PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Kaldyum
600 mg, prolonged-release hard capsules
Potassium chloride
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Kaldyum is and what it is used for
Important information before taking Kaldyum
How to take Kaldyum
Possible side effects
How to store Kaldyum
Contents of the pack and other information

1. What Kaldyum is and what it is used for

Kaldyum is used for the prevention and treatment of potassium deficiency in the body. Potassium deficiency
may result from taking certain medicines, e.g. diuretics (water tablets), or from specific diseases (e.g. gastrointestinal disorders associated with vomiting or diarrhoea).

2. Important information before using Kaldyum

When not to use Kaldyum

if the patient is allergic to potassium or any of the other ingredients of this medicine (listed in section 6);
if the patient has hyperkalemia (excess potassium in blood serum), caused by certain diseases or medications [hyperkalemia may occur, for example, when certain diuretics (potassium-sparing diuretics) or antihypertensive drugs (e.g. so-called ACE inhibitors) are administered, in adrenal cortex insufficiency, kidney failure, acidosis (blood acidification, e.g. in diabetic patients), after tissue injuries (severe burns affecting 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;
acute dehydration;
if the patient has gastrointestinal tract obstruction or esophageal stricture making swallowing difficult.

Warnings and precautions
Before starting treatment with Kaldyum, discuss this with your doctor or pharmacist.
Before prescribing the medicine, the doctor may check the blood potassium level and perform an EKG.
Inform the doctor about the presence of ulcers or other gastrointestinal diseases.
If the patient is taking cardiac glycosides (medications used in heart diseases), inform the treating physician, as sudden discontinuation of Kaldyum may be harmful.
In certain conditions, the doctor may prescribe another potassium-containing medication; in other cases, additional medication may be recommended to be taken together with Kaldyum.
Follow the diet prescribed by your doctor.

Kaldyum and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Exercise caution when using Kaldyum together with the following medicines:

ACE inhibitors (medicines used to treat hypertension), potassium-sparing diuretics, as concomitant use may lead to very high potassium levels in blood serum;
potassium-rich food products and herbal preparations (e.g. leaves and roots of dandelion, bananas, tomatoes, orange juice) which increase the risk of elevated potassium levels in blood serum;
angiotensin II receptor blockers and aliskiren (medicines used to treat high blood pressure and certain heart conditions) which may lead to increased potassium levels in blood serum;
proton pump inhibitors (medicines reducing gastric acid secretion) which may lead to increased potassium levels in blood serum;
nonsteroidal anti-inflammatory drugs, anticholinergic drugs, as they may exacerbate adverse effects in the gastrointestinal tract;
cardiac glycosides (used in heart failure treatment), beta-adrenergic drugs (used to treat hypertension and/or cardiac arrhythmias), heparin (an anticoagulant), cyclosporine (a cytostatic drug). The doctor may perform regular monitoring of serum potassium levels when any of these drugs are used concomitantly with Kaldyum.

If you have any doubts regarding medications being taken, consult your doctor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Kaldyum may be used during pregnancy and breastfeeding, according to medical indications and recommended dosage.
Driving and operating machinery
There are no restrictions.

3. How to use Kaldyum

This medicine should always be used exactly as prescribed by the physician. In case of doubts, consult
your doctor or pharmacist.
The dosage is determined by the physician according to individual patient needs.
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 serum potassium concentration.
If the daily dose exceeds 2 capsules, it should be divided into two or more divided doses.
The capsule should usually be swallowed whole, with a glass of water, during or after a meal.
Patients fed via gastric or intestinal tube
In patients receiving nutrition via a gastric or intestinal tube, the capsule may be opened and the pellets mixed with food or liquid administered through the tube.
Use in children
Experience with use in children is limited.
Renal impairment
Kaldyum should not be administered in severe renal impairment (see section "When not to use Kaldyum").
Hepatic impairment
No studies have been conducted in patients with hepatic impairment.
Elderly patients
Due to possible deterioration of renal function in elderly patients, dose reduction may be necessary.
Use of a higher than recommended dose of Kaldyum
If a higher than recommended dose of Kaldyum has been taken, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose: muscle weakness, hypotension, cardiac arrhythmias, and even cardiac arrest.
Treatment: gastric lavage may be performed, along with administration of intravenous sodium chloride solution, glucose and insulin, and forced diuresis. Peritoneal dialysis or hemodialysis may be required.
Missed dose of Kaldyum
Do not take a double dose to make up for a missed dose.
If you have any further questions concerning use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop taking the medicine immediately and contact your doctor if any of the following symptoms occur:

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

Other adverse reactions:

nausea, vomiting, diarrhoea, abdominal pain.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Kaldyum

Store below 25°C.
Keep in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Kaldyum contains
The active substance in Kaldyum is potassium chloride.
Each prolonged-release hard capsule contains 600 mg of potassium chloride, corresponding to 8 mmol of potassium ions (315 mg of potassium ions).
The other ingredients are:
microcrystalline cellulose, polyacrylate dispersion 30%, dimethicone, talc, anhydrous colloidal silicon dioxide, indigotine (E 132).
Capsule shell composition:
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 packaging consists of a colourless glass bottle with a PE cap, placed in a cardboard box.
Pack contents: 50 or 100 capsules.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Hungarian Marketing Authorisation Numbers (country of export):
OGYI-T-5297/01
OGYI-T-5297/02

Parallel Import Authorisation Number: 186/21