Calcium resonium

Patient Information Leaflet: Information for the User

CALCIUM RESONIUM
1.2 g calcium ions/15 g, oral powder or powder for rectal suspension
Calcii polystyreni sulfonas
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Leaflet Contents

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

Calcium Resonium contains as its active substance the calcium salt of sulfonated polystyrene resin. The medicine belongs to a group of medicines known as "ion-exchange resins". Calcium Resonium is used in the treatment of hyperkalemia (excessively high potassium levels in the blood). The medicine removes excess potassium from the body, restoring its normal blood concentration. The medicine is commonly used in patients with kidney problems and in dialyzed patients. Calcium Resonium is also used in patients in whom the use of sodium polystyrene sulfonate (Resonium A) is contraindicated due to its sodium content.

2. Important information before using Calcium Resonium

When not to use Calcium Resonium:

• if the patient is allergic to calcium salt of 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, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• if the patient has low blood potassium levels.
• if the patient has medical conditions causing increased calcium levels in the blood, such as thyroid (parathyroid) disorders or certain types of tumors.
• if the patient's intestines are partially or completely blocked (intestinal obstruction).
• if the patient is using a sweetener called sorbitol (a "sugar-free" sweetener used in food products) or consuming products containing sorbitol. This is because administration of Calcium Resonium either as monotherapy or in combination with sorbitol may lead to gastrointestinal narrowing, severe intestinal damage, necrosis, and perforation. Sorbitol in any form must not be taken during treatment with Calcium Resonium.
• Calcium Resonium must not be administered orally to newborns. Its use is contraindicated in newborns with postoperative or drug-induced intestinal atony (absence of intestinal peristalsis).

Do not use Calcium Resonium if any of the above apply to the patient.
If in doubt, contact a doctor, nurse, or pharmacist before using Calcium Resonium.

Warnings and precautions

Talk to a doctor, nurse, or pharmacist before starting Calcium Resonium if:

• the patient is taking other medicines taken by mouth;
• the patient has heart problems;
• the patient has high blood pressure;
• the patient has kidney problems;
• the patient has swollen hands or feet (edema);
• the patient has low levels of potassium, calcium, or magnesium in the blood;
• the patient suffers from constipation;
• the patient has abnormal bowel movements due to illness (including those occurring after surgery or caused by medications), as these may lead to various disorders, including bloating, severe constipation, reduced blood flow to the intestine, or intestinal perforation;
• the medicine has been prescribed for a child who was premature, had low birth weight, or has reduced intestinal motility.

If the patient is unsure whether any of the above apply, they should contact a doctor, nurse, or pharmacist before using Calcium Resonium.

Calcium Resonium and other medicines

Tell the doctor, nurse, or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is because Calcium Resonium may affect the action of other medicines, and other medicines may also affect the action of Calcium Resonium.

In particular, inform the doctor if the patient is taking:

• medicines taken by mouth. Calcium Resonium may bind oral medicines, which could reduce their gastrointestinal absorption and effectiveness. An interval should be maintained between administration of Calcium Resonium and other oral medicines.
• medicines containing sorbitol. Concomitant administration with Calcium Resonium is contraindicated (see section 2 and section 4).
• medicines containing salts such as magnesium, potassium, or calcium. If the patient is unsure, they should consult their doctor.
• certain laxatives containing magnesium.
• certain antacids used for indigestion, containing magnesium or aluminum.
• digoxin or similar digitalis-based medicines – used for heart problems.
• levothyroxine or thyroxine – used for hypothyroidism.
• lithium – used for psychiatric disorders.

If the patient is unsure whether any of the above apply, they should contact a doctor, nurse, or pharmacist before using Calcium Resonium.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or planning to have a child, she should consult a doctor before using this medicine.

Calcium Resonium contains sodium

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

3. How to use Calcium Resonium

This medicine is usually administered by a doctor or nurse. If the patient is unsure why they
are receiving Calcium Resonium or has any questions regarding the dose being used, they should
speak with their doctor, nurse, or pharmacist.

