Kalium effervescens bezcukrovi

Leaflet included in the packaging: patient information

Potassium effervescence sugar-free,

782 mg of potassium ions/3 g, effervescent granules

Potassium citrate+Potassium hydrogen carbonate
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Potassium effervescence sugar-free and what is it used for
• 2. Important information before taking Potassium effervescence sugar-free
• 3. How to take Potassium effervescence sugar-free
• 4. Possible undesirable effects
• 5. How to store Potassium effervescence sugar-free
• 6. Package contents and other information

1. What is Potassium effervescence sugar-free and what is it used for

Potassium effervescence sugar-free is a medicine that contains 782 mg of potassium ions in a sachet.
Potassium is the main cation of cellular fluid and one of the most important elements
that make up body fluids. It participates in many enzymatic reactions
and physiological processes, including the proper functioning of the nervous and muscular systems
and carbohydrate metabolism. Along with sodium and chloride ions, it affects
the body's water management, participates in maintaining acid-base balance and osmotic pressure.
The medicine is prescribed to supplement potassium deficiencies, regardless of the cause, in the course of
diabetes, prolonged diarrhea, in the presence of intestinal fistulas, and during treatment with medications,
that may lead to hypokalemia, such as certain diuretics, steroid hormones, and digitalis glycosides.
Potassium effervescence sugar-free can be used by diabetic patients, as it does not
contain sugar.

2. Important information before taking Potassium effervescence sugar-free

When not to take Potassium effervescence sugar-free:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in the case of phenylketonuria, since the medicine contains a source of phenylalanine and may be harmful to patients with phenylketonuria;
• if the patient has elevated potassium levels in the blood (hyperkalemia);
• in the case of adrenal insufficiency, anuria, and uremia in acute renal failure;
• in uremia in chronic renal failure;
• in adrenal insufficiency;
• when taking potassium-sparing diuretics;
• in ventricular arrhythmias;
• in Addison's disease;
• in severe dehydration;
• in the case of extensive tissue damage associated with severe burns.

Warnings and precautions

Before starting treatment with Potassium effervescence sugar-free, you should discuss it with your doctor
or pharmacist.
In the event of severe nausea, vomiting, or severe abdominal pain, you should
stop taking Potassium effervescence sugar-free.

Children

Potassium effervescence sugar-free should not be used in children under 12 years of age.

Special caution when taking Potassium effervescence sugar-free in certain patient groups

Before and during treatment, the doctor will recommend regular blood potassium level tests, heart function monitoring (ECG), and kidney function tests. In some patients, potassium deficiency is accompanied by magnesium deficiency, so the doctor will also recommend testing magnesium ion levels in the blood.

Patients with kidney function disorders

Patients with kidney function disorders should take Potassium effervescence sugar-free with special caution, due to the risk of a dangerous increase in blood potassium levels. Before and during treatment, the doctor will recommend regular blood potassium level tests, heart function monitoring, and kidney function tests.

Patients over 65 years of age

Due to the risk of overdose and often co-existing renal insufficiency, the medicine should be used with caution in this age group. Before and during treatment, the doctor will recommend regular blood potassium level tests and heart function monitoring.

Patients with heart function disorders

Due to the risk of overdose and the occurrence of life-threatening heart arrhythmias, the medicine should be used with caution in this patient group. Before and during treatment, the doctor will recommend regular blood potassium level tests and heart function monitoring.

Additionally, special caution should be exercised when taking Potassium effervescence sugar-free:

• in muscle spasms caused by working in high temperatures;
• when taking other medicines that contain potassium or affect its levels;
• in people with a tendency to allergies, due to the presence of cochineal red, which can cause allergic reactions.

Potassium effervescence sugar-free and other medicines

You should tell your doctor about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take.
In particular, you should inform your doctor about taking the following medicines:
Blood pressure lowering medicines:

• potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride);
• angiotensin-converting enzyme inhibitors (e.g. captopril, enalapril, lisinopril);
• angiotensin II receptor antagonists (e.g. losartan, valsartan, irbesartan);
• beta-adrenergic blockers (e.g. propranolol, bisoprolol). When taking Potassium effervescence sugar-free with the above-mentioned medicines, there may be a dangerous, life-threatening increase in blood potassium levels. People with renal insufficiency and the elderly are particularly at risk.

Cardiac glycosides:

• digitalis glycosides (e.g. digoxin). As a result of concurrent use of digitalis glycosides with Potassium effervescence sugar-free, there may be a disruption of heart function due to an increase in blood potassium levels.

Anti-inflammatory medicines:

• non-steroidal anti-inflammatory medicines (e.g. indomethacin, ibuprofen, diclofenac). Concurrent use of Potassium effervescence sugar-free with the above-mentioned medicines may cause a dangerous increase in blood potassium levels.

