KAYEXALATE 454 G Proszek do sporządzania zawiesiny doustnej

Treść ulotki

1. Kayexalate powder for oral and rectal suspension
   1. What is Kayexalate and what is it used for
   2. What you need to know before you take Kayexalate
   3. How to take Kayexalate
   4. Possible side effects
   5. How to store Kayexalate
   6. Contents of the pack and other information

Kayexalate powder for oral and rectal suspension

sodium polystyrene sulfonate

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Kayexalate is and what it is used for
• 2. What you need to know before you take Kayexalate
• 3. How to take Kayexalate
• 4. Possible side effects
• 5. How to store Kayexalate
• 6. Contents of the pack and other information

1. What is Kayexalate and what is it used for

Kayexalate contains the active ingredient sodium polystyrene sulfonate and belongs to the class of
medicines called "medicines for the treatment of hyperkalemia”.
Kayexalate is indicated for the treatment of hyperkalemia, i.e. it works by lowering the amount of
potassium in the blood.

2. What you need to know before you take Kayexalate

Do not take Kayexalate

• if you are allergic to sodium polystyrene sulfonate or to any of the other ingredients of this medicine (listed in section 6);
• if you have a potassium level in the blood less than 5 mEq/l;
• if you have problems with the functioning of the intestine (obstructive intestinal pathology).

Kayexalate should not be administered orally to newborns and infants with reduced
intestinal function (following surgery or induced by drugs).

Warnings and precautions
Take this medicine following exactly the instructions of your doctor or pharmacist.
Consult your doctor or pharmacist before taking Kayexalate:

• If you are using other medicines orally, as Kayexalate may decrease their absorption and effectiveness. Avoid the concomitant use of Kayexalate with other oral medicines. Take Kayexalate at least 3 hours before or 3 hours after taking another oral medicine. If you suffer from gastroparesis (a stomach condition that causes food to stay in the stomach for much longer than normal), a 6-hour interval should be considered.
• If you have a low potassium level in the blood; especially if you are taking medicines for

the heart belonging to the class of “digitalis”, treatment with Kayexalate may lead to a
significant decrease in the amount of potassium in the blood. For this reason, your doctor may
perform checks during treatment. Therapy should still be discontinued as soon as the amount of
potassium in the blood falls below 5 mEq/l (see “Do not take Kayexalate”).

• If you suffer from electrolyte disorders; Kayexalate may increase the elimination of magnesium and calcium in the blood. In this regard, your doctor may decide to subject you to checks during treatment.
• If the potassium level in the blood is very high, because the medicine Kayexalate may not be sufficient to lower this concentration and the doctor may decide to modify the therapy (treatment with glucose and insulin or with sodium bicarbonate intravenously). In the presence of a severe increase in the amount of potassium in the blood (hyperkalemia) caused by conditions of rapid tissue destruction (burns and renal failure), the doctor may decide to resort to dialysis (peritoneal dialysis or hemodialysis).
• If you are using sorbitol, because if taken with Kayexalate it may cause narrowing of the intestine (gastrointestinal stenosis), severe reduction of blood in the intestine (intestinal ischemia), with severe intestinal damage (necrosis), which may lead to perforation of the intestine (intestinal perforation).
• If you are taking Kayexalate and experience significant constipation (clinically significant constipation), stop taking it immediately until the bowel function returns to normal. Do not take laxatives containing magnesium or sorbitol (see “Other medicines and Kayexalate”).
• If you have to take the medicine orally, put yourself in a correct position, to avoid the medicine entering the airways (aspiration) with resulting complications at the level of the bronchi and lungs (bronchopulmonary).
• If you are at risk of increased sodium levels in the blood or if you suffer from heart disease (severe congestive heart failure), severe high blood pressure (severe hypertension), kidney problems or if you have swelling in the lower extremities due to fluid retention (marked edema), take Kayexalate with caution. In some cases, your doctor may request control tests, modify the therapy or diet.
• If you suffer from severe kidney failure (chronic uremia) or have injuries of various kinds to the stomach or intestine, you should take Kayexalate with caution.
• If you suffer from severe kidney failure (uricemia), if you have been burned recently, if you have injuries to the stomach and intestine (gastrointestinal lesions) or if you have reduced stomach or intestinal function (reduced gastrointestinal motility), the doctor may decide to use other medicines to reduce the concentration of potassium in the blood.
• If you use calcium carbonate or aluminum hydroxide as they are absorbed in the presence of sodium polystyrene sulfonate, causing a modification of the acidity in the blood which, in extreme cases, could trigger seizures. In particular, the use of antacids (aluminum hydroxide) may require an increase in the dose of the resin with accumulation in the gastric cavity and formation of compact masses.

