Maglek b6 forte

Patient Information Leaflet

Maglek B6 Forte, 100 mg magnesium ions Mg + 10 mg, coated tablets
Magnesii citras + Pyridoxini hydrochloridum

Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
You must always use this medicine exactly as described in this patient leaflet or as your doctor, pharmacist, or nurse has recommended.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If your symptoms do not improve or if you feel worse, you should consult your doctor.

Contents of the leaflet

1. What Maglek B6 Forte is and what it is used for
2. What you need to know before taking Maglek B6 Forte
3. How to take Maglek B6 Forte
4. Possible side effects
5. How to store Maglek B6 Forte
6. Contents of the pack and other information

1. What Maglek B6 Forte is and what it is used for

Maglek B6 Forte contains magnesium ions and pyridoxine hydrochloride (vitamin B6).
The medicine helps correct magnesium deficiency in the body.
Magnesium is a cation essential for the proper functioning of numerous biochemical processes in the body. Its biological role involves the activation of various enzymes.
Magnesium 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 extent of absorption depends on its dietary content. Magnesium deficiency may cause disturbances in the muscular and central nervous systems. Vitamin B6 increases gastrointestinal absorption of magnesium by 20–40%.
Maglek B6 Forte is indicated for the treatment and prevention of magnesium deficiency.
The presence of any of the following symptoms may indicate magnesium deficiency:

• 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 sensations, eyelid twitching.

Supplementing magnesium may alleviate the above symptoms.
This product should be used after excluding other causes of symptoms unrelated to magnesium deficiency and when improvement or increased magnesium intake cannot be achieved through an appropriate diet.
If no improvement is observed after one month of treatment with Maglek B6 Forte, continued use is not recommended.

2. Important information before using Maglek B6 Forte

When not to use Maglek B6 Forte:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute renal failure (creatinine clearance < 30 ml/min);
• if the patient is concurrently using levodopa;
• if the patient has been diagnosed with hypermagnesemia;
• if the patient has been diagnosed with significant hypotension;
• if the patient has been diagnosed with 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 Maglek B6 Forte, discuss it with your doctor, pharmacist, or nurse.
In cases of concomitant magnesium and calcium deficiency, magnesium deficiency should be corrected first.
In cases of severe magnesium deficiency and impaired absorption, treatment should be initiated under medical supervision with intravenous magnesium.
Long-term use of high doses of magnesium may contribute to the development of dental caries.
Administration of the medicine in doses higher than recommended may cause diarrhea.
Extreme caution should be exercised in patients with moderate renal impairment due to the risk of elevated blood magnesium levels.
Prolonged use of magnesium may increase blood potassium concentration, especially in patients with controlled 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 positional sensation, tingling in hands and feet, as well as gradually progressive coordination disorders. In most cases, symptoms resolve after discontinuation of pyridoxine.

Children and adolescents
Maglek B6 Forte is used in adults and children aged 6 years or older.
If you have any doubts, consult your doctor or pharmacist.

Maglek B6 Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Inform your doctor or pharmacist if the patient is taking any of the following medicines, as they may cause magnesium and/or vitamin B6 deficiency by, among others, increasing their excretion from the body or impairing absorption:

• amphotericin B (a medicine used to treat severe systemic fungal infections),
• isoniazid, cycloserine (medicines used in the treatment of tuberculosis),
• bisphosphonates (medicines used in the treatment of osteoporosis),
• diuretics (e.g. thiazides or furosemide),
• cisplatin, cetuximab or erlotinib (medicines used in cancer treatment),
• cyclosporine A, rapamycin (medicines used in transplantation),
• penicillamine (a medicine used in the treatment of rheumatoid arthritis and heavy metal poisoning),
• 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, zinc compounds or calcium salts,
• contraceptive medicines,
• laxatives,
• aminoglycoside antibiotics,
• DNA virus polymerase inhibitors.

