Magnefar B6

Package Leaflet: Information for the Patient

Magnefar B, 50 mg + 5.05 mg, Coated Tablets

Magnesium Citrate + Pyridoxine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised 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 Undesirable 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 is Magnefar B and What is it Used for
• 2. Important Information Before Taking Magnefar B
• 3. How to Take Magnefar B
• 4. Possible Undesirable Effects
• 5. How to Store Magnefar B
• 6. Contents of the Package and Other Information

1. What is Magnefar B and What is it Used for

Magnefar B Contains 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 Crucial Role in the Process of Cardiac Muscle Contraction and Affects the State of Neuro-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 is 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 Spasms 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, Continuing Treatment is not Recommended.

2. Important Information Before Taking Magnefar B

When Not to Take Magnefar B:

• If the Patient is Allergic to Magnesium Citrate, Pyridoxine Hydrochloride
• Or any of the Other Components of this Medication (Listed in Section 6);
• If the Patient has been Diagnosed with 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 been Diagnosed with Myasthenia Gravis (an Acquired, Chronic Disease Characterized by Rapid Fatigue and Weakness of Skeletal Muscles).

Warnings and Precautions

Before Starting to Take Magnefar B, Discuss it with a 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 Initiated 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 Medication in a Higher Dose than Recommended may Cause Diarrhea.
Particular 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 Gradually Progressing Coordination Disorders. In Most Cases, Symptoms Disappear after Discontinuation of Pyridoxine.
If Undesirable Effects Occur, the Use of the Medication Should be Temporarily Discontinued or the Dose Reduced Until the Symptoms Disappear.
Children and Adolescents
Magnefar B is Used in Adults and Children Aged 6 Years or Older.
In Case of Any Doubts, Consult a Doctor or Pharmacist.

Magnefar B and Other Medications

Inform the Doctor or Pharmacist About All Medications Currently Being Taken or Recently Taken, as well as Planned Medications.
Inform the Doctor or Pharmacist if the Patient is Taking any of the Following Medications, as they may Cause Magnesium and/or Vitamin B6 Deficiency by Increasing their Excretion from the Body or Reducing Absorption:

• Certain Antibiotics (Cisplatin, Cyclosporine A, Rifampicin, Amphotericin B, Penicillamine, Isoniazid, Cycloserine);
• Bisphosphonates (Medications Used to Treat Osteoporosis);
• Diuretics (e.g., Thiazides or Furosemide);
• Cetuximab or Erlotinib (Medications Used to Treat Cancer);
• Proton Pump Inhibitors (Medications Used to Treat Heartburn, such as Pantoprazole or Omeprazole);
• Foscarnet (an Antiviral Medication);
• Pentamidine (a Medication Used to Treat Parasitic Infections or Pneumonia);
• Hydralazine (a Medication Used to Lower Blood Pressure);
• Phosphates, Iron Compounds, or Calcium Salts;
• Contraceptives;
• Laxatives.

In the Case of Using these Medications, it may be Necessary to Individually Adjust the Dose of Magnefar B.
Inform the Doctor or Pharmacist if the Patient is Taking Levodopa (a Medication Used to Treat Parkinson's Disease), as Vitamin B6 may Inhibit its Action.
Do not Take Medications Containing Magnesium and Certain Antibiotics (Fluoroquinolones, Tetracyclines) or Medications Used to Treat Osteoporosis (Bisphosphonates) at the Same Time, as Magnesium may Reduce their Absorption from the Gastrointestinal Tract. Maintain an Interval of at Least 2-3 Hours Between Taking these Medications and Magnefar B.
When Used Together with Lithium Carbonate, Potassium-Sparing Diuretics (such as Amiloride and Spironolactone), or Other Medications Containing Magnesium (such as Laxatives, Antacids), there is a Risk of Hypermagnesemia and Symptoms of Magnesium Poisoning. The Risk is Particularly Increased in Patients with Renal Impairment.

Using Magnefar B with Food, Drinks, and Alcohol

The Medication Should be Taken During Meals 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 a Doctor or Pharmacist Before Taking this Medication.
Pregnancy
The Medication may be Used During Pregnancy Only in Agreement with a Doctor.
Studies have not Shown any Harmful Effects of Magnesium During Pregnancy.
Breastfeeding
The Medication may be Used During Breastfeeding Only in Agreement with a Doctor.
It is Recommended that the Daily Dose of Vitamin B6 does not Exceed 20 mg 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 Contains Small Doses of Vitamin B6.

Driving and Operating Machinery

Magnefar B does not Affect the Ability to Drive and Operate Machinery.
Magnefar B Contains Less than 1 mmol (23 mg)of Sodium per Recommended Dose, which Means the Medication is Considered "Sodium-Free".

3. How to Take Magnefar B

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubts, Consult a Doctor or Pharmacist.

Dosage for Magnesium Deficiency Treatment

Magnefar B
Adults:
6 to 8 Tablets per Day, in 2 or 3 Divided Doses, During Meals.
Children and Adolescents:
Recommendations for Dosage in Children are as Follows:
Do not Use the Medication in Children Under 6 Years of Age and with a Body Weight Below 20 kg.
Tablets Should be Swallowed Whole, Washed Down with a Large Amount of Water.
Tablets Should be Taken During Meals.
Usually, the Treatment Lasts 1 Month.

Taking a Higher Dose of Magnefar B than Recommended

In Case of Taking a Higher Dose of the Medication than Recommended, Consult a Doctor or Pharmacist Immediately.
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

Do not Take a Double Dose to Make up for a Missed Dose.

Discontinuing Magnefar B

In Case of Any Further Doubts Regarding the Use of these Medications, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Magnefar B can Cause Undesirable Effects, although not Everybody will Experience them.
During Treatment with Magnefar B, the Following Undesirable Effects may Occur:
Rare(may Occur in up to 1 in 100 People) :Abdominal Pain, Loose Stools or Diarrhea at the Beginning of Treatment (usually Mild and Transient); Redness of the Skin.
Very Rare(may Occur in up to 1 in 10,000 People) :Allergic Reactions.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those not Listed in this Leaflet, Inform a Doctor or Pharmacist. Undesirable 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
Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Magnefar B

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
Do not Use this Medication After the Expiration Date Stated on the Box and Blister.
The Expiration Date Refers to the Last Day of the Given Month.
Do not Store at a Temperature Above 30°C.
Store in the Original Packaging to Protect from Moisture.
Medications Should not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Magnefar B Contains

• The Active Substances of the Medication are Magnesium Citrate and Pyridoxine Hydrochloride (Vitamin B6).

Magnefar B, 50 mg + 5.05 mg
One Coated Tablet Contains 50 mg of Magnesium Ions in the Form of Magnesium Citrate (Magnesii citras) and 5.05 mg of Pyridoxine Hydrochloride (Pyridoxini hydrochloridum).

• Other Ingredients are: Tablet Core: Microcrystalline Cellulose (Type 102), Microcrystalline Cellulose (Type 105), Crospovidone (Type A), Crosscarmellose Sodium, Magnesium Stearate, Silica Colloidal Anhydrous,.

Tablet Coating (Opadry AMB II White 88A180040): Polyvinyl Alcohol, Talc, Titanium Dioxide (E 171), Glycerol Monocaprylate (Type 1), Sodium Lauryl Sulfate.

What Magnefar B Looks Like and What the Package Contains

Magnefar B:
Coated Tablets are Prolonged, White, Convex on Both Sides, with a Length of 16.5 mm ± 0.3 mm and a Width of 8.0 mm ± 0.2 mm.
Tablets are Packaged in PVC/PVDC/Aluminum Blisters, Together with the Patient Leaflet in a Cardboard Box.
Package Sizes:
The Package Contains 10, 20, 30, 50, 60, 90, or 120 Coated Tablets of Magnefar B.
Not all Package 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
e-mail: [email protected]

Date of the Last Update of the Leaflet: