Magnefar B6 Bio

Leaflet attached to the packaging: patient information

Magnefar B Bio, 60 mg + 6.06 mg, coated tablets

Magnefar B Forte, 100 mg + 10.10 mg, coated tablets

Magnesium citrate + Pyridoxine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 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 packaging 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 B6). Magnesium is an essential cation for the proper course of many biochemical processes in the body. Its biological role involves the activation of a series of enzymes. It plays a significant role in the contraction of the heart muscle and affects the state of nervous and muscular excitability. Magnesium is only partially absorbed from the gastrointestinal tract, mainly in the small intestine, and the degree of absorption depends on the content in food. Magnesium deficiency can cause disorders of the muscular and central nervous systems. Magnefar B Bio and Magnefar B Forte are recommended for the treatment and prevention of magnesium deficiency. Magnesium deficiency may be indicated by the occurrence of the following symptoms:

• nervousness, irritability, mood swings, mild anxiety, restlessness, transient fatigue, lethargy, sleep disorders of mild severity;
• anxiety symptoms, such as gastrointestinal cramps or heart palpitations (without cardiac disorders);
• muscle cramps, tingling, eyelid twitching.

Supplementing magnesium can alleviate the above symptoms of deficiency. If there is no improvement after a month of taking Magnefar B Bio or Magnefar B Forte, continuing treatment is not recommended.

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

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

• if the patient is allergic to magnesium citrate, pyridoxine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypermagnesemia (elevated magnesium levels in the blood);
• if the patient has acute renal failure (creatinine clearance <30 ml min);< li>
• if the patient has significant hypotension;
• if the patient has an atrioventricular block;
• if the patient has 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, the patient should discuss it with their doctor or pharmacist. In the case of combined magnesium and calcium deficiency, magnesium deficiency should be corrected first. In the case of severe magnesium deficiency and malabsorption, treatment should be started under medical supervision with intravenous magnesium administration. Long-term use of high doses of magnesium may contribute to the development of tooth decay. Taking the medicine in a dose higher than recommended may cause diarrhea. Special caution should be exercised in patients with moderate renal impairment, due to the risk of elevated magnesium levels in the blood. As a result of long-term use of magnesium, potassium levels in the blood may increase, especially in patients with controlled potassium intake and impaired renal function. Long-term use of pyridoxine (for several months or years) may cause sensory nerve disorders. Symptoms include: numbness and disturbances of position sense, tingling in hands and feet, as well as progressively worsening coordination disorders. In most cases, symptoms disappear after discontinuation of pyridoxine. If side effects occur, the patient should temporarily discontinue the medicine or reduce the dose until the symptoms disappear. Children and adolescents Magnefar B Bio and Magnefar B Forte are used in adults and children over 6 years of age. In case of any doubts, the patient should consult a doctor or pharmacist.

Magnefar B Bio and Magnefar B Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor or pharmacist if they are taking any of the following medicines, as they may cause magnesium and/or vitamin B6 deficiency by increasing their excretion from the body or impairing absorption:

• certain antibiotics (cisplatin, cyclosporine A, rifampicin, amphotericin B, penicillamine, isoniazid, cycloserine);
• bisphosphonates (medicines used to treat osteoporosis);
• diuretics (e.g., thiazides or furosemide);
• cetuximab or erlotinib (medicines used to treat cancer);
• 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;
• contraceptives;
• laxatives. In the case of taking these medicines, it may be necessary to individually adjust the dose of Magnefar B Bio and Magnefar B Forte.

The patient should inform their doctor or pharmacist if they are taking levodopa (a medicine used to treat Parkinson's disease), as vitamin B6 may inhibit its action. The patient should not take medicines containing magnesium and certain antibiotics (fluoroquinolones, tetracyclines) or medicines used to treat osteoporosis (bisphosphonates) at the same time, as magnesium may reduce their absorption from the gastrointestinal tract. The patient should maintain an interval of at least 2-3 hours between taking these medicines and taking Magnefar B Bio or Magnefar B Forte. When magnesium preparations are used concurrently with lithium carbonate, potassium-sparing diuretics (such as amiloride and spironolactone), or other medicines containing magnesium (such as laxatives or antacids), there is a risk of hypermagnesemia and symptoms of magnesium poisoning. The risk is particularly increased in patients with renal impairment.

Magnefar B Bio and Magnefar B Forte with food, drinks, and alcohol

The medicine should be taken during a meal and washed down with a large amount of water (one glass).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy The medicine can be used during pregnancy only in consultation with a doctor. Studies have not shown any harmful effects of magnesium during pregnancy. Breastfeeding The medicine can be used during breastfeeding only in consultation with a doctor. It is recommended that the dose of vitamin B6 does not exceed 20 mg per day during breastfeeding. Fertility Studies on vitamin B6 have shown its effect on fertility in men. However, this effect occurs only at very high doses. Magnefar B Bio and Magnefar B Forte contain small doses of vitamin B6.

Driving and using machines

Magnefar B Bio and Magnefar B Forte do not affect the ability to drive and use machines.

Magnefar B Bio and Magnefar B Forte contain sodium

The medicines contain less than 1 mmol (23 mg) of sodium per recommended dose, which means they are considered "sodium-free".

3. How to take Magnefar B Bio and Magnefar B Forte

These medicines should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.

Dosing for magnesium deficiency treatment

Magnefar B Bio Adults:5 to 6 tablets per day, in 2 or 3 divided doses, during a meal. Children and adolescents:The recommended dosages for children are as follows: Do not use the medicine in children under 6 years of age and with a body weight below 20 kg. Magnefar B Forte Adults:3 to 4 tablets per day, in 2 or 3 divided doses, during a meal. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow. Children and adolescents:The recommended dosages for children are as follows:

Taking a higher dose of Magnefar B Bio or Magnefar B Forte than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist. Overdose of magnesium taken orally does not cause toxic reactions in patients with normal renal function. In patients with renal impairment, magnesium poisoning may occur.

Missing a dose of Magnefar B Bio or Magnefar B Forte

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Magnefar B Bio or Magnefar B Forte

In case of any further doubts about taking these medicines, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Magnefar B Bio and Magnefar B Forte can cause side effects, although not everybody gets them. During treatment with Magnefar B Bio and Magnefar B Forte, the following side effects may occur:

Rarely:abdominal pain, loose stools, or diarrhea at the beginning of treatment (usually mild and transient); skin redness. Very rarely:allergic reactions.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. Reporting side effects will help to gather more information on the safety of the medicine.

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

Do not store above 30°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Magnefar B Bio and Magnefar B Forte contain

• The active substances of the medicines are magnesium citrate and pyridoxine hydrochloride (vitamin B6).

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 ingredients are: Tablet core: microcrystalline cellulose, crospovidone (type A), sodium carmellose, colloidal anhydrous silica, magnesium stearate. Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monokaprylocapronate (type 1), sodium lauryl sulfate.

What Magnefar B Bio and Magnefar B Forte look like and contents of the pack

Magnefar B Bio: Coated tablets, white, biconvex, 16.5 mm ± 0.3 mm in length and 8.0 mm ± 0.2 mm in width. Magnefar B Forte: Coated tablets, white, biconvex, 19.3 mm ± 0.3 mm in length and 8.8 mm ± 0.3 mm in width, with a single transverse score line. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses. The tablets are packaged in PVC/PVDC/Aluminum blisters, 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 authorization 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]

Date of last revision of the leaflet: 27.10.2023