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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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

• acute dehydration;

Warnings and precautions

Before starting to take Kaldyum, discuss it with your doctor or pharmacist.
Before prescribing the medicine, the doctor may check the potassium level in the blood and perform an EKG.
Inform your doctor about any ulcers or other gastrointestinal diseases.
If you are taking digitalis glycosides (medicines used for heart conditions), inform your doctor, as sudden discontinuation of Kaldyum may be harmful.
In some cases, the 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 and plant products (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). The doctor may regularly monitor 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 plan to have a child, consult your doctor or pharmacist 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 unsure, consult your doctor or pharmacist.
The doctor will determine the dosage based on the individual needs of the patient.

Adults

Prophylaxis: 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 failure

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

Liver failure

No studies have been conducted in patients with liver failure.

Elderly patients

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

Overdose of Kaldyum

If you have taken more than the recommended dose of Kaldyum, consult your doctor or pharmacist immediately.
Overdose symptoms: 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.
If you have any further doubts about taking this medicine, consult 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 immediately if you experience any of the following symptoms:

• tarry (black) stools (due to bleeding, ulcers, perforation, and gastrointestinal obstruction);
• 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 any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, National Institute of Pharmacy and Nutrition, Alkotmány u. 3-5, 1054 Budapest, Hungary, phone: +36 1 472-8154, fax: +36 1 472-8155, website: https://www.ogyei.gov.hu.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kaldyum

Store in a temperature below 25°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 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, hypromellose, dimethicone, talc, colloidal anhydrous silica, indigo carmine (E 132)
Capsule shell:
cap: gelatin, indigo carmine (E 132), erythrosine (E 127).
body: gelatin.

What Kaldyum looks like and contents of the pack

Kaldyum is a hard capsule with a blue cap and a transparent body.
The capsule contains a mixture of light blue and white or almost white pellets.
The packaging is a glass bottle with a polyethylene cap, in a cardboard box.
Pack size: 50 or 100 capsules (1 bottle of 100 capsules or 2 bottles of 50 capsules).
For more detailed information, consult the marketing authorization holder or 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
License number in Hungary, the country of export: OGYI-T-5297/01
OGYI-T-5297/02

License number for parallel import: 23/13 Date of approval of the leaflet: 13.01.2023

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