Resinsodium oral suspension powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

RESINSODIO powder for oral suspension

Sodium polystyrene sulfonate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

2.- What you need to know before taking RESINSODIO

3.- How to take RESINSODIO

4.- Possible adverse effects

5.- How to store RESINSODIO

6.- Contents of the pack and other information

1. What RESINSODIO is and what it is used for

RESINSODIO is supplied as a powder for oral administration in multi-dose containers of 400 g.

Sodium polystyrene sulfonate is a medicinal product belonging to the group of drugs used in the treatment of hyperkalemia and which acts by reducing blood potassium ion concentration.

RESINSODIO is used for:

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

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

Do not take RESINSODIO

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use RESINSODIO

• If you suffer from constipation, as you may be more sensitive to worsening of this condition. If laxatives are used to prevent this problem, magnesium-based laxatives should be avoided.
• Make sure to take the medicine in the correct posture.
• If you are taking antacids and/or laxatives (magnesium, aluminum or calcium hydroxide, aluminum carbonate). In these cases, it is recommended to separate the administration by at least 2 hours.
• If you have renal insufficiency.
• If you have hypertension.
• If you have heart failure.
• If you are on a diet restricting sodium intake.
• 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 bowel movements due to your medical condition (including conditions after surgery or due to medications), as these may cause various disorders, including bloating, severe constipation, reduced blood flow to the intestine, or intestinal perforation.

Use of RESINSODIO with other medicines

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

Inform your doctor if you are taking any of the following medicines, as they may interact with sodium polystyrene sulfonate, and it may be necessary to adjust the dose or discontinue one of the treatments:

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

Taking RESINSODIO with food and drinks

Administration of RESINSODIO with fruit juices is not recommended (due to their high potassium content).

Foods containing the sweetener sorbitol should be avoided.

Pregnancy and breastfeeding

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

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

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

Driving and using machines

It is unknown whether administration of sodium polystyrene sulfonate may affect the ability to drive vehicles or operate machinery.

RESINSODIO oral suspension powder

This medicine contains 1,651 mg of sodium (the main component of table/cooking salt) per 15 g dose unit. This corresponds to 82.6% of the maximum daily recommended sodium intake for an adult. Consult your doctor or pharmacist if you need to take RESINSODIO for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

This medicine contains up to 35 mg of sodium benzoate (E-211) per 15 g dose unit.

3. How to take RESINSODIO

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

It is recommended that you 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 daily suspended in water or sugar water.

• Children:

Recommended dose:

Acute hyperkalaemia: 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, contact your doctor or pharmacist immediately, indicating the medicine and the amount ingested.

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

If you forget to take RESINSODIO

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

If you stop treatment with RESINSODIO

If you have missed several doses, consult your doctor so they can advise you on the dosing regimen to follow until you reach your maintenance dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone 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 elderly people

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

• diarrhoea
• decreased appetite (anorexia)

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

• large, hard, dry mass of faeces (faecaloma) 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 pulmonary aspiration of the medicine, which can be prevented by maintaining an upright position when taking the dose

Contact 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 vomit that looks like "coffee grounds"

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and other information

Composition of RESINSODIO

• The active substance is sodium polystyrene sulfonate. Each 100 g of oral suspension powder contains 99.75 g of sodium polystyrene sulfonate. Each 15 g dose unit of oral suspension powder contains 14.96 g of sodium polystyrene sulfonate.
• The other component is vanilla flavour (containing sodium benzoate (E-211)).

Appearance of the medicinal product and contents of the container

RESINSODIO is a fine, golden or brown powder for oral suspension, with a slight vanilla taste and odour.

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

Marketing Authorisation Holder and Manufacturer

LABORATORIOS RUBIO, S.A.

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

08755 Castellbisbal (Barcelona) Spain

Date of the most recent review of this package leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/