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IOPIDINE 5MG/ML EYE DROPS

Active substance(s): APRACLONIDINE / APRACLONIDINE HYDROCHLORIDE

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KAPVORM

PMS ZWART
à 100 %

64248-2

Package Leaflet - Information for the User

IOPIDINE

®

5 mg/ml eye drops, solution
Apraclonidine (as hydrochloride)

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

4. Possible side effects

2. Before you use IOPIDINE

6. Further information

5. How to store IOPIDINE

3. How to use IOPIDINE

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.

2

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

BEFORE YOU USE IOPIDINE®

Do not use IOPIDINE...

Using IOPIDINE with food and drink

• If you have a history of severe or unstable heart
disease or circulatory problems.

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

• If you are allergic to apraclonidine, clonidine or
any of the ingredients listed in section 6.

Using other medicines

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

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 your 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.

Continued over

InDesign CS4

Iopidine 5 mg/ml - 5/10 ml

recto-verso

GBI

AANTAL KLEUREN : 1

HB

26-08-2013

Local
Graphics

140 x 335 / 140 x 22 mm

Approval

BELGIUM 64248-2

BESOP-00326

Affiliates

V2

Ready for sending:

as is.

new proof.

Final release:

as is.

new proof.

With approval in Catalyst you confirm that this proof contains an accurate translation of the
English Corporate Standard text, and is in compliance with the registered information and
the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if
mentioned, storage conditions and trademarks.

KAPVORM

PMS ZWART
à 100% - 20%

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.

How to use

• Do not touch your eye or
eyelid, surrounding areas or other
surfaces with the dropper. It could
infect the drops.

• Wash your hands before you start.
• Twist off the bottle cap.
• Hold the bottle pointing down,
between your thumb and fingers.

• Gently press on the base of the
3
bottle to release one drop at a time
(picture 2).

1

• 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 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.

2

• If you use drops in both eyes, repeat the steps for
your other eye. Put the bottle cap firmly back on
immediately after use.
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 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.

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
immediately.
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

5

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.
• 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.

HOW TO STORE IOPIDINE®

• Keep out of the reach and sight of children.
• Do not refrigerate or freeze or store above 25°C.
• Keep the bottle tightly closed and in the outer
carton.
• 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.

6

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.

• 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.

FURTHER INFORMATION

What IOPIDINE contains

What IOPIDINE looks like and
contents of the pack

• The active substance is apraclonidine
5 mg/ml (as hydrochloride).
• The other ingredients are sodium chloride, sodium
acetate trihydrate, benzalkonium chloride,
hydrochloric acid and/or sodium hydroxide (to
adjust pH) and purified water.

Marketing authorisation holder :
Alcon Laboratories (UK) Ltd.
Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.

IOPIDINE is a clear, colourless to pale yellow
solution supplied in a pack containing a 5 ml
or 10 ml plastic bottle with a screw cap.

Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in August 2013.
®

© 2005, 2011, 2013 Novartis
07-2013

64248-2

InDesign CS4

Iopidine 5 mg/ml - 5/10 ml

recto-verso

GBI

AANTAL KLEUREN : 1

HB

26-08-2013

Local
Graphics

140 x 335 / 140 x 22 mm

Approval

BELGIUM 64248-2

BESOP-00326

Affiliates

V2

Ready for sending:

as is.

new proof.

Final release:

as is.

new proof.

With approval in Catalyst you confirm that this proof contains an accurate translation of the
English Corporate Standard text, and is in compliance with the registered information and
the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if
mentioned, storage conditions and trademarks.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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