RESINCALCIO POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Resincalcio Powder for Oral Suspension

Calcium 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 symptoms are the same as yours.
• If you experience 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 is Resincalcio and what is it used for
2. What you need to know before you take Resincalcio
3. How to take Resincalcio
4. Possible side effects
5. Storage of Resincalcio
6. Contents of the pack and other information

1. What is Resincalcio and what is it used for

Resincalcio contains Calcium Polystyrene Sulfonate. Calcium Polystyrene Sulfonate is an ion exchange resin used in the treatment of hyperkalemia and acts by decreasing the concentration of potassium ions in the blood.

Resincalcio is indicated in:

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

2. What you need to know before you take Resincalcio

Do not take Resincalcio:

• If you are allergic to polystyrene sulfonate resins or to any of the other components of this medicine (listed in section 6).
• If you have high blood calcium levels.
• If you have renal insufficiency associated with diseases such as hyperparathyroidism, multiple myeloma, sarcoidosis, or metastatic carcinoma.
• If you have obstructive disease of the intestine.
• If you are taking sorbitol.
• It must not be administered orally in neonates.
• If you have very low blood potassium levels.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Resincalcio.

• If you are taking Resincalcio, your doctor should perform frequent blood tests to monitor your ion levels.
• Be careful if you have constipation, as you are more sensitive to worsening of this condition. If you use laxatives to prevent this problem, it is recommended to avoid laxatives based on magnesium and/or sorbitol.
• Try to take the medicine in the correct position (it is important to stay upright while taking the medicine so that powder is not introduced into the lungs).
• If you have abnormal bowel movements due to your medical condition (including conditions after surgery or the use of medications), as they can cause various disorders, including bloating, severe constipation, decreased blood risk to the intestine, or intestinal rupture.

Using Resincalcio with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are taking any of the following medicines, as they may interact with Calcium Polystyrene Sulfonate, and it may be necessary to change the dose or interrupt one of the treatments:

• Levothyroxine or thyroxine (medicines used in thyroid diseases).
• Tetracyclines (a certain group of antibiotics).
• Cardiac glycosides such as digoxin (medicines used for some heart diseases).
• 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.
• Lithium (a medicine used in mental illnesses).
• Sorbitol (a laxative).

Taking Resincalcio with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

It is not known if the administration of Calcium Polystyrene Sulfonate can alter the ability to drive vehicles or operate machines.

Resincalcio contains sodium benzoate (E-211) and sodium

This medicine contains a maximum of 35 mg of sodium benzoate (E-211) per dose.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is, essentially "sodium-free".

3. How to take Resincalcio

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

This medicine is administered orally. It is recommended to take Resincalcio with enough water or sugared water.

Try to take the medicine in the correct position (it is important to stay upright while taking the medicine so that powder is not introduced into the lungs).

The recommended dose is:

• Adults:

Administer 15 g of Resincalcio three or four times a day suspended in water or sugared water.

• Children:

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 Resincalcio than you should

If you have taken more Resincalcio 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 915 620 420.

If you forget to take Resincalcio

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

If you stop taking Resincalcio

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):

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

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

• diarrhea
• loss of appetite (anorexia)

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

• large, hard, and dry fecal mass (fecalomas) 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 position while taking the medicine.

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

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

If you think any of the side effects are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Resincalcio

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 which is stated on the packaging after EXP.

The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Resincalcio

• The active substance is Calcium Polystyrene Sulfonate. Each 100 g of powder for oral suspension contains 99.75 g of Calcium Polystyrene Sulfonate.
• The other ingredients are: vanilla flavor (contains sodium benzoate (E-211)).

Appearance of the product and pack contents

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

• Multidose bottles of 400 g capacity, accompanied by a dosing spoon whose content is approximately 5 g of powder for oral suspension.
• 26 single-dose sachets of 15 g of powder for oral suspension.

Marketing authorization holder and manufacturer

LABORATORIOS RUBIÓ S.A.,

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

08755 CASTELLBISBAL (Barcelona) SPAIN

Date of 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.gob.es/).