Magvit B6

Leaflet attached to the packaging: patient information

Magvit B

48 mg of magnesium ions + 5 mg of pyridoxine hydrochloride

enteric-coated tablets
Magnesium lactate + Pyridoxine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a 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 a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Magvit B is a medicine containing magnesium salt of lactic acid and vitamin B (pyridoxine hydrochloride).
Magnesium regulates the flow of ions in the cell - reduces nervous and muscular excitability.
It 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
hypertension, coronary heart disease, heart attack, and arrhythmias.
Vitamin B facilitates the absorption and transport of magnesium from the gastrointestinal tract into the blood, and then
through biological membranes into the cells, and reduces the amount of magnesium excreted in the urine,
allowing for the maintenance of a normal intracellular magnesium pool. Additionally, the amount of vitamin B contained in one tablet of Magvit B is sufficient to protect the body against deficiency. Vitamin B deficiency in humans can manifest as skin and mucous membrane inflammation, mental disorders, convulsions, polyneuritis, and anemia resulting from hemoglobin deficiency.
The indication for the use of Magvit B is the prevention and treatment of magnesium and/or vitamin B deficiencies.
Prophylactically, Magvit B is used:

• in states of chronic physical and mental fatigue,
• during intense mental and physical work,
• in situations causing stress and nervous excitability,
• in sleep disorders and nervous depression,
• in muscle pain,
• in the prevention of atherosclerosis and heart attacks.

Magvit B is used as a supplement to the treatment of:

• heart and circulatory system diseases, such as hypertension, congestive heart failure, arrhythmias,
• in the therapy of muscle tremors and limb numbness,
• in states of nervous depression,
• during convalescence after bone fractures or in the comprehensive treatment of osteoporosis,
• in hypomagnesemia caused by prolonged use of diuretic and laxative medications.

2. Important information before taking Magvit B

When not to take Magvit B:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe renal impairment,
• if the patient has hypermagnesemia, hypervitaminosis B,
• if the patient has atrioventricular block,
• if the patient has myasthenia gravis,
• if the patient has parkinsonism treated with L-dopa without the use of peripheral decarboxylase inhibitors of levodopa,
• if the patient has significant hypotension,
• if the patient has malabsorption from the gastrointestinal tract, diarrhea.

Warnings and precautions

Before starting to take Magvit B, you should discuss it with your doctor or pharmacist.
When taking oral tetracycline preparations, a three-hour interval should be maintained between the administration of the antibiotic and Magvit B due to the reduced absorption of tetracyclines from the gastrointestinal tract. Patients with heart and kidney function disorders should consult their doctor before taking the medicine.

Magvit B and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Magnesium reduces the absorption of theophylline, tetracyclines, iron preparations, fluorine compounds, and oral anticoagulant medications from the warfarin group.
Phosphates, high doses of calcium, excessive lipids (fats), phytates (found in coarse-grained cereal products) reduce magnesium absorption from the gastrointestinal tract. Diuretic medications, cisplatin, cycloserine, mineralocorticosteroids, and increased magnesium excretion in the urine. Aminoglycosides, muscle relaxants, and colistin used simultaneously with magnesium preparations can cause muscle paralysis. As a result of urine alkalization, there is a decrease in renal excretion of quinidine, which is associated with the risk of its overdose. Vitamin B may reduce the concentration of phenytoin in blood serum. The use of cycloserine, hydralazine, isoniazid, penicillamine, and oral contraceptives leads to an increased demand for vitamin B.

Magvit B with food and drink

The medicine should not be taken on an empty stomach, as it may cause diarrhea.

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 taking this medicine.
Magvit B can be used during pregnancy and lactation only in agreement with the doctor.

Driving and using machines

No negative effect on the ability to drive and use machines has been observed.

Magvit B contains:

• sucrose.If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
• less than 1 mmol (23 mg) of sodiumper tablet, which means the medicine is considered "sodium-free".

3. How to take Magvit B

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
Prophylactically

Adults and children over 12 years old (adolescents)

1 time a day 2 tablets or 1 to 2 tablets 2 times a day

Use in children under 12 years old

According to the doctor's recommendation.
Therapeutically
Only with a doctor's prescription.
The medicine should be taken with water.

Taking a higher dose of Magvit B than recommended

In case of overdose, whose symptoms are: nausea and vomiting, diarrhea, blood pressure drop, muscle weakness, breathing difficulties, arrhythmias, sensory disturbances, limb pain, abundant oral hydration should be applied.

Missing a dose of Magvit B

A double dose should not be taken to make up for a missed dose.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, gastrointestinal disorders may occur. When following the recommended doses, side effects do not occur.
In some people, during the use of Magvit B, other side effects may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to: the Department of Adverse Reaction Monitoring 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, you can help gather more information on the safety of the medicine.

5. How to store Magvit B

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Store in the original packaging.
Do not use Magvit B after the expiry date stated on the packaging. The expiry date refers to the last day of the given 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. Contents of the packaging and other information

What Magvit B contains

The active substances of the medicine are: magnesium ions (in the form of magnesium lactate dihydrate) and pyridoxine hydrochloride (vitamin B).
One tablet contains 48 mg of magnesium lactate dihydrate and 5 mg of pyridoxine hydrochloride.
The other ingredients are:

• core tablet ingredients: microcrystalline cellulose, sucrose, polyvinyl alcohol, colloidal silica, talc, magnesium stearate.
• coating ingredients: methacrylic acid copolymer (Eudragit L 100-55), talc, titanium dioxide (E171), macrogol 6000, povidone K 25, silicone emulsion SE2, sodium hydroxide.

What Magvit B looks like and what the packaging contains

Magvit B is a white, oval tablet.
The immediate packaging is an aluminum/PVC blister pack in a cardboard box.
The packaging contains 20, 30, or 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: angelini@angelini.pl

Manufacturer:

Wörwag Pharma Operations Sp. z o.o.
ul. Gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki
The patient leaflet in a format suitable for the blind and visually impaired is available at the marketing authorization holder's headquarters.
Date of the last update of the leaflet:April 2022