Magnez + vit. B6 Biofarm

Package Leaflet: Information for the User

Magnez + vit. B Biofarm

34 mg of magnesium ions + 5 mg of pyridoxine hydrochloride

tablets
Magnesium hydroaspartate + 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.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of Contents of the Package Leaflet:

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

1. What is Magnez + vit. B Biofarm and what is it used for

Magnez + vit. B Biofarm contains magnesium and vitamin B.
Magnesium is involved in the proper functioning of the nervous system, musculoskeletal system, respiratory system, cardiovascular system, hormonal system, hematopoietic system, and immune system. It affects the function of the auditory and visual nerves. It reduces stress susceptibility (in cases of emotional imbalance, anxiety, fatigue associated with premenstrual syndrome, depression, migraine, and intense mental effort), reduces nervous-muscular excitability (in cases of nervous-muscular hypersensitivity, attention deficit hyperactivity disorder in children, increased motor activity - heavy physical work, sports), ensures proper muscle contractility (e.g., nocturnal leg cramps), has a protective effect on the heart muscle (in cases of heart failure, hypertension), and counteracts coronary heart disease. It acts as an anticoagulant factor and prevents calcification of blood vessels, and affects the proper development and mineralization of the bone system.
A magnesium deficiency may manifest as physical and mental fatigue, increased irritability, stress susceptibility, muscle tension, cardiac arrhythmia, and hypertension.
Vitamin B increases magnesium absorption from the gastrointestinal tract and reduces magnesium excretion from the body. Vitamin B in a dose of 5 mg, contained in Magnez + vit. B Biofarm, primarily has a beneficial effect on the absorption of magnesium aspartate.
Taking Magnez + vit. B Biofarm is recommended for the prevention and treatment of magnesium and vitamin B deficiencies.

Magnez + vit. B Biofarm is recommended for therapeutic and preventive purposes.

2. Important information before using Magnez + vit. B Biofarm

When not to use Magnez + vit. B Biofarm

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

Warnings and precautions

Before starting to take Magnez + vit. B Biofarm, the doctor or pharmacist should be consulted.

• the medicine should not be taken on an empty stomach,
• the recommended dose should not be exceeded, as this may cause diarrhea, which in the case of persistence may lead to dangerous dehydration of the body,
• with long-term use of the medicine, magnesium levels in the serum should be monitored.

Magnez + vit. B Biofarm and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any medicines planned to be taken.
Magnesium salts administered simultaneously with fluoroquinolone and tetracycline antibiotics, as well as oral anticoagulants - primarily warfarin derivatives, and preparations containing phosphates, iron and calcium compounds - affect the mutual reduction of absorption from the gastrointestinal tract.
Taking cycloserine, isoniazid (medicines used to treat tuberculosis), hydralazine (used to treat hypertension), penicillamine (used to treat rheumatoid arthritis) reduces the content of vitamin B in the body.
Vitamin B in doses even slightly exceeding the recommended daily intake accelerates metabolism and reverses the action of L-dopa used without decarboxylase inhibitors (a medicine used to treat Parkinson's disease).
Diuretics (furosemide, ethacrynic acid) increase magnesium excretion in the urine.
Long-term use of potassium-sparing diuretics may increase magnesium resorption in the renal tubules and cause hypermagnesemia.
Other products containing magnesium, such as laxatives and antacids, used simultaneously with magnesium hydroaspartate may cause symptoms of magnesium poisoning, especially in patients with kidney failure.
Use with caution with digitalis glycosides (used in heart failure).

Taking Magnez + vit. B Biofarm with food and drink

The medicine should be taken after a meal, washed down with a small amount of liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using the medicine. In recommended doses, the medicine may be used during pregnancy and lactation only if necessary.

Driving and using machines

The medicine does not impair psychophysical abilities and may be used by people driving vehicles or operating machines.

3. How to use Magnez + vit. B Biofarm

This medicine should always be used exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The medicine should be taken orally.
Magnez + vit. B Biofarm should be taken after a meal, washed down with a small amount of liquid.
The dividing line on the tablet is not intended for breaking the tablet.
In case of magnesium and vitamin B deficiency:

• adults and children over 12 years of age usually: 1 to 2 tablets of the medicine 3 times a day.
• children under 12 years of age usually: 1 tablet 3 times a day.

For prevention:

• adults and children over 12 years of age usually: 1 to 2 tablets 1 time a day.

Any increase in dose should be consulted with a doctor.

Taking a higher dose of Magnez + vit. B Biofarm than recommended

Symptoms of overdose rarely occur in patients with normal kidney function.
Taking the medicine in recommended doses significantly exceeding the recommended dose may cause: allergic reactions, nausea, abdominal pain, diarrhea, and dehydration of the body.
In case of diarrhea, the daily dose should be reduced or the medicine should be temporarily discontinued.
Other symptoms of overdose include: asystole (lack of heart contractions), bradycardia (slow heart rate), symptoms of drowsiness, coma, hypotension (low blood pressure), muscle paralysis, kidney failure, and respiratory disorders.
Treatment of overdose: products containing magnesium should be discontinued, and breathing should be supported. The specific antidote is calcium gluconate.
In case of taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of Magnez + vit. B Biofarm

Treatment should be continued, following the dosage regimen of Magnez + vit. B Biofarm. A double dose should not be taken to make up for a missed dose.

Stopping the use of Magnez + vit. B Biofarm

In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The medicine may cause disturbances in atrioventricular conduction.
Sometimes, after taking the medicine, nausea and diarrhea may occur, which usually resolve on their own.
Redness of the skin may also occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the doctor or pharmacist should be informed. 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 e-mail: ndl@urpl.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 Magnez + vit. B Biofarm

The medicine should be stored out of sight and reach of children.
Store in closed containers.
Store at a temperature below 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Magnez + vit. B Biofarm contains

• The active substances of the medicine are magnesium hydroaspartate and pyridoxine hydrochloride (vitamin B). One tablet contains 500 mg of magnesium hydroaspartate tetrahydrate (equivalent to 34 mg of magnesium ions) and 5 mg of pyridoxine hydrochloride (vitamin B).
• The other ingredients are: microcrystalline cellulose, magnesium stearate, and hypromellose.

What Magnez + vit. B Biofarm looks like and what the package contains

White, elongated, biconvex tablets with a smooth surface, with a dividing line on one side.
The tablets are packaged in aluminum/PVC blisters, placed in a cardboard box.
The package contains 30, 50, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Polska
Tel.: +48 61 66 51 500

Date of approval of the package leaflet: