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Package Leaflet: Information for the User

IOPIDINE® 5 mg/ml
eye drops, solution
(apraclonidine hydrochloride)

If you have a history of, or are taking medicine to treat, any of the following:
• Any heart disease (including angina, heart attacks or heart failure)
• High blood pressure or other circulatory problems (including stroke,
Raynaud’s disease and fainting spells)
• Kidney or liver problems
• Depression
• Parkinson's disease
• Diabetes or low blood sugar. IOPIDINE may hide the signs and symptoms of
a sudden reduction in blood sugar such as a fast heart beat or trembling.
• If you are due to have an operation.

This product is called IOPIDINE 5 mg/ml eye drops, solution but will be referred
to as IOPIDINE throughout this leaflet.

If any of these apply, you may still be able to use IOPIDINE, but discuss it
with your doctor first.

Read all of this leaflet carefully before you start using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Using IOPIDINE with food and drink

In this leaflet:
1. What IOPIDINE is and what it is used for
2. Before you use IOPIDINE
3. How to use IOPIDINE
4. Possible side effects
5. How to store IOPIDINE
6. Further information

1. What IOPIDINE is and what it is used for

No alcohol should be consumed during treatment with IOPIDINE as it can
increase its effects.

Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. IOPIDINE
must not be used if you are taking monoamine oxidase inhibitor
antidepressants or tricyclic antidepressants. IOPIDINE must also not be used if
you are taking medicines of the class of sympathomimetics that are taken either
orally or via injection. IOPIDINE may increase the effects of some medicines
used to treat - depression - asthma - high blood pressure - heart medicines
containing digoxin or digitoxin - some forms of mental illness and Parkinson’s
disease; and may interact with - some pain killers - sedatives - anaesthetic tricyclic antidepressants - phenothiazines - cough and cold remedies - glaucoma
medications such as timolol, brimonidine or dipivefrine - eye drops used to
whiten the eye.

IOPIDINE belongs to a group of medicines known as alpha agonists.

Pregnancy and breast-feeding

It is used in the treatment of chronic glaucoma in people who are already
receiving other medicines to treat this disease.

If you are pregnant or might get pregnant, or if you are breast-feeding a baby,
talk to your doctor before you use IOPIDINE.
IOPIDINE should not be used during pregnancy or breast-feeding.

In these people, IOPIDINE helps to reduce the fluid pressure in the eye and can
delay the need for pressure relieving eye surgery.

Driving and using machines

2. Before you use IOPIDINE
Do not use IOPIDINE...
• If you have a history of severe or unstable heart disease or circulatory
• If you are allergic to apraclonidine, clonidine or any of the ingredients listed in
section 6.
• If you are currently taking monoamine oxidase inhibitors antidepressants or
tricycylic antidepressants.
• If you are currently taking medicines of the class of sympathomimetics that are
taken either orally or via injection.
• In CHILDREN under 12 years of age.
Ask your doctor for advice.

Take special care...
• Only use IOPIDINE for dropping in your eye(s).
• IOPIDINE may not continue to control your eye pressure after you have used
them for a period of time. Your doctor will examine you often while you are
using IOPIDINE to see whether the eye drops are still working for you.
• As IOPIDINE decreases the pressure in your eye(s), you should have your eye
pressure checked regularly to ensure that the pressure in your eye(s) remains
under control.

This type of medicine may cause you to feel sleepy and dizzy. If you do, you
should not drive or operate machinery.

Important information if you wear Contact Lenses
Do not use the drops while wearing contact lenses. You should remove
contact lenses (hard or soft) before using IOPIDINE and wait at least 15 minutes
after use before putting your lenses back in. There is a preservative in
IOPIDINE (benzalkonium chloride) that may cause eye irritation and is known to
discolour soft contact lenses.

3. How to use IOPIDINE
The usual dose
The usual dose is 1 drop into your eye(s), 3 times each day.
Remove the loose collar from the cap when the bottle is first opened.
Always use IOPIDINE exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.

