Package leaflet: Information for the patient

MAGNEZIN, 130 mg of magnesium ions, tablets
500 mg Magnesii subcarbonas ponderosus
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents of the leaflet

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

1. What MAGNEZIN is and what it is used for

MAGNEZIN is a medicine containing magnesium (130 mg of magnesium ions).
Magnesium is an essential element for the proper functioning of the body (involved in the activity of numerous enzymes, bone tissue mineralization, muscle contractions, and normal heart function). Deficiency may result from various causes. Magnesium deficiency can have serious health consequences.
Indications for MAGNEZIN: MAGNEZIN can be used for therapeutic and prophylactic purposes.
Therapeutic use:

Cardiac arrhythmias (supportive treatment);
Heart failure associated with ventricular arrhythmias (supportive treatment);
Muscle cramps and numbness of limbs;
Muscle pain;
Chronic fatigue;
Excessive nervous excitability;
Sleep disturbances.

Prophylactic use:

During prolonged use of certain diuretic medicines;
During use of oral contraceptive drugs;
During slimming diets;
During periods of increased physical exertion.

2. Important information before using the medicine MAGNEZIN

When not to use MAGNEZIN

If the patient is allergic to magnesium carbonate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, swelling of the face, lips, tongue or difficulty breathing (if such symptoms occur, contact a doctor immediately).

If the patient has:

elevated magnesium levels in blood (hypermagnesemia);
severe renal insufficiency;
atrioventricular conduction block (impaired electrical signal conduction in the heart);
myasthenia gravis – a serious muscle disorder;
arterial blood pressure lower than 100/60 mmHg;
diarrhoea.

Warnings and precautions
If the patient has impaired kidney function, MAGNEZIN should be used with caution and regular blood tests to monitor magnesium levels are required. Use of this medicine may lead to accumulation of excessive amounts of magnesium in the body.
MAGNEZIN administered in doses exceeding 2 g per day may have a laxative effect.
Consult a doctor even if the above warnings refer to conditions that occurred in the past.

MAGNEZIN and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Concurrent administration of MAGNEZIN with the following may reduce their absorption and thus decrease their effectiveness: tetracyclines (e.g. doxycycline), iron-containing medicines, fluoroquinolones (e.g. ciprofloxacin), and certain oral anticoagulants (medicines that reduce blood clotting).
The following medicines and substances reduce intestinal absorption of magnesium and may reduce the effectiveness of MAGNEZIN: phosphates, high doses of calcium, phytates, and high dietary fat intake.
The following medicines increase urinary excretion of magnesium and may reduce the effectiveness of MAGNEZIN: loop diuretics (i.e. certain diuretics, e.g. furosemide), aminoglycoside antibiotics (e.g. gentamicin), certain hormonal medicines (consult your doctor for details), certain anticancer medicines (consult your doctor for details), amphotericin B (an antifungal medicine).
Intravenous calcium salts reduce the effect of MAGNEZIN, whereas vitamin B enhances its effect.

MAGNEZIN with food and drink
Avoid taking MAGNEZIN during or immediately after meals rich in calcium and fats, as they may reduce absorption of the medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
MAGNEZIN may be used during pregnancy.
Breastfeeding women may use MAGNEZIN.

Driving and operating machinery
MAGNEZIN has no effect or negligible effect on the ability to drive vehicles or operate machinery.

MAGNEZIN contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use MAGNEZIN

Use in adults
The usual dose of MAGNEZIN is:

prophylactically: 500 mg (1 tablet of 500 mg) per day,
therapeutically: the dose should be individually adjusted according to the indication and magnesium ion requirements. To correct magnesium deficiency, the usual dose is 1500 mg (3 tablets of 500 mg) per day. The daily dose is usually divided into 3 equal single doses.

The tablet should be swallowed whole with water. Single doses should preferably be taken at equal intervals throughout the day.
Do not take on an empty stomach.

Use in children and adolescents
Dosage of the medicinal product in children and adolescents should be determined by a physician.

Duration of treatment
The duration of treatment should be determined by a physician based on the patient's response and laboratory test results.
Treatment should not be discontinued immediately when blood magnesium concentration returns to normal; it should be continued for some additional time.

Overdose of MAGNEZIN
Symptoms of overdose with magnesium-containing medicinal products may include: diarrhoea, skin flushing, marked drop in arterial blood pressure, significant slowing of heart rate, insomnia, feeling of general weakness, marked muscle weakness or even paralysis, disorientation, coma, cardiac arrest (in cases of very severe overdose or coexisting heart disease).
If a much larger than recommended dose has been taken, contact a physician immediately or go to a hospital. Show the doctor the medicine packaging.

Missed dose of MAGNEZIN
If a dose is missed, take it as soon as possible, unless the time for the next dose is approaching. In that case, the missed dose should not be taken at all.
Do not use a double dose to make up for a missed dose.

Stopping treatment with MAGNEZIN
Do not discontinue treatment without consulting a physician, even if the patient feels better.
If you have any further doubts regarding the use of this medicinal product, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
MAGNEZIN is a medicine very well tolerated. It rarely causes adverse reactions, which are usually mild in severity.
Gastrointestinal disorders are the most commonly observed. High doses of the medicine may have a mild laxative effect.
Hypersensitivity reactions after taking MAGNEZIN cannot be excluded, although such reactions have not been reported to date.
Severe adverse reactions related to the use of MAGNEZIN have not been reported.
Adverse reactions associated with the use of MAGNEZIN are listed below.
Uncommon (may affect fewer than 1 in 100 people): soft stools, nausea, vomiting.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
Phone: +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 MAGNEZIN

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Tablets packed in pharmaceutical containers, high-density polyethylene (HDPE) bottles with a polypropylene cap and a tamper-evident ring and a desiccant should be used within 6 months after opening the container.
Do not use this medicine after the expiry date stated on the packaging after "EXP". 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. This will help protect the environment.

6. Contents of the packaging and other information

What MAGNEZIN contains
The active substance is heavy magnesium carbonate.

One tablet of MAGNEZIN contains 130 mg of magnesium ions in the form of 500 mg of heavy magnesium carbonate (Magnesii subcarbonas ponderosus).
The other ingredients are: microcrystalline cellulose, crospovidone, sodium lauryl sulfate, polyvinyl alcohol, colloidal anhydrous silica, magnesium stearate.

What MAGNEZIN looks like and contents of the pack
An oval tablet, almost white to white, biconvex, with an embossed "500" on one side.
Approximately 17 mm long and 9 mm wide.
MAGNEZIN is packed in:

Transparent Aluminium/PVC/PE/PVDC foil blisters in cardboard boxes
White Aluminium/PVC/PE/PVDC foil blisters in cardboard boxes
Transparent Aluminium/PVC/Aclar/PVC foil blisters in cardboard boxes
Pharmaceutical containers made of HDPE polyethylene with a polpropylene screw cap with tamper-evident ring and desiccant, packed in cardboard boxes.
Not all pack sizes and types may be marketed.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: (22) 755 50 81

For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]
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