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IZINOVA CONCENTRATE FOR ORAL SOLUTION

Active substance(s): MAGNESIUM SULPHATE HEPTAHYDRATE / POTASSIUM SULPHATE / SODIUM SULPHATE ANHYDROUS

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1045138

1045138 - Izinova GB:- 17/12/15 10:15 Page1

PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

IZINOVA

concentrate for oral solution
Sodium sulphate anhydrous,
magnesium sulphate heptahydrate
and potassium sulphate



This medicine is subject to
additional monitoring. This will
allow quick identification of new
safety information. You can help by
reporting any side effects you may
get. See the end of section 4 for
how to report side effects.
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Always take this medicine exactly
as described in this leaflet or as
your doctor, pharmacist or nurse
have told you.
• Keep this leaflet. You may need
to read it again.
• Ask your pharmacist if you need
more information or advice.
• If you get any side effects, talk
to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this
leaflet. See section 4.
• You must talk to a doctor if you
do not feel better or if you feel
worse.
What is in this leaflet
1. What Izinova is and what it is
used for
2. What you need to know before
you take Izinova
3. How to take Izinova
4. Possible side effects
5. How to store Izinova
6. Contents of the pack and other
information
1. What Izinova is and what it is
used for
Izinova contains three different
active substances called: sodium
sulphate, magnesium sulphate and
potassium sulphate.
Izinova is used in adults to cleanse
your bowel before a medical
procedure or bowel surgery.
Izinova is not a treatment for
constipation.
Izinova must be diluted before use
with the amount of water stated
in the method of administration
(see section 3).
2. What you need to know
before you take Izinova
Do not take Izinova if:
• You are allergic to sodium
sulphate, magnesium sulphate or
potassium sulphate or any of the
other ingredients of this medicine
(listed in section 6).
• You have any of the following
stomach or gut problems:
– a known or suspected obstruction
in the gut
– a perforated gut wall
– a stomach emptying problem
(such as gastroparesis)
– paralysis of the gut
– toxic colitis or toxic megacolon
– excessive vomiting.
• You are severely dehydrated.
• You have a severe heart problem
(congestive heart failure).
• You have ascites (excessive
build-up of fluid in your abdomen).
• You have a severe kidney problem
(severe renal insufficiency).

• You suffer from active inflammatory
bowel disease (Crohn’s disease
or ulcerative colitis).
If you are not sure, talk to your
doctor before taking Izinova.
Warnings and precautions
Talk to your doctor before taking
Izinova if:
• You are dehydrated (the signs
may include dry mouth, feeling
thirsty, headache, feeling dizzy,
urinating less than usual, extreme
fatigue, heart palpitations and
confusion).
• You have ever had abnormal
sodium or potassium levels in
your blood.
• You have a heart problem.
Izinova may affect the rhythm of
the heart due to changes in the
levels of salts in the blood. Your
doctor may need to monitor you
during your treatment.
• You have a kidney problem.
• You have a liver problem.
• You have a ‘uric acid’ problem
(gout or any other).
• You have a problem swallowing.
• You have ‘reflux’ where acid from
your stomach goes into your
food pipe.
• You are physically weak or in
fragile health.
• You have reduced movement
in part or all of your intestines
(hypomotility).
• You have history of medical
conditions or gastrointestinal
surgery that predispose to
hypomotility disorders.
If you are frail or elderly (65 years
old or more), have a serious kidney,
liver, or heart condition or if you are
at risk of changes to levels of salts
in your body (electrolyte imbalances)
your doctor may decide to perform
a specific monitoring before and
after the procedure. You should
also pay particular attention to the
recommendations given in this
section of the leaflet as well as in
the section ‘Other medicines and
Izinova’ and ‘How to take Izinova’.
If you suffer from significant vomiting
or if you feel symptoms of dehydration
(e.g. dry mouth, feeling thirsty) after
taking this medicine, please contact
your doctor who should set up
rehydration measures.
If any of the above apply to you
(or you are not sure), talk to your
doctor before taking Izinova.
You will have frequent, loose bowel
movements after taking the medicine.
This is normal and shows that the
medicine is working. Make sure
you stay near to a toilet until the
effect of the medicine has worn off.
You should follow the instructions
for use of Izinova exactly and drink
as much water or clear liquids as
you need to stop you becoming
dehydrated.
Children and adolescents
Izinova is not for use in patients
below 18 years old. Its safety and
efficacy has not yet been established
in this population.
Other medicines and Izinova
Tell your doctor or pharmacist if
you are taking, have recently taken
or might take any other medicines.
This includes medicines obtained
without a prescription and herbal
medicines.