Children
Do not give Kayexalate orally to a newborn. If you administer Kayexalate rectally to a
child or infant, pay close attention to how you dilute the powder and the dosage because
it may become a single block (impaction).
If you have to give Kayexalate to a premature newborn or a low-weight newborn, be very careful
because it may increase the likelihood of severe bleeding in the stomach and
intestine (digestive bleeding), severe injury to the stomach and intestine (colonic necrosis) and
increased concentration of sodium in the blood (sodium overload).

Other medicines and Kayexalate
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Associations not recommended (see “Warnings and precautions”):

• Do not use this medicine at the same time as other medicines orally because Kayexalate may bind to other oral medicines reducing their gastrointestinal absorption and effectiveness. It is necessary that the administration of Kayexalate is separated from that of other oral medicines (see the paragraph “Warnings and precautions”).
• Do not use sorbitol because if taken with Kayexalate it may cause you serious intestinal damage as well as serious reactions at the level of the stomach and intestine, which could lead to death. The association of the two drugs should therefore be avoided. Associations requiring attention:
• If you are taking medicines for the cure of stomach acidity “Non-absorbable cationic donor antacids” (magnesium hydroxide and aluminum carbonate) or laxatives with Kayexalate you must have particular attention because a modification of the acidity in the blood known as “systemic alkalosis” can occur.
• Other medicines called “cationic donors”: the action of Kayexalate may be reduced.
• Be very careful if you are taking medicines against acidity based on aluminum hydroxide at the same time as the Kayexalate medicine because an intestinal blockage (intestinal obstruction) due to the formation of compact masses may occur
• It is not recommended to take medicines based on digitalis if you are taking Kayexalate because low levels of potassium in the blood may increase the likelihood of an increase in toxic effects of digitalis on the heart, in particular alteration of the heartbeat (ventricular arrhythmias) and other alterations in the functioning of the heart (AV nodal dissociations).
• If you are taking medicines based on lithium you should be careful because taking it with Kayexalate may decrease the absorption of lithium.
• If you are taking medicines for the thyroid based on thyroxine you should be careful because taking it with Kayexalate may decrease the absorption of thyroxine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The medicine Kayexalate is not absorbed at the level of the stomach and intestine. Although there
is no data on the use of the medicine Kayexalate during pregnancy and breastfeeding, it is not
recommended for use in the first trimester of pregnancy. Kayexalate should be administered during
subsequent periods of pregnancy only if absolutely necessary and under strict control.

3. How to take Kayexalate

Take this medicine always exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
The medicine Kayexalate is taken mainly by mouth, but it can also be taken
rectally if you have difficulty taking Kayexalate by mouth (due to vomiting or problems
at the level of the stomach and the upper part of the intestine). The doctor may prescribe Kayexalate both
orally and rectally in order to achieve faster initial results. If both routes are used initially,
it is probably not necessary to continue rectal administration when the resin administered orally has reached the rectum.
The duration of therapy depends on the severity and duration of hyperkalemia.
The resin must be dissolved in water shortly before use and should not be stored dissolved in water
for more than 24 hours. Heat can alter the properties of the resin (do not exceed 37°C).
This medicine should not be mixed with other medicines.
The doctor may decide to modify the doses based on the tests that have been prescribed for you.

Adults and the elderly

Oral route
The recommended dose is:
15 g (one measuring scoop) 1-4 times a day.
Take the powder after making it into a paste (pulped) or suspended in a small amount of water or,
to make it more palatable, in water and sugar (not fruit juices, which contain
potassium); use little water (use 3 or 4 ml per gram of powder), especially if you have problems with
kidney function (renal insufficiency)
The doctor may decide to give you the medicine Kayexalate via a tube (directly into the
stomach) or have you take the powder by mixing it with food.

• Take Kayexalate at least 3 hours before or 3 hours after other medicines taken orally. If you suffer from gastroparesis (a stomach condition that causes food to remain in the stomach for much longer than normal), an interval of 6 hours is necessary.

Rectal route
The recommended dose is:
30 g of powder (two measuring scoops) dissolved in 150-200 ml of water or 10% dextrose 1-2 times a day;
the powder suspended in the liquid must be administered as an enema and retained in the rectum for
the time subsequently recommended (retention enema).
Before taking the medicine Kayexalate rectally, you must perform a cleansing enema.
You should retain the Kayexalate enema for 10-12 hours, if possible, and then perform
a cleansing enema to remove the drug.
The Kayexalate suspension should be gently shaken during administration.
The Kayexalate suspension should be administered at body temperature, without exceeding 37°C
because heating can alter the properties of the medicine.
You must perform the cleansing enema with a sodium-free solution, also heated to
body temperature; two liters of cleansing solution may be necessary.

