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Minims Atropine Sulphate 1%

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PACKAGE LEAFLET: INFORMATION FOR THE USER PP1/1364/V2

Minims® Atropine Sulphate 1% w/v Eye Drops, solution

(atropine sulphate)

Read all this leaflet carefully before you start using your medicine. It contains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Remember this medicine is for you. Do not give it to someone else.

In this leaflet:

1.    What Minims Atropine Sulphate eye drops are and what they are used for

2.    Before you use your eye drops

3.    How to use your eye drops

4.    Possible side effects

5.    How to store your eye drops

6.    Further information

1.    What Minims Atropine Sulphate eye drops are and what they are used for

Minims Atropine Sulphate contains a mydriatic and cycloplegic agent. It is used to enlarge the pupil of your eye. Your doctor or eye specialist may use it to examine your eye more closely, or as part of a treatment program.

This medicine is indicated for children, adults and the elderly.

2.    Before you use your eye drops Do not use these drops if

■    you are allergic to the active substance (atropine sulphate ) or any of the ingredients (refer to the end of this leaflet).

■    you have history of closed angle glaucoma (with your eyes likely to develop sudden increased internal pressure when the pupil is enlarged).

If you are pregnant, may be pregnant, or are breastfeeding

Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative.

Contact lenses

Your doctor will ask you to remove your contact lenses prior to the administration of the drops.

Do not wear your contact lenses until the effects of the drops have completely worn off.

Driving and using machines

As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.

3. How to use your eye drops

The drops are in special single use “Minims” units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion.

Dosage

The normal dose is one drop in each eye. If necessary, your doctor or eye specialist will tell you to use more than one drop.

Method of administration

The doctor or eye specialist will normally put the drops in your eye for you, but if you are putting the eye drops in yourself, then follow these instructions carefully:

1.    Wash your hands.

2.    Use a mirror, this will help you to see what you are doing.

3.    Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit.

4.    Pull your lower eyelid down gently, and then carefully place 1 drop inside your lower eyelid.

5.    Close your eye and blink a few times to make sure your eye is covered by the liquid.

6.    Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining into your nose and throat. This is especially advisable in children, the elderly and population at risk.

7.    Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains.

If you use more Minims Atropine Sulphate than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately.

PL 20774/1364 POM


4.    Possible side effects

The following side effects may occur occasionally:

■    the skin around the eyes can be sore. Your eyes can be swollen, red and itchy. This is more likely to happen if the drops are used more than once.

■    dry mouth,

■    flushing of the skin,

■    increased body temperature,

■    constipation,

■    difficulty in passing urine,

■    fast heartbeat.

If any of the side effects gets serious, please seek immediate medical attention. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store your eye drops

Keep out of the sight and reach of children.

Do not use the eye drops after the expiry date which is stated on the overwrap of each unit and on the carton after the letters “EXP”. The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Store in original container in order to protect from light.

If your medicine show any signs of deterioration or discolouration, consult your pharmacist for advice. If damaged please tell your doctor or pharmacist.

6. Further information

What do your eye drops contain

■    The active ingredient is atropine sulphate. Each Minims unit contains approximately 0.5 ml eye drops solution of atropine sulphate 1% w/v (5 mg).

■    The other ingredients are hydrochloric acid (for pH adjustment) and purified water.

This medicine does not contain a preservative as it is a sterile single use unit.

Contents of the pack

Clear, colourless, sterile eye drop in a plastic single use unit.

Each carton contains 20 units.

Minims Atropine Sulphate 1% w/v Eye Drops, solution

Manufactured by: Laboratoire Chauvin S.A. Z.I. Ripotier, 07200 Aubenas -France. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton,

BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.

Leaflet revision date: 22nd October 2013

Minims is a registered trademark of Bausch & Lomb BV.

PP1/1364/V2