Magnefar b6 bio

Package leaflet: Information for the user

Magnefar B Bio, 60 mg + 6.06 mg, coated tablets
Magnefar B Forte, 100 mg + 10.10 mg, coated tablets
Magnesii citras + Pyridoxini hydrochloridum
Please read this leaflet carefully before using the 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, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, consult your doctor.

Leaflet contents

1. What are Magnefar B Bio and Magnefar B Forte and what are they used for
2. Important information before taking Magnefar B Bio and Magnefar B Forte
3. How to take Magnefar B Bio and Magnefar B Forte
4. Possible side effects
5. How to store Magnefar B Bio and Magnefar B Forte
6. Contents of the pack and other information

1. What are Magnefar B Bio and Magnefar B Forte and what are they used for

Magnefar B Bio and Magnefar B Forte contain magnesium ions and pyridoxine hydrochloride (vitamin B ).
Magnesium is a cation essential for the proper course of many biochemical processes in the body. Its biological role involves the activation of numerous enzymes. It plays an important role in myocardial contraction and affects neuromuscular excitability.
Magnesium is only partially absorbed from the gastrointestinal tract, mainly in the small intestine, and the degree of absorption depends on dietary content. Magnesium deficiency may cause disorders of the muscular and central nervous systems.
Magnefar B Bio and Magnefar B Forte are indicated for the treatment and prevention of magnesium deficiency.
Magnesium deficiency may be indicated by the following symptoms:

• Nervousness, irritability, mood swings, mild anxiety, restlessness, transient fatigue, drowsiness, mild sleep disturbances;
• Anxiety symptoms such as gastrointestinal cramps or palpitations (without heart disorders);
• Muscle cramps, tingling, eyelid twitching.

Supplementing magnesium may alleviate the above-mentioned deficiency symptoms. If there is no improvement after one month of treatment with Magnefar B Bio or Magnefar B Forte, continuation of therapy is not recommended.

2. Important information before using Magnefar B Bio and Magnefar B Forte

When not to use Magnefar B Bio and Magnefar B Forte:

• if the patient is allergic to magnesium citrate, pyridoxine hydrochloride, or any of the other components of this medicine (listed in section 6);
• if the patient has hypermagnesaemia (elevated magnesium blood levels);
• if the patient has acute renal failure (creatinine clearance < 30 ml/min.);
• if the patient has significant hypotension;
• if the patient has atrioventricular block;
• if the patient has been diagnosed with myasthenia gravis (an acquired, chronic disease characterized by rapid fatigue and weakness of skeletal muscles).

Warnings and precautions
Before starting treatment with Magnefar B Bio or Magnefar B Forte, discuss this with your doctor or pharmacist.
In cases of concurrent magnesium and calcium deficiency, magnesium deficiency should be corrected first.
In cases of severe magnesium deficiency and malabsorption, treatment should be initiated under medical supervision with intravenous magnesium administration.
Long-term use of high doses of magnesium may contribute to the development of dental caries.
Administration of doses higher than recommended may cause diarrhoea.
Extreme caution should be exercised in patients with moderate renal impairment due to the risk of elevated magnesium blood levels.
Long-term use of magnesium may increase blood potassium levels, especially in patients with restricted potassium intake and impaired kidney function.
Long-term use of pyridoxine (for several months or years) may cause sensory nerve disorders. Symptoms include numbness and disturbances in position sense, tingling in hands and feet, as well as gradually progressing coordination disorders. In most cases, symptoms resolve after discontinuation of pyridoxine.
If adverse effects occur, temporarily discontinue the medicine until symptoms subside or reduce the dose.

Children and adolescents
Magnefar B Bio and Magnefar B Forte are indicated for use in adults and children aged 6 years and older.
If in doubt, consult a doctor or pharmacist.

Magnefar B Bio and Magnefar B Forte with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor or pharmacist if you are taking any of the following medicines, as they may cause magnesium and/or vitamin B deficiency by, among other mechanisms, increasing their excretion from the body or impairing their absorption:

• certain antibiotics (cisplatin, cyclosporine A, rifampicin, amphotericin B, penicillamine, isoniazid, cycloserine);
• bisphosphonates (medicines used in the treatment of osteoporosis);
• diuretics (e.g. thiazides or furosemide);
• cetuximab or erlotinib (medicines used in cancer treatment);
• proton pump inhibitors (medicines used to treat heartburn, such as pantoprazole or omeprazole);
• foscarnet (an antiviral medicine);
• pentamidine (a medicine used to treat parasitic infections or lung infections);
• hydralazine (a medicine used to lower blood pressure);
• phosphates, iron compounds, or calcium salts;
• hormonal contraceptives;
• laxatives.
  When taking these medicines, individual dose adjustment of Magnefar B Bio and Magnefar B Forte may be necessary.

Inform your doctor or pharmacist if you are taking levodopa (a medicine used in the treatment of Parkinson's disease), as vitamin B may inhibit its effect.
Do not take magnesium-containing medicines simultaneously with certain antibiotics (fluoroquinolones, tetracyclines) or medicines used in the treatment of osteoporosis (so-called bisphosphonates), as magnesium may reduce their gastrointestinal absorption. At least a 2-3 hour interval should be maintained between taking these medicines and Magnefar B Bio or Magnefar B Forte.
When magnesium preparations are used concomitantly with lithium carbonate, potassium-sparing diuretics (such as amiloride and spironolactone), or other magnesium-containing medicines (such as laxatives, antacids), there is a risk of hypermagnesaemia and symptoms of magnesium poisoning. The risk is particularly increased in patients with renal impairment.

Magnefar B Bio and Magnefar B Forte with food, drink, and alcohol
Take the medicine during a meal and drink it with a large amount of water (one glass).

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
This medicine may be used during pregnancy only under medical supervision.
Studies have not shown harmful effects of magnesium during pregnancy.

Breastfeeding
This medicine may be used during breastfeeding only under medical supervision.
It is recommended that the daily dose of vitamin B does not exceed 20 mg during breastfeeding.

Fertility
Studies on vitamin B have shown its effect on male fertility. However, this effect occurs only at very high doses. Magnefar B Bio and Magnefar B Forte contain low doses of vitamin B.

Driving and operating machinery
Magnefar B Bio and Magnefar B Forte have no influence on the ability to drive or operate machinery.

Magnefar B Bio and Magnefar B Forte contain sodium
The medicines contain less than 1 mmol (23 mg) of sodium per recommended dose unit; therefore, they are considered "sodium-free".

3. How to use Magnefar B Bio and Magnefar B Forte medicines

These medicines should always be taken exactly as described in this patient leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage for the treatment of magnesium deficiency
Magnefar B Bio
Adults:
5 to 6 tablets per day, in 2 or 3 divided doses, taken with meals.
Children and adolescents:
Dosage recommendations for children are as follows:

The medicine should not be used in children under 6 years of age and weighing less than 20 kg.
Magnefar B6 Forte
Adults:
3 to 4 tablets per day, in 2 or 3 divided doses, taken with meals.
The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
Children and adolescents:
Dosage recommendations for children are as follows:

Use of a higher than recommended dose of Magnefar B Bio or Magnefar B Forte
If a higher than recommended dose of the medicine has been taken, consult a doctor or
pharmacist immediately.
Overdose of magnesium taken orally does not cause toxic reactions in patients
with normal kidney function. In patients with renal insufficiency, magnesium poisoning
may occur.
Missing a dose of Magnefar B Bio or Magnefar B Forte
Do not take a double dose to make up for a missed dose.
Stopping treatment with Magnefar B Bio or Magnefar B Forte
If you have any further doubts regarding the use of these medicines, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, these products may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with Magnefar B Bio and Magnefar B Forte:
Rarely: abdominal pain, loose stools or diarrhoea at the beginning of treatment (usually mild and transient); skin redness.
Very rarely: allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Magnefar B Bio and Magnefar B Forte medicines

Do not store at temperatures above 30°C.
Keep the medicine in a place that is out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
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 you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Magnefar B Bio and Magnefar B Forte medicinal products contain

• The active substances in these medicinal products are magnesium citrate and pyridoxine hydrochloride (vitamin B ).

Magnefar B Bio, 60 mg + 6.06 mg
One coated tablet contains 60 mg of magnesium ions in the form of magnesium citrate
( Magnesii citras ) and 6.06 mg of pyridoxine hydrochloride ( Pyridoxini hydrochloridum ).
Magnefar B Forte, 100 mg + 10.10 mg
One coated tablet contains 100 mg of magnesium ions in the form of magnesium citrate
( Magnesii citras ) and 10.10 mg of pyridoxine hydrochloride ( Pyridoxini hydrochloridum ).

• Other components are:
  Tablet core: microcrystalline cellulose, crospovidone (type A), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocapronate (type 1), sodium lauryl sulfate.

What Magnefar B Bio and Magnefar B Forte look like and contents of the pack
Magnefar B Bio:
Elongated, white, biconvex coated tablets, 16.5 mm ± 0.3 mm in length and 8.0 mm ± 0.2 mm in width.
Magnefar B Forte:
Elongated, white, biconvex coated tablets, 19.2 mm ± 0.3 mm in length and 8.7 mm ± 0.3 mm in width, with a single-scored line on one side.
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed together with the patient leaflet in a cardboard box. Pack sizes:
Magnefar B Bio
10, 30, 50, 60, 90 or 120 coated tablets
Magnefar B Forte
10, 30, 50, 60, 90 or 120 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]