Continued over Î

3. How to use IOPIDINE (continued)

How to use
• Wash your hands before you start.
• Twist off the bottle cap.
• Hold the bottle pointing down,
between your thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with a
finger until there is a 'pocket'
between the eyelid and your eye.
The drop will go in here (picture 1).
• Bring the bottle tip close to the eye.
Do this in front of a mirror if it helps.
• Do not touch your eye or eyelid,
surrounding areas or other surfaces
with the dropper. It could infect the drops.
• Gently press on the base of the bottle
to release one drop at a time (picture 2).
• Do not squeeze the bottle,
only a gentle press on the bottom
is needed.
• After using IOPIDINE, press a finger
into the corner of your eye, by the
nose (picture 3). This helps to
stop IOPIDINE getting into the rest of
the body.
• If you use drops in both eyes,
repeat the steps for your other eye.
Put the bottle cap firmly back on
immediately after use.
• If a drop misses your eye, try again.
• If you forget to use IOPIDINE, continue with the next dose as
planned. However, if it is almost time for your next dose, skip the
missed dose and go back to your regular dosing schedule.
• Do not use a double dose to make up.
• If IOPIDINE is swallowed, see your doctor immediately.
• If you use more IOPIDINE than you should rinse it all out with warm
water. Do not put in any more drops until it is time for your next regular
dose. In case of accidental ingestion, symptoms of overdose may
include decreased blood pressure, drowsiness, decreased heart rate,
hypoventilation (reduced rate and depth of breathing), and convulsion.
If you are using other eye drop or eye ointment medicines, leave
at least 5 minutes between each medicine. Eye ointments should be
administered last.
If you have any further questions on the use of IOPIDINE, ask your
doctor or pharmacist.

Common (affect 1 to 10 people in 100):
discomfort - watery eyes - swelling of the eyelids - gritty feeling in the eye - dry
eye - eyelid crusting.
Uncommon (affect 1 to 10 people in 1000):
bumps under the eyelids - swelling of the eye - abnormal vision - pain inflammation and irritation of the eye or eyelids - corneal (the front part of the
eye) surface damage - sensitivity to light - redness of the eyelid - raising or
pulling up of the eyelids - increase in pupil size - reduced vision - blurred vision drooping of eyelid - discharge or whitening of the eye.
• You may also experience effects in other areas of your body including:
Common: dry mouth - inflammation inside the nose - dermatitis - dry nose weakness - headache - unusual taste.
Uncommon: chest pain - swelling of your hands, feet or extremities - irregular
heart beat - constipation - nausea - feeling tired - sore throat - runny nose muscle aches - poor coordination - sleepiness - dizziness - tingling feeling nervousness - depression - difficulty sleeping - shortness of breath or difficulty
breathing - unusual sense of smell - facial swelling - irritability - widening of
blood vessels.
If any of the side effects get serious, or you notice any side effects not listed
in this leaflet, tell your doctor or pharmacist.

5. How to store IOPIDINE
• Keep out of the sight and reach of children.
• Do not refrigerate or freeze or store above 25°C.
• Keep the bottle in the outer carton to protect it from light.
• Do not use the drops after the expiry date (marked 'Exp') on the bottle and the
carton. The expiry date refers to the last day of that month.
• Stop using the bottle 4 weeks after first opening, to prevent infections.
• Medicines should not be disposed of via waste water or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
• Do not pass this medicine on to others. It may harm them, even if their
symptoms are the same as yours.
• If the medicine becomes discoloured or shows any other signs of deterioration,
you should seek the advice of your pharmacist who will advise you what to do.

6. Further information
What IOPIDINE contains
• The active substance is apraclonidine. Each 1 ml of solution contains 5 mg
apraclonidine (as hydrochloride).
• The other ingredients are sodium chloride, sodium acetate, benzalkonium
chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified

What IOPIDINE looks like and contents of the pack
4. Possible side effects
Like all medicines, IOPIDINE can cause side effects, although not everybody
gets them.
IOPIDINE can cause allergic reactions. If you experience one or more of the
following eye symptoms - redness - itching - discomfort - watery eyes abnormal sensation - eye and eyelid swelling - poor vision - see your doctor
If your vision gets worse straight after using IOPIDINE, stop use and see
your doctor immediately.
• You may experience some or all of the following effects in your eye(s):
Very Common (affect more than 1 person in 10):
Increased redness - itching - inflammation.

IOPIDINE is a clear, colourless to pale yellow solution supplied in a pack
containing a 5 ml plastic bottle with a screw cap.
This product is manufactured by SA Alcon-Couvreur NV, Rijksweg 14, B-2870
Puurs, Belgium. It is procured from within the EU and repackaged by Mediwin
Limited. Product Licence Holder: Mediport Limited, 13 Martello Enterprise
Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, UK.
PL No: 18980/0811


IOPIDINE is a registered trademark of ALCON INC
Date of leaflet preparation: 25/07/2012


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.