Package leaflet: Information for the patient

ASPAR ESPEFA PREMIUM, 250 mg + 250 mg, tablets
Magnesium hydroaspartate + Potassium hydroaspartate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the instructions provided by the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens after 30 days, consult your doctor.

Table of contents:

What Aspar Espefa Premium is and what it is used for
Important information before taking Aspar Espefa Premium
How to take Aspar Espefa Premium
Possible side effects
How to store Aspar Espefa Premium
Contents of the pack and other information

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

The medicine contains well-absorbable salts – magnesium and potassium aspartate – derived from aspartic acid, an important structural component of the body. It helps correct deficiencies of magnesium and potassium, which may cause disturbances in cellular energy metabolism and membrane permeability, changes in muscle contractility, impaired nerve conduction, and reduced platelet stability.
Indications:
Supplementation of magnesium and potassium deficiencies (not requiring intravenous administration):

In cardiac arrhythmias and tachycardia, especially those related to magnesium and potassium deficiency;
Prophylactically in ischemic heart disease, in cases of threatened myocardial infarction;
During post-infarction convalescence;
After infectious diseases or surgical procedures associated with loss of magnesium and potassium;
As a protective agent against adverse effects of long-term treatment with cardiac glycosides and diuretics (e.g. thiazides, furosemide).

2. Important information before using Aspar Espefa Premium

When not to use Aspar Espefa Premium:

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

Warnings and precautions
Before starting treatment with Aspar Espefa Premium, consult your doctor.
Exercise particular caution when using Aspar Espefa Premium:

during long-term use, in case of severe diarrhea, and in patients treated with cardiac glycosides; in such cases, serum levels of magnesium and potassium should be monitored, and if necessary, also levels in erythrocytes;
in patients with peptic ulcer disease.

This medicine should not be administered in neoplastic diseases without prior consultation with a doctor.
Use of Aspar Espefa Premium in patients with impaired renal and (or) hepatic function
Aspar Espefa Premium should be used with caution in patients with severe renal and (or) hepatic impairment due to the risk of hypermagnesemia or hyperkalemia.
Aspar Espefa Premium and other medicines
Magnesium compounds reduce the absorption of tetracyclines, iron, fluoride compounds, and anticoagulants of the warfarin group. Aminoglycoside antibiotics, loop diuretics, cisplatin, cycloserine, mitramycin, amphotericin B, and mineralocorticoids increase magnesium excretion.
Potassium-sparing diuretics and other potassium-containing medicines may increase serum potassium ion concentration.
Aspar Espefa Premium with food and drink
Magnesium absorption is reduced in the presence of dietary phosphates, calcium, lipids, and phytates.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to use Aspar Espefa Premium

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
The recommended dose is 2 to 6 tablets daily, divided into several doses.
The total daily requirement of magnesium for the body is generally considered not to exceed 5 mg/kg body weight, and up to 780 mg of potassium ions per day may be administered for the prevention of potassium deficiency.
Use of a higher than recommended dose of Aspar Espefa Premium
If more than the recommended dose of Aspar Espefa Premium has been taken, consult a doctor or pharmacist immediately.
Symptoms of overdose following oral administration include diarrhea or vomiting. In severe poisoning, calcium salts are administered intravenously or dialysis is performed.
Missed dose of Aspar Espefa Premium
Do not take a double dose to make up for a missed dose.
Stopping treatment with Aspar Espefa Premium
If you have any further questions regarding 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 will experience them.
Rarely, especially in patients with impaired kidney function, hyperkalemia may occur,
leading to irregular and slow heartbeat or gastrointestinal irritation (abdominal pain, nausea,
diarrhea, vomiting).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
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
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aspar Espefa Premium

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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). Each tablet contains 250 mg of magnesium hydroaspartate and 250 mg of potassium hydroaspartate, corresponding to 17 mg of magnesium ions and 54 mg of potassium ions.
The other ingredients (excipients) are: povidone, sodium croscarmellose, colloidal anhydrous silica, talc, magnesium stearate.

What Aspar Espefa Premium looks like and contents of the pack
Aspar Espefa Premium is a white to cream-coloured, oval, biconvex tablet.
The pack contains 50, 75 or 150 tablets (blister packs in a cardboard box).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków
Tel.: 12 639 27 27
Fax: 12 639 96 45
Information for blind and partially sighted people: 800-007-777