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

Administration of the medicine

• Calcium Resonium is administered orally or rectally (into the lower part of the gastrointestinal tract). In newborns, it is administered exclusively via the rectal route.
• The medicine must not be mixed with fruit juice, as this may impair its proper action.
• When administered orally, it is important that the patient sits upright during administration to avoid inhaling the powder into the lungs.
• When administered rectally, the medicine should be retained in the lower gastrointestinal tract for at least 9 hours. Afterwards, the colon should be flushed to remove the resin.
• The resin suspension should be prepared immediately before use; after 24 hours, the suspension is no longer suitable for use.
• Calcium Resonium should be administered 3 hours before or 3 hours after other orally administered medicines. Calcium Resonium may bind to orally administered medicines, which could reduce their gastrointestinal absorption and effectiveness. In patients with gastroparesis (delayed gastric emptying), a 6-hour interval between medicines should be considered.

Recommended dose
Adults (including elderly patients):
Orally

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

Rectally

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

In certain cases, the medicine may be administered both orally and rectally simultaneously. This
applies when potassium levels need to be rapidly reduced. If initially administered both orally and
rectally, rectal administration may be discontinued once the orally administered resin reaches the rectum.
Children:
Orally

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

Rectally

• If a child cannot take the medicine orally, it may be administered rectally using at least the same dose that would have been given orally, suspended in a proportional amount of 10% glucose solution in water.

Newborns:
Calcium Resonium in newborns is used exclusively via the rectal route.

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

It is important to administer the correct dose of the medicine to children and newborns. If an excessive
dose is administered, severe constipation may occur in children and newborns.
Administration of a higher than recommended dose of Calcium Resonium
It is unlikely that a doctor or nurse would administer too high a dose of the medicine. The doctor or
nurse will monitor the progress of treatment and verify which medicine is being used. If the patient has
any doubts about the dose being administered, they should consult their doctor or nurse.
If a patient receives too high a dose of Calcium Resonium, the following symptoms may occur:

• feeling of irritability or disorientation
• difficulty concentrating
• muscle weakness and diminished reflexes, leading to paralysis
• breathing difficulties
• rapid heartbeat or palpitations
• muscle spasms
• apnea

Missed dose of Calcium Resonium
The doctor or nurse will instruct the patient when to take the medicine. It is unlikely that a dose will
be missed. If the patient suspects they may have missed a dose, they should inform their doctor or
nurse.
Stopping treatment with Calcium Resonium
Calcium Resonium should be continued until the doctor decides to discontinue it. If the patient
stops taking Calcium Resonium, their condition may return.
Blood tests
During treatment, the doctor may recommend regular blood tests to monitor levels of electrolytes
(potassium, sodium, calcium, and magnesium).
If there are any further doubts regarding the use of this medicine, please consult your doctor,
pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You should immediately contact your doctor or nurse if any of the following serious side effects occur:

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

You should contact your doctor or nurse if any of the following side effects occur:

• feeling tired, disoriented, muscle weakness, muscle cramps or irregular heartbeat.
• feeling shaky, tremors or muscle spasms. This may be caused by low levels of calcium or magnesium 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 caused by high levels of sodium in the body.
• stomach upset, intestinal pain, narrowing of the gastrointestinal tract or intestinal obstruction.
• severe abdominal pain or collapse.
• loss of appetite.
• nausea, vomiting, constipation or diarrhoea.
• shortness of breath or cough. These may be early signs of a serious chest infection. This may be caused by accidentally inhaling the medicine into the lungs.
• faecal impaction (impaction) following rectal administration of the medicine, especially in children, and bezoars (solid masses) following oral administration.

Cases of gastrointestinal ischaemia, ischaemic colitis, gastric or intestinal ulceration or necrosis have been reported, which may lead to intestinal perforation and, occasionally, death.
Reporting of side effects
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Calcium Resonium

This medicine will be stored by a 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Calcium Resonium contains

• The active substance is calcium salt of polystyrene sulfonate resin 99.934%. 15 g of powder contains 1.2 g of calcium ions in the form of calcium salt of polystyrene sulfonate resin 99.934%.
• Other ingredients: 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 supplied in packs containing 300 g of powder with an included 15 g measuring spoon.
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturer
Astrea Amilly
196 rue du Marechal Juin
45200 Amilly
France
This leaflet does not contain all the information about the medicine. If you have any questions or doubts, please consult your doctor, nurse or pharmacist.
For more detailed information, contact the local representative of the Marketing Authorisation Holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00