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IOPIDINE 0.5% W/V EYE DROPS SOLUTION

Active substance(s): APRACLONIDINE

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Iopidine ®0.5% w/v Eye Drops Solution

Ref: 0051/160115/1/F

(apraclonidine hydrochloride)
Patient Information 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.
Your medicine is called Iopidine Eye Drops but will
be referred to as Iopidine throughout the leaflet.

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.
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
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

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.

• 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

4

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 container in the outer carton.
• 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 one
month after first opening.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
• If your Eye Drops show any sign of deterioration or
discolouration, consult your pharmacist for advice.

6

Further Information

What Iopidine contains
The active substance contains apraclonidine
hydrochloride 0.575% w/v (equivalent to
apraclonidine 0.5%w/v).
Other ingredients: benzalkonium chloride 0.1
mg/ml 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.

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 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 0.5% w/v Eye Drops Solution 5ml
Iopidine is a clear, colourless to pale yellow
solution contained in a white 5 ml plastic dropper
bottle with a tamper evident seal prior to first
opening.
Manufacturer and Licence Holder
This medicine is manufactured by SA
Alcon-Couvreur NV, B-2870 Puurs, Belgium and is

POM

PL 33723/0051 - Iopidine

Iopidine is a registered trademark of Alcon Inc.
Leaflet revision date: 16/01/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

• You may also experience effects in other areas
of your body including:
Ref: 0051/160115/1/B

Ref: 0051/160115/2/F

®

Apraclonidine 0.5% w/v Eye Drops Solution
(apraclonidine hydrochloride)
Patient Information 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.
Your medicine is called Apraclonidine Eye Drops but
will be referred to as Apraclonidine throughout the
leaflet.

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

What Apraclonidine is and what it is
used for

APRACLONIDINE 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, APRACLONIDINE helps to reduce
the fluid pressure in the eye and can delay the need
for pressure relieving eye surgery

2

Before you use Apraclonidine

Do not use APRACLONIDINE...
• 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 APRACLONIDINE for dropping in your
eye(s).
• APRACLONIDINE 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 APRACLONIDINE to see whether
the eye drops are still working for you.
• As APRACLONIDINE 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. APRACLONIDINE
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
APRACLONIDINE, but discuss it with your doctor
first.
Using APRACLONIDINE with food and drink
No alcohol should be consumed during treatment
with APRACLONIDINE 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.
APRACLONIDINE must not be used if you are
taking monoamine oxidase inhibitor antidepressants
or tricyclic antidepressants. APRACLONIDINE
must also not be used if your are taking medicines
of the class of sympathomimetics that are taken
either orally or via injection. APRACLONIDINE 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 APRACLONIDINE.
APRACLONIDINE 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 APRACLONIDINE and wait at
least 15 minutes after use before putting your lenses
back in. There is a preservative in
APRACLONIDINE (benzalkonium chloride) that may
cause eye irritation and is known to discolour soft
contact lenses
3

How to use Apraclonidine

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 APRACLONIDINE exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

• 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 APRACLONIDINE, press a finger into
the corner of your eye, by the nose (picture 3).
This helps to stop APRACLONIDINE 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 APRACLONIDINE, 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 APRACLONIDINE is swallowed, see your
doctor immediately.
• If you use more APRACLONIDINE 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
APRACLONIDINE, ask your doctor or pharmacist

4

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 Apraclonidine

• Keep out of the sight and reach of children.
• Do not store above 25°C. Do not refrigerate or
freeze. Keep the container in the outer carton.
• 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 one
month after first opening.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
• If your Eye Drops show any sign of deterioration or
discolouration, consult your pharmacist for advice.

6

Further Information

What APRACLONIDINE contains
The active substance contains apraclonidine
hydrochloride 0.575% w/v (equivalent to
apraclonidine 0.5%w/v).
Other ingredients: benzalkonium chloride 0.1
mg/ml 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.

Possible side effects

Like all medicines, APRACLONIDINE can cause
side effects, although not everybody gets them.
APRACLONIDINE 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
APRACLONIDINE, 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 APRACLONIDINE looks like and contents
of the pack
APRACLONIDINE 0.5% w/v Eye Drops Solution
5ml.
APRACLONIDINE is a clear, colourless to pale
yellow solution contained in a white 5 ml plastic
dropper bottle with a tamper evident seal prior to
first opening.
Manufacturer and Licence Holder
This medicine is manufactured by SA
Alcon-Couvreur NV, B-2870 Puurs, Belgium and is

POM PL 33723/0051 - Apraclonidine
Apraclonidine is a registered trademark of Alcon Inc.
Leaflet revision date: 16/01/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

• You may also experience effects in other areas
of your body including:
Ref: 0051/160115/2/B

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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