Patient Information Leaflet

Magne-Balans Plus
17 mg magnesium ions + 54 mg potassium ions, tablets
Magnesii hydroaspartas + Kalii hydroaspartas
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Table of Contents

What Magne-Balans Plus is and what it is used for
Important information before taking Magne-Balans Plus
How to take Magne-Balans Plus
Possible side effects
How to store Magne-Balans Plus
Contents of the pack and other information

1. What Magne-Balans Plus is and what it is used for

Magne-Balans Plus is a medicinal product containing magnesium and potassium in the form of aspartates.
Magnesium, potassium, and aspartic acid are involved in metabolic processes, maintenance of ionic balance, and nerve and neuromuscular conduction in the human body.

Magnesium
The highest concentrations of magnesium are found in tissues with the most intense metabolic activity: the brain, heart muscle, and liver. Magnesium cooperates with calcium ions in the formation of bone structure.
Adequate magnesium levels contribute to:

Reduction of hyperexcitability;
Easier concentration and falling asleep;
Reduced susceptibility to stress and muscle disorders such as tremors, cramps, and tics;
Lowered risk of coronary heart disease, myocardial infarction, and cardiac arrhythmias. Magnesium deficiency increases the risk of coronary heart disease, myocardial infarction, and cardiac arrhythmias.

Potassium
The concentration of potassium ions within human cells is 15 times higher than in the extracellular fluid. Disruption of this balance, due to disturbances in potassium metabolism (e.g., potassium deficiency), usually poses a serious threat to the normal function of:

The nervous system, affecting nerve and neuromuscular conduction (movement, heart function, activity of other internal organs);
The transport system moving various substances into and out of tissue cells (nutrition, respiration, excretion);
The cardiovascular and excretory systems in regulating water-electrolyte balance (maintenance of peripheral blood pressure and blood pH).

Aspartic acid acts as a neurotransmitter in the central nervous system. It stimulates bodily activity by regulating intracellular concentrations of potassium, sodium, and calcium ions.

Indications
Magne-Balans Plus is used prophylactically and as a supplement in states of deficiency of magnesium, potassium, and aspartate.

2. Important information before taking Magne-Balans Plus

When not to take Magne-Balans Plus

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the patient has renal failure or adrenal insufficiency;
if the patient has hyperkalaemia (increased potassium levels in blood);
if the patient has hypermagnesaemia (increased magnesium levels in blood);
if the patient has heart rhythm disorders;
if the patient has myasthenia gravis – a rare disease characterised by excessive muscle weakness;
if the patient has low blood pressure. An existing tumour condition is considered a relative contraindication.

Warnings and precautions
Before starting treatment with Magne-Balans Plus, discuss this with your doctor or pharmacist:

if the patient is dehydrated;
if the patient has extensive tissue damage (e.g. large surface area burns);
in elderly patients due to reduced potassium excretion;
if the patient is taking other medicines containing magnesium and potassium, due to the risk of overdose. If the medicine is used long-term, magnesium and potassium levels in blood should be monitored regularly.

Magne-Balans Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking any of the following medicines, they should inform their doctor:

oral anticoagulants of the warfarin type;
medicines or dietary supplements containing phosphates, iron compounds, or high doses of calcium, as a 3-hour interval between administration of both products is recommended;
antibiotics of the fluoroquinolone and tetracycline groups, as a 3-hour interval between administration of both medicines is recommended;
potassium-sparing diuretics;
ACE inhibitors (medicines used in the treatment of hypertension and heart failure);
non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indomethacin used for pain treatment);
cardiac glycosides (digitalis), as potassium compounds reduce their effect. Concurrent use of other magnesium-containing products (with laxative or gastric acid-neutralising properties) may cause symptoms of magnesium poisoning, especially in patients with renal insufficiency.

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should contact their doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Magne-Balans Plus

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
This is an oral medicine.
Recommended dose
Adults: on average, from 2 to 6 tablets daily, divided into doses after breakfast and evening meal.
This medicine does not contain sugar.
Taking more than the recommended dose of Magne-Balans Plus
If more than the recommended dose has been taken, consult a doctor or pharmacist immediately.
In case of overdose, the following may occur:

hyperkalemia (increased potassium levels in blood, manifested by muscle pain and tingling, dizziness);
neuromuscular blockade indicated by loss of tendon reflexes;
respiratory disturbances;
bradycardia (abnormally slow heartbeat);
decreased blood pressure;
reduced cardiac output.

Missing a dose of Magne-Balans Plus
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse effects may occur:

nausea, vomiting, diarrhoea;
heart rhythm disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
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 Magne-Balans Plus

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and the carton. The expiry date refers to the last day of the stated month.
Labelling on the blister
Lot: batch number
EXP: expiry date
Medicines must 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 Magne-Balans Plus contains

The active substances are magnesium aspartate hydrochloride, potassium aspartate hydrochloride.
1 tablet contains 17 mg of magnesium ions in the form of magnesium aspartate hydrochloride, 54 mg of potassium ions in the form of potassium aspartate hydrochloride.
Other ingredients: potato starch, anhydrous colloidal silicon dioxide, polyvinyl alcohol, talc, magnesium stearate.

What Magne-Balans Plus looks like and contents of the pack
The medicine is in the form of tablets.
Tablets are packed in blisters and cardboard boxes. Each box contains 50 tablets.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów