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CALCIUM POLYSTYRENE SULFONATE 99.934% W/W POWDER FOR ORAL/RECTAL SUSPENSION

Active substance(s): CALCIUM POLYSTYRENE SULFONATE / CALCIUM POLYSTYRENE SULFONATE

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

2993
04.03.17[3]

(calcium polystyrene sulfonate)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using the above name but will be referred to as
Calcium Resonium throughout the following.
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
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
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
- 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:
- 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
- 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
- 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
- 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
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
5. HOW TO STORE CALCIUM RESONIUM
Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from moisture.
After reconstitution suspension should be used within 24 hours.
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.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Calcium Resonium contains
- 99.934% w/w of the active substance, calcium polystyrene sulfonate
- One level measuring spoon contains 15g of Calcium Resonium.
- 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 measuring spoon.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured Sanofi Winthrop Industrie, 196 avenue du Maréchal Juin,
45200 Amilly, France.
Sanofi-Synthelabo Limited, Edgefield Avenue, Fawdon, Newcastle Upon
Tyne NE3 3TT, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/2993

Leaflet revision and issue date (Ref) 04.03.17[3]
Resonium is a trademark of Sanofi.

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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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