Israel - English - Ministry of Health
Consult your doctor if you are not sure.
(laxatives) that contain magnesium.
Some medicines for indigestion (antacids)
that contain magnesium or potassium.
Digoxin or medicines similar to digitalis -
for heart problems.
treatment of an under-active thyroid.
Lithium – for treatment of mental illnesses.
If you are not sure, consult the doctor before
commencing treatment with Kayexalate.
Pregnancy and breastfeeding:
Consult the doctor or pharmacist before
using this medicine if:
You are pregnant, can become pregnant
or think you may be pregnant.
You are breastfeeding or plan to
Always use this medicine according to the
doctor’s instructions. Check with the doctor
or pharmacist if you are unsure.
The dosage will depend on blood test
determined by the child’s weight.
Each measuring spoon contains 15 g of
It is forbidden to heat Kayexalate –
heating can change the properties of
Consult the doctor with regard to
prophylactic measures or treatment for
constipation sometimes caused by use of
Taking the medicine:
This medicine is intended for oral or
immediately after preparing it.
If given by mouth, mix with a small
amount of water up to half a glass,
depending on the dose, and drink
immediately. Sweetened water can be
used to improve the taste. Similarly, a
paste can be made with sweeteners, such
as jam or honey.
Do not mix this medicine with fruit
juice; this may impair the activity of the
If the medicine is given orally, remain
in an upright position when taking the
medicine in order to prevent aspiration of
the powder into the respiratory system.
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Active ingredient and its quantity:
Sodium polystyrene sulfonate 99.934%
Inactive ingredients – see section 6.
Read this leaflet carefully in its entirety before using this
medicine. Keep this leaflet; you may need to read it again. This
leaflet contains concise information about the medicine.
This medicine has been prescribed to treat you. Do not pass
it on to others. It may harm them even if it seems to you that
their medical condition is similar.
If a side effect worsens or if you experience a side effect
not mentioned in this leaflet, please refer to a doctor or
If you have further questions, refer to a doctor or pharmacist.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for the treatment of excess blood
This preparation contains an ion-exchange resin which, when
passing through the gastrointestinal tract, releases sodium ions
and, instead, binds mostly potassium ions. The preparation is
not absorbed in the body.
Therapeutic group: Medicines for the treatment of
hyperkalemia and hyperphosphatemia.
2. BEFORE USING THE MEDICINE:
Do not use the medicine if:
You are allergic (hypersensitive) to
sodium polystyrene sulfonate or if
you have a known sensitivity to any of
the other components of this medicine
(see details in section 6). Signs of an
allergic reaction include: rash, edema
or breathing problems, swelling of the
lips, face, throat or tongue.
You have been told that you suffer
from low blood potassium levels
Your gut is partially or completely
blocked (obstructive bowel disease).
You are taking a sweetener called
sorbitol (“no sugar” sweetener). This is
because taking sorbitol and Kayexalate
concomitantly may cause narrowing
of the gut (gastrointestinal stenosis)
and decreased blood flow to the gut
(intestinal ischemia), which cause
severe damage to the gut (necrosis and
perforation). Do not take sorbitol during
treatment with Kayexalate.
Do not use in neonates with reduced
gut motility (caused by surgery or
Do not administer the medicine orally
Special warnings regarding use of the
Before treatment with this medicine,
inform the doctor if:
You have or have suffered in the past from
irregularities in the digestive system.
You have heart problems.
You have high blood pressure.
You have kidney problems.
You have swelling in your arms or legs
In premature and low-birthweight babies,
caution must be taken with regard to
overdose or insufficient dilution when
If you are not sure if the listed conditions
apply to you, consult the doctor before
commencing treatment with Kayexalate.
If you are taking, or have recently taken,
other medicines, including nonprescription
medicines and nutritional supplements,
inform the doctor or pharmacist. It is
especially important to inform the doctor
or pharmacist if you are taking:
Medicines that contain salts such as
magnesium, potassium or calcium.
After opening for the first time, the
preparation can be used for up to one
6. FURTHER INFORMATION
In addition to the active ingredient,
the medicine also contains: saccharin,
Each measuring spoon (15 g powder)
contains 345 mg sodium.
What the medicine looks like and the
contents of the package:
Kayexalate is a brownish-yellow powder,
packaged in a 454 g container with a
15 g measuring spoon.
License holder and address:
sanofi-aventis Israel ltd.
Address: P.O.B 8090, Netanya 4250499.
Manufacturer and address:
Sanofi Winthrop Industrie, France.
This leaflet was checked and approved by
the Ministry of Health in March 2014.
This leaflet does not contain all the
information about your medicine. If you
have any question or are not sure about
anything, please ask your doctor.
Registration number of the medicine in
the National Drug Registry of the Ministry
of Health: 1415921158
If administered rectally, a preparation for
rectal use should be made. Refer to the
medical staff for instructions.
Try to keep the medicine in the rectum
for at least 4-10 hours. Afterwards, wash
the area thoroughly.
The dosage and treatment regimen will
be determined by the doctor only. Do not
exceed the recommended dose!
If you accidentally took a higher dosage,
or if a child accidentally swallowed the
medicine, proceed to a hospital emergency
room immediately and bring the package
of the medicine with you. If you took an
overdose, you may suffer from the following
signs: feeling irritable or confused, being
unable to concentrate, muscle weakness
and weakened reflexes that may lead to
paralysis, breathing problems, faster or
pounding heartbeat, muscle cramps.
If you suspect that you forgot to take
this medicine at the scheduled time, do
not take a double dose. Consult your doctor
regarding the rest of treatment.
Adhere to the treatment recommended by
the doctor. Even if there is an improvement
in your health, do not stop treatment with
this medicine without consulting the doctor
problems, swelling of the lips, face,
throat or tongue.
Blood in vomit or black stools.
Refer to the doctor as soon as possible
if you suffer from the following side
weakness, muscle cramps or a change
in heart rate. These signs may be due to
low levels of potassium in your body.
Feeling jittery, fits or muscle cramps. This
may be due to low levels of calcium or
magnesium in your body.
High blood pressure, kidney problems,
heart problems or swelling in the limbs.
This may be due to high levels of sodium
in your body.
Stomach upset, pain in the gut, narrowing
or blockage of the gut.
Decreased blood flow to the gut which
causes intense abdominal pain or
Lack of appetite.
Feeling sick, being sick, constipation or
Feeling short of breath or coughing.
This may be the first sign of a serious
If you stop taking the medicine: Take
Kayexalate until your doctor tells you to
stop the treatment. If you discontinue the
treatment against the doctor’s instructions,
your ailment may recur.
Your doctor will instruct you to regularly
perform blood tests while you are taking
this medicine. This is to check the levels
of salts (potassium, sodium, calcium and
magnesium) in your blood.
Do not take medicines in the dark! Check
the label and the dose each time you take
medicine. Wear glasses if you need them.
If you have further questions regarding
use of this medicine, consult the doctor
4. SIDE EFFECTS
As with any medicine, use of Kayexalate may
cause side effects in some users. Do not be
alarmed when reading the list of side effects.
You may not experience any of them.
Refer to the doctor immediately if you
notice any of the following severe side
You have an allergic reaction. Signs may
include: rash, swallowing or breathing
chest infection, which can be caused by
accidentally breathing in this medicine.
Side effects and drug interactions in
children and infants:
Parents must inform the attending doctor
of any side effects and about any other
medicines being administered to the child!
See special side effects and drug interactions
If any of the side effects worsen, or persist
for more than a few days, or if you suffer
from a side effect not mentioned in this
leaflet, consult the doctor.
5. HOW SHOULD THE MEDICINE BE
Avoid poisoning! This medicine and any
other medicine must be kept in a closed
place out of the reach of children and/or
infants to avoid poisoning. Do not induce
vomiting without explicit instruction from
Do not use the medicine after the expiry
date (exp. date) that appears on the
package. The expiry date refers to the last
day of that month.
Store at a temperature below 30°C.
Close firmly to avoid penetration of light
רשואו קדבנ ונכותו תואירבה דרשמ ידי לע עבקנ הז ןולע טמרופ ודי לע ץרמ ךיראתב
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Sodium Polystyrene Sulfonate 99.934% w/w.
3. PHARMACEUTICAL FORM
Powder for oral and rectal suspension.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of hyperkalemia.
4.2 Posology and method of administration
Sodium Polystyrene sulfonate is for oral or rectal administration only.
The quantity of sodium polystyrene sulfonate to be administered is directly related to the level of potassium in
the blood; it should therefore be adjusted to individual patient needs.
As a guide:
A dosage of 15 g, or 1 measuring-spoonful or 4 level teaspoonfuls, once to four times a day by oromucosal use,
is commonly prescribed. Sodium polystyrene sulfonate is administered after being put in suspension in a little
water. Patients may decide to add a little fruit syrup to the water. Suspension in fruit juice is not allowed,
because of the latter's high potassium content.
This route should be reserved for the patients who are 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
Sodium polystyrene sulfonate can be administered in an enema after being put in suspension in 100 ml of 10%
dextrose solution at body temperature, or after mixing equal proportions of water and a 2% methylcellulose
The liquid containing the sodium polystyrene sulfonate in suspension should be agitated gently during
administration to ensure it remains in suspension. The enema should be retained for 4 to 10 hours if possible,
followed by a cleansing enema.
This operation can be repeated twice a day, if necessary.
N.B.: given that ion exchange occurs mainly in the colon, it may be necessary at the beginning of treatment to
start by administering the product in both an enema and by oromucosal use. A reduction in blood potassium
levels will thus be achieved more rapidly and then can be sustained by oral administration.
When it is necessary to pursue treatment for a long period of time, monitoring ensured by assays of blood
potassium levels will enable adjustment of the effective dose.
Adjustments of quantity should be based on the principle that 1 g of resin eliminates1 mmol (1 mEq) of
potassium. The usual initial dosage via the oral route in children is1 g/kg body weight/day in several intakes,
which can then be reduced for maintenance therapy to 0.5 g/kg body weight/day.
When refused by mouth, Sodium polystyrene sulfonate can be administered in children via the rectal route at
the same dosage as that used via the oral route and using the same methods as in adults.
Sodium polystyrene sulfonate should only be administered via the rectal route. The minimum effective dose is
between 0.5 g/kg and 1 g/kg body weight/day.
- In patients with plasma potassium levels below 5mmol/litre,
- History of hypersensitivity to polystyrene sulfonate resins,
- Obstructive bowel disease (oral route),
- Kayexalate should not be administered orally to neonates and is contraindicated in neonates with reduced gut
motility (post-operatively or drug-induced).
Use of this medicinal product is generally inadvisable in combination with sorbitol (see section: 4.4 Special
warnings, 4.5 Interactions).
4.4 Special warnings and special precautions for use
Special precautions for use:
Gastrointestinal stenosis, intestinal ischemia and its complications (necrosis and perforation) may occur in
patients treated with polystyrene sulfonate, especially in patients using sorbitol. Therefore, concomitant use of
Sorbitol with sodium polystyrene sulfonate is not recommended (see section 4.5 Interactions and section 4.8
The possibility of severe potassium depletion should be considered, and adequate clinical and biochemical
control is essential during treatment, especially in patients on digitalis. Administration of the resin should be
stopped when the serum potassium falls to 5mmol/litre.
Other Electrolyte disorders
Because the resin may bind calcium and magnesium ions, deficiencies of these electrolytes may occur.
