Resonium A

Package Leaflet: Information for the User

RESONIUM A

1.42 g sodium ions/15 g, oral powder or for rectal suspension

Sodium polystyrene sulfonate

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Resonium A contains the active substance sodium polystyrene sulfonate.
Resonium A belongs to a group of medicines called ion exchange resins.
Resonium A is used to treat hyperkalemia (too high levels of potassium in the blood). The medicine removes excess potassium from the body, restoring normal potassium levels in the blood. The medicine is used in patients with kidney problems and in patients undergoing dialysis.

2. Before you take Resonium A

Do not take Resonium A:

• if you are allergic to sodium polystyrene sulfonate, other polystyrene sulfonate resins 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 lips, face, throat or tongue.
• if you have low levels of potassium in your blood.
• if your intestines are partially or completely blocked (intestinal obstruction).
• if you are taking a sweetener called sorbitol (a sugar-free sweetener used in food) or if you are consuming products that contain it. This is because when taking Resonium A alone or in combination with sorbitol, narrowing of the gastrointestinal tract and serious damage to the intestines, their necrosis and perforation may occur in patients. During treatment with Resonium A, you must not take sorbitol in any form.
• Resonium A must not be taken orally in newborns. Its use is contraindicated in newborns with postoperative or drug-induced intestinal atony (cessation of intestinal peristalsis).

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

Warnings and precautions

Before starting treatment with Resonium A, 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);\li>
• you have low levels of potassium, calcium or magnesium in your blood;
• you have constipation;
• you have abnormal bowel movements due to illness (including those that occur after surgery or are caused by medications), 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 premature, had 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 Resonium A.

Resonium A and other medicines

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

• oral medicines. Resonium A may bind to oral medicines, reducing their absorption from the gastrointestinal tract and efficacy. A gap should be maintained between the administration of Resonium A and other oral medicines.
• medicines containing sorbitol. Concurrent administration with Resonium A 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 the foxglove plant - 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 Resonium A.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Patients at risk due to increased sodium intake: the medicine is a source of sodium, so caution should be exercised in patients where increased sodium intake may be harmful (e.g., patients with severe congestive heart failure, severe hypertension, kidney damage or significant edema). In such cases, proper clinical and biochemical monitoring is necessary.

Resonium A contains sodium

This medicine contains from 1400 mg to 1700 mg of sodium (the main component of common salt) per dose.
This corresponds to 70% to 85% of the maximum recommended daily intake of sodium in the diet for adults.
Patients taking Resonium A for a long time should ask their doctor or pharmacist for advice, especially if they have been prescribed a low-salt diet.

3. How to take Resonium A

This medicine is usually given by a doctor or nurse. If you are not sure why you are being given Resonium A or have any questions about your dose, talk to your doctor, nurse or pharmacist.

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

Administration

• Resonium A is given orally or rectally (into the rectum). In newborns, it is given rectally only.
• The medicine must not be mixed with fruit juice, as this may prevent the medicine from working properly.
• When taking the medicine orally, it is important 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, the rectum should be flushed to remove the resin.
• The resin suspension should be prepared shortly before use; after 24 hours, the suspension is no longer suitable for use.
• Resonium A should be given 3 hours before or 3 hours after taking other oral medicines. Resonium A may bind to oral medicines, reducing their absorption from the gastrointestinal tract and efficacy. In patients with gastroparesis (delayed gastric emptying), consider maintaining a 6-hour interval between administrations.

Recommended dose:

Adults (including the elderly):

Oral:

• 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:

• 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 the potassium level needs 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:

• 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:

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

Newborns:

Resonium A is used in newborns 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 important 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 Resonium A

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor or nurse will monitor your progress and check which medicines you are taking.
If you are in doubt about why you are being given a dose of Resonium A, talk to your doctor or nurse.
If you take too much Resonium A, you may experience the following symptoms:

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

Missed dose of Resonium A

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 treatment with Resonium A

Continue to take Resonium A until your doctor decides to stop it. If you stop taking Resonium A, 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, Resonium A can cause side effects, although not everybody gets them.

Seek immediate medical attention 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 blood that resembles coffee grounds.
• allergic reaction. Symptoms may include: rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
• blood in vomit or black, tarry stools.

Tell 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 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 due to high levels of sodium in the body.
• upset stomach, intestinal pain, narrowing of the gastrointestinal 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 with inhaled air.
• fecal 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C, 02-222 Warszawa,
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 Resonium A

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 that month.
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 Resonium A contains

• The active substance is sodium polystyrene sulfonate 99.934%. 15 g of powder contains 1.42 g of sodium ions in the form of sodium polystyrene sulfonate 99.934%.
• The other ingredients are vanillin and saccharin.

What Resonium A looks like and contents of the pack

Resonium A is a cream-colored powder with a vanilla odor. It is available in packs containing 454 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.Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warszawa
tel.: +48 22 280 00 00
Date of last revision of the leaflet: