KAYEXALATE

Consult your doctor if you are not sure.

Some

medicines

constipation

(laxatives) that contain magnesium.

Some medicines for indigestion (antacids)

that contain magnesium or potassium.

Digoxin or medicines similar to digitalis -

for heart problems.

Levothyroxine

thyroxine

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

breastfeed.

3. HOW

SHOULD

YOU

USE

THE

MEDICINE:

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

results.

For

children,

dosage

will

determined by the child’s weight.

Each measuring spoon contains 15 g of

Kayexalate powder.

It is forbidden to heat Kayexalate –

heating can change the properties of

the preparation.

Consult the doctor with regard to

prophylactic measures or treatment for

constipation sometimes caused by use of

the preparation.

Taking the medicine:

This medicine is intended for oral or

rectal use.

Use

Kayexalate

suspension

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

medicine.

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

Kayexalate

Powder

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

pharmacist.

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

potassium (hyperkalemia).

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

(hypokalemia).

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

medicinal treatment).

Do not administer the medicine orally

to neonates.

Special warnings regarding use of the

medicine:

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

(oedema).

In premature and low-birthweight babies,

caution must be taken with regard to

overdose or insufficient dilution when

rectally administered.

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

month.

6. FURTHER INFORMATION

In addition to the active ingredient,

the medicine also contains: saccharin,

vanillin.

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

effects:

Feeling

tired,

confusion,

muscle

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.

Weight gain.

Stomach upset, pain in the gut, narrowing

or blockage of the gut.

Decreased blood flow to the gut which

causes intense abdominal pain or

collapse.

Lack of appetite.

Feeling sick, being sick, constipation or

diarrhea.

Feeling short of breath or coughing.

This may be the first sign of a serious

or pharmacist.

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.

Blood tests

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

or pharmacist.

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

effects:

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

detailed above.

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

STORED?

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

the doctor.

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

and humidity.

רשואו קדבנ ונכותו תואירבה דרשמ ידי לע עבקנ הז ןולע טמרופ ודי לע ץרמ ךיראתב

2014

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

KAYEXALATE

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:

In adults

Oral route:

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.

Rectal route:

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

results.

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

suspension.

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.

In children

Oral route:

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.

Rectal route:

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.

In newborns:

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.

4.3 Contraindications

- 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:

Sorbitol

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

Undesirable effects).

Hypokalaemia:

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.

Other risks

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

Overdose).

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.

Gastrointestinal ischemia,

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.

4.9 Overdose

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

6.1 Excipients

Kayexalate also contains: Vanillin and Saccharin.

6.2 Incompatibilities

There are no specific incompatibilities.

6.3 Shelf life

48 months

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.

7. MANUFACTURER

Sanofi Winthrop Industrie, France

8. LICENSE HOLDER

Sanofi-aventis Israel ltd.

Beni Gaon st.10, POB 8090, Netanya, Israel.