When taking these medicines, individual dose adjustment of Maglek B6 Forte may be necessary.
Inform your doctor or pharmacist if the patient is taking levodopa (a medicine used in the treatment of Parkinson's disease), as vitamin B6 may inhibit its effect. Also inform your doctor or pharmacist if the patient is taking phenobarbital and phenytoin (antiepileptic medicines), as vitamin B6 may reduce blood levels of these medicines.
Concomitant use of vitamin B6 with cisplatin and altretamine (medicines used in cancer treatment) is not recommended. Therapy with these medicines may be less effective.
Do not take simultaneously medicines containing magnesium and 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 administration of Maglek B6 Forte.
When magnesium preparations are used concomitantly with lithium carbonate, potassium-sparing diuretics (such as amiloride and spironolactone), or other medicines 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.
Magnesium-containing medicines should be taken 3 to 4 hours before or after taking the following medicines: aminoquinolines, quinidine and its derivatives, nitrofurantoin, penicillamine, eltrombopag, nitroxoline, to avoid impaired absorption.
Magnesium deficiency may increase the risk of digoxin toxicity. However, concomitant administration of magnesium and digoxin may impair digoxin absorption. An interval of approximately 2 hours should be maintained between administration of magnesium and digoxin.

Maglek B6 Forte with food, drink and alcohol
The medicine should be taken during meals, with water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have children, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The medicine may be used during pregnancy only after consultation with a doctor.
Studies have not shown harmful effects of magnesium during pregnancy.

Breastfeeding
The medicine may be used during breastfeeding only in consultation with a doctor.
It is recommended that breastfeeding women take vitamin B6 in a dose not exceeding 20 mg per day.

Fertility
Studies on vitamin B6 have shown its effect on male fertility. However, this effect is observed only at very high doses. Maglek B6 Forte contains low doses of vitamin B6.

Driving and operating machinery
Maglek B6 Forte has no influence on the ability to drive vehicles or operate machinery.

Maglek B6 Forte contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to take Maglek B6 Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Adults:
3 to 4 tablets per day, divided into 2 or 3 doses, taken during meals.
Use in children and adolescents
aged 6 years and older (with body weight approximately 20 kg):
10 to 30 mg/kg body weight per day, i.e. 2 to 4 tablets per day, divided into 2 or 3 doses, taken during meals.
If you feel that the effect of Maglek B6 Forte is too strong or too weak, consult your doctor.
Taking more than the recommended dose of Maglek B6 Forte
If more than the recommended dose has been taken, seek immediate advice from a doctor or pharmacist.
Overdose of orally administered magnesium does not cause toxic reactions in patients with normal kidney function.
In patients with renal impairment, magnesium poisoning may occur.
Missed dose of Maglek B6 Forte
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Maglek B6 Forte:
Rare (may occur in fewer than 1 in 1,000 people):

• abdominal pain
• loose stools or diarrhoea at the beginning of treatment (usually mild and transient)
• skin redness

Very rare (may occur in fewer than 1 in 10,000 people):

• allergic reactions

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the safety of the medicine.

5. How to store Maglek B6 Forte

Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 30°C. Keep the blisters in the outer packaging
to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister after:
EXP. The expiry date refers to the last day of the stated month.
Medicines should 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 package and other information

What Maglek B6 Forte contains

• The active substances in this medicine are magnesium citrate and pyridoxine hydrochloride (vitamin B6).

One coated tablet contains 100 mg of magnesium ions in the form of magnesium citrate
(Magnesii citras) and 10 mg of pyridoxine hydrochloride (Pyridoxini hydrochloridum).

• Other ingredients are:
  Tablet core: monohydrate lactose, macrogol 6000, microcrystalline cellulose, crospovidone (Type A), colloidal anhydrous silica, magnesium stearate.
  Tablet coating: polyvinyl alcohol, calcium carbonate (E 170), macrogol 4000, talc.

What Maglek B6 Forte looks like and contents of the pack
White or almost white, biconvex, oval film-coated tablets, which may have darker specks, with the imprint “Mg FORTE” on one side, measuring 17.2 ± 1 mm in length and 10.2 ± 0.6 mm in width.
The pack contains 30, 60, 90 or 120 film-coated tablets of Maglek B6 Forte, packed in PVC/PVDC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LEK-AM sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60