IOPIDINE 0.5% EYE DROPS SOLUTION

Active substance: APRACLONIDINE

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S418 LEAFLET Iopidine 20121026

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.
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.

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

In this leaflet:

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.

1. What Iopidine is and what it is used for

Driving and using machines

2. Before you use Iopidine

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

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.

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.

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

Remove the loose collar from the cap when the bottle is first
opened.

2. BEFORE YOU USE IOPIDINE

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

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.

How to use



In CHILDREN under 12 years of age.



Wash your hands before you start.

Ask your doctor for advice.



Twist off the bottle cap.

Take special care...



Hold the bottle pointing down, between your thumb and fingers.



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



Tilt your head back.



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.



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).





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.

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).

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)





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

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





Kidney or liver problems

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.



Depression





Parkinson’s disease

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



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 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 you are due to have an operation.



Do not use a double dose to make up.

6. FURTHER INFORMATION



If Iopidine is swallowed, see your doctor immediately.

What Iopidine contains



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.



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.



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.

What Iopidine looks like and contents of the pack



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

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.

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 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.
5. HOW TO STORE IOPIDINE


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.

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: 26 October 2012
Iopidine is a registered trade mark of Alcon Inc, Switzerland.
S418 LEAFLET Iopidine 20121026

S418 LEAFLET Apraclonidine 20121026

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.
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.

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 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.
Pregnancy and breast-feeding

1. What Apraclonidine is and what it is used for

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.

2. Before you use Apraclonidine

Driving and using machines

3. How to use Apraclonidine
4. Possible side effects

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

5. How to store Apraclonidine

Important information if you wear Contact Lenses

6. Further information

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.

In this leaflet:

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.

3. HOW TO USE APRACLONIDINE

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

The usual dose

2. BEFORE YOU USE APRACLONIDINE

Remove the loose collar from the cap when the bottle is first
opened.

Do not use Apraclonidine...


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



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.



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

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



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.

How to use

Take special care...



Wash your hands before you start.



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



Twist off the bottle cap.



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.



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.



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)

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





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

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





Kidney or liver problems

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



Depression





Parkinson’s disease

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.



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



If you are due to have an operation.



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. 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.


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 APRACLONIDINE


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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.



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.

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.

What Apraclonidine 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.
Apraclonidine 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: 26 October 2012
S418 LEAFLET Apraclonidine 20121026

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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