If you are taking any other medicines,
take them one to three hours before
taking Izinova or at least one hour
after the end of your cleansing
process. This is because the
diarrhoea caused by Izinova can
flush medicines from the body so
they may not work as expected.
Special care should be taken with:
• Medicines which may change the
levels of fluid or salts in the blood
(such as diuretics, calcium channel
blockers or lithium treatment) or
medicines that affect the rhythm
of the heart.
• Medicines regularly taken
by mouth: for example, oral
contraceptives, medicines for
epilepsy or diabetes or antibiotics,
levothyroxine (a hormone to treat
reduced function of the thyroid
gland), or digoxine (used for
heart problems) because Izinova
may delay or completely prevent
the absorption of these oral
medicines, making them less
effective or ineffective.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think that you may be pregnant or
are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.
If you are breast-feeding, you
should not breast-feed your child
for 48 hours after taking the second
dose of Izinova.
Driving and using machines
Izinova is not likely to affect you
being able to drive or use any tools
or machines.
Izinova contains sodium and
potassium
If you are on a controlled salt
(sodium or potassium) diet, please
note that each bottle of Izinova
contains 5.683g (247.2 mmol)
sodium and 1.405g (35.9 mmol)
potassium.
3. How to take Izinova
Always take this medicine exactly
as described in this leaflet or as
your doctor has told you. Check
with your doctor or pharmacist if
you are not sure.
Taking this medicine
• Take this medicine by mouth.
• The day before your procedure
you can have a light breakfast.
After breakfast only have clear
liquids for lunch, dinner and any
other meals until the procedure is
performed. Do not drink red and
purple liquids, milk or alcoholic
beverages.
• Izinova is provided as 2 bottles
packed in a box with a cup for
dilution and to give the medicine.
You need all these for your
treatment.
• Do not drink the content of both
bottles at the same time.
• Do not drink the content of the
bottles before you have diluted
them.
• Do not forget to drink the extra
amount of water or authorised
clear liquid.
• Your doctor will give you a form
to record the time you start the
treatment and the amount of
liquids you have drunk during
the bowel cleansing preparation.
You should follow the instructions
exactly and drink as much water
or clear liquids as you need to
stop you becoming dehydrated.

1045138 - Izinova GB:- 17/12/15 10:15 Page2

• ‘Clear liquids’ are water, tea
or coffee (no milk or non-dairy
creamer), fizzy (carbonated) or
still (non-carbonated) soft drinks,
strained fruit juices without pulp
(not coloured red or purple), clear
soup or soup strained to remove
any solids.
Do not drink any alcoholic
beverages.
How and when to take this
medicine
Izinova can either be taken as a
‘Two-day’ or as a ‘One-day’ plan.
Your doctor will decide which plan
you should take and its timing.
– In the absence of anaesthesia,
you have to stop drinking any
liquid at least one hour before
the start of the procedure.
– In case of anaesthesia, you have
to stop drinking any liquid usually
at least 2 hours before the start
of the procedure, taking into
account the instructions of
the anaesthetist.
‘Two-day’ plan
The administration is divided
between the evening before the
procedure and the morning of
the day of the procedure.
The day before the procedure:
– begin the first part of the plan
(first bottle) in the early evening
(i.e. not later than 6 pm).
The day of the procedure:
– begin the second part of the
plan (second bottle) in the early
morning, 10 to 12 hours after
starting the first part of the plan
(first bottle).
‘One-day’ plan
The administration is started and
completed the evening before
the procedure.
The day before the procedure:
– begin the first part of the plan
(first bottle) in the early evening
(i.e. not later than 6 pm).
– begin the second part of the
plan (second bottle) about
2 hours after starting the first
part of the plan (first bottle).
Whatever the plan selected by your
doctor, the following steps should
be followed for both the first and
the second parts of the plan:
Open the childproof bottle
by pressing down on the
lid and twisting anticlockwise.
2

3

4

5

6

Pour the contents of one
bottle of Izinova into the
cup.

Add water to the medicine
until the level reaches the
line on the cup.