Accordingly, patients should be monitored for all applicable electrolyte disturbances.
In the event of constipation with a clinical effect, treatment should be discontinued until a return to normal
motility. Magnesium-based laxatives require precautions for use (see section 4.5 Interactions).
The patient must remain in an appropriate position while ingesting the resin so as to avoid inhalation which
could cause bronchial and pulmonary complications
Children and neonates
In neonates, sodium polystyrene sulfonate should not be given by the oral route. In children and neonates
particular care is needed with rectal administration as excessive dosage or inadequate dilution could result in
impaction of the resin. Due to the risk of digestive haemorrhage or colonic necrosis, particular care should be
observed in premature infants or low birth weight infants.
Patients at risk from an increase in sodium load
Care should be taken when administering to patients in whom an increase in sodium load may be detrimental
(i.e. congestive heart failure, hypertension, renal damage or oedema). In such instances, adequate clinical and
biochemical control is essential. The calcium form of the resin may have advantages in this situation.
4.5 Interactions with other medicinal products and other forms of interaction
Concomitant use not recommended
Sorbitol (oral and rectal routes):
Concomitant use of Sorbitol with sodium polystyrene sulfonate is not
recommended due to cases of intestinal necrosis and other serious gastrointestinal adverse reactions, which
may be fatal (see sections 4.
5 Interactions and 4.8 Undesirable effects).
To be used with caution
- Cation-donating agents: may reduce the potassium binding effectiveness of Kayexalate.
- Non-absorbable cation-donating antacids and laxatives: There have been reports of systemic alkalosis
following concurrent administration of cation-exchange resins and non-absorbable cation-donating antacids
and laxatives such as magnesium hydroxide and aluminium carbonate.
- Aluminium hydroxide: Intestinal obstruction due to concretions of aluminium hydroxide has been reported
when aluminium hydroxide has been combined with the resin.
- Digitalis-like drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-
V nodal dissociation, are likely to be exaggerated if hypokalaemia is allowed to develop. (See 4.4 Special
warnings and special precautions for use).
- Lithium: Possible decrease of lithium absorption.
Levothyroxine: Possible decrease of levothyroxine absorption.
4.6 Fertility, pregnancy and lactation
No data are available on the use of resin during pregnancy and lactation. The administration of Kayexalate in
pregnancy and during breast feeding therefore is not advised unless, in the opinion of physician, the potential
benefits outweigh any potential risks.
4.7 Effects on ability to drive and use machines
There are no specific warnings.
4.8 Undesirable effects
- Metabolism and nutrition disorders
In accordance with its pharmacological actions, the resin may give rise to sodium retention, hypokalaemia and
hypocalcaemia, and their related clinical manifestations (see section 4.4 Special warnings and section 4.9
Cases of hypomagnesaemia have been reported.
- Gastrointestinal disorders
Gastric irritation, anorexia, nausea, vomiting, constipation and occasionally diarrhoea may occur. Faecal
impaction following rectal administration particularly in children, and gastrointestinal concretions (bezoars)
following oral administration have been reported. Gastrointestinal stenosis and intestinal obstruction have also
been reported, possibly, due to co-existing pathology or inadequate dilution of resin.
ischemic colitis, gastro-intestinal tract ulceration or necrosis, which could lead to
intestinal perforation have been reported, which is sometimes fatal.
The majority of cases have been reported with concomitant use of Sorbitol (see section 4.4 Special warnings
and section 4.5 Interactions).
- Respiratory, thoracic and mediastinal disorders
Some cases of acute bronchitis and/or bronco-pneumonia associated with inhalation of particles of sodium
polystyrene sulfonate have been described.
Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of
hypokalemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, and
eventually frank paralysis. Apnea may be a serious consequence of this progression. Electrocardiographic
changes may be consistent with hypokalemia; cardiac arrhythmia may occur. Hypocalcemic tetany may occur.
