POTASION 600 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Potasion 600 mg Hard Capsules

Potassium Chloride

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

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Potasion Capsules are and what they are used for
2. What you need to know before taking Potasion Capsules
3. How to take Potasion Capsules
4. Possible side effects
5. Storage of Potasion Capsules
6. Package Contents and Additional Information

1. What Potasion Capsules are and what they are used for

Potasion is a mineral supplement.

Potasion is used to treat hypokalemia (low potassium levels) in situations such as:

• potassium loss caused by treatment with other medications such as diuretics (used to increase urine elimination), corticosteroids, and laxatives,
• potassium loss caused by digestive problems (diarrhea, vomiting), kidney problems, hyperaldosteronism (a disease in which there is an increase in the hormone called aldosterone) with normal kidney function.

Potasion is also used for:

• treatment of digitalis toxicity (a condition caused by excessive levels of digitalis medications, used for heart conditions),
• treatment of hypokalemic periodic familial paralysis (a rare inherited disease that causes episodes of severe muscle weakness with low potassium levels in the blood),
• post-surgical care when there is a potassium deficit.

2. What you need to know before taking Potasion Capsules

Do not take Potasion Capsules

• If you are allergic (hypersensitive) to potassium chloride or any other component of Potasion.
• If a blood test has shown that you have hyperkalemia (high potassium levels in the blood).
• If you have any condition that impairs or prevents gastrointestinal transit (the passage of food through the digestive system), such as intestinal obstruction, narrowing of the digestive tract, or paralytic ileus (blockage of the intestine).
• If you have peptic ulcer (ulcer in the stomach or the first part of the small intestine, called the duodenum) or gastrointestinal bleeding (blood loss originating from any part of the digestive system).
• If you have kidney failure.
• If you have oliguria or anuria (kidney disease characterized by little or no urine production).
• If you have Addison's disease (a disorder that occurs when the adrenal glands do not produce enough of their hormones).

Be cautious when taking Potasion Capsules

• If you have diseases that predispose you to hyperkalemia (elevated potassium levels in the blood), such as kidney problems, acute dehydration, or skin tissue destruction that occurs in severe burns.
• If you are being treated with potassium-sparing diuretics (medications that reduce the amount of fluid in the body) or digitalis medications. Before starting treatment with Potasion, your doctor will order tests to monitor your kidney function.
• If you have heart conditions or kidney problems. Regular monitoring of potassium levels in the blood and periodic review of the electrocardiogram are recommended.
• If you are over 65 years old. Your doctor will advise you to have tests to monitor your potassium levels.
• If you have had peptic ulcer disease.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Consult your doctor if you are taking any of the following medications:

• potassium-sparing diuretics (amiloride, spironolactone, triamterene), angiotensin-converting enzyme inhibitors (ACE inhibitors, used to treat high blood pressure), non-steroidal anti-inflammatory drugs (NSAIDs, used to treat pain and inflammation), beta-blockers (used to treat heart conditions), cyclosporine (used in transplants), heparin (used to prevent blood clot formation), and medications containing potassium. These may promote potassium accumulation in the blood,
• laxatives, corticotropin (ACTH, a hormone secreted in the brain), corticosteroids, amphotericin B (an antibiotic used to prevent the growth of certain types of fungi), gentamicin, penicillins, or polymyxin B. These may lead to increased potassium elimination in the blood,
• ion exchange resins such as sodium polystyrene sulfonate. These resins decrease serum potassium concentrations due to the substitution of potassium with sodium,
• digitalis medications,
• calcium salts,
• insulin (used to control blood sugar levels),
• bicarbonate,
• quinidine (used to treat heart conditions),
• vitamin B12,
• antimuscarinics (delay gastric emptying).

Interference with laboratory tests

If you are going to undergo any diagnostic tests (including blood tests, urine tests, dipstick tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Potasion Capsules with food and drinks

Do not season food with potassium-containing salt substitutes.

Use in people over 65 years old

Do not use in people over 65 years old without consulting a doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant before taking this medication. In pregnant women, high doses are not recommended.

Administration of this medication in pregnant women should only be done when recommended by a doctor, as gastrointestinal transit may be delayed.

During breastfeeding, high doses of this medication are not recommended.

Driving and using machines

No cases have been reported in which Potasion has affected driving or the use of machines.

3. How to take Potasion Capsules

Follow your doctor's instructions for taking Potasion exactly. Consult your doctor or pharmacist if you have any questions.

Take this medication with food or immediately after.

The contents of the Potasion capsules can be crushed, chewed, or sprinkled over a spoonful of soft food if the patient is unable to swallow the capsule whole.

The normal dose is:

• in preventive treatments: 2-3 capsules per day, in 2-3 doses,
• in curative treatments: 5-12 capsules per day, in 2-3 doses.

If you take more Potasion Capsules than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the package and package leaflet of the medication to the healthcare professional.

Go to the hospital immediately for symptomatic treatment.

If you forget to take Potasion Capsules

Take the dose as soon as possible. However, if it is close to the time of the next dose, skip the missed dose and take the next dose at the correct time.

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

4. Possible side effects

Like all medications, Potasion can cause side effects, although not everyone experiences them.

The following side effects have been observed with unknown frequency (cannot be estimated due to lack of data):

Metabolic and nutritional disorders

Hyperkalemia (elevated potassium levels in the blood): may occur if this medication is administered in excess, especially in patients with kidney problems. To correct mild increases that occur in prolonged treatments, it may be sufficient to interrupt the intake of this medication and other medications that may cause such an increase, as well as avoid foods with high potassium content.

In case of a significant increase in potassium levels in the blood, symptoms may include paresthesia of the extremities (tingling in hands or feet), muscle weakness, paralysis, cardiac arrhythmias (heart rhythm disorders), atrioventricular block (a heart condition related to the transmission of the cardiac impulse), cardiac arrest, and mental confusion.

Gastrointestinal disorders

On some occasions, irritation of the stomach and intestinal mucosa may occur, resulting in nausea, vomiting, diarrhea, or colic after taking it. To minimize the occurrence of these side effects, it is recommended to take this medication with meals or immediately after.

The presentation of this medication in microcapsules reduces the risk of ulcers that may occur during treatment with other potassium chloride-based medications.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Potasion Capsules

Keep out of the reach and sight of children.

Do not use Potasion after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Potasion Capsules

• The active ingredient is potassium chloride. Each hard capsule contains 600 mg of potassium chloride.
• The other ingredients are: ethylcellulose, talc, gelatin, and titanium dioxide.

Appearance of the product and package contents

Potasion capsules are white, opaque hard capsules. They are presented in PVC/aluminum blisters. Each package contains 60 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

DESMA Laboratorio Farmacéutico SL

Paseo de la Castellana 121, Escalera Izquierda 3ºB

28046 Madrid

Spain

Manufacturer

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

and

Laboratorio Farmaceutico SIT S.r.l.

Via Camillo Benso Conte Di Cavour 70

27035 Mede (PV)

Italy

Date of the last revision of this package leaflet: July 2024

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