RESINSODIO POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

RESINSODIO Powder for Oral Suspension

Sodium Polystyrene Sulfonate

Read all of this leaflet carefully before you start 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What RESINSODIO is and what it is used for

2. What you need to know before you take RESINSODIO

3. How to take RESINSODIO

4. Possible side effects

5. Storage of RESINSODIO

6. Contents of the pack and further information

1. What RESINSODIO is and what it is used for

RESINSODIO is presented as a powder for oral administration in multidose containers of 400 g.

Sodium polystyrene sulfonate is a drug that belongs to the group of medications used in the treatment of hyperkalemia and acts by decreasing the concentration of potassium ions in the blood.

RESINSODIO is used in:

Treatment and prevention of hyperkalemia (high levels of potassium in the blood).

2. What you need to know before you take RESINSODIO

Do not take RESINSODIO

• If you are allergic (hypersensitive) to sodium polystyrene sulfonate or any of the other components of this medicine (listed in section 6).
• If you have high blood sodium levels.
• If you have blood potassium levels below 5 mmol/l.
• If you have severe hypertension.
• If you have obstructive disease of the intestine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use RESINSODIO

• If you suffer from constipation, as you are more sensitive to worsening of this condition. In case of using laxatives to prevent this problem, it is recommended to avoid laxatives based on magnesium.
• Try to take the medicine in a correct posture.
• If you are taking antacids and/or laxatives (magnesium hydroxide, aluminum or calcium, and aluminum carbonate). In these cases, it is recommended to space out the intake by at least 2 hours.
• If you have kidney failure.
• If you have hypertension.
• If you have heart failure.
• If you are on a diet where you have been limited in sodium.
• If you are taking sorbitol.
• If you are taking RESINSODIO, your doctor should perform frequent blood tests to monitor your ion levels.
• If you have abnormal intestinal movements due to your medical condition (including conditions after surgery or the use of medications), as they can cause various disorders, including swelling, severe constipation, decreased blood flow to the intestine, or intestinal rupture.

Using RESINSODIO with other medicines

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

Tell your doctor if you take any of the following medicines, as they may interact with sodium polystyrene sulfonate, and it may be necessary to vary the dose or interrupt one of the treatments:

• Levothyroxine or Thyroxine
• Cardiac glycosides (digoxin)
• Antacids and laxatives (magnesium hydroxide, aluminum or calcium, aluminum carbonate, etc.). In these cases, it is recommended to space out the intake by at least 2 hours.
• Tetracyclines (a specific group of antibiotics)
• Lithium (used in mental illnesses)

Taking RESINSODIO with food and drinks

It is not recommended to administer RESINSODIO with juices (due to their high potassium content).

Foods containing a sweetener called sorbitol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As there are no studies that provide conclusive data on the safety of using this medicine in pregnant women, the administration of RESINSODIO should be closely supervised by the doctor.

There are no studies that provide conclusive data on the safety of using this medicine in breastfeeding women. Therefore, the administration of RESINSODIO should be closely supervised by the doctor.

Driving and using machines

It is unknown whether the administration of sodium polystyrene sulfonate can alter the ability to drive vehicles or operate machines.

RESINSODIO Powder for Oral Suspension

This medicine contains 1.651 mg of sodium (the main component of table salt/cooking salt) in each 15 g dose unit. This is equivalent to 82.6% of the maximum daily sodium intake recommended for an adult. Consult your doctor or pharmacist if you need RESINSODIO for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

This medicine contains a maximum of 35 mg of sodium benzoate (E-211) in each 15 g dose unit.

3. How to take RESINSODIO

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is recommended to take RESINSODIO with sufficient water or sugared water.

The recommended dose is:

• Adults:

Recommended dose: administer 15 g of RESINSODIO three or four times a day suspended in water or sugared water.

• Children:

Recommended dose:

Acute Hyperkalemia: The recommended dose is up to 1 g per kg of body weight per day, divided into several doses.

Maintenance: The recommended dose is 500 mg per kg of body weight per day, divided into several doses.

If you take more RESINSODIO than you should

If you take more RESINSODIO than you should, consult your doctor or pharmacist immediately, indicating the medicine and the amount ingested.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone (91) 562.04.20

If you forget to take RESINSODIO

Do not take a double dose to make up for forgotten doses.

If you stop taking RESINSODIO

If you have forgotten to take several doses, consult your doctor to indicate the dosage schedule to follow until you reach your maintenance dose.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people):

• low calcium levels in the blood
• low potassium levels in the blood
• nausea
• constipation in elderly people

Uncommon (may affect up to 1 in 100 people):

• diarrhea
• decreased appetite (anorexia)

Rare (may affect up to 1 in 1,000 people):

• large, hard, and dry fecal mass (fecaloma) in severe cases

Very rare (may affect up to 1 in 10,000 people):

• Tissue death (necrosis) of the colon.
• Acute inflammation of the bronchi or a particular type of pneumonia caused by inhalation of the medicine, which can be prevented by maintaining a correct posture when taking the dose.

Consult your doctor or nurse immediately if you notice any of the following serious side effects:

• Severe stomach pain, rectal pain
• Swelling, severe constipation
• Severe nausea and vomiting
• Black, bloody, or tarry stools, coughing up blood or vomiting that looks like "coffee grounds"

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of RESINSODIO

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of RESINSODIO

• The active ingredient is sodium polystyrene sulfonate. Each 100 g of powder for oral suspension contains 99.75 g of sodium polystyrene sulfonate. Each 15 g dose unit of powder for oral suspension contains 14.96 g of sodium polystyrene sulfonate.
• The other ingredients are vanilla flavor (contains sodium benzoate (E-211)).

Appearance of the product and contents of the pack

RESINSODIO is a fine, golden or brown powder for oral suspension with a slight flavor and odor of vanilla.

It is presented in multidose containers of 400 g of powder.

Marketing authorization holder and manufacturer

LABORATORIOS RUBIO, S.A.

C/ Industria, 29. Pol. Ind. Comte de Sert,

08755 Castellbisbal (Barcelona) Spain

Date of the last revision of this leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/