Aspar Espefa Premium

Package Leaflet: Information for the Patient

ASPAR ESPEFA PREMIUM, 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 the package leaflet for the patient or as advised by a doctor or pharmacist.

• This 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 possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 30 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Aspar Espefa Premium and what is it used for

The medicine contains well-absorbed salts - magnesium and potassium aspartate, which are important building components of the body. It supplements magnesium and potassium deficiencies that may cause disorders of cellular energy metabolism and permeability of their membranes, changes in muscle excitability, nerve conduction, and decreased platelet stability.

Indications for use:

Supplementing magnesium and potassium deficiencies (not requiring intravenous administration of elements):

• in arrhythmias and heart hyperexcitability, especially with magnesium and potassium deficiency;
• for the prevention of ischemic heart disease, in case of myocardial infarction risk;
• in post-myocardial infarction rehabilitation;
• after infectious diseases or surgical procedures, during which magnesium and potassium loss occurred;
• as a drug to counteract the side effects of long-term use of cardiac glycosides and diuretics (e.g., thiazides, furosemide).

2. Important information before taking Aspar Espefa Premium

When not to take Aspar Espefa Premium:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has renal failure;
• if the patient has a urinary tract infection;
• if the patient has hyperkalemia, hypermagnesemia;
• if the patient has an atrioventricular block;
• if the patient suffers from muscle weakness myasthenia gravis.

Warnings and precautions

Before starting to take Aspar Espefa Premium, the patient should discuss it with their doctor.
Particular caution should be exercised when taking Aspar Espefa Premium:

• in case of long-term use and in case of severe diarrhea, as well as in patients treated with cardiac glycosides; then, the level of magnesium and potassium in the blood serum should be controlled, and if necessary, also in erythrocytes;
• in patients with stomach ulcers.

The medicine should not be administered in cancer diseases without consulting a doctor.

Using Aspar Espefa Premium in patients with kidney and/or liver function disorders

In case of severe kidney and/or liver disorders, Aspar Espefa Premium should be used with caution due to the possibility of hypermagnesemia or hyperkalemia.

Aspar Espefa Premium and other medicines

Magnesium compounds reduce the absorption of tetracyclines, iron, fluorine compounds, and anticoagulant medications derived from warfarin. Aminoglycoside antibiotics, loop diuretics, cisplatin, cyclosporine, mitramycin, amphotericin B, and mineralocorticosteroids increase magnesium excretion.
Potassium-sparing diuretics and other potassium-containing medications may increase the concentration of potassium ions in the blood serum.

Aspar Espefa Premium with food and drink

Magnesium absorption is reduced in the presence of phosphates, calcium, lipids, and phytates in the diet.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Driving and using machines

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

3. How to take Aspar Espefa Premium

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
The recommended dose is 2 to 6 tablets per day in divided doses.
It is assumed that the total daily requirement of magnesium for the body does not exceed 5 mg/kg of body weight, and when preventing potassium deficiencies, up to 780 mg of ions per day is administered.

Taking a higher dose of Aspar Espefa Premium than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
Symptoms of overdose after oral administration are diarrhea or vomiting. In case of severe poisoning, calcium salts are administered intravenously or dialysis is performed.

Missing a dose of Aspar Espefa Premium

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

Stopping the use of Aspar Espefa Premium

In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, especially in patients with kidney function disorders, hyperkalemia may occur with irregular and slow heart rate or gastrointestinal irritation (abdominal pain, nausea, diarrhea, vomiting).

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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
Phone: +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 gather more information on the safety of the medicine.

5. How to store Aspar Espefa Premium

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Aspar Espefa Premium contains

• The active substances of the medicine are magnesium hydroaspartate (Magnesii hydroaspartas) and potassium hydroaspartate (Kalii hydroaspartas). One tablet contains 250 mg of magnesium hydroaspartate and 250 mg of potassium hydroaspartate, which corresponds to 17 mg of magnesium ions and 54 mg of potassium ions.
• The other ingredients (excipients) are: povidone, sodium croscarmellose, anhydrous colloidal silica, talc, magnesium stearate.

What Aspar Espefa Premium looks like and contents of the pack

Aspar Espefa Premium is a white to cream-colored, oval, biconvex tablet.
The packaging contains 50, 75, or 150 tablets (blister packs in a cardboard box).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków
Phone: 12 639 27 27
Fax: 12 639 96 45

Information for the blind and visually impaired: 800-007-777

Date of the last update of the leaflet: