Patient Information Leaflet

Magvit B
48 mg magnesium ions + 5 mg pyridoxine hydrochloride
enteric-coated tablets
Magnesii lactas + Pyridoxini hydrochloridum
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

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

Magvit B is a medicinal product containing magnesium lactate and vitamin B (pyridoxine hydrochloride).
Magnesium regulates ion flow within the cell – it reduces neuromuscular excitability.
It cooperates 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 dysfunction. Magnesium deficiency increases the risk of arterial hypertension, coronary artery disease, myocardial infarction, and cardiac arrhythmias.
Vitamin B facilitates the absorption and transport of magnesium from the gastrointestinal tract into the blood, and subsequently across biological membranes into cells. It also reduces the amount of magnesium excreted in urine, thereby helping to maintain adequate intracellular magnesium levels. Furthermore, the amount of vitamin B contained in one tablet of Magvit B is sufficient to prevent vitamin B deficiency. Vitamin B deficiency in humans may manifest as inflammation of the skin and mucous membranes, psychiatric disturbances, convulsions, polyneuritis, and anemia due to hemoglobin deficiency.
The indication for administration of Magvit B is the prevention and treatment of consequences of magnesium and/or vitamin B deficiency.

Magvit B is used prophylactically:

in states of chronic physical and mental fatigue,
during periods of intense mental and physical exertion,
in situations causing stress and nervous hyperexcitability,
in sleep disorders and nervous depression,
in muscle pain,
in the prevention of atherosclerosis and myocardial infarction.

Magvit B is used as adjunctive therapy in:

cardiovascular diseases such as arterial hypertension, congestive heart failure, and cardiac arrhythmias,
treatment of muscle tremors and limb paresthesia,
states of nervous depression,
during convalescence after bone fractures or as part of comprehensive osteoporosis treatment,
in hypomagnesemia induced by long-term use of diuretics and laxatives.

2. Information before using Magvit B6

When not to use Magvit B6:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
if the patient has severe renal insufficiency,
if the patient has hypermagnesemia, hypervitaminosis B6,
if the patient has atrioventricular block,
if the patient has myasthenia gravis,
if the patient has parkinsonism treated with L-dopa without concomitant use of a peripheral decarboxylase inhibitor of levodopa,
if the patient has significant hypotension,
if the patient has gastrointestinal absorption disorders or diarrhea.

Warnings and precautions

Before starting treatment with Magvit B6, consult your doctor or pharmacist.
A three-hour interval should be maintained between the administration of tetracycline antibiotics and Magvit B6 due to reduced gastrointestinal absorption of tetracyclines. Patients with impaired heart or kidney function should consult their doctor before taking this medicine.

Magvit B6 and other medicines

Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Magnesium reduces the absorption of theophyllines, tetracyclines, iron preparations, fluoride compounds, and oral anticoagulants of the warfarin group.
Phosphates, high doses of calcium, excess lipids (fats), phytates (e.g. contained in coarse grain products), reduce magnesium absorption from the gastrointestinal tract. Diuretics, cisplatin, cycloserine, and mineralocorticosteroids increase magnesium excretion in urine. Concomitant use of aminoglycosides, muscle relaxants, and colistin with magnesium-containing preparations may cause muscular paralysis. Alkalinization of urine leads to decreased renal elimination of quinidine, increasing the risk of quinidine overdose. Vitamin B6 may reduce serum phenytoin concentration. The use of cycloserine, hydralazine, isoniazid, penicillamine, and oral contraceptives increases the requirement for vitamin B6.

Magvit B6 with food and drink

Do not take the medicine on an empty stomach, as it may cause diarrhea.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Magvit B6 may be used during pregnancy and lactation only under medical supervision.

Driving and operating machinery

No negative effects on the ability to drive or operate machinery have been observed.

Magvit B6 contains:

sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Magvit B

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Prophylactically
Adults and children over 12 years of age (adolescents)
Once daily, 2 tablets or 1 to 2 tablets twice daily
Use in children under 12 years of age
According to physician's recommendation.
Therapeutically
Prescription only.
The tablet should be taken with water.
Taking more than the recommended dose of Magvit B
In case of overdose, whose symptoms may include: nausea and vomiting, diarrhoea, drop in blood
pressure, muscle weakness, breathing difficulties, heart rhythm disturbances, sensory disturbances, limb pain,
abundant oral hydration should be administered.
Missed dose of Magvit B
Do not take a double dose to make up for the missed dose.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Gastrointestinal disturbances may rarely occur. When the recommended doses are observed,
adverse symptoms do not usually appear.
In some individuals, other adverse effects may occur during treatment with Magvit B.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects
can be reported directly to: Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Magvit B
Keep this medicine out of the sight and reach of children.
Store below 25°C. Protect from light.
Keep 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Magvit B6 contains
The active substances in the medicine are: magnesium ions (in the form of magnesium lactate dihydrate) and pyridoxine hydrochloride (vitamin B6).
One tablet contains 48 mg of magnesium lactate dihydrate and 5 mg of pyridoxine hydrochloride.
Other components are:

tablet core ingredients: microcrystalline cellulose, sucrose, polyvinyl alcohol, colloidal hydrated 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 the medicine Magvit B6 looks like and contents of the pack
Magvit B6 is in the form of white, oval tablets.
The immediate packaging consists of an aluminium/PVC foil blister in a cardboard box.
The pack contains 50 or 70 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
Tel.: (22) 70 28 200
E-mail: [email protected]

Manufacturer:
Wörwag Pharma Operations Sp. z o.o.
ul. Gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki
Marketing Authorisation Holder.