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Package leaflet:
Information for the user

Sorbisterit ,

powder for oral/rectal suspension
Calcium polystyrene sulphonate

What is in this leaflet
1. What Sorbisterit® is and what it is
used for
2. What you need to know before you
use Sorbisterit®
3. How to use Sorbisterit®
4. Possible side effects
5. How to store Sorbisterit


6. Contents of the pack and other

Read all of this leaflet carefully
before you start taking this
medicine 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 or pharmacist.
-- This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs of
illness are the same as yours.
-- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

1. What Sorbisterit® is and what
it is used for

2. What you need to know
before you use Sorbisterit®

Sorbisterit® is used in the treatment of
hyperkalaemia (raised blood potassium
content), in patients who have kidney
problems and those on dialysis (removal
of waste products from the blood).

Do not use Sorbisterit®

Sorbisterit is a cation exchange resin
(insoluble structure which releases certain
ions in exchange for other ions) that
exchanges potassium for calcium in the
gut. As a result, it reduces the uptake of
potassium into the blood.

-- if your blood contains too little
potassium, manifested in a severe form
by muscle cramps or muscle weakness
and fatigue
-- if your blood contains too much
-- if you are allergic to calcium polystyrene
sulphonate or any of the other
ingredients of this medicine (listed in
section 6)
-- if you suffer from constipation or
complete blockage of the bowel
-- concomitant administration of sorbitol
(a laxative)

-- in newborn babies by the oral route


-- in newborn babies with constipation

Special care is necessary when used in
children and newborn babies, as too high
a dosage or incorrect dilution may cause
the resin to have too strong an effect.
Particular caution is necessary in subjects
with a low body weight especially
neonates on account of gastrointestinal
haemorrhages and the risk of death
(necrosis of the colon).

Warnings and precautions
Talk to your doctor or pharmacist before
using Sorbisterit®
-- if used orally. You must use it sitting
upright to prevent inhalation of the
-- if you are constipated, you must tell
your doctor before using this medicinal
The electrolyte content of your blood
must be checked daily.
Ask your doctor for advice if any of the
above warnings applies to you now or
has done so in the past.

Other medicines and Sorbisterit®
Tell your doctor if you are taking, have
recently taken or might take any other
You should consult your doctor
particularly if you are taking

-- medicines that increase the
efficiency of the heart, such as
digoxin (cardiac glycosides), as their
action may be enhanced;
-- medicines that remove fluid from
tissues, such as hydrochlorothiazide
(thiazide diuretics) or furosemide and
torasemide (loop diuretics);
-- sorbitol must not be used as a laxative,
as there is a risk of injury of the colon
-- potassium-containing medicines;

-- medicines to treat heartburn or
laxatives, such as magnesium
hydroxide, aluminium hydroxide or
calcium carbonate.
These medicines and Sorbisterit®
should be used at least three hours
-- oral tetracycline, an antibiotic, as its
effect is reduced by Sorbisterit®;
-- L-thyroxine: Sorbisterit® reduces the
uptake and consequently the effect of
this thyroid medicine. You must take
L-thyroxine several hours after using
-- lithium: an antidepressant, as its
uptake may be reduced by Sorbisterit®.

-- certain medicines which affect
the nerve cells or nerve fibers
(anticholinergics) as there is an
increased risk of side effects of
Sorbisterit® on the stomach.

Sorbisterit® with food and drink
Sorbisterit® must not be used with fruit
juices (e.g. pineapple, grapefruit, orange,
tomato or grape juice) rich in potassium,
as this may adversely affect the action of

Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before using this

You should not use Sorbisterit®
during pregnancy or breast-feeding
unless its use is considered essential
by your doctor.

Driving and using machines
There are no known effects on the ability
to drive or use machines.

Sorbisterit® contains sucrose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to use Sorbisterit®

-- Children:

Always use this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

0.5 – 1 g powder per kilogram of body
weight per day, stirred into approximately
150 ml of liquid. This preparation is used
in at least three divided doses over a
period of 24 hours.

The necessary duration of treatment is
dependent on the daily measurements
of the potassium level in the blood.
The recommended dose is:

Suitable liquids are water, tea or soft
drinks. Sorbisterit® must be used with
the main meals with the upper body in
an upright position.

Oral use

Rectal use

-- Adults and the elderly:

-- Adults and the elderly:

1 measuring spoonful (20 g powder)
1 – 3 times daily, stirred into
approximately 150 ml of liquid.

After using an enema, 2 measuring
spoonfuls of Sorbisterit® (40 g) are
dispersed in 150 ml of 5% glucose
solution and administered via the anus
1 – 3 times daily.

If you use more Sorbisterit® than
you should

Retention time: 6 hours.
-- Children:
Administration via the anus takes place
if Sorbisterit® cannot be swallowed.
0.5 – 1 g powder per kilogram of body
weight per day are dispersed in 150 ml
of 5% glucose solution and administered
in at least three divided doses over
a period of 24 hours. Six hours after
introduction into the anus, the colon
should be irrigated to remove the resin.
If you feel that the effect of Sorbisterit
is too strong or too weak, ask your
doctor or pharmacist for advice.


If you have used too much Sorbisterit ,
tell your doctor or pharmacist
immediately. In general, an over-dose of
Sorbisterit® may lead to a reduced level
of potassium in the blood (hypokalaemia)
with symptoms of cramps, discomfort in
the legs that is experienced while sitting
still, extreme weakness of the body, and
on occasion, paralysis. Abnormal heart
beat may occur.

Other side effects of overdose may
take the form of a raised calcium
level in the blood (hypercalcaemia)
with symptoms such as fatique,
muscle weakness, frequent urination,
constipation, abnormal heart beat,
kidney failure or coma.

Further, an overdose may lead to
constipation, complete bowel blockage
and fluid accumulation.

If you forget to use Sorbisterit®
Ask your doctor or pharmacist for
Do not take a double dose to make up
for a forgotten dose.

If you stop using Sorbisterit


This may lead to an increase in the
potassium content of the blood.
If you have any further questions on the
use of this medicine, ask your doctor or

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Assessment of side effects was based
on the following frequency data:
very common: may affect more than
1 per 10 people

may affect up to 1 in
10 people
may affect up to 1 in
100 people
may affect up to 1 in
1,000 people

very rare:

not known:

may affect up to 1 in
10,000 people, including
isolated reports
cannot be estimated from
the available data


-- constipation
-- diarrhoea
-- stomach ulcers


-- injury of the colon, which may lead
to perforation of the intestine

-- too much calcium in the blood

-- loss of appetite

-- too little potassium in the blood,
manifested in severe form by muscle
cramps or muscle weakness and

-- bowel blockage

-- too little magnesium in the blood
-- nausea
-- vomiting


-- complete bowel blockage, resulting
in severe cases from
-- accumulation of the resin in the

-- “thickening” of the stools after rectal
use in children
-- formation of plugs after oral use in
newborn babies
-- bleeding from the anus has been
observed after rectal use in low-birthweight premature and new born babies
very rare:

-- acute inflammation of the airways,
manifested by coughing and bringing
up of phlegm, and/or a particular type
of pneumonia caused by inhalation of
this medicine.
In case of oral use, you may have
difficulties swallowing the rather large
amount of dissolved powder.

Reporting of side effects

5. How to store Sorbisterit®

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:

Keep this medicine out of the sight
and reach of children.

GB: the Yellow Card Scheme, Website:

Do not use Sorbisterit after the expiry
date which is stated on the container after
“EXP”. The expiry date refers to the last
day of that month.

M: ADR Reporting, The Medicines
Authority, Post-Licensing Directorate,
203 Level 3, Rue, D’Argens, GŻR-1368
Gżira, Website:,
By reporting side effects you can help
provide more information on the safety
of this medicine.

Keep the container tightly closed in order
to protect from moisture.

Expiry date after first opening: 3 months.
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 to protect the environment.

6. Contents of the pack and
other information

What Sorbisterit® looks like and
contents of the pack

What Sorbisterit contains

Sorbisterit® is a cream to light brown
fine powder and is available in a 500 g
container with a measuring spoon.


-- The active substance is calcium
polystyrene sulphonate.
1 g Sorbisterit® contains 759 to 949 mg
calcium polystyrene sulphonate.
20 g Sorbisterit® contain 15.18 to
18.98 g calcium polystyrene
-- The other ingredients are sucrose
and anhydrous citric acid.

Fresenius Medical Care
Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H.,

Marketing Authorisation Holder
and Manufacturer

Local representative

Marketing Authorisation Holder:
Fresenius Medical Care Nephrologica
Deutschland GmbH
61346 Bad Homburg v.d.H.,

M: Pharma-Cos Limited
Telephone: (+356) 2144 1870

GB: Fresenius Medical Care (UK) Ltd
Tel: + 44 (0)1623 445100

This leaflet was last revised in


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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.