Sorbisterit powder

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcium polystyrene sulfonate

Available from:

Stanningley Pharma Ltd

ATC code:

V03AE01

INN (International Name):

Calcium polystyrene sulfonate

Dosage:

854mg/1gram

Pharmaceutical form:

Powder for oral or rectal suspension

Administration route:

Rectal; Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09020101; GTIN: 4046241070408

Patient Information leaflet

1/5
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sorbisterit, powder for oral/rectal suspension
Calcium polystyrene sulphonate
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.
_ _
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
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

Summary of Product characteristics

SORBISTERIT, POWDER FOR ORAL/RECTAL SUSPENSION
Summary of Product Characteristics Updated 25-Jan-2013 | Stanningley
Pharma Limited
1. Name of the medicinal product
Sorbisterit, powder for oral/rectal suspension
2. Qualitative and quantitative composition
1 g powder contains:
759 - 949 mg calcium polystyrene sulphonate, corresponding to 1.8 mmol
calcium.
Excipients: 50.74 mg – 240.74 mg sucrose
20 g powder contain:
15.18 – 18.98 g calcium polystyrene sulphonate, corresponding to 36
mmol calcium
Excipients: 1.01 – 4.81 g sucrose
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral/rectal suspension cream to light brown fine powder
4. Clinical particulars
4.1 Therapeutic indications
Treatment of hyperkalaemia, in patients with acute and chronic renal
insufficiency, including patients
undergoing dialysis treatment.
4.2 Posology and method of administration
To be administered orally or as a retention enema.
The dosing recommendations are to be looked upon as guidelines. The
exact need should be decided
depending on regular clinical and biochemical controls.
The length of treatment needed with Sorbisterit cation exchange resin
depends on the results of the daily
measurement of the serum potassium. If serum potassium falls to 5
mmol/l, therapy should be suspended.
When the serum potassium rises above 5 mmol/l, therapy should be
recommenced.
Oral route:
_In adults, including the elderly:_
20 grams powder 1 to 3 times daily (1 measuring spoon), stirred into
about 150 ml liquid.
In infants and children:
0.5 to 1.0 g/kg body weight per day in several doses, stirred into
about 150 ml liquid. This preparation
must be taken in at least three divided doses over a period of 24
hours.
Calcium polystyrene sulphonate should not be given orally to neonates.
Sorbisterit must be taken after an interval of at least 3 hours after
antacids and laxatives such as
magnesium hydroxide, aluminium hydroxide or calcium carbonate. (see
section 4.4).
Sorbisterit must be taken with food.
For suitable liquids fo