CALCIUM RESONIUM

Active substance: CALCIUM POLYSTYRENE SULPHONATE

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ATELIER Kayexalate

Page 1 = Front

ID number:
Version and Date:
Previous ID number:

540284

V2 - 19/12/2013
523825

Product type:
LABEL (7 pages)
Product name:
ETL CALCIUM RESONIUM 300G GB-L
Country:
GB
Artwork by:
Plant:

Technical Data

540284

Calcium Resonium® 99.934% w/w
Powder for Oral/Rectal Suspension
calcium polystyrene sulfonate

V.P.
AMILLY PHARMA

Format: 300 x 90 (7 pages)
Number of colors: 2 + Braille
■ PMS 1785 C
■ PMS Process Black C

Ink jet printing area

■ Cutter

For oral or rectal administration after reconstitution.
Calcium Cycle Ion Exchange Resin
Flavoured powder form of calcium polystyrene sulfonate
for removing excess potassium from the body.

calcium resonium

MAIN PAGE:
Minimum point size of text: 9 pt

300g powder

LEAFLET:
Minimum point size of text: 9 pt
Space between lines: 10 pt
Narrowed: 100 %

One level measuring spoon contains 15g of Calcium
Resonium.
Always read the leaflet attached before use and for details
of dosage regime.
Use as directed by your doctor.
KEEP OUT OF SIGHT AND REACH OF CHILDREN
STORE IN A DRY PLACE
MA Holder:
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
PL: 04425/0620
Malta MA: 082/04101
MAH: Sanofi-Aventis Malta
Triq Kan. K. Pirotta, B’Kara, BKR 1114, Malta
Sanofi UK and Sanofi-Aventis Malta are members of the
Sanofi Group.

*540284*

Fonts: Ocean Sans Pro SAN - C39P24N
Native file: In Design CS5
Layout of cutting: AY_ETL_300 x 90_7P_A_1
Modifications

5:AKKCIN=ZU[VXX:>

For Sanofi-Aventis use only

PACKAGING TEAM

V1 - 21/11/2013: New regulatory text.
V2 - 19/12/2013: Corrections.

Pre-cut
Page 7 = back

Base material

540284

Laminate

Calcium Resonium® 99.934% w/w
Powder for Oral/Rectal Suspension
calcium polystyrene sulfonate
For oral or rectal administration after reconstitution.
Calcium Cycle Ion Exchange Resin
Flavoured powder form of calcium polystyrene sulfonate
for removing excess potassium from the body.

300g powder

Braille :

calcium resonium

One level measuring spoon contains 15g of Calcium
Resonium.
Always read the leaflet attached before use and for details
of dosage regime.
Use as directed by your doctor.
KEEP OUT OF SIGHT AND REACH OF CHILDREN
STORE IN A DRY PLACE
MA Holder:
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
PL: 04425/0620
Malta MA: 082/04101
MAH: Sanofi-Aventis Malta
Triq Kan. K. Pirotta, B’Kara, BKR
1114, Malta
Sanofi UK and Sanofi-Aventis
Malta are members of the
Sanofi Group.

5:AKKCIN=ZU[VXX:>

Page 2
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Calcium Resonium® 99.934% w/w Powder for Oral/Rectal
Suspension
calcium polystyrene sulfonate
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help






Read all of this leaflet carefully because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine is only 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 gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor, nurse or pharmacist.

5. How to store Calcium Resonium
6. Further information
1. What Calcium Resonium is and what it is used for
Calcium Resonium contains a medicine called calcium polystyrene sulfonate.
This belongs to a group of medicines called ‘ion exchange resins’.
Calcium Resonium is used to treat something called ‘hyperkalaemia’. This is
when there is too much potassium in your blood. It works by removing this extra
potassium to bring your levels back to normal. It is often given to people who
have kidney problems and people on dialysis.
2. Before you are given Calcium Resonium

In this leaflet:
1. What Calcium Resonium is and what it is used for
2. Before you are given Calcium Resonium
3. How Calcium Resonium is given
4. Possible side effects

Do not use this medicine and tell your doctor or nurse if:
You are allergic (hypersensitive) to calcium polystyrene sulfonate or any of the
other ingredients in this medicine (listed in section 6 Further Information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
You have been told that you have a low level of potassium in your blood
You have been told you have problems that result in high levels of calcium in
your body such as thyroid problems or some types of cancer

Page 3

Your gut is partially or completely blocked (obstructive bowel disease)
You are taking a sweetener called sorbitol (a «sugar-free» sweetener used to
sweeten food). This is because taking sorbitol and Calcium Resonium at the
same time can cause narrowing of the gut wall (gastrointestinal stenosis)
and reduced blood flow to the gut wall (intestinal ischemia) causing severe
damage to your gut (necrosis and perforation). You must not take any
sorbitol whilst using Calcium Resonium.
Do not use this medicine if any of the above applies to you. If you are not
sure, talk to your doctor, nurse or pharmacist before using Calcium Resonium.
Take special care and check with your doctor, nurse or pharmacist
before using Calcium Resonium if:
p It is for your baby, and they were premature, had a low birth-weight or
have reduced gut movement
If you are not sure if any of the above apply to you, talk to your doctor, nurse
or pharmacist before using Calcium Resonium.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you can
buy without prescription, including herbal medicines. This is because Calcium
Resonium can affect the way other medicines work. Also some medicines can
affect the way Calcium Resonium works.

