Skip to Content

IOPIDINE 1% W/V OPHTHALMIC SOLUTION

Active substance(s): APRACLONIDINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Notice IOPIDINE
UK-IRL (GBI)
AB

431202
Bleu banquise

Insert R°/V° 115 x 306 mm
Chalvet ou Tonnellier

Contrôlé par rapport à

[]FILM

l’épreuve V.......... du.............................

Contrôlé et approuvé par

/ []BAT

Name

Name

5° proof 14/01/2016

QQ 1/1 NOIR

QQ DECOUPE

Plan Alcon : 110702 V1
Type machine : MANUEL

431202

Package Leaflet : Information for the User

Date

Date

in one drop 1 hour before your laser surgery and
another drop immediately after surgery.
After being given IOPIDINE, you will be
instructed to press a finger to the corner of
your eye, by your nose. This helps to stop
IOPIDINE getting into the rest of the body.
Children
This medicine is not for use in children.

IOPIDINE 1%w/v
eye drops solution
(Apraclonidine Hydrochloride)

1937

4. Possible side effects
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 pharmacist.
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.
RA APPROVAL

The undersigned :

In this leaflet
1. What IOPIDINE is and what it is used for
2. Before you are given IOPIDINE
3. How IOPIDINE is given to you
4. Possible side effects
5. How IOPIDINE is stored
6. Further information
IOPIDINE eye drops will be put in by your
doctor. This leaflet is provided to give you
information on your medicine.

1. What IOPIDINE is and what it is
used for
IOPIDINE eye drops contain apraclonidine which
is used to control or prevent the pressure in the
eye increasing after laser surgery.

2. Before you are given IOPIDINE
This medicine may not be suitable for you. If it
is not suitable your doctor may want to give
you another medicine so it is important you
check all of the points below:
IOPIDINE will not be used
* in children (this medicine is not for anyone
under the age of 18);
** If you are allergic to clonidine,
apraclonidine or any of the ingredients
listed in the “Other ingredients” section
of this leaflet (section 6)
* if you have a history of any severe or
unstable and uncontrolled heart disease
(including chest pain, angina, heart attacks
or heart failure);
If you think any of the above conditions apply to
you or if you are not sure, talk to your doctor first.
Special care will be taken using IOPIDINE.
Ask your doctor for advice if:
* you suffer from, or are taking
medication for:
- heart disease (including chest pain,
angina, heart attacks or heart failure;
- high blood pressure;
- circulatory problems (including stroke,
Raynaud’s disease or Buerger’s disease);
- vasovagal attacks (fainting spells);
- reduced kidney or liver function;
If any of the above apply to you, you may be at
greater risk for effects on your heart or
circulatory system so your blood pressure and
heart rate will be closely monitored.
* you suffer from depression, as
medicines like clonidine have been
associated with depression;
* you suffer from diabetes or low blood
sugar, as this medicine may hide the signs
and symptoms of a sudden reduction in blood
sugar such as a fast heartbeat or trembling;
* you regularly drink alcohol, as IOPIDINE
may increase its effect;
* you have had an extreme response to
other medicines that lower the pressure

inside your eye, so your eye pressure should
be monitored closely;
If any of the above applies to you, or if you are
not sure, talk to your doctor first.
Using other medicines
IOPIDINE will not be used
* if you are taking monoamine oxidase
inhibitors (used to treat depression) e.g.
phenelzine, isocarboxazid, tranylcypromine,
moclobemide
* if you are taking tricyclic antidepressants
(often used to treat depression) e.g.
amitriptyline, imipramine, doxepin, mianserin,
trazodone, dosulepin, lofepramine;
* if you are currently using medicines
containing sympathomimetic agents.
These agents are used to treat many
diseases, including asthma e.g. salbutamol,
terbutaline, bambuterol, Parkinson’s disease
and heart disease and also may be present in
cough and cold remedies.
Special care will be taken using IOPIDINE
* if you are using eye drops to treat
glaucoma which contain sympathomimetics
e.g. phenylephrine, brimonidine, dipivefrine
as your blood pressure may increase; or
* if you are taking sleeping tablets,
sedatives or painkillers, as IOPIDINE
may increase their effects;
* if you are taking or have taken
neuroleptics (major tranquillisers used to
treat some forms of mental illness e.g.
chlorpromazine, flupentixol, haloperidol) as
your blood pressure could become too low;
When there might be effects on your blood
pressure then your blood pressure and heart
rate will be closely monitored.
Discuss any medicines you are taking with your
doctor before you are given IOPIDINE, including
medicines obtained without a prescription.
Using IOPIDINE with food and drink
IOPIDINE should be used with caution if you
regularly drink alcohol or have recently drunk
alcohol.
Use during pregnancy and breastfeeding
If you are pregnant, planning to become
pregnant or are breastfeeding, IOPIDINE
should only be used if clearly needed.
Your doctor should have discussed this with
you. If not, ask your doctor for advice before
taking any medicine.
Driving and using machines
This type of medicine may cause you to feel
sleepy. If you are affected, do not drive or use
any tools or machines.

