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APRACLONIDINE 5 MG/ML EYE DROPS SOLUTION

Active substance(s): APRACLONIDINE

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PATIENT INFORMATION LEAFLET

3010
14.07.17[2]

Iopidine® 5 mg/ml, Eye Drops, Solution
(apraclonidine hydrochloride)
Your medicine is available using the above name but it will be referred to
as Iopidine throughout this leaflet
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.
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
Iopidine belongs to a group of medicines known as alpha agonists.
It is used in the treatment of chronic glaucoma in people who are
already receiving other medicines to treat this disease.
In these people, Iopidine helps to reduce the fluid pressure in the eye and
can delay the need for pressure relieving eye surgery.
2. Before you use Iopidine
Do not use Iopidine...
 If you have a history of severe or unstable heart disease or
circulatory problems.
 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.

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.

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).

If any of these apply, you may still be able to use Iopidine, but discuss
it with your doctor first.
Using Iopidine with food and drink
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.
Pregnancy and breast-feeding
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.
Driving and using machines
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.

 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.

4. Possible side effects
Like all medicines, Iopidine can cause side effects, although not
everybody gets them.

 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.

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 immediately.

6. Further information
What Iopidine contains
Each ml of solution contains 5 mg apraclonidine (as hydrochloride).
Iopidine also contains benzalkonium chloride as a preservative, sodium
acetate trihydrate, sodium chloride, and purified water. Very small
amounts of hydrochloric acid and/or sodium hydroxide may have been
added to regulate the acidity/alkalinity of the product to ensure comfort in
the eye.

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.
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
your 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.

What Iopidine looks like and contents of the pack
Iopidine is a clear, colourless to pale yellow solution contained in a 5 ml
plastic dropper bottle
Manufacturer and Product Licence Holder
Manufactured by SA ALCON-COUVREUR NV, Rijksweg 14, B-2870
Puurs, Belgium and procured from the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/3010

Leaflet revision and issue date Ref: 14.07.17[2]
Iopidine is a registered trademark of Alcon, Inc

 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store Iopidine
 Keep out of the sight and reach of children.
 Do not store above 25°C. Do not refrigerate or freeze.
 Keep the bottle in the outer carton to protect from light.
 Do not use this medicine after the expiry date shown as "EXP" on the
bottle and carton.
 This medicine must not be used for more than 4 weeks after first
opening.
 If the eye drops become discoloured or show signs of any deterioration
you should seek the advice of your pharmacist.
 If your doctor tells you to stop taking this medicine, return any unused
medicine to your doctor or pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

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Further information

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

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