Appropriate measures should be taken to correct serum electrolytes (potassium, calcium), and the resin should
be removed from the alimentary tract by appropriate use of laxatives or enemas.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Kayexalate is a cation exchange resin for the treatment of hyperkalaemia.
5.2 Pharmacokinetic properties
Ion exchange resins with a particle size ranging from 5 - 10 micrometres (as in Kayexalate) are not absorbed
from the gastro-intestinal tract and are wholly excreted in the faeces.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in
other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
Kayexalate also contains: Vanillin and Saccharin.
There are no specific incompatibilities.
6.3 Shelf life
The product can be used for up to 1 month from its opening.
6.4 Special precautions for storage
Store below 30
C. Should be firmly closed to protect from light and humidity.
6.5 Nature and contents of container
HDPE bottles sealed with LDPE caps containing 454g of powder.
6.6 Special precautions for disposal and other handling
Suspension of the resin should be freshly prepared. Heating may alter the exchange properties of the resin.
Sanofi Winthrop Industrie, France
8. LICENSE HOLDER
Sanofi-aventis Israel ltd.
Beni Gaon st.10, POB 8090, Netanya, Israel.
ןולעב )תוחיטב ןולעב )תוחיטב
sanofi aventis Israel ltd
שומיש הפורתב :םא הפורתב שמתשהל ןיא
תאז .)"רכוס אלל" קיתממ( לוטיברוס םשב קיתממ לטונ ךנה הלולע תינמז וב טאלאסקאיקו לוטיברוס תליטנש םושמ םורגל ( םייעמב תורציהל
הדירילו ) ( יעמל םד תמירזב
םימרוגש ,) רומח קזנל םייעמב
necrosis and perforation
לוטיברוס לוטיל ןיא .) .טאלאסקאיקב לופיטה תעב
תועפות . יאוול תועפותמ לבוס ךנה םא ירשפאה םדקהב אפורל תונפל שי :תואבה יאוול
םייעמ תמיסח ,םייעמב םיבאכ ,הביק לוקלק וא תורציה םייעמ תמיסח
תמרוגש םייעמל םד תמירזב הדירי וא קזח ןטב באכל .תוטטומתה
ןולעב )תוחיטב ןולעב )תוחיטב
sanofi aventis Israel ltd
ןולעב טסקט יחכונ טסקט
4.4 Special Warnings and
Special Precautions for
Special precautions for use:
Gastrointestinal stenosis, intestinal ischemia and its complications
)necrosis and perforation( may occur in patients treated with
polystyrene sulfonate, especially in patients using sorbitol.
Therefore, concomitant use of sorbitol with sodium polystyrene
sulfonate is not recommended since cases of intestinal necrosis,
which may be fatal, have been reported )see Section 4.5 and
4.5 Interactions with
other medicinal products
Concomitant use not recommended
Sorbitol )oral and rectal routes(:
Concomitant use of Sorbitol with
sodium polystyrene sulfonate is not recommended due to cases of
intestinal necrosis and other serious gastrointestinal adverse
reactions, which may be fatal )see sections 4.4 and 4.8(.
4.8 Undesirable Effects
Gastric irritation, anorexia, nausea, vomiting, constipation and
occasionally diarrhoea may occur. Faecal impaction following
rectal administration particularly in children, and gastrointestinal
concretions )bezoars( following oral administration have been
reported. Gastrointestinal stenosis and intestinal obstruction have
also been reported although this has been extremely rare and,
possibly, a reflection of due to co-existing pathology or inadequate
dilution of resin.
Gastrointestinal ischemia, ischemic colitis, gastro-intestinal
tract ulceration or necrosis, which could lead to intestinal
perforation have been reported, which is sometimes fatal.
Intestinal necrosis The majority of cases have been reported with
concomitant use of Sorbitol )see Section 4.4 Special warnings and
Section 4.5 Interactions(.