plastic dropper bottle with a tamper proof seal.

Ingredients

Atropt Eye Drops contain atropine sulphate in a sterile aqueous base thickened with hypromellose.

The excipients or non-active ingredients are:

Disodium edetate, benzalkonium chloride, hypromellose, boric acid and freshly distilled water.

Strengths

Atropt Eye Drops are presented as 0.5% and 1% strengths.

Sponsor

Sigma Pharmaceuticals Pty Ltd

(A.C.N. 004 118 594)

1408 Centre Road
Clayton VIC 3136
Australia

(03)-9839 2800

Australian Registration numbers for Atropt Eye Drops are:

Atropt 0.5% eye drops AUST R 19647.
Atropt 1.0% eye drops AUST R 19648.

This document was prepared in August 1999.



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