Calcium Resonium

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM POLYSTYRENE SULFONATE

Available from:

Sanofi Malta Limited

ATC code:

A12AA20

INN (International Name):

CALCIUM POLYSTYRENE SULFONATE

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

CALCIUM POLYSTYRENE SULFONATE 99.934 % (W/W)

Prescription type:

POM

Therapeutic area:

MINERAL SUPPLEMENTS

Authorization status:

Authorised

Authorization date:

2007-08-20

Patient Information leaflet

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² Your gut is partially or completely blocked (obstructive bowel
disease)
² 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 severe damage to your gut. 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 aff ect the way other medicines work. Also some
medicines can 
aff ect 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 pregna

Summary of Product characteristics

 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

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

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

 Each bottle contains 99.934% w/w of the active substance Calcium
Polystyrene Sulfonate. 

For a full list of excipients, see section 6.1. 

3. 
   PHARMACEUTICAL FORM 

Powder for Oral/Rectal Suspension 

Cream or light brown coloured, fine powder 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Calcium  Resonium  is  an  ion-exchange  resin  that  is  recommended  for  the  treatment  of 
hyperkalaemia  associated  with  anuria  or  severe  oliguria.  It  is  also  used  to  treat 
hyperkalaemia in patients requiring dialysis and in patients on regular haemodialysis or on 
prolonged peritoneal dialysis. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Calcium Resonium is for oral or rectal administration only. 

The  dosage  recommendations  detailed  below  are  a  guide  only;  the  precise  requirements 
should be decided on the basis of regular serum
electrolyte determinations.  

ADULTS, INCLUDING THE ELDERLY: 

Oral 
Usual dose 15g, three to four times a day.  Each dose should
be given as a suspension in a 
small amount of water or, for greater palatability, in
syrup (but not fruit juices which 
contain potassium), in the ratio of 3 to 4ml per gram of resin. 

Rectal 
This route should be reserved for the patient who is vomiting or
who has upper 
gastrointestinal tract problems, including paralytic ileus or it
may be used simultaneously 
with the oral route for more rapid initial results. The resin
may be given rectally as a 
suspension of 30g resin in 150ml of water or 10% dextrose, as a
daily retention enema. In 
the initial stages administration by