Leaflet: information for the user

Calcium Resinate powder for oral suspension

Calcium polystyrene sulfonate

Read this 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 must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Calcium Resinate and for what it is used

2. What you need to know before starting to take Calcium Resinate

3. How to take Calcium Resinate

4. Possible side effects

5. Storage of Calcium Resinate

6. Contents of the pack and additional information

Resincalcio contains calcium sulfonated polystyrene.The calcium sulfonated polystyrene is an ionic exchange resin used in the treatment of hyperkalemia and acts by reducing the concentration of potassium ions in the blood.

Resincalcio is indicated for:

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

Do not take Resincalcio:

• If you are allergic to polystyrene sulfonate or any of the other components of this medication (listed in section 6).
• If you have elevated levels of calcium in your blood.
• If you have kidney insufficiency associated with conditions such as hyperparathyroidism, multiple myeloma, sarcoidosis, or metastatic carcinoma.
• If you have intestinal obstruction disease.
• If you are taking sorbitol.
• Do not administer orally in neonates.
• If you have very low levels of potassium in your blood.

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 especially careful if you have constipation, as you are more susceptible to worsening this condition. In case of using laxatives to prevent this problem, it is recommended to avoid magnesium and/or sorbitol-based laxatives.
• Take the medication in a correct posture (it is essential to remain upright while taking the medication to prevent powder from entering the lungs).
• If you have abnormal bowel 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 intestinal blood flow, or intestinal rupture.

Use of Resincalcio with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Levotiroxine or thyroxine (medications used for thyroid diseases).
• Tetracyclines (a specific group of antibiotics).
• Cardiac glycosides such as digoxin (medications used for some heart diseases).
• Antacids and laxatives (magnesium hydroxide, aluminum, or calcium carbonate, etc.). In these cases, it is recommended to space the intake by at least 2 hours.
• Lithium (medication used for mental disorders).
• Sorbitol (a laxative).

Administration of Resincalcio with food and beverages

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and operating machines

The administration of calcium polystyrene sulfonate may not alter your ability to drive vehicles or operate machines.

Resincalcio contains sodium benzoate (E-211) and sodium

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

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

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

This medication is administered orally. It is recommended that you take Resincalcio with a sufficient amount of water or sugar water.

Make sure to take the medication in a correct posture (it is important to remain upright while taking the medication to prevent powder from entering the lungs).

The recommended dose is:

• Adults:

Administer15 gof Resincalcio three or four times a day suspended in water or sugar water.

• Children:

Acute hyperkalemia:The recommended dose is up to1 gper 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 moreResincalciothan you should

If you have taken more Resincalcio 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 915 620 420.

If you forgot to take Resincalcio

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

If you interrupt treatment with Resincalcio

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 may produce adverse effects, although not everyone will experience them.

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

• Hypercalcemia
• 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 stools (fecalomas) 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 a correct position when taking the medication.

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"

If you consider any of the side effects you are experiencing to be severe, or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

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

This product does not require special conservation conditions.

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 after CAD.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Resincalcio

• The active ingredient is calcium polystyrene sulfonate. Each100 gof oral suspension powder contains99.75 gof calcium polystyrene sulfonate.
• The other components are: vanilla flavor (contains sodium benzoate (E-211)).

Appearance of the product and contents of the packaging

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

• Multi-dose bottles of400 gcapacity, accompanied by a dosing spoon containing approximately5 gof oral suspension powder.
• 26 single-dose sachets of15 gof oral suspension powder.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Rubió S.A.,

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

08755 Castellbisbal (Barcelona) SPAIN

Last review date of this leaflet: September 2023

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