Kaldium

Package Leaflet: Information for the User

Kaldyum

600 mg, prolonged-release hard capsules

Potassium chloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Kaldyum and what is it used for
• 2. Important information before taking Kaldyum
• 3. How to take Kaldyum
• 4. Possible side effects
• 5. How to store Kaldyum
• 6. Contents of the pack 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. The deficiency may be caused by taking certain medications, such as diuretics (water pills), or by certain diseases (e.g., gastrointestinal diseases with vomiting or diarrhea).

2. Important information before taking Kaldyum

When not to take Kaldyum

• if you are allergic to potassium or any of the other ingredients of this medicine (listed in section 6);
• if you have hyperkalemia (high potassium levels in the blood), caused by certain diseases and medications [hyperkalemia may occur, for example, when 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 you have severe kidney disease;
• if you have Addison's disease (chronic adrenal insufficiency) and are not being treated for it;
• severe dehydration;
• if you have gastrointestinal obstruction or esophageal narrowing that makes swallowing difficult.

Warnings and precautions

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

Kaldyum and other medicines

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

• ACE inhibitors (medicines 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 (medicines used to treat high blood pressure and certain heart conditions) may lead to increased potassium levels in the blood;
• proton pump inhibitors (medicines that reduce stomach acid production) may lead to increased potassium levels in the blood;
• non-steroidal anti-inflammatory drugs, anticholinergic medicines, as they may exacerbate gastrointestinal side effects;
• digitalis glycosides (used to treat heart failure), beta-adrenergic medicines (used to treat high blood pressure and/or heart rhythm disorders), heparin (a medicine that prevents blood clotting), cyclosporine (a cytostatic medicine). Your doctor may regularly monitor your potassium levels in the blood when taking any of these medicines with Kaldyum.

If you have any doubts about the medicines you are taking, consult your doctor.

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.
Kaldyum can be used during pregnancy and breastfeeding, in accordance with the indications and recommended dosage.

Driving and using machines

There are no restrictions.

3. How to take Kaldyum

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the dosage based on your individual needs.
Adults
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 potassium levels in the blood.
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 a gastric or intestinal tube
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 impairment

In severe kidney impairment, the use of Kaldyum is contraindicated (see section "When not to take Kaldyum").

Liver impairment

No studies have been conducted in patients with liver impairment.

The elderly

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

Overdose of Kaldyum

If you have taken more than the recommended dose of Kaldyum, seek medical attention immediately.
Symptoms of overdose: muscle weakness, low 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Other side effects:

• nausea, vomiting, diarrhea, abdominal pain.

Reporting side effects

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

5. How to store Kaldyum

Store in a temperature below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date (month, year) stated on the carton after "Expiry date". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kaldyum contains

The active substance of Kaldyum is potassium chloride.
Each prolonged-release capsule contains 600 mg of potassium chloride, equivalent to 8 mmol of potassium ions (315 mg of potassium ions).
The other ingredients are:
microcrystalline cellulose, polyacrylate, dimethicone, talc, colloidal anhydrous silica,
indigotine (E 132).
Composition of the capsule shell:
cap: gelatin, indigotine (E 132), erythrosine (E 127);
body: gelatin.

What Kaldyum looks like and contents of the pack

The medicine is in the form of capsules with a blue cap and a transparent body.
The capsule contains a mixture of light blue and white or almost white pellets.
The pack consists of a colorless glass bottle with a PE cap in a cardboard box.
Each pack contains 50 or 100 capsules.

Marketing authorization holder

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

EGIS Pharmaceuticals PLC.
Mátyás király u. 65
9900 Körmend
Hungary
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:07.10.2022