Other medicines:

• immunosuppressive medicines (medicines that suppress the activity of the immune system, e.g. cyclosporine, tacrolimus);
• heparin (a medicine that prevents blood clotting);
• other medicines or products that contain potassium. Concurrent use of Potassium effervescence sugar-free with the above-mentioned medicines may cause a dangerous increase in blood potassium levels.
• corticosteroids (medicines with anti-inflammatory effects); Concurrent use of Potassium effervescence sugar-free with corticosteroids may cause potassium level disorders.

The citrates contained in the medicine alkalize the urine, which can change the excretion of many medicines, such as salicylates, barbiturates, tetracyclines, and the half-life of medicines such as sympathomimetics and stimulants.

Taking Potassium effervescence sugar-free with food and drink

You should remember that a diet rich in sodium chloride (table salt) increases potassium excretion, and thus
reduces the effectiveness of Potassium effervescence sugar-free.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
You should exercise special caution, especially during the first trimester of pregnancy. Potassium effervescence sugar-free should only be taken on the explicit advice of a doctor and in the doses prescribed by the doctor.
You should exercise special caution during breastfeeding. Potassium effervescence sugar-free should only be taken on the explicit advice of a doctor and in the doses prescribed by the doctor.

Driving and operating machinery

Taking Potassium effervescence sugar-free has no effect or no significant effect on the ability to drive and operate machinery.

3. How to take Potassium effervescence sugar-free

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The recommended dose is 1 or 2 sachets in the first dose, and then, depending on the potassium deficiency, from 1 to 2 sachets per day.
Method of administration
The contents of the sachet should be dissolved in 1/3 of a glass of cool water and the slightly effervescent liquid should be drunk.
In order to minimize undesirable effects from the gastrointestinal tract (such as nausea, vomiting, diarrhea), it is recommended to take Potassium effervescence sugar-free during or at the end of a meal.

Taking a higher dose of Potassium effervescence sugar-free than recommended

In the event of taking a higher dose of Potassium effervescence sugar-free than recommended, you should immediately consult a doctor or pharmacist.
Prolonged use of Potassium effervescence sugar-free in doses higher than prescribed by the doctor may lead to hyperkalemia (an increase in blood potassium levels), the symptoms of which are: apathy, confusion, fatigue, muscle weakness, tingling, paralysis, shortness of breath, heart rhythm disturbances, irregular heartbeat, and cardiac arrest.
In the event of the above-mentioned overdose symptoms, you should stop taking the medicine and contact your doctor.

Missing a dose of Potassium effervescence sugar-free

In the event of missing a dose, you should take the medicine as soon as possible.
If it is almost time for the next dose, you should wait and take it at the scheduled time.
You should not take a double dose to make up for the missed dose.

4. Possible undesirable effects

Potassium effervescence sugar-free is generally well tolerated.
Like all medicines, it can cause undesirable effects, although not everybody gets them.
The undesirable effects are listed below according to the system and organ classification and frequency of occurrence. The frequency of occurrence in each organ is defined as follows:

• very common: (may occur in more than 1 in 10 people);
• common: (may occur in 1 to 10 people in 100);
• uncommon: (may occur in 1 to 10 people in 1,000);
• rare: (may occur in 1 to 10 people in 10,000);
• very rare: (may occur in less than 1 in 10,000 people);
• unknown: frequency cannot be estimated from available data.

Gastrointestinal disorders
Unknown frequency: nausea, vomiting, diarrhea, bloating, abdominal discomfort.
Metabolic and nutritional disorders
Unknown frequency: increased blood potassium levels, so-called hyperkalemia.
Cardiac disorders
Unknown frequency: irregular heartbeat, cardiac conduction disorders.

Reporting undesirable effects

If you experience any undesirable effects, including any undesirable effects not mentioned in the leaflet, you should inform your doctor or pharmacist or nurse. Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Potassium effervescence sugar-free

Store in a temperature below 25°C. Protect from moisture.
The medicine should be stored in a place out of 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 given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Potassium effervescence sugar-free contains

• The active substance of the medicine is potassium ions in the form of potassium citrate (Kalii citras)and potassium hydrogen carbonate (Kalii hydrogenocarbonas). One sachet contains 782 mg of potassium ions.
• The other ingredients are: citric acid, macrogol 6000, anhydrous colloidal silica, lemon flavor, aspartame (E 951), cochineal red (E 124).

What Potassium effervescence sugar-free looks like and what the package contains

20 sachets, each containing 3 g of effervescent granules, in a cardboard box.

Marketing authorization holder and manufacturer

Pharmaceutical-Chemical Company "Synteza" Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
fax 61 876-51-79
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Poland
Pharmaceutical-Chemical Company "Synteza" Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

Date of last revision of the leaflet: