Kalipoz prolongatum

Package Leaflet: Information for the User

Kalipoz Prolongatum

391 mg of potassium ions, prolonged-release tablets

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 or pharmacist.
• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Kalipoz Prolongatum and what is it used for
• 2. Important information before taking Kalipoz Prolongatum
• 3. How to take Kalipoz Prolongatum
• 4. Possible side effects
• 5. How to store Kalipoz Prolongatum
• 6. Contents of the pack and other information

1. What is Kalipoz Prolongatum and what is it used for

Kalipoz Prolongatum is a medicine that contains potassium chloride. The medicine is in the form of prolonged-release tablets. This means that the potassium chloride is released slowly as the tablet passes through the digestive system. The form of the medicine reduces the irritating effect on the stomach and intestinal mucosa. It also protects against a sudden increase in potassium levels in the blood.
Normal potassium levels in the blood serum range from 3.7 to 5.3 mmol/l. Lower potassium levels are referred to as hypokalemia.
Indications for use of Kalipoz Prolongatum:

• prevention and treatment of potassium deficiency in the body (hypokalemia).

2. Important information before taking Kalipoz Prolongatum

When not to take Kalipoz Prolongatum

Do not take Kalipoz Prolongatum if you have:

• an allergy (hypersensitivity) to potassium chloride or any of the other ingredients of this medicine (listed in section 6),
• hypersensitivity to products containing potassium,
• high potassium levels in the blood (hyperkalemia),
• kidney failure,
• adrenal insufficiency (Addison's disease),
• hyporeninemic hypoaldosteronism (a deficiency of a hormone involved in the regulation of electrolyte balance),
• a congenital disease - paramyotonia (characterized by increased muscle tension, sometimes with muscle hypertrophy and difficulty performing movements),
• metabolic disorders, including acidosis (accumulation of acidic substances in the blood)

occurring in poorly treated diabetes,

• severe dehydration,
• conditions involving extensive cell destruction (e.g. severe burns),
• gastrointestinal bleeding,
• exacerbation of ulcerative disease symptoms,
• disorders that hinder the movement of the medicine in the digestive system,

or if you are taking certain diuretics (that reduce potassium excretion, such as spironolactone, canrenone, amiloride, triamterene, eplerenone. See subsection: Kalipoz Prolongatumand other medicines).

Warnings and precautions

Before taking Kalipoz Prolongatum, you should inform your doctor:

• if you have kidney function disorders. There is a risk of dangerous potassium level increase in the blood. During treatment, your doctor will prescribe regular potassium level tests, heart and kidney function monitoring;
• if you have black stools, vomit coffee grounds-like contents or have severe abdominal pain. In such cases, you should immediately stop taking the medicine and contact your doctor as soon as possible;
• if you have heart diseases;
• if you have liver diseases.

Children and adolescents

Kalipoz Prolongatum is not recommended for use in children and adolescents.
Elderly patients (over 65 years old) should use Kalipoz Prolongatum with caution due to the risk of overdose. Your doctor will prescribe regular potassium level tests.
Before and during treatment with Kalipoz Prolongatum, your doctor will prescribe regular potassium level tests and heart function monitoring (ECG).
In some patients, magnesium deficiencies caused by diuretic use may prevent potassium level correction, so your doctor will also monitor magnesium levels in the blood.
Great caution should be exercised when using potassium chloride in patients with liver function disorders.

Kalipoz Prolongatum and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription.
Kalipoz Prolongatum may affect the action of other medicines. Similarly, other medicines may affect the action of Kalipoz Prolongatum.
Periodically check potassium levels in the blood during concurrent use of other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

Blood pressure lowering medicines:

• potassium-sparing diuretics (reducing potassium excretion) such as spironolactone, canrenone, amiloride, eplerenone or triamterene (see subsection: When not to takeKalipozProlongatum),
• angiotensin-converting enzyme inhibitors (e.g. captopril, enalapril),
• angiotensin II receptor antagonists (sartans),
• beta-adrenergic blockers (e.g. metoprolol, propranolol),
• direct renin inhibitors (e.g. aliskiren). When used concurrently with Kalipoz Prolongatum, they may cause dangerous potassium level increase in the blood. This can be life-threatening, especially in patients with kidney failure.

Anti-inflammatory medicines:

• non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin, ibuprofen, diclofenac. When taken concurrently with Kalipoz Prolongatum, they may cause dangerous potassium level increase in the blood.

Cardiac medicines:

• cardiac glycosides (e.g. digoxin). Excessive potassium level increase in the blood may cause heart function disorders.

Anticholinergic medicines:

• anticholinergic medicines (e.g. atropine, ipratropium bromide) used in ophthalmology, respiratory and gastrointestinal disorders.

Proton pump inhibitors
Proton pump inhibitors (e.g. omeprazole, pantoprazole) used in ulcerative disease, among others. When taken concurrently with Kalipoz Prolongatum, they may cause dangerous potassium level increase in the blood.
Other medicines:

• cyclosporine - an immunosuppressive medicine (weakening the body's defense reaction), used to prevent transplant rejection and in other diseases.
• heparin (a medicine that prevents blood clotting). When administered concurrently with Kalipoz Prolongatum, it may cause dangerous potassium level increase in the blood.
• other medicines or products containing potassium (see subsection: When not to takeKalipozProlongatum). This may lead to dangerous potassium level increase in the blood .

Taking Kalipoz Prolongatum with food and drink

Reduce salt intake in your diet. Salt reduces the effectiveness of Kalipoz Prolongatum.

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.
Kalipoz Prolongatum may be used during pregnancy and breastfeeding, only on the explicit advice of a doctor.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

The medicine contains lactose, red iron oxide, and sodium

Lactose

Kalipoz Prolongatum contains a sugar called lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Red iron oxide

Due to the presence of red iron oxide, the medicine may cause allergic reactions.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Kalipoz Prolongatum

Always take Kalipoz Prolongatum exactly as your doctor has told you.
If you are not sure, ask your doctor.

Usual dose:

• for prevention and mild potassium deficiency: 1 to 2 tablets per day,
• for significant potassium deficiency: 2 to 6 tablets per day.

When determining the dose, consider the potassium content in your diet (fruits, vegetables, juices).
Take Kalipoz Prolongatum during or immediately after a meal, with a large amount of water. This will reduce the irritating effect of the medicine on the digestive system mucosa.
Swallow the tablets whole. Do not chew. Do not divide them, as they will lose their prolonged-release properties. Releasing the entire dose in a short time may cause side effects.
Tablet residues are excreted in the feces. This does not reduce the effectiveness of the medicine.

If you take more Kalipoz Prolongatum than you should

If you have taken more Kalipoz Prolongatum than you should, contact your doctor or pharmacist immediately.

If you experience any of the following overdose symptoms, stop taking the medicine

and contact your doctor.
The severity of symptoms depends on the degree of potassium level increase in the blood above normal. Symptoms include:

• heart and blood vessel disorders (significant blood pressure drop, shock, heart rhythm disorders that can lead to cardiac arrest),
• nervous and muscular disorders (sensory disturbances, convulsions, loss of reflexes, respiratory failure caused by muscle paralysis),
• excessive potassium level increase in the blood,
• changes in the ECG recording.

Rarely, after taking a very large dose of the medicine, the formation of pharmacobezoars (pseudo-stones in the intestines) has been observed. The formation of pharmacobezoars can cause prolonged potassium chloride release, many hours after its administration.

If you experience overdose symptoms, stop taking the medicine and contact your doctor.

Forget to take Kalipoz Prolongatum

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Kalipoz Prolongatum can cause side effects, although not everybody gets them .

The following side effects may occur:

• heart rhythm disorders (too fast, too slow or irregular heartbeat),
• nausea (vomiting), vomiting, burning sensation in the stomach and esophagus, discomfort in the abdomen, abdominal pain, bloating, diarrhea or constipation, obstruction, bleeding,
• stomach and duodenal ulcers (the risk is higher when taking higher doses of the medicine),
• mild damage to the small intestine mucosa (ulcers). If gastrointestinal bleeding occurs, stop taking the medicine and contact your doctor immediately,
• rash (red, itchy bumps on the skin), itching, urticaria,
• potassium level increase in the blood (hyperkalemia). During treatment with Kalipoz Prolongatum, potassium levels in the blood should be monitored to prevent hyperkalemia.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Kalipoz Prolongatum

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Protect from moisture.
Store in the original package.
Do not use this medicine after the expiry date stated on the package. 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 Kalipoz Prolongatum contains

The active substance is potassium chloride.
One tablet contains 391 mg of potassium ions (10 mEq K ).
The other ingredients are:

• tablet core: lactose monohydrate, ammonio methacrylate copolymer (type B), talc, silica colloidal anhydrous, magnesium stearate.
• tablet coating: talc, titanium dioxide, ammonio methacrylate copolymer (type B), ammonio methacrylate copolymer (type A), red iron oxide (E 172), macrogol 6000.

What Kalipoz Prolongatum looks like and contents of the pack

The medicine is in the form of prolonged-release tablets. The tablets are pink.
The tablets are biconvex, with a smooth surface, and without cracks.
One carton contains 30 or 60 tablets.

Marketing authorization holder

GSK PSC Poland sp. z o.o.
ul. Grunwaldzka 189,
60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information, please contact the marketing authorization holder's representative.
Date of last revision of the leaflet:June 2022