SORBISTERIT POWDER FOR ORAL/RECTAL SUSPENSION

Active substance: CALCIUM POLYSTYRENE SULPHONATE

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Package leaflet: information
for the user
Sorbisterit®
Powder for oral/rectal suspension
Calcium polystyrene sulphonate

In this leaflet:
1. What Sorbisterit® is and what
it is used for
2. Before you use Sorbisterit®
3. How to use Sorbisterit

®

4. Possible side effects
5. How to store Sorbisterit®
6. Further information

Read all of this leaflet carefully
before you start taking this
medicine.
• 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. 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 or pharmacist.

1. What Sorbisterit® is and what
Sorbisterit® is used for?
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).
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.

2. Before you use Sorbisterit®
Do not use Sorbisterit®
• 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
calcium
• if you are allergic (hypersensitive) to
calcium polystyrene sulphonate or any
of the other ingredients of Sorbisterit®
• 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

Take special care with Sorbisterit®
• if it is to be taken orally. You must take it
sitting upright to prevent inhalation of
the liquid.
• if you are constipated, you must tell your
doctor before you are taking this
medicinal product.
• if you are taking other medicines: see
“Using other medicines”
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.

Using other medicines
Please tell your doctor if you are taking
or have recently taken other medicines,
including medicines obtained without a
prescription.
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
(necrosis);
• 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 apart.
• 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
Sorbisterit®.
• 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.

Taking 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
Sorbisterit®.
Pregnancy and breast-feeding
You should not use Sorbisterit® during
pregnancy or breast-feeding unless its
use is considered essential by your
doctor.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
There are no known effects on the ability
to drive or use machines.

Important information about some of
the ingredients of Sorbisterit®
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®
Always use Sorbisterit® exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
The necessary duration of treatment is
dependent on the daily measurements of
the potassium level in the blood.
The usual dose is:
Oral use
• Adults and the elderly:
1 measuring spoonful (20 g powder)
1 - 3 times daily, stirred into
approximately 150 ml of liquid.
• Children:
0.5 - 1 g powder per kilogram of body
weight, stirred into approximately
150 ml of liquid.

This preparation is taken in at least
three divided doses over a period of
24 hours.
Suitable liquids are water, tea or soft
drinks. Sorbisterit® must be taken with
the main meals with the upper body in
an upright position.
Rectal use
• Adults and the elderly:
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.
Retention time: 6 hours.
• Children:
Administration via the anus takes place
if Sorbisterit® cannot be swallowed.
The dosage is the same as for oral use.

Dilution takes place in exactly the same
way as already described for use in
adults.
Six hours after introduction into the anus,
the colon should be irrigated to remove
the resin. 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.
If you feel that the effect of Sorbisterit® is
too strong or too weak, ask your doctor
or pharmacist for advice.

If you use more Sorbisterit® than you
should
If you have used too much Sorbisterit®,
tell your doctor or pharmacist
immediately. In general, an overdose 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 advice.
Do not take a double dose of Sorbisterit®
to make up for a forgotten dose.
If you stop taking Sorbisterit
This may lead to an increase in the
potassium content of the blood.
®

4. Possible side effects
Like all medicines, Sorbisterit® can cause
side effects, although not everybody gets
them.
Assessment of side effects was based on
the following frequency data:
very common:

common:

uncommon:

more than 1 per 10 treated
subjects

less than 1 per 10 but
more than 1 per 100
treated subjects

less than 1 per 100 but
more than 1 per 1,000
treated subjects

rare:

very rare:

not known:

less than 1 per 1,000 but
more than 1 per 10,000
treated subjects
less than 1 per 10,000
treated subjects, including
isolated reports
cannot be estimated from
the available data

common:
• too much calcium in the blood
• too little potassium in the blood,
manifested in severe form by muscle
cramps or muscle weakness and fatigue
• too little magnesium in the blood
• nausea
• vomiting

uncommon:
• constipation
• diarrhoea
• stomach ulcers
• injury of the colon, which may lead to
perforation of the intestine
• loss of appetite
• bowel blockage
rare:
• complete bowel blockage, resulting in
severe cases from
- accumulation of the resin in the
intestine
- “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 newborn 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
Sorbisterit®
In case of oral use, you may have
difficulties swallowing the rather large
amount of dissolved powder.
If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

5. How to store Sorbisterit®

6. Further information

Keep out of the reach and sight of
children.
Keep the container tightly closed in order
to protect from moisture.

What Sorbisterit® contains
• 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 sulphonate.
• the other ingredients are sucrose and
anhydrous citric acid.

Do not use Sorbisterit® after the expiry
date which is stated on the container after
“EXP”.
Expiry date after first opening:
three months
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.

What Sorbisterit® look like and contents
of the pack
Sorbisterit® is a cream to light brown fine
powder and is available in a 500 g
container with a measuring spoon.
Marketing Authorisation Holder and
Manufacturer
MA Holder: Fresenius Medical Care
Nephrologica Deutschland GmbH

Manufacturer:
Fresenius Medical Care
Deutschland GmbH
61346 Bad Homburg v.d.H., Germany
Local Representatives
POM
Fresenius Medical Care (UK) Ltd.
Nunn Brook Road, Huthwaite
Nottinghamshire NG17 2HU, England
Tel.: 0044 (0) 1623445 100
Pharma-Cos Ltd
Pharma-Cos House, Triq C.Portanier
Santa Venera SVR 1732, Malta
Tel.: +356 2144 1870

This medicinal product is authorised in
the Member States of the EEA under the
following names:
A Sorbisterit 1,8 mmol/g Pulver zur
Herstellung einer Suspension zum
Einnehmen oder einer Rektalsuspension
B Sorbisterit, 1,8 mmol Ca/gram,
poeder voor orale suspensie of suspensie
voor rectaal gebruik
CY GR Sorbisterit, Κόνις για πόσιμο
εναιώρημα/ορθικό εναιώρημα
CZ Resical prášek pro přípravu perorální
nebo rektální suspenze
D
L Resical, Pulver zur Herstellung
einer Suspension zum Einnehmen oder zur
Herstellung einer Rektalsuspension
DK Sorbisterit, pulver til oral
suspension/rektal væske, suspension

E Sorbisterit, polvo para suspensión
oral/rectal
EST Sorbisterit, suukaudse- või
rektaalsuspensiooni pulber
F ResiKali, poudre pour suspension
buvable ou rectale
FIN Sorbisterit, jauhe oraalisuspensiota/
peräruiskesuspensiota varten
GB Sorbisterit, powder for oral/rectal
suspension
H Resical por belsőleges
szuszpenzióhoz vagy
végbélszuszpenzióhoz
I Sorbisterit, polvere per sospensione
orale o per sospensione rettale
IS Sorbisterit mixtúruduft,
dreifa/endaþarmsdreifa, stofn
LT Sorbisterit milteliai
geriamajai/tiesiosios žarnos suspensijai

LV Sorbisterit pulveris iekšķīgi lietojamas
vai rektālās suspensijas pagatavošanai
M Sorbisterit
N Sorbisterit, pulver til
mikstur/rektalvæske, suspensjon
NL Sorbisterit, poeder voor orale/rectale
suspensie 90 % m/m
P Resical, pó para suspensão oral/rectal
PL Sorbisterit, proszek do sporządzania
zawiesiny doustnej lub doodbytniczej
S Sorbisterit, pulver till oral/rektal
suspension
SK Sorbisterit, prášok na
perorálnu/rektálnu suspenziu
SLO Sorbisterit prašek za
peroralno/rektalno suspenzijo

This leaflet was last approved in
December 2012
010M0104/03UK-M

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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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