In particular, check with your doctor if you are taking the following medicines:
• Medicines that contain salts such as magnesium, potassium or calcium. Ask
your doctor if you are not sure
• Some medicines for constipation (laxatives) that contain magnesium
• Some medicines for indigestion (antacids) that contain magnesium or
aluminium
• Digoxin or similar medicines from digitalis - for heart problems
• Levothyroxine or thyroxine - for an under-active thyroid
• Lithium - for mental illness
If you are not sure if any of the above applies to you, talk to your doctor, nurse
or pharmacist before using Calcium Resonium.
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if:
• You are pregnant, might become pregnant, or think you may be pregnant
• You are breast-feeding or planning to breast-feed
Ask your doctor or pharmacist for advice before taking any medicine.
3. How Calcium Resonium is given
Your doctor or nurse will normally give you this medicine. If you are not sure
why you are being given Calcium Resonium or have any questions about how
much Calcium Resonium is being given to you, speak to your doctor, nurse or
pharmacist.
• The dose will depend on the results of blood tests

Page 4
• For children the dose is also worked out according to how much the child
weighs
Having the medicine
• Calcium Resonium can be given by mouth or put into the back passage
(rectum)
• If given by mouth the powder can be swallowed with a little water or be
made into a paste with something sweet, such as jam or honey
• It should not be mixed with fruit juice, this will stop the medicine working
properly
• If given by mouth, it is important to sit up while taking the medicine so that
you do not breathe in any powder into your lungs
• If given by the back passage you should try to keep the medicine in your
back passage for at least 9 hours. Then it needs to be thoroughly washed
out
How much is normally given:
Adults (including the elderly)
By mouth
• The usual dose is 15g (one spoonful) three or four times a day
Into the back passage
• The usual dose is 30g (two spoonfuls) once a day
In some cases, the medicine may be given both by mouth and into the

back passage. This is where your potassium levels need to be lowered more
quickly.
Children
If your child cannot take the medicine by mouth, it may be given into the
back passage.
• The daily dose is 1g for each kilogram of bodyweight
• Once the medicine has started working the dose may be lowered to
0.5g daily for each kilogram of bodyweight
New-born babies
Calcium Resonium is only given into the back passage
• The daily dose is between 0.5g and 1g for each kilogram of bodyweight
It is important to give the right dose for children and babies. If too much is
given, children and babies could get serious constipation.
If you have more Calcium Resonium than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your
doctor and nurse will be checking your progress, and checking the medicine
that you are given. Ask them if you are not sure why you are getting a dose
of medicine.
If you are given too much Calcium Resonium the following effects may
happen:
• Feeling irritable or confused
• Being unable to concentrate

Page 5






Muscle weakness and poor reflexes leading to paralysis
Breathing problems
Faster or pounding heartbeat
Muscle cramps

If you miss a dose of Calcium Resonium
Your doctor or nurse will give instructions about when to have your medicine.
It is unlikely that a dose will be missed. If you think that you may have missed
a dose, talk to your doctor or nurse.
If you stop being given Calcium Resonium
Keep having Calcium Resonium until your doctor tells you to stop. If you stop
having Calcium Resonium, your illness may come back.
Blood Tests
Your doctor may do regular blood tests while you are taking this medicine. This
is to check the levels of salts (potassium, sodium, calcium and magnesium)
in your blood.
If you have any further questions on the use of this product, ask your
doctor, nurse or pharmacist.

4. Possible side effects
Like all medicines, Calcium Resonium can cause side effects, although not
everybody gets them.
Tell a doctor or nurse straight away if you notice any of the following
serious side effects:
• You have an allergic reaction. The signs may include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
• Blood in your sick (vomit) or black tarry stools
Talk to your doctor or nurse if you get any of the following side effects:
• Feeling tired, confused, having muscle weakness, cramps or a change in
heart rate. These may be due to having low levels of potassium in your
body
• Feeling jittery, having fits or muscle cramps. This may be due to low levels
of calcium or magnesium in your body
• Increased thirst or needing to go to the toilet more often
• High blood pressure, kidney problems, heart problems or swelling in your
limbs. This may be due to high levels of sodium in your body
• Stomach upset, pain in your gut, narrowing or blockage of the gut
• Reduced blood flow to the gut wall causing severe abdominal (tummy)
pain, or collapse
• Loss of appetite

Page 6

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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate,
203 Level 3, Rue D’Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
email: postlicensing.medicinesauthority@gov.mt
5. How to store Calcium Resonium
This medicine will be kept by your doctor or pharmacist in a safe place where
children cannot see or reach it. Store in a dry place.
Do not use Calcium Resonium after the expiry date which is stated on the
container. The expiry date refers to the last date of that month.

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.
6. Further Information
What Calcium Resonium contains
• 99.934% w/w of the active substance, calcium polystyrene sulfonate
• The other ingredients are saccharin and vanillin
What Calcium Resonium looks like and contents of the pack
Calcium Resonium is a cream or light brown coloured, fine powder. It is
supplied in containers of 300g with a 15g scoop.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie, 196 avenue du Maréchal Juin, 45200 Amilly, France
This leaflet does not contain all the information about your medicine. If you have
any questions or are not sure about anything, ask your doctor, nurse or pharmacist.
This leaflet was last revised in 01/2014
© Sanofi 1990 - 2014

540284

• Feeling sick, being sick, constipation or diarrhoea
• Feeling short of breath or coughing. This could be the first sign of a
serious chest infection. This can be caused by accidentally breathing in this
medicine

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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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