Leaflet: information for the user

Potasion 600 mg hard capsules

Potassium chloride

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 Potasion capsules are and for what they are used

2. What you need to know before starting to take Potasion capsules

3. How to take Potasion capsules

4. Possible side effects

5. Storage of Potasion capsules

6. Contents of the pack and additional information

Potasionis a mineral supplement.

Potasion is used for the treatment of hypokalemia (a decrease in potassium levels) in situations such as:

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

Potasionis also used for:

• treatment of intoxication with certain medications called digitalis (used for the heart),
• treatment of familial periodic paralysis with hypokalemia (a rare inherited disease that causes severe episodes of muscle weakness with a decrease in potassium levels in the blood),
• postoperative care when there is a deficit in potassium intake.

Do not take Potasion capsules

• If you are allergic (hypersensitive) to potassium chloride or any of the other components of Potasion.
• If your doctor has told you that you have hyperkalemia (high levels of potassium in the blood) after a blood test.
• If you have any condition that makes it difficult or impossible for food to pass through the digestive system, such as intestinal obstruction, narrowing of the digestive tract, or paralytic ileus (intestinal blockage).
• If you have a peptic ulcer (ulcer located 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 tract).
• If you have kidney insufficiency (kidney problems).
• If you have oliguria or anuria (kidney disease in which little or no urine is produced).
• If you have Addison's disease (a disorder that occurs when the adrenal glands do not produce enough of their hormones).

Be especially careful with Potasion capsules

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

Use of other medications

Inform 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), nonsteroidal anti-inflammatory drugs (NSAIDs, used to treat both pain and inflammation), beta-blockers (used to treat primarily heart problems), cyclosporine (used in transplants), heparin (used to prevent blood clotting), and medications containing potassium. They may promote the accumulation of potassium 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. They may lead to increased potassium elimination from the blood,
• cation exchange resins of the sodium cycle, such as polystyrene sulfonate sodium. These resins decrease serum potassium concentrations due to the substitution of potassium by sodium,
• digitalis,
• calcium salts,
• insulin (used to control blood sugar levels),
• bicarbonate,
• quinidine (used to treat heart problems),
• vitamin B12,
• antimuscarinics (delay gastric emptying).

Interference with analytical tests

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

Taking Potasion capsules with food and drinks

You should not season food with low-sodium salt that contains potassium.

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

This medication should only be administered to pregnant women when recommended by the doctor, as the passage through the digestive system may be delayed.

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

Driving and operating machinery

No cases have been described in which Potasion has affected driving or operating machinery.

Follow exactly the administration instructions for Potasion as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

You should 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 entire capsule.

The normal dose is:

• in preventive treatments : 2-3 capsules daily, in 2-3 doses,
• in curative treatments : 5-12 capsules daily, 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Go immediately to a hospital for symptomatic treatment.

If you forgot to take Potasion capsules

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

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

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

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

Metabolic and nutritional disorders

Hyperkalemia (elevated potassium levels in blood): this can occur if the medication is taken in excess, especially in patients with kidney problems. To correct the mild increase that occurs during prolonged treatment, it may be sufficient to stop taking this medication and other medications that may cause this increase, as well as avoid foods with high potassium content.

In the 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 alterations), atrioventricular block (a heart disease related to the transmission of the cardiac impulse), cardiac arrest, and mental confusion.

Gastrointestinal disorders

In some cases, it may cause irritation of the stomach and intestinal mucosa, resulting in nausea, vomiting, diarrhea, or abdominal cramps after taking it. To reduce the occurrence of these adverse 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 specialties.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it 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 on the safety of this medication.

Keep out of reach and sight of children.

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

Store below 30°C.

Medicines should not be disposed of through drains or in the trash.Deposit empty packaging and unused medicines at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Potasion capsules

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

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

DESMA Pharmaceutical Laboratory SL

Paseo de la Castellana 121,Escalera Izquierda 3ºB

28046 Madrid

Spain

Responsible for manufacturing

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

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

and

Laboratory Farmaceutico SIT S.r.l.

Via Camillo Benso Conte Di Cavour 70

27035 Mede (PV)

Italy

Last review date of this leaflet: July 2024

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