Steps 1 to 6 should take around
2 hours and should be repeated
for the second part of the plan.
Whatever the plan, you have to
stop drinking any liquid:
– At least one hour before the start
of the procedure in the absence
of anaesthesia,
– Usually at least 2 hours before the
start of the procedure in case of
anaesthesia, taking into account
the instructions of the anaesthetist.
If you take more Izinova than you
should
• If you think you have taken too
much Izinova, or did not dilute
as instructed, or did not drink
enough additional water, tell your
doctor and drink sufficient water
or clear liquids to stop you
becoming dehydrated.
If you forget to take Izinova
• If you forget a dose, talk to your
doctor as soon as possible as it
may mean that the medicine will
not work as expected.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although
not everybody gets them. The
following side effects may
happen with this medicine:
Stop taking Izinova and see a
doctor straight away, if you
notice any of the following:
• An allergic reaction – the signs
may include skin rash or redness,
itching, difficulty breathing or
swelling of the throat.
Other side effects include:
Very common (may affect more
than 1 in 10 people)
• General discomfort
• Feeling sick (nausea) or being
sick (vomiting)
• Stomach bloating or pain.
Uncommon (may affect up to
1 in 100 people)
• Chills
• Dry mouth
• Headache
• Dizziness
• Pain when urinating
• Discomfort in your anus or rectum
• Changes in the level of certain
things in your blood. Examples
include: increased aspartate
aminotransferase, creatine
phosphokinase, lactate
dehydrogenase, phosphorus,
bilirubin or uric acid and decreased
sodium, potassium or calcium.
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 Izinova
• Keep this medicine out of the
sight and reach of children.
Take your time (over half
• Do not use this medicine after
an hour to an hour) to drink
the expiry date which is stated
all the liquid in the cup.
on the carton and bottle after
EXP. The expiry date refers to the
IMPORTANT: Drink two (2)
last day of that month.
more cups of water or
• This medicine does not require
clear liquid. Each time, fill
any special temperature storage
the cup with water or clear
conditions.
liquid to the line.
• Store in the original package, in
order to protect from light.
• After first opening the bottle
Take your time (over half
and/or diluting with water, the
an hour) to drink all the
solution should be used
liquid of each cup.
immediately.

• Do not throw away any medicines
via wastewater or household
waste. Ask your pharmacist how
to throw away medicines you no
longer use. These measures will
help protect the environment.
6. Contents of the pack and
other information
What Izinova contains
• The active substances are: sodium
sulphate anhydrous, magnesium
sulphate heptahydrate and
potassium sulphate. Each bottle of
about 176 ml concentrate contains
17.510 g sodium sulphate
anhydrous, 3.276 g magnesium
sulphate heptahydrate and
3.130 g potassium sulphate.
The total content of electrolyte ions
is as follows:
Contents
Contents
in g
in mmol
1
2
1
2
bottle bottles bottle bottles
Sodium*
5.683 11.366 247.2 494.4
Potassium 1.405 2.81
35.9
71.8
Magnesium 0.323 0.646 13.3
26.6
Sulphate
14.844 29.688 154.5 309.0
* derived from sodium sulphate (active
ingredient) and sodium benzoate
(excipient).

• The other ingredients are sodium
benzoate (E211), citric acid
anhydrous, malic acid, sucralose,
purified water and fruit cocktail
flavour (which contains natural and
synthetic flavouring substances,
propylene glycol E1520, ethyl
alcohol, acetic acid and benzoic
acid E210).
What Izinova looks like and
contents of the pack
• This medicine is a concentrate
for oral solution, the concentrate
is clear or slightly hazy.
• It is provided as 2 bottles of
about 176 ml each packed in a
box with a cup, with a volume of
about half a litre, for dilution and
to give the medicine.
• Pack sizes can be available as:
– 1 pack of two bottles and one cup
– 24 x 1 pack of two bottles and
one cup
– 6 x 24 (=144) x 1 pack of two
bottles and one cup
– 14 x 24 (=336) x 1 pack of two
bottles and one cup
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ipsen Limited
190 Bath Road
Slough
Berkshire
SL1 3XE
UK
Tel. +44 (0) 1753 627777
Distributed by: Actavis, Barnstaple,
EX32 8NS, UK
Manufacturer
Beaufour Ipsen Industrie
Rue Ethé Virton – 28100 Dreux
France
Tel. +33(0)2 37 65 46 00
This medicinal product is authorised
in the Member States of the EEA
under the following names:
Izinova - France, United Kingdom,
Italy.
Eziclen - Belgium, Czech Republic,
Estonia, Germany, Greece, Latvia,
Lithuania, Luxembourg, Netherlands,
Poland, Portugal, Romania, Spain.
Is this leaflet hard to see or read?
Please phone +44 (0) 1271 385257
and ask for help.
This leaflet was last revised in
December 2015.

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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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