Package leaflet: Information for the user

Magnez + wit. B6 Biofarm
34 mg of magnesium ions + 5 mg of pyridoxine hydrochloride
tablets
Magnesii hydroaspartas + Pyridoxini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a 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 adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet:

What Magnez + wit. B6 Biofarm is and what it is used for
Important information before taking Magnez + wit. B6 Biofarm
How to take Magnez + wit. B6 Biofarm
Possible side effects
How to store Magnez + wit. B6 Biofarm
Contents of the pack and other information

1. What Magnez + wit. B6 Biofarm is and what it is used for

Magnez + wit. B6 Biofarm contains magnesium and vitamin B6.
Magnesium plays a role in the proper functioning of the nervous, musculoskeletal, respiratory, cardiovascular, hormonal, haematopoietic and immune systems. It affects the function of auditory and visual nerves. It reduces susceptibility to stress (in the absence of emotional balance, anxiety, fatigue associated with premenstrual tension syndrome, depression, migraine, during intense mental effort), reduces neuromuscular excitability (in neuromuscular hypersensitivity, hyperkinetic movement disorder in children, increased physical activity – heavy physical work, sports), ensures normal muscle contractility (e.g. nocturnal calf cramps), exerts a protective effect on the myocardium (in heart failure, arterial hypertension), counteracts myocardial ischaemia. It acts as an anti-thrombotic agent and prevents vascular calcification, and influences proper development and mineralization of the skeletal system.
Magnesium deficiency may manifest as physical and mental fatigue, increased irritability, susceptibility to stress, muscle tension, cardiac arrhythmia, and arterial hypertension.
Vitamin B6 enhances the absorption of magnesium from the gastrointestinal tract and reduces magnesium excretion from the body. The 5 mg dose of vitamin B6 contained in Magnez + wit. B6 Biofarm primarily improves the absorption of magnesium aspartate.
The use of Magnez + wit. B6 Biofarm is recommended for prophylaxis of deficiency and for treatment of magnesium and vitamin B6 deficiency states.
Magnez + wit. B6 Biofarm is indicated for both therapeutic and prophylactic purposes.

2. Information before using Magnez + wit. B6 Biofarm

When not to use Magnez + wit. B6 Biofarm

if the patient is allergic to magnesium hydroaspartate, pyridoxine hydrochloride (vitamin B6), or any of the other ingredients of this medicine (listed in section 6),
if the patient is taking antibiotics,
if the patient has diarrhoea,
if the patient has hypermagnesemia (elevated magnesium levels in the blood),
if the patient has vitamin B6 hypervitaminosis (elevated vitamin B6 levels in the blood),
if the patient has acute renal failure,
if the patient has significant arterial hypotension,
if the patient has atrioventricular block,
if the patient has a condition called myasthenia gravis (an acquired, chronic disease characterized by rapid fatigue and weakness of skeletal muscles).

Warnings and precautions
Before starting to take Magnez + wit. B6 Biofarm, discuss it with your doctor or pharmacist.

do not take the medicine on an empty stomach,
do not exceed the recommended dose, as this may cause diarrhoea; if this condition persists, it may lead to dangerous dehydration,
during long-term use of the medicine, serum magnesium levels should be monitored.

Magnez + wit. B6 Biofarm and other medicines
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.
Magnesium salts administered simultaneously with fluoroquinolone and tetracycline antibiotics, and oral anticoagulants—especially warfarin derivatives—as well as preparations containing phosphates, iron and calcium compounds, may mutually reduce gastrointestinal absorption.
The use of cycloserine, isoniazid (medicines used in the treatment of tuberculosis), hydralazine (used in the treatment of hypertension), and penicillamine (used, among others, in the treatment of rheumatoid arthritis) decreases vitamin B6 levels in the body.
Vitamin B6, even in doses slightly exceeding the recommended daily intake, accelerates metabolism and reverses the effect of L-dopa when administered without decarboxylase inhibitors (a medicine used in Parkinson's disease).
Diuretics (furosemide, ethacrynic acid) increase urinary excretion of magnesium.
Long-term use of potassium-sparing diuretics may increase magnesium reabsorption in the renal tubules and lead to hypermagnesemia.
Other magnesium-containing products such as laxatives and antacids may, when used simultaneously with magnesium hydroaspartate, cause symptoms of magnesium poisoning, especially in patients with renal impairment.
Use with caution with cardiac glycosides (used in heart failure).

Use of Magnez + wit. B6 Biofarm with food and drink
The medicine should be taken after a meal, with a small amount of liquid.

Pregnancy and breastfeeding
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.
This medicine may be used during pregnancy and lactation only in recommended doses and only when clearly necessary.

Driving and operating machinery
The medicine does not impair psychophysical performance and may be used by people driving vehicles or operating machinery.

3. How to use Magnez + wit. B6 Biofarm

This medicine should always be taken exactly as described in the patient information leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally.
Magnez + wit. B6 Biofarm should be taken after meals, with a small amount of liquid.
The break line on the tablet is not intended for splitting the tablet.

For magnesium and vitamin B6 deficiency:

Adults and children over 12 years of age: usually 1 to 2 tablets three times daily.
Children under 12 years of age: usually 1 tablet three times daily.

For prophylaxis:

Adults and children over 12 years of age: usually 1 to 2 tablets once daily.

Any increase in dosage should be discussed with a doctor.

Taking more Magnez + wit. B6 Biofarm than recommended
Overdose symptoms rarely occur in patients with normal kidney function.
Taking doses significantly exceeding the recommended amount may cause: allergic reactions, nausea, abdominal pain, diarrhoea, and dehydration.
If diarrhoea occurs, the daily dose should be reduced or the medicine temporarily discontinued.
Other overdose symptoms include: asystole (absence of heart contractions), bradycardia (slow heart rate), drowsiness, coma, hypotension (low blood pressure), muscle paralysis, renal failure, and respiratory depression.
Treatment of overdose: discontinue products containing magnesium, maintain respiration. Specific antidote is calcium gluconate.
In case of overdose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Magnez + wit. B6 Biofarm
Continue treatment according to the recommended dosing regimen.
Do not take a double dose to make up for a missed dose.

Stopping Magnez + wit. B6 Biofarm
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although
not everyone will experience them.
The medicine may cause atrioventricular conduction disturbances.
Sometimes nausea and diarrhoea may occur after using the medicine, which usually resolve spontaneously.
Skin redness may also occur.
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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Magnez + wit. B6 Biofarm

Keep this medicine out of sight and reach of children.
Store in closed packaging.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after:
"Expiry date:". 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 dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Magnez + wit. B6 Biofarm contains

The active substances in this medicine are magnesium aspartate hydrochloride and pyridoxine hydrochloride (vitamin B6). Each tablet contains 500 mg of magnesium aspartate hydrochloride tetrahydrate (equivalent to 34 mg of magnesium ions) and 5 mg of pyridoxine hydrochloride (vitamin B6).
Other ingredients are: microcrystalline cellulose, magnesium stearate and hypromellose.

What Magnez + wit. B6 Biofarm looks like and contents of the pack
White, elongated, biconvex tablets with a smooth surface and a break line on one side.
The tablets are packed in blisters made of aluminium/PVC foil, placed in a cardboard box.
The pack contains 30, 50 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIOFARM Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Poland
Tel.: +48 61 66 51 500