Leaflet: information for the user

RESINSODIO powder for oral suspension

Sodium polystyrene sulfonate

Read this leaflet carefully before starting to take the medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.- What is RESINSODIO and what it is used for

2.- What you need to know before starting to take RESINSODIO

3.- How to take RESINSODIO

4.- Possible adverse effects

5.- Storage of RESINSODIO

6.- Contents of the pack and additional information

RESINSODIO is presented in the form of powder for oral administration in multi-dose containers of 400 g.

Sodium polystyrene sulfonate is a medication that belongs to the group of drugs used in the treatment of hyperkalemia and acts by reducing the concentration of potassium ions in the blood.

RESINSODIO is used in:

The treatment and prevention of hyperkalemia (elevated levels of potassium in the blood).

Do not take RESINSODIO

• If you are allergic (hypersensitive) to sodium polystyrene sulfonate or to any of the other components of this medication (listed in section 6)
• If you have high levels of sodium in your blood.
• If you have low levels of potassium in your blood (less than 5 mmol/l).
• If you have severe high blood pressure.
• If you have intestinal obstruction disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to use RESINSODIO

• If you have constipation, as you are more sensitive to this situation worsening. In case of using laxatives to prevent this problem, it is recommended to avoid magnesium-based laxatives.
• Take the medication 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 the intake a minimum of 2 hours.
• If you have kidney insufficiency.
• If you have high blood pressure.
• If you have heart failure.
• If you are following a diet in which you have been limited in sodium.
• If you are taking sorbitol.
• If you are taking RESINSODIO, your doctor should perform frequent blood tests to control 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 may cause various disorders, including swelling, severe constipation, decreased blood flow to the intestine, or intestinal rupture.

Use of RESINSODIO with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you take any of the following medications, as they may interact with sodium polystyrene sulfonate, so the dose may need to be adjusted or one of the treatments interrupted:

• Levotiroxine or Tiroxine
• Cardiac glycosides (digoxin)
• Antacids and laxatives (magnesium hydroxide, aluminum or calcium, aluminum carbonate, etc.). In these cases, it is recommended to space the intake a minimum of 2 hours
• Tetracyclines (a group of antibiotics)
• Lithium (used in mental disorders)

Taking RESINSODIO with food and drinks

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

Avoid foods containing a sweetener called sorbitol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

As there are no studies that allow obtaining conclusive data on the safety of using this medication in pregnant women, the administration of RESINSODIO should be closely monitored by the doctor.

There are no studies that allow obtaining conclusive data on the safety of using this medication in breastfeeding women. Therefore, the administration of RESINSODIO should be closely monitored by the doctor.

Driving and operating machines

The effect of polystyrene sulfonate sodium on the ability to drive vehicles or operate machines is unknown.

RESINSODIO powder for oral suspension

This medication contains 1,651 mg of sodium (main component of table salt/for cooking) 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-sodium diet.

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

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

It is recommended to take RESINSODIO with a sufficient amount of water or sugar water.

The recommended dose is:

•Adults:

Recommended dose: administer 15 g of RESINSODIO three or four times a day suspended in water or sugar 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 medication and the amount ingested.

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

If you forgot to take RESINSODIO

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with RESINSODIO

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

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

Like all medications, this medication can produce adverse effects, although not all people will experience them.

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

• Low levels of calcium in the blood
• Low levels of potassium in the blood
• Nausea
• Constipation in older adults

Less frequent (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 stool mass (fecaloma) in severe cases

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

• Death of colon tissue (necrosis).
• Acute inflammation of the bronchi or a particular type of pneumonia caused by inhalation of the medication that can be prevented by maintaining the correct position when taking the dose.

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

• Intense stomach pain, rectal pain
• Swelling, severe constipation
• Intense nausea and vomiting
• Black, bloody, or tar-like stools, coughing up blood, or vomiting that appears like "coffee grounds"

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even ifit is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of RESINSODIO

• The active principle is polystyrenesulfonate of sodium. Each 100 g of oral suspension powder contains 99.75 g of polystyrenesulfonate of sodium. Each dosage unit of 15 g of oral suspension powder contains 14.96 g of polystyrenesulfonate of sodium.
• The other components are vanilla flavor (contains sodium benzoate (E-211)).

Appearance of the product and contents of the packaging

RESINSODIO is a fine, golden or brown oral suspension powder with a light taste and vanilla odor.

It is presented in multi-dose containers of 400 g of powder.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Rubio, S.A.

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

08755 Castellbisbal (Barcelona) Spain

Date of the last review of this leaflet: September 2023

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/