Calcium Resonium

Package Leaflet: Information for the User

CALCIUM RESONIUM

1.2 g of calcium ions/15 g, oral powder or for rectal suspension preparation

Calcium polystyrene sulfonate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, nurse, or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Calcium Resonium and what is it used for
• 2. Important information before taking Calcium Resonium
• 3. How to take Calcium Resonium
• 4. Possible side effects
• 5. How to store Calcium Resonium
• 6. Contents of the pack and other information

1. What is Calcium Resonium and what is it used for

Calcium Resonium contains the active substance calcium polystyrene sulfonate. It belongs to a group of medicines called "ion exchange resins". Calcium Resonium is used to treat hyperkalemia (too high potassium levels in the blood). The medicine removes excess potassium from the body, restoring its normal level in the blood. It is often used in patients with kidney problems and in patients undergoing dialysis. Calcium Resonium is also used in patients for whom the use of sodium polystyrene sulfonate (Resonium A) is contraindicated due to its sodium content.

2. Important information before taking Calcium Resonium

When not to use Calcium Resonium:

• if you are allergic to calcium polystyrene sulfonate, other polystyrene sulfonates, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, swallowing or breathing problems, swelling of the face, lips, throat, or tongue.
• if you have low potassium levels in the blood.
• if you have conditions that cause high calcium levels in the blood, such as parathyroid problems or certain types of cancer.
• if your intestines are partially or completely blocked (intestinal obstruction).
• if you are taking a sweetener called sorbitol (a "sugar-free" sweetener used to sweeten food) or consuming products to which it is added. This is because when taking Calcium Resonium alone or in combination with sorbitol, it may cause narrowing of the digestive tract and serious damage to the intestines, their necrosis, and perforation. When taking Calcium Resonium, you should not take sorbitol in any form.
• Calcium Resonium should not be used orally in newborns. Its use is contraindicated in newborns with postoperative or drug-induced intestinal atony (cessation of intestinal peristalsis).

Do not use Calcium Resonium if any of the above applies to you. If in doubt, consult your doctor, nurse, or pharmacist before taking Calcium Resonium.

Warnings and precautions

Before starting to take Calcium Resonium, discuss it with your doctor, nurse, or pharmacist if:

• you are taking other oral medicines;
• you have heart problems;
• you have high blood pressure;
• you have kidney problems;
• you have swollen arms or legs (edema).
• you have low levels of potassium, calcium, or magnesium in the blood;
• you have constipation;
• you have abnormal bowel movements due to illness (including those that occur after surgery or are caused by medication), as they may cause various disorders, including bloating, severe constipation, reduced blood flow to the intestine, or intestinal rupture.
• the medicine has been prescribed for a child who is a premature baby, had a low birth weight, or has reduced intestinal motility.

If you are not sure if any of the above applies to you, consult your doctor, nurse, or pharmacist before taking Calcium Resonium.

Calcium Resonium and other medicines

Tell your doctor, nurse, or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is because Calcium Resonium may affect the action of other medicines. Other medicines may also affect the action of Calcium Resonium. In particular, inform your doctor if you are taking:

• oral medicines. Calcium Resonium may bind to oral medicines, reducing their absorption from the digestive tract and effectiveness. Keep a gap between taking Calcium Resonium and other oral medicines.
• medicines containing sorbitol. Concurrent administration with Calcium Resonium is contraindicated (see sections 2 and 4).
• medicines containing salts, such as magnesium, potassium, or calcium. If you are unsure, consult your doctor.
• certain laxatives (stimulant laxatives) that contain magnesium.
• certain antacids (acid-neutralizing medicines) that contain magnesium or aluminum.
• digoxin or similar medicines from digitalis - used for heart problems.
• levothyroxine or thyroxine - used for hypothyroidism.
• lithium - used for mental illnesses.

If you are not sure if any of the above applies to you, consult your doctor, nurse, or pharmacist before taking Calcium Resonium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Calcium Resonium contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 15 g of powder, which means the medicine is considered "sodium-free".

3. How to take Calcium Resonium

This medicine is usually administered by a doctor or nurse. If you are unsure why you are being given Calcium Resonium or have any questions about the dose of Calcium Resonium you are being given, talk to your doctor, nurse, or pharmacist.

• The dose of the medicine depends on the results of blood tests.
• In children, the dose is also calculated based on the child's body weight.

Administration of the medicine

• Calcium Resonium is given orally or rectally (into the rectum). In newborns, it is given rectally only.
• The medicine should not be mixed with fruit juice, as this may prevent the medicine from working properly.
• When taking the medicine orally, it is essential to sit up during administration to avoid inhaling the powder into the lungs.
• When administering rectally, try to keep the medicine in the rectum for at least 9 hours. Then, flush the rectum to remove the resin.
• The resin suspension should be prepared shortly before use; after 24 hours, the suspension is no longer suitable for use.
• Calcium Resonium should be given 3 hours before or 3 hours after taking other oral medicines. Calcium Resonium may bind to oral medicines, reducing their absorption from the digestive tract and effectiveness. In patients with gastroparesis (delayed gastric emptying), consider maintaining a 6-hour gap between administering medicines.

Recommended dose

Adults (including elderly patients):

Oral administration:

• The recommended dose is 15 g (one full spoon) three or four times a day. Each dose should be given as a suspension in a small amount of water, or for better taste, in a sweet drink (except fruit juices, which contain potassium) in a ratio of 3 to 4 ml per gram of resin.

Rectal administration:

• The recommended dose is 30 g (two full spoons) once a day in 150 ml of water or 10% glucose solution.

In some cases, the medicine may be given both orally and rectally. This applies to situations where potassium levels need to be reduced quickly. If the medicine is initially given orally and rectally, rectal administration can be discontinued when the orally administered resin reaches the rectum.

Children:

Oral administration:

• The initial daily dose is 1 g per kilogram of body weight in divided doses. The medicine is given orally, preferably with a drink (but not with fruit juices, as they contain a lot of potassium) or with a small amount of jam or honey.
• Then, the daily dose may be reduced to 0.5 g per kilogram of body weight (maintenance dose).

Rectal administration:

• If the child cannot take the medicine orally, it can be given rectally, using a dose of at least the same as would be given orally, suspended in an appropriate amount of 10% glucose solution in water.

Newborns:

Calcium Resonium in newborns is used rectally only.

• The dose used is the smallest effective dose in the range of 0.5 g to 1 g per kilogram of body weight, diluted as for adults.

It is essential to give children and newborns the correct dose of the medicine. If too high a dose of the medicine is given to children and newborns, severe constipation may occur.

Overdose of Calcium Resonium

It is unlikely that a doctor or nurse will give too much medicine. The doctor or nurse will monitor the progress of the treatment and check which medicine is being used for the patient. If you have any doubts about why you are being given a dose of the medicine, ask your doctor or nurse. If you take too much Calcium Resonium, the following symptoms may occur:

• irritability or disorientation
• concentration problems
• muscle weakness and decreased reflexes, leading to paralysis
• breathing difficulties
• rapid heartbeat or palpitations
• muscle cramps
• apnea.

Missed dose of Calcium Resonium

Your doctor or nurse will instruct you when to take the medicine. It is unlikely that a dose of the medicine will be missed. If you suspect that you may have missed a dose of the medicine, tell your doctor or nurse.

Stopping the use of Calcium Resonium

Use Calcium Resonium until your doctor decides to stop it. If you stop taking Calcium Resonium, your illness may return.

Blood tests

During treatment, your doctor may recommend regular blood tests to check the levels of salts (potassium, sodium, calcium, and magnesium) in your blood. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Calcium Resonium can cause side effects, although not everybody gets them.

Inform your doctor or nurse immediately if you experience any of the following serious side effects:

• severe abdominal pain, anal pain.
• bloating, severe constipation.
• severe nausea and vomiting.
• black, bloody, or tarry stools, coughing up blood or vomiting coffee ground-like material.
• allergic reaction. Symptoms may include: rash, swallowing or breathing problems, swelling of the face, lips, throat, or tongue.
• blood in vomit or black, tarry stools.

Inform your doctor or nurse if you experience any of the following side effects:

• feeling tired, disoriented, muscle weakness, cramps, or heart rhythm disturbances.
• feeling shaky, trembling, or muscle cramps. This may be due to low calcium or magnesium levels in the body.
• increased thirst or need to urinate frequently.
• high blood pressure, kidney problems, heart problems, or swelling of the limbs. This may be due to high sodium levels in the body.
• upset stomach, abdominal pain, narrowing of the digestive tract, or intestinal obstruction.
• severe abdominal pain or shock.
• loss of appetite.
• nausea, vomiting, constipation, or diarrhea.
• shortness of breath or cough. These may be the first symptoms of a serious chest infection. This may be due to accidental inhalation of the medicine into the lungs.
• rectal impaction after rectal administration, especially in children, and bezoars after oral administration.

There have been reports of intestinal ischemia, ischemic colitis, gastric or intestinal ulcers, or necrosis, which can lead to intestinal perforation and, in some cases, death.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcium Resonium

This medicine will be stored by your doctor or pharmacist in a safe place, out of sight and reach of children. The medicine should be stored in a dry place. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Calcium Resonium contains

• The active substance of the medicine is calcium polystyrene sulfonate 99.934%. 15 g of powder contains 1.2 g of calcium ions in the form of calcium polystyrene sulfonate 99.934%.
• The other ingredients are vanillin and saccharin.

What Calcium Resonium looks like and contents of the pack

Calcium Resonium is a cream-colored powder with a vanilla odor. It is available in packs containing 300 g of powder with a 15 g spoon attached.

Marketing authorization holder

Sanofi Winthrop Industrie, 82, Avenue Raspail, 94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie, 196 rue du Marechal Juin, 45200 Amilly, France. This leaflet does not contain all the information about your medicine. If you have any questions or doubts, ask your doctor, nurse, or pharmacist. For more detailed information, contact your local representative of the marketing authorization holder: Sanofi Sp. z o.o., ul. Marcina Kasprzaka 6, 01-211 Warsaw, tel.: +48 22 280 00 00.

Date of last revision of the leaflet: