Magnokal

Package Leaflet: Information for the User

Magnokal, 250 mg + 250 mg, tablets

Magnesium hydroaspartate + Potassium hydroaspartate

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

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 7-8 days there is no improvement or the patient feels worse, a doctor should be consulted.

Package Leaflet Contents:

• 1. What is Magnokal and what is it used for
• 2. Important information before taking Magnokal
• 3. How to take Magnokal
• 4. Possible side effects
• 5. How to store Magnokal
• 6. Package contents and other information

1. What is Magnokal and what is it used for

• as a supportive treatment for cardiovascular and heart muscle diseases. In arrhythmia and hyperexcitability of the heart - especially in cases of magnesium and potassium deficiencies and in post-infarction rehabilitation
• prophylactically and therapeutically in states of magnesium and potassium deficiency
• during periods of recovery after surgical procedures and after infectious diseases
• digitalis glycoside poisoning, as a supplement during the use of diuretic drugs.

Magnokal is a medicine with a combined effect of magnesium, potassium, and aspartic acid. It supplements the deficiency of these substances in the body and prevents their deficiency, both during periods of increased demand and in cases of inadequate intake. Aspartic acid participates in the metabolism of nerve tissue cells, acts as a neurotransmitter in the central nervous system, and has a stimulating effect on the body's activity. Potassium and magnesium are ions involved in many metabolic processes in the body.
If after 7-8 days there is no improvement or the patient feels worse, a doctor should be consulted.

2. Important information before taking Magnokal

When not to take Magnokal

• in case of severe kidney failure
• increased potassium or magnesium levels in the blood serum
• urinary tract infections
• conduction disorders of the atrioventricular node (block) of the heart
• decreased heart rate (bradycardia)
• myasthenia gravis -a disease characterized by muscle weakness and fatigue
• significant hypotension.

Warnings and precautions

Before starting to take Magnokal, the doctor or pharmacist should be consulted.
The medicine should not be taken in acute dehydration, extensive tissue destruction (e.g., large-area burns). Magnokal should not be taken during antibiotic therapy and with other potassium-containing medicines. It should be used with caution in gastric ulcer disease.
During the use of the medicine, potassium and magnesium levels in the blood serum should be monitored, a control ECG examination should be performed, and kidney function should be monitored. The medicine does not contain sugar.

Magnokal and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as about medicines that the patient plans to take.
Concomitant use of magnesium and antibiotics from the tetracycline group and nitrofurantoin may weaken their absorption; to avoid interactions, a two-hour interval between taking the medicines is recommended.
Administration of oral antidiabetic sulfonylurea derivatives with magnesium-containing medicines may cause a greater decrease in blood glucose levels than expected.
Potassium salts may weaken the effect of digitalis glycosides and cause heart rhythm disturbances.
Concomitant use of potassium salts and potassium-sparing diuretics, ACE inhibitors (e.g., enalapril, perindopril), or anti-inflammatory and analgesic medicines (e.g., indomethacin) may result in excessive potassium levels (hyperkalemia).

Magnokal with food and drink

Food does not affect the absorption of potassium hydroaspartate hemihydrate and magnesium hydroaspartate tetrahydrate.

Using Magnokal in patients with kidney failure

In patients with kidney failure taking other potassium preparations or potassium-sparing diuretics, the dose prescribed by the doctor may need to be modified.

Pregnancy and breastfeeding

Pregnancy

Before taking any medicine, a doctor or pharmacist should be consulted.

Breastfeeding

Before taking any medicine, a doctor or pharmacist should be consulted.

Driving and using machines

The medicine does not affect the ability to drive or operate machines.

3. How to take Magnokal

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The medicine is taken orally, 2 to 6 tablets per day, in two divided doses, after meals.

Using a higher dose of Magnokal than recommended

No cases of overdose have been reported so far.

Missing a dose of Magnokal

A double dose should not be taken to make up for a missed dose.

Stopping the use of Magnokal

In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sometimes gastrointestinal disorders (nausea and diarrhea) may occur, which usually resolve on their own, and a metallic taste in the mouth. High doses of the medicine may cause conduction disorders. Redness of the skin, insomnia, and muscle weakness may occur.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
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 Magnokal

Store in a temperature below 25°C in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Magnokal contains

• The active substances of the medicine are magnesium hydroaspartate tetrahydrate and potassium hydroaspartate hemihydrate.
• The other ingredients are: potato starch, povidone 25, magnesium stearate.

What Magnokal looks like and what the package contains

Tablets.
1 bottle containing 50 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Poland

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
To obtain more detailed information about this medicine, the local representative of the marketing authorization holder should be contacted:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel.: +48 (22) 543 60 00

Date of last revision of the package leaflet: