Kaldium

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Kaldyum

600 mg, Prolonged-Release Hard Capsules

Potassium Chloride

Table of Contents of the Leaflet

• 1. What is Kaldyum and What is it Used For
• 2. Important Information Before Using Kaldyum
• 3. How to Use Kaldyum
• 4. Possible Side Effects
• 5. How to Store Kaldyum
• 6. Package Contents and Other Information

1. What is Kaldyum and What is it Used For

Kaldyum is used for the prevention and treatment of potassium deficiency in the body. Deficiency may be caused by taking certain medications, such as diuretics (water pills), or by certain diseases (e.g., gastrointestinal disorders with vomiting or diarrhea).

2. Important Information Before Using Kaldyum

When Not to Use Kaldyum:

• if the patient is allergic to potassium or any other component of this medication (listed in section 6);
• if the patient has hyperkalemia (excess potassium in the blood), caused by certain diseases and medications [hyperkalemia may occur, among others, in the case of taking certain diuretics (potassium-sparing diuretics) or antihypertensive medications (e.g., ACE inhibitors), in adrenal insufficiency, kidney failure, acidosis (blood acidification, e.g., in diabetic patients), or after tissue damage (severe burns covering a large body surface area)];
• if the patient has severe kidney disease;
• if the patient has Addison's disease (chronic adrenal insufficiency) and is not being treated for it;
• severe dehydration;
• if the patient has gastrointestinal obstruction or esophageal narrowing that makes swallowing difficult.

Warnings and Precautions

Before starting to use Kaldyum, discuss it with your doctor or pharmacist.

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

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Before prescribing the medication, your doctor may check your blood potassium levels and perform an EKG.
Tell your doctor if you have ulcers or other gastrointestinal diseases.
If you are taking digitalis glycosides (medications used for heart conditions), inform your doctor, as sudden discontinuation of Kaldyum may be harmful.
In some cases, your doctor may prescribe another potassium-containing medication, while in other cases, they may recommend taking an additional medication with Kaldyum.
Follow the diet prescribed by your doctor.

Kaldyum and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Be cautious when taking Kaldyum with the following medications:

• ACE inhibitors (medications used to treat high blood pressure), potassium-sparing diuretics, as concurrent use may lead to very high potassium levels in the blood;
• potassium-rich food products and plants (e.g., dandelion leaves and roots, bananas, tomatoes, orange juice) increase the risk of elevated potassium levels in the blood;
• angiotensin II receptor blockers and aliskiren (medications used to treat high blood pressure and certain heart conditions) may lead to increased potassium levels in the blood;
• proton pump inhibitors (medications that reduce stomach acid production) may lead to increased potassium levels in the blood;
• nonsteroidal anti-inflammatory medications, anticholinergic medications, as they may exacerbate gastrointestinal side effects;
• digitalis glycosides (used to treat heart failure), beta-adrenergic medications (used to treat high blood pressure and/or heart rhythm disorders), heparin (a medication that prevents blood clotting), cyclosporine (a cytostatic medication). Your doctor may regularly monitor your blood potassium levels if you are taking any of these medications with Kaldyum.

In case of doubts about the medications you are taking, consult your doctor.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.
Kaldyum can be used during pregnancy and breastfeeding, in accordance with the indications and recommended dosage.

Driving and Operating Machinery

There are no restrictions.

3. How to Use Kaldyum

Always use this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the dosage based on your individual needs.
Adults
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Prevention: the recommended dose is 2 or 3 capsules per day;
Treatment: the recommended dose is 5 to 12 capsules per day, with regular monitoring of blood potassium levels.
If the daily dose exceeds 2 capsules, it should be divided into two or more doses.
Usually, the capsule should be swallowed whole, with a glass of water, during or after a meal.
Patients with Gastric or Intestinal Feeding Tubes
If the patient is being fed through a gastric or intestinal tube, the capsule can be opened and the pellets mixed with food or liquid administered through the tube.

Use in Children

Experience with the use of Kaldyum in children is limited.

Kidney Failure

In severe kidney failure, the use of Kaldyum is contraindicated (see section "When Not to Use Kaldyum").

Liver Failure

No studies have been conducted in patients with liver failure.

Elderly Patients

Due to possible decreased kidney function in elderly patients, dose reduction may be necessary.

Overdose of Kaldyum

In case of overdose, consult your doctor or pharmacist immediately.
Symptoms of overdose: muscle weakness, decreased blood pressure, arrhythmias, and even cardiac arrest.
Treatment: gastric lavage, infusion of sodium chloride, glucose, and insulin, and forced diuresis may be used. Dialysis (peritoneal or hemodialysis) may be necessary.

Missed Dose of Kaldyum

Do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Kaldyum can cause side effects, although not everybody gets them.
Stop using the medication and consult your doctor immediately if you experience any of the following symptoms:

• tarry (black) stools (due to bleeding, ulcers, perforation, and gastrointestinal obstruction):
• abnormal sensations, such as burning, stinging, tingling, itching (paresthesia), muscle weakness, paralysis, irregular heartbeat, low blood pressure (symptoms of high potassium levels in the blood).

Other side effects:
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• nausea, vomiting, diarrhea, abdominal pain.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Kaldyum

Store in a temperature below 25°C.
Keep out of sight and reach of children.
Do not use this medication after the expiration date (month, year) stated on the packaging.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Kaldyum Contains

The active substance of Kaldyum is potassium chloride.
Each prolonged-release hard capsule contains 600 mg of potassium chloride, equivalent to 8 mmol of potassium ions (315 mg of potassium ions).
Other ingredients are:
microcrystalline cellulose, polyacrylate dispersion 30%, dimethicone, talc, colloidal silica, indigo carmine (E 132).
Capsule Shell:
cap: gelatin, indigo carmine (E 132), erythrosine (E 127);
body: gelatin.

What Kaldyum Looks Like and What the Package Contains

The medication is in the form of capsules with a blue cap and a transparent lower part.
The capsule contains a mixture of light blue and white or almost white pellets.
The packaging consists of a colorless glass bottle with a polyethylene cap, in a cardboard box.
Package contents: 50 or 100 capsules.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Hungary, the Country of Export:

Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
H-1106 Budapest
Hungary

Manufacturer:

Egis Gyógyszergyár Zrt.
Mátyás király u. 65.
H-9900 Körmend
Hungary

Parallel Importer:

InPharm Sp. z o.o.
Strumykowa Street 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska Street 249
04-458 Warsaw
Marketing Authorization Number in Hungary, the Country of Export:OGYI-T-5297/01
OGYI-T-5297/02
Parallel Import Authorization Number:172/13
Date of Leaflet Approval: 13.03.2023
[Information about the Trademark]
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