Children
Experience with the use of KAYEXALATE in children is limited.

Oral route
The recommended initial dose is:
1 g/kg of body weight per day, divided into several doses.
For maintenance, it can be reduced to 0.5 g/kg of body weight per day.
The dose in smaller children should be proportionally lower.
For the method of administration, see “adults”.

Rectal route
The recommended dose is:
at least equal to the recommended dose for oral administration, suspended in an adequately
proportioned amount of water and 10% dextrose.
The same administration methods described in “Adults and the elderly” apply. Maximum caution is recommended in the case of children or infants because an excessive dose or inadequate dilution can cause Kayexalate to compact with possible consequent obstruction
of the intestine due to very compacted stools (fecaloma).

Infants
Experience with the use of KAYEXALATE in infants is limited and administration should only occur
rectally.

Rectal route
The recommended dose is:
between 0.5 g/kg and 1 g/kg (the minimum effective dose).
The same administration methods described in “Adults and the elderly” apply. Maximum caution is recommended if it is a child or infant because an excessive dose or inadequate dilution can cause Kayexalate to compact with possible consequent obstruction
of the intestine due to very compacted stools (fecaloma).

If you take more Kayexalate than you should
In case of accidental ingestion/administration of an excessive dose of Kayexalate, immediately inform
your doctor or go to the nearest hospital.
If you take an excessive dose of Kayexalate, you may experience a severe decrease in the amount of
potassium in your blood, which may cause irritability, confusion, slowing of intellectual abilities,
muscle weakness, decreased reflexes (hyporeflexia) and possibly paralysis (flaccid paralysis). A severe decrease in the amount of potassium in the blood can lead to excessive pauses
during breathing (apnea), changes in the electrocardiogram and alteration of
heartbeat (cardiac arrhythmias). If you take an excessive dose of Kayexalate, you may experience a
decrease in the amount of calcium in your blood, with consequent involuntary muscle contractions
(tetany).

If you forget to take Kayexalate
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:- increased amount of sodium in the blood
(sodium retention), decreased amount of potassium in the blood (hypokalaemia) and
decreased calcium in the blood (hypocalcaemia);

• reduction of the amount of magnesium in the blood (hypomagnesaemia);
• irritation of the stomach (gastric irritation), loss of appetite (anorexia), nausea and vomiting, reduced bowel function (constipation) and diarrhoea;
• intestinal obstruction due to compacted stools (faecalomas), in elderly patients treated with a high dose or in children after rectal administration;
• narrowing of the stomach and intestines (gastrointestinal stenosis) and intestinal obstruction,

due to a coexisting condition (problems with the stomach or intestines), taking
medicines based on aluminium hydroxide or inadequate dilution of the resin;

• formation of compacted masses of medicine at the level of the stomach and intestines (gastrointestinal bezoar) with intestinal obstruction or formation of “crystals” of medicine adhering to the mucosa of the stomach and intestines (gastrointestinal);
• severe reduction of blood in the intestine (gastrointestinal ischemia), abdominal pain due to reduced blood in the intestine (ischemic colitis), lesions at the level of the stomach and intestine (gastrointestinal ulcerations) or severe intestinal lesions (necrosis) which can lead to perforation of the intestine (intestinal perforation) which can sometimes be fatal, particularly after sorbitol use;
• acute bronchitis and/or bronchopneumonia associated with inhalation of the powder.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Kayexalate

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Kayexalate contains

• The active ingredient is sodium polystyrene sulfonate. Each bottle contains 453.7 g of sodium polystyrene sulfonate
• The other ingredients are vanillin, saccharin.

Description of the appearance of Kayexalate and contents of the pack
Kayexalate is presented as a yellow-golden coloured powder in a bottle containing 454 g of
powder for oral and rectal suspension, with a 15 g dosing spoon.

Marketing Authorisation Holder
Sanofi S.p.A. – Viale L. Bodio, 37/B - Milan

Manufacturer
SANOFI SYNTHELABO LIMITED - Edgefield Avenue - Fawdon Newcastle-Upon-Tyne NE3 3TT (UK)

or
SANOFI WINTHROP INDUSTRIE - 196, Avenue du Marechal Juin - Amilly (France)