MAGLEK B6

Patient Information Leaflet

Maglek B 51 mg Mg + 5 mg, tablets
Magnesii lactas + Pyridoxini hydrochloridum

Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• 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, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Maglek B is and what it is used for
2. Important information before taking Maglek B
3. How to take Maglek B
4. Possible side effects
5. How to store Maglek B
6. Contents of the pack and other information

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

Maglek B is a medicinal product containing magnesium lactate and vitamin B(_6) (pyridoxine).
The magnesium contained in the preparation is in the form of a salt that is easily absorbed by the body. Magnesium ions rank fourth in abundance among cations in the human body. Normal magnesium levels depend on dietary intake and highly efficient mechanisms limiting magnesium excretion via the gastrointestinal tract and kidneys. When following a diet high in calcium and phosphates, gastrointestinal absorption of magnesium 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, myocardial infarction, and cardiac arrhythmias.

It has been demonstrated that vitamin B(_6) (pyridoxine) enhances the efficiency of magnesium absorption from the gastrointestinal tract into plasma by approximately 40%.
The biologically active form of pyridoxine—phosphoric ester—participates in amino acid metabolism, including the synthesis of neurotransmitters in the central nervous system, influences glucose concentration in muscles, and contributes to hemoglobin synthesis.

In humans, vitamin B(_6) deficiency (avitaminosis B(_6)) manifests as nausea, vomiting, inflammatory changes and damage to the skin and mucous membranes, mental disturbances, convulsions, polyneuritis, and microcytic anemia. Subclinical vitamin B(_6) deficiency, presenting as psychological imbalance and general weakness, has been identified in approximately 40% of elderly individuals.

Indications for use
Maglek B is indicated to supplement diagnosed deficiencies of magnesium and vitamin B(_6) in the body, as well as for the prevention of deficiencies and associated complications.

Prophylactically, Maglek B is recommended:

• In conditions leading to magnesium deficiency: chronic physical and mental fatigue, dietary errors (consumption of large amounts of processed food), adherence to weight-loss diets, excessive coffee consumption, tobacco smoking, and alcohol intake; prolonged use of laxatives, oral contraceptives, certain diuretics, and osmotic diuresis in diabetic patients with chronic hyperglycemia; chronic diseases causing malabsorption (malabsorption syndromes);
• For prevention of atherosclerosis and myocardial infarction.

As supportive therapy, Maglek B may be used after consultation with a doctor to complement treatment in:

• Cardiovascular diseases such as arterial hypertension, congestive heart failure, and cardiac arrhythmias;
• Hypotonic muscle spasms and limb paresthesia;
• States of nervous depression;
• During convalescence after bone fractures or as part of comprehensive osteoporosis treatment.

2. Important information before using Maglek B

When not to use Maglek B
Do not use Maglek B if:

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

Do not use the medicine if the patient is taking levodopa without a peripheral decarboxylase inhibitor of L-DOPA.

Warnings and precautions
Before starting treatment with Maglek B, consult your doctor or pharmacist.
In patients with impaired renal function, dosage reduction should be considered (according to monitored serum magnesium ion concentration).
Lack of effect or significantly reduced efficacy of Maglek B may occur in patients with impaired intestinal absorption.

Maglek B and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Concomitant use of aminoglycosides, muscle relaxants, and colistin with magnesium ions may lead to muscular paralysis.
Do not take tetracyclines, calcium compounds, phosphates, fluoride, or oral anticoagulants simultaneously.
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 certain antimalarial drugs.
Hydralazine, isoniazid, cycloserine, and penicillin form inactive complexes with vitamin B(_6), thereby reducing its concentration in the body. Also, oral contraceptives increase the requirement for pyridoxine. Vitamin B(_6) may reduce serum phenytoin concentration; when administered to patients taking levodopa without a peripheral decarboxylase inhibitor of L-DOPA, it may reduce 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 diarrhoea.
Alcohol and tobacco reduce the effectiveness of magnesium absorption from the gastrointestinal tract.

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 or pharmacist before using this medicine.
Use only as directed by a physician.
The decision to use Maglek B in pregnant women, women who are breastfeeding, or women planning to have children should always be discussed with a doctor.

Driving and operating machinery
Maglek B has no influence on the ability to drive or operate machinery.

3. How to use Maglek B

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Maglek B is intended for adults and children over 6 years of age.
For prophylaxis, 1 to 2 tablets per day should be taken.
For other indications – as directed by a doctor.
Taking a higher than recommended dose of Maglek B
Prolonged use of doses exceeding the recommended ones may lead to symptoms described under side effects, as well as decreased blood pressure, muscle weakness, breathing difficulties, and cardiac rhythm disturbances as a result of alkalosis or milk-alkali syndrome.
If such symptoms occur, discontinue the medicine, initiate intensive oral rehydration, and contact a doctor immediately.
Missed dose of Maglek B
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
When the medicine is used at the recommended dosage, adverse reactions usually do not occur.
Gastrointestinal disturbances may occasionally occur. Long-term, regular administration of vitamin B at a dose of 50 mg/day may lead to peripheral sensory neuropathy, while daily doses exceeding 200 mg may lead to folic acid deficiency, respiratory disorders, and various types of dermatoses.
In some individuals, other adverse reactions may occur during treatment with Maglek B6.

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, Phone: +48 22 4921301, Fax: +48 22 4921309, 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 this medicine.

5. How to store Maglek B6

Keep this medicine out of sight and reach of children. Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging following: 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Maglek B contains

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

What Maglek B looks like and contents of the pack
Maglek B is a white, oval, biconvex tablet with a smooth surface,
possibly containing darker specks, without damage. On one side of the tablet, the imprint "MAGLEK" is embossed.
The tablets are packed in a polyethylene container closed with a lid, which together with the patient leaflet is placed in a cardboard box. One container contains 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company,
Ostrzykowizna 14 A
05-170 Zakroczym
Tel. (+48) (22) 785 27 60
Fax: (+48) (22) 785 27 60 ext. 106