Kaldyum

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Kaldyum is and what it is 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 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 certain 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 taking certain diuretics (potassium-sparing diuretics) or antihypertensive drugs (e.g. so-called ACE inhibitors), in adrenal cortex insufficiency, kidney failure, acidosis (blood acidification, e.g. in diabetic patients), or after tissue injuries (severe burns affecting a large surface area of the body)];
• 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 obstruction or esophageal narrowing that makes swallowing difficult.

Warnings and precautions
Before starting to use Kaldyum, discuss this with your doctor or pharmacist.
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Before prescribing the medicine, the doctor may check blood potassium levels and perform an ECG.
Inform your doctor about the presence of ulcers or other gastrointestinal disorders.
If taking cardiac glycosides (medicines used in heart conditions) concurrently, inform your treating physician, as abruptly stopping Kaldyum may be harmful.
In certain conditions, the doctor may prescribe a different potassium-containing medicine; 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 currently used, recently taken, or planned to be used.
Exercise caution when using Kaldyum together with the following medicines:

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

If in doubt about concomitant medicines, consult your doctor.

Pregnancy and breastfeeding
If the patient is pregnant, 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 taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
The dosage is determined by the doctor according to the individual needs of the patient.
Adults
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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 administered in 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
If the patient is fed through 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 must not be administered in severe renal impairment (see section "When not to use Kaldyum").
Hepatic impairment
Studies in patients with hepatic impairment have not been conducted.
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, consult your doctor or pharmacist immediately.
Symptoms of overdose: muscle weakness, hypotension, cardiac arrhythmias, and even cardiac arrest.
Treatment: gastric lavage may be performed, together with administration of 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets 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:
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• nausea, vomiting, diarrhea, 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 at 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 helps to provide more information on the safety of the medicine.

5. How to store Kaldyum

Store 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 packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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, colloidal anhydrous silica,
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
Kaldyum is a capsule 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 clear glass bottle with a polyethylene screw cap, placed in a cardboard box.
Pack sizes: 50 or 100 capsules.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Hungary, country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
H-1106 Budapest
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Hungary

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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Numbers in Hungary, country of export: OGYI-T-5297/01
OGYI-T-5297/02

Parallel Import Authorisation Number: 172/13
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