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APRACLONIDINE 0.5% EYE DROPS SOLUTION

Active substance: APRACLONIDINE

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S418 LEAFLET Iopidine 20150324

PACKAGE LEAFLET: INFORMATION FOR THE USER
IOPIDINE 0.5% EYE DROPS SOLUTION
(apraclonidine hydrochloride)
Your medicine is known as Iopidine 0.5% Eye Drops Solution but
will be referred to as Iopidine throughout the following patient
information leaflet.



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

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

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.

4. Possible side effects
5. How to store Iopidine
6. Further information
1. WHAT IOPIDINE IS AND WHAT IT IS USED FOR

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

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.

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



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

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.



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

3. HOW TO USE IOPIDINE



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.

2. BEFORE YOU USE IOPIDINE
Do not use Iopidine...

Ask your doctor for advice.
Take special care...

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.



Only use Iopidine for dropping in your eye(s).

How to use



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.



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.



Any heart disease (including angina, heart attacks or heart
failure)

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).





High blood pressure or other circulatory problems (including
stroke, Raynaud’s disease and fainting spells)

Bring the bottle tip close to the eye. Do
this in front of a mirror if it helps.





Kidney or liver problems



Depression

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



Parkinson’s disease



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.



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:




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.



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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Iopidine should not be stored above 25°C. Do not refrigerate or
freeze. Keep the container in the outer carton to protect from
light. Discard one month after first opening.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Do not use a double dose to make up.



5. HOW TO STORE IOPIDINE

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.

6. FURTHER INFORMATION
What Iopidine contains


It contains 0.5%w/v (5mg in each millilitre) of the active
ingredient apraclonidine (as hydrochloride).



Iopidine also contains the following inactive ingredients:
hydrochloric acid and/or sodium hydroxide, benzalkonium
chloride, sodium acetate (trihydrate), sodium chloride and
purified water.

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.

What Iopidine looks like and contents of the pack
It is a clear, colourless solution in a white plastic bottle with a white
tamper evident screw cap.
Iopidine is available in 5ml plastic dropper bottles.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by SA Alcon-Couvreur NV, Rijksweg
14, B-2870 Puurs, Belgium.
POM

PL No: 19488/0418

Leaflet revision date: 24 March 2015
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.


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.
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.

Iopidine is a registered trade mark of Alcon Inc, Switzerland.
S418 LEAFLET Iopidine 20150324

S418 LEAFLET Apraclonidine 20150324

PACKAGE LEAFLET: INFORMATION FOR THE USER
APRACLONIDINE 0.5% EYE DROPS SOLUTION
(apraclonidine hydrochloride)
Your medicine is known as Apraclonidine 0.5% Eye Drops Solution
but will be referred to as Apraclonidine throughout the following
patient information leaflet.



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

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 Apraclonidine is and what it is used for
2. Before you use Apraclonidine
3. How to use Apraclonidine

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 you 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.

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.

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

2. BEFORE YOU USE APRACLONIDINE
Do not use Apraclonidine...

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.



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.

3. HOW TO USE APRACLONIDINE



If you are currently taking medicines of the class of
sympathomimetics that are taken either orally or via injection.

The usual dose is 1 drop into your eye(s), 3 times each day.



In CHILDREN under 12 years of age.

Ask your doctor for advice.
Take special care...


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.

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.

Only use Apraclonidine for dropping in your eye(s).



The usual dose



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



Parkinson’s disease



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).

Depression



How to use



Do not squeeze the bottle, only a gentle press on the bottom
is needed.

5. HOW TO STORE APRACLONIDINE


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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.





Apraclonidine should not be stored above 25°C. Do not
refrigerate or freeze. Keep the container in the outer carton to
protect from light. Discard one month after first opening.

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





Do not use after the expiry date printed on the carton or bottle
label.

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.

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

6. FURTHER INFORMATION
What Apraclonidine contains


It contains 0.5%w/v (5mg in each millilitre) of the active
ingredient apraclonidine (as hydrochloride).



Apraclonidine also contains the following inactive ingredients:
hydrochloric acid and/or sodium hydroxide, benzalkonium
chloride, sodium acetate (trihydrate), sodium chloride and
purified water.

If you have any further questions on the use of Apraclonidine,
ask your doctor or pharmacist.

What Apraclonidine looks like and contents of the pack

4. POSSIBLE SIDE EFFECTS

It is a clear, colourless solution in a white plastic bottle with a white
tamper evident screw cap.

Like all medicines, Apraclonidine can cause side effects, although
not everybody gets them.

Apraclonidine is available in 5ml plastic dropper bottles.

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.

Product Licence holder

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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by SA Alcon-Couvreur NV, Rijksweg
14, B-2870 Puurs, Belgium.
POM

Common (affect 1 to 10 people in 100): discomfort - watery eyes swelling of the eyelids - gritty feeling in the eye - dry eye - eyelid
crusting.

PL No: 19488/0418

Leaflet revision date: 24 March 2015

S418 LEAFLET Apraclonidine 20150324

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.


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.
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.

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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