Magnezin

Package Leaflet: Information for the Patient

MAGNEZIN, 130 mg of magnesium ions, tablets

500 mg of Magnesium subcarbonate

Read the 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 patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is MAGNEZIN and what is it used for

MAGNEZIN is a medicine that contains magnesium (130 mg of magnesium ions).
Magnesium is an essential element for the proper functioning of the body (for the action of many enzymes, the mineralization of bone tissue, muscle contractions, and the proper functioning of the heart). Many factors can lead to its deficiency. Magnesium deficiency can have serious consequences for health.

Indications for the use of MAGNEZIN:

MAGNEZIN can be used for therapeutic and preventive purposes.
Therapeutically:

• heart rhythm disorders (supportive treatment);
• heart failure with accompanying ventricular arrhythmias (supportive treatment);
• muscle cramps and numbness of the limbs;
• muscle pain;
• chronic fatigue;
• excessive nervous excitability;
• sleep disorders.

Preventively:

• during long-term use of certain diuretic drugs;
• during the use of oral contraceptives;
• during weight loss treatments;
• during periods of increased physical exertion.

2. Important information before taking MAGNEZIN

When not to take MAGNEZIN

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

If you have:

• high blood magnesium levels (hypermagnesemia);
• severe kidney failure;
• conduction disorders in the heart (atrioventricular block);
• myasthenia gravis (a severe muscle disease);
• blood pressure below 100/60 mmHg;
• diarrhea.

Warnings and precautions

If kidney function disorders are detected in you, MAGNEZIN should be taken with caution, regularly undergoing blood magnesium level tests. Taking the medicine may lead to an accumulation of excessive amounts of magnesium in the body.
MAGNEZIN administered in a dose above 2 g per day may have a laxative effect.
You should consult your doctor, even if the above warnings concern situations that have occurred in the past.

MAGNEZIN and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
MAGNEZIN taken simultaneously with: tetracyclines (e.g., doxycycline), iron-containing medicines, fluoroquinolones (e.g., ciprofloxacin), and some oral anticoagulants (reducing blood clotting) reduces the absorption of these medicines and may reduce their effectiveness.
The following medicines and substances reduce magnesium absorption from the intestines and may reduce the effectiveness of MAGNEZIN: phosphates, high doses of calcium, phytates, and a large amount of fats in the diet.
The following medicines increase magnesium excretion in the urine and may reduce the effectiveness of MAGNEZIN: loop diuretics (i.e., some diuretic medicines, e.g., furosemide), aminoglycoside antibiotics (e.g., gentamicin), some hormonal medicines (for details, ask your doctor), some anticancer medicines (for details, ask your doctor), and amphotericin B (an antifungal medicine).
Calcium salts administered intravenously weaken the effect of MAGNEZIN, while vitamin B enhances its effect.

MAGNEZIN with food and drink

You should avoid taking MAGNEZIN during or immediately after meals containing foods rich in calcium and fats, as they may reduce the absorption of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
MAGNEZIN can be used during pregnancy.
Breastfeeding women can take MAGNEZIN.

Driving and using machines

MAGNEZIN has no significant effect or a negligible effect on the ability to drive and use machines.

MAGNEZIN contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take MAGNEZIN

Administration in adults

The usual dose of MAGNEZIN is:

• preventively: 500 mg (1 tablet of 500 mg) per day,
• therapeutically: the dose is determined individually depending on the indications and the need for magnesium ions. To supplement magnesium deficiencies, 1500 mg (3 tablets of 500 mg) per day is usually taken. The daily dose is usually divided into 3 equal single doses.

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

Administration in children and adolescents

The dosage of MAGNEZIN in children and adolescents is determined by the doctor.

Duration of treatment

The duration of treatment is determined by the doctor based on the patient's response and laboratory test results.
Treatment should not be discontinued when the magnesium blood level test result is normal, but it should be continued for some time.

Taking a higher dose of MAGNEZIN than recommended

Symptoms of magnesium overdose may include: diarrhea, skin redness, significant decrease in blood pressure, significant slowing of heart rate, insomnia, feeling of general weakness, significant muscle weakness or even paralysis, disorientation, coma, and cardiac arrest (in case of very significant overdose or co-existing heart diseases).
In case of taking a much higher dose of the medicine than recommended, you should immediately contact your doctor or go to the hospital. You should show the doctor the package with the tablets.

Missing a dose of MAGNEZIN

In case of missing a dose, you should take it as soon as possible, unless it is almost time for the next dose. In this case, you should not take the missed dose at all.
You should not take a double dose to make up for the missed dose.

Stopping MAGNEZIN treatment

You should not stop treatment without consulting your doctor, even if you feel better.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, MAGNEZIN can cause side effects, although not everybody gets them.
MAGNEZIN is a very well-tolerated medicine. It rarely causes side effects, and they are usually mild. The most common side effects are gastrointestinal disorders. High doses of the medicine may have a mild laxative effect.
Allergic reactions to MAGNEZIN have not been described so far.
Severe side effects related to MAGNEZIN have not been reported.
Side effects related to MAGNEZIN are listed below.
Uncommon (may occur in less than 1 in 100 people) side effects include: soft stools, nausea, vomiting.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. 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 MAGNEZIN

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Tablets packaged in pharmaceutical containers, polyethylene HDPE with a polypropylene cap with a guarantee ring and a desiccant, should be used within 6 months after opening the container.
Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date means the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What MAGNEZIN contains

The active substance of the medicine is magnesium carbonate.

• -One tablet of MAGNEZIN contains 130 mg of magnesium ions in the form of 500 mg of magnesium carbonate (Magnesium subcarbonate). The other ingredients are: microcrystalline cellulose, crospovidone, sodium lauryl sulfate, polyvinyl alcohol, anhydrous colloidal silica, and magnesium stearate.

What MAGNEZIN looks like and what the package contains

The tablet is oval, almost white to white, biconvex, with an embossing "500" on one side. Length approx. 17 mm, width approx. 9 mm.
MAGNEZIN is packaged in:
blister packs of transparent Aluminum/PVC/PE/PVDC film in a cardboard box
blister packs of white Aluminum/PVC/PE/PVDC film in a cardboard box
blister packs of transparent Aluminum/PVC/Aclar/PVC film in a cardboard box
pharmaceutical containers, polyethylene HDPE with a polypropylene cap with a guarantee ring and a desiccant in a cardboard box.
The box contains 30 tablets or 60 tablets and a patient leaflet.
Not all sizes and types of packaging may be on the market.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: (22) 755 50 81
To obtain more detailed information about the medicine, you should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of the last update of the leaflet:

((logo of the marketing authorization holder))
((pharmaceutical code))