3. How IOPIDINE is given to you
Adults and elderly
IOPIDINE comes in a specially designed container
which can be used only once. Your doctor will put

name

vorname

confirms 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
- components if mentionned
- shelflife if mentionned
- storage conditions
- trademarks

This proof is approved :
R as is
R conditionally
Customer request :
R new proof
Signature and date :

Like all medicines, IOPIDINE can have side
effects, although not everybody gets them.
When used before and after laser surgery,
you may experience some or all of the
following reactions in your eyes.
Common
(may affect up to one in 10 people treated)
- redness in the eye or eyes.
Uncommon
(may affect up to one in 100 people treated)
- bleeding on the surface of your eye
(conjunctival haemorrhage);
- one pupil getting bigger;
- eye inflammation (which may include pain,
heat, redness or swelling of the eye); or
- your upper eyelid lifting up.
Or, you may suffer reaction in other areas of
your body.
Uncommon
(may affect up to one in 100 people treated)
- a dry feeling in your nose; or
- an irregular heartbeat.
Additional experience with IOPIDINE has
shown that when used once or twice daily
repeatedly for other uses (not laser
surgery), patients may experience some or
all of the following reactions in their eyes.
Uncommon
(may affect up to one in 100 people treated)
- extremely low pressure inside the eye
(your doctor will see this during eye tests);
- reduced or dim vision;
- bleeding on the surface of your eye;
- the pupil getting bigger;
- blurred vision;
- eye allergy;
- your upper eyelid lifting;
- your eye itching;
- your eye feeling dry;
- an eye disorder (whitening of the surface
of the eye);
- eye irritation;
- discomfort; or
- an unusual or uncomfortable feeling in
your eye.
Or, reactions in other parts of the body.
Uncommon
(may affect up to one per 100 people treated)
- difficulty sleeping;
- disturbed dreams;
- fainting spells;
- burning or tingling sensations;
- a lower sex drive;
- feeling irritated;
- a slow heartbeat or palpitations;
- dizziness or feeling faint when you sit up
or stand up;
- diarrhoea;
- being sick or vomiting;
- pain or discomfort in your stomach.
Rare
(may affect up to one in 1000 people treated)
- reduced sensation or numbness;
- a bad or unusual taste in your mouth;
- headaches;

- shortness of breath;
- a runny nose or too much saliva;
- a dry feeling, or burning in your nose;
- a dry mouth;
- increased sweating;
- itching skin;
- pain in your arms or legs;
- heaviness or pain in your chest;
- tiredness; and
- feeling hot or cold.
If you experience an allergic
reaction, feel unusually dizzy or
lightheaded, or experience
irregular heartbeats, you
should tell your doctor
immediately.
Reporting of side effects
If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet. You can also report side
effects directly via the national reporting
system (see details below). By reporting side
effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website : www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace - IRL - Dublin 2
Tel : +353 1 6764971
Fax : +353 1 6762517
Website : www.hpra.ie
e-mail : medsafety@hpra.ie

5. How IOPIDINE is stored
• This medicine should not be used after the
expiry date shown as ‘EXP’ on the package
and plastic container. The expiry date refers
to the last day of that month.
• This medicine should not be stored above
25°C and should be kept in the outer carton
to protect it from the light.
• Keep out of the reach and sight of children.
• The medicine should be used immediately
after opening the container.

6. Further information
The active substance is apraclonidine
1%w/v (10mg/ml) (as hydrochloride).
Other ingredients are sodium acetate,
sodium chloride and purified water. Very small
amounts of hydrochloric acid or sodium
hydroxide may have been added to make the
drops comfortable for your eyes.
IOPIDINE eye drops solution is pale yellow
and comes in a container of 0.25 ml.
The marketing authorisation holder
for IOPIDINE is:
Alcon Laboratories (UK) Ltd
Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR
United Kingdom
The manufacturer of IOPIDINE is:
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in January 2016.
© 2013, 2016 Novartis

431202

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.

Hide