Maglek B6

Package Leaflet: Information for the User

Maglek B 51 mg Mg + 5 mg, tablets,

Magnesium lactate + Pyridoxine hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• 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.

Table of Contents of the Leaflet:

• 1. What is Maglek B and what is it used for
• 2. Important information before using Maglek B
• 3. How to use Maglek B
• 4. Possible side effects
• 5. How to store Maglek B
• 6. Package contents and other information

1. What is Maglek B and what is it used for

Maglek B is a medicine containing magnesium lactate and vitamin B6. The magnesium in the medicine is in the form of a salt that is easily absorbed by the body. Magnesium ions are the fourth most abundant cations in the human body. The proper concentration of magnesium depends on its intake with the diet and the extremely efficient function of limiting magnesium excretion through the gastrointestinal tract and kidneys. In the case of a high-calcium and high-phosphorus diet, magnesium absorption from the gastrointestinal tract is impaired. Magnesium interacts with calcium ions in the formation of bone structure. Symptoms of magnesium deficiency include hyperexcitability, difficulty concentrating and falling asleep, increased susceptibility to stress, and muscle function disorders. Magnesium deficiency increases the risk of coronary heart disease, heart attack, and arrhythmias. It has been found that vitamin B6 - pyridoxine increases the effectiveness of magnesium absorption from the gastrointestinal tract into the blood by about 40%. The active form of pyridoxine in the body - phosphate ester - participates in amino acid metabolism, including the process of creating neurotransmitters in the central nervous system, affects the growth of glucose concentration in muscles, and is involved in the synthesis of hemoglobin. In humans, vitamin B6 deficiency is manifested by nausea, vomiting, inflammation, and damage to the skin and mucous membranes, mental disorders, convulsions, polyneuritis, and microcytic anemia. In about 40% of older people, subclinical vitamin B6 deficiencies have been found, manifested by mental balance disorders and general weakness.

Indications for Use

The indication for the use of the medicinal product Maglek B is to supplement diagnosed magnesium and vitamin B6 deficiencies in the body, as well as to prevent deficiencies and complications related to these deficiencies. As a preventive measure, Maglek B is recommended:

• in situations that cause magnesium deficiencies: states of chronic physical and mental fatigue, dietary errors (consuming large amounts of processed food) and the use of slimming diets, consuming large amounts of coffee, tobacco addiction, and alcohol consumption; long-term use of laxatives, oral contraceptives, and certain diuretics, as well as osmotic diuresis in diabetic patients with chronic hyperglycemia, chronic diseases that impair absorption (malabsorption syndromes);
• to prevent atherosclerosis and heart attacks. As a supportive treatment, Maglek B may be used after consulting a doctor as a supplement to the treatment of:
• heart and circulatory diseases, such as hypertension, congestive heart failure, arrhythmias;
• atomic muscle cramps and limb numbness;
• in states of nervous depression;
• during convalescence after bone fractures or in the comprehensive treatment of osteoporosis.

2. Important Information Before Using Maglek B

When Not to Use Maglek B

Maglek B should not be used in the case of:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• hypermagnesemia of various etiologies,
• severe renal impairment,
• atrioventricular block of the heart,
• significant hypotension,
• myasthenia gravis,
• during diarrhea.

The medicine should not be used if the patient is taking levodopa without a peripheral L-DOPA decarboxylase inhibitor.

Warnings and Precautions

Before starting to use Maglek B, the patient should discuss it with their doctor or pharmacist. In patients with impaired renal function, the need to reduce the dose of the medicine should be considered (according to the controlled concentration of magnesium ions in the blood). The lack or significantly reduced effect of Maglek B occurs in people with impaired intestinal absorption.

Maglek B and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Aminoglycosides, muscle relaxants, and colistin used simultaneously with magnesium ions may cause muscle paralysis. The patient should not take tetracycline, calcium compounds, phosphates, fluorine, and oral anticoagulants at the same time. Bisphosphonates (alendronate, etidronate) should be taken at least 2 hours before or after taking magnesium. Magnesium may reduce the activity of chlorpromazine and quinolones. Magnesium may affect the absorption of digoxin, nitrofurantoin, and some antimalarial drugs. Hydralazine, isoniazid, cycloserine, and penicillin form inactive compounds with vitamin B6, reducing its concentration in the body. Oral contraceptives also increase the demand for pyridoxine. Vitamin B6 may reduce the concentration of phenytoin in the blood, and when used by patients taking levodopa without a peripheral L-DOPA decarboxylase inhibitor, it weakens the effectiveness of levodopa in the treatment of parkinsonism.

Maglek B with Food, Drink, and Alcohol

Maglek B should be taken before or after a meal.

Do Not Take the Medicine on an Empty Stomach as it May Cause Diarrhea

Alcohol and tobacco reduce the effectiveness of magnesium absorption from the gastrointestinal tract.

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 or pharmacist before using this medicine. The medicine should only be used as directed by a doctor. The decision to use Maglek B in pregnant or breastfeeding women or those planning to have a child should be made in consultation with a doctor each time.

Driving and Using Machines

Maglek B does not affect the ability to drive or use machines.

3. How to Use Maglek B

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. Maglek B is intended for adults and children over 6 years of age. For prevention, 1 to 2 tablets should be taken daily. In other indications, the medicine should be used as directed by a doctor.

Using a Higher Dose of Maglek B than Recommended

When taking the medicine for a long time in doses exceeding the recommended ones, side effects may occur, as well as a decrease in blood pressure, muscle weakness, breathing difficulties, and arrhythmias as a result of alkalosis or the milk-alkali syndrome. If such symptoms occur, the patient should stop using the medicine, apply intensive oral hydration, and contact their doctor immediately.

Missing a Dose of Maglek B

The patient should not take a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medicines, Maglek B can cause side effects, although not everybody gets them. At the recommended dosage, side effects usually do not occur. Occasionally, gastrointestinal disorders may occur. Long-term systematic use of vitamin B6 in a dose of 50 mg/day may cause peripheral sensory neuropathy, while daily doses exceeding 200 mg may lead to folic acid deficiency, respiratory disorders, and various dermatoses. During the use of Maglek B, other side effects may occur in some people.

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, Tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to Store Maglek B

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use the medicine after the expiry date stated on the packaging after: Expiry Date (EXP). The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Maglek B Contains

• The active substances of the medicine are: magnesium lactate, in the amount of 500 mg (51 mg Mg) and pyridoxine hydrochloride (vit. B6), in the amount of 5 mg - in one tablet.
• The other ingredients are: microcrystalline cellulose, hypromellose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

What Maglek B Looks Like and What the Package Contains

Maglek B is a white, oval, biconvex tablet with a smooth surface, with permissible darker spots, without damage. On one side of the tablet, the marking "MAGLEK" is embossed. The tablets are packaged in a polyethylene container with a lid, which, along with the patient leaflet, is placed in a cardboard box. One container contains 50 or 100 tablets. The tablets are also packaged in PVC/PVDC/Aluminum blisters, which are placed in a cardboard box along with the patient leaflet. A single package contains 50, 60, 90, 120, or 150 tablets. Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LEK-AM Pharmaceutical Company Ltd.,
Ostrzykowizna 14 A
05-170 Zakroczym
Tel. (+48) (22) 785 27 60
Fax: (+48) (22) 785 27 60 ext. 106
Date of the last update of the leaflet: 08.11.2024