Package leaflet: Information for the patient

Asmag B6 Forte, 100 mg Mg + 10 mg, coated tablets
Magnesii citras + Pyridoxini hydrochloridum
Please read this leaflet carefully before taking this 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, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your symptoms do not improve or worsen, consult your doctor.

Table of contents

What Asmag B6 Forte is and what it is used for
Important information before taking Asmag B6 Forte
How to take Asmag B6 Forte
Possible side effects
How to store Asmag B6 Forte
Contents of the pack and other information

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

Asmag B6 Forte is a medicine containing magnesium ions and pyridoxine hydrochloride (vitamin B6).
It is used to 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. It plays an important role in myocardial contraction and influences neuromuscular excitability.
Vitamin B6 increases magnesium absorption from the gastrointestinal tract by 20–40%, facilitates its transport into body cells, and helps maintain adequate intracellular magnesium stores.
Asmag B6 Forte is indicated for the treatment of magnesium deficiency.
The presence 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 (in the absence of heart disorders);
Muscle cramps, tingling sensations, eyelid twitching.

Supplementing magnesium may help alleviate these deficiency symptoms.
This medicine should be used only after excluding other potential causes of these symptoms and when adequate magnesium intake cannot be achieved through proper diet.
If no improvement is observed after one month of treatment with Asmag B6 Forte, continued use is not recommended.

2. Important information before using Asmag B Forte

When not to use Asmag 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 severe renal impairment (creatinine clearance less than 30 ml/min);
if the patient has hypermagnesemia (elevated magnesium levels in the blood);
if the patient has significant arterial hypotension;
if the patient has atrioventricular block;
if the patient has a disease called myasthenia gravis (a chronic condition characterized by excessive muscle weakness);
if the patient is concurrently using levodopa.

Warnings and precautions
Before starting treatment with Asmag B Forte, discuss this 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 malabsorption, treatment should be initiated under medical supervision with intravenous magnesium.
Particular caution is required in patients with moderate renal impairment due to the risk of developing high blood magnesium levels.
Long-term use of high doses of magnesium may contribute to the development of dental caries.
Long-term use of magnesium may increase blood potassium levels, especially in patients with restricted potassium intake and impaired kidney function.
Administration of the medicine in doses higher than recommended may cause diarrhea.
Long-term use of pyridoxine (for several months or even years) may lead to sensory axonal neuropathy (damage to sensory nerves). Symptoms include: numbness and disturbances in position sense, tingling in the distal parts of the limbs (hands and feet), as well as gradually progressing sensory ataxia (impaired coordination of movement). In most cases, symptoms resolve after discontinuation of pyridoxine.

Children and adolescents
Asmag B Forte may be used in adults and children aged 6 years and older.
If in doubt, consult your doctor or pharmacist.

Asmag B Forte and 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:

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 compounds, or calcium salts;
oral contraceptives;
laxatives;
aminoglycoside antibiotics;
DNA virus polymerase inhibitors.

When taking these medicines, individual dose adjustment of Asmag 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 reduce its effectiveness.
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 Asmag 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 developing hypermagnesemia and symptoms of magnesium toxicity. The risk is particularly increased in patients with renal impairment.

Asmag B Forte with food, drink, and alcohol
Take the medicine during meals, with water.

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 breastfeeding women take vitamin B in a dose not exceeding 20 mg per day.

Fertility
Studies on vitamin B have shown effects on male fertility. However, this effect occurs only at very high doses. Asmag B Forte contains low doses of vitamin B.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

Asmag B Forte contains lactose.
One tablet contains 10.05 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Asmag B Forte

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Dosage instructions
Age Body weight Dose
Children aged 6–12 years 21–30 kg 1 to 2 tablets per day, in 1 or 2 divided doses.
31–39 kg 2 to 3 tablets per day, in 2 or 3 divided doses.
Adults and adolescents ≥ 40 kg 3 to 4 tablets per day, in 2 or 3 divided doses.
above 12 years of age

Asmag B Forte should be taken during a meal, with water.

Taking more Asmag B Forte than recommended
If you take more than the recommended dose, consult your doctor or pharmacist.
Oral magnesium overdose does not cause toxic reactions in patients with normal kidney function. However, in patients with renal impairment, magnesium poisoning may occur.

Missing a dose of Asmag B Forte
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with Asmag B6 Forte:
Rare (may affect less than 1 in 1,000 patients):

loose stools or diarrhoea at the beginning of treatment (usually mild and transient);
abdominal pain;
skin redness. Very rare (may affect less than 1 in 10,000 patients):
allergic reactions.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Asmag B Forte

Keep this medicine out of the sight and reach of children.
Store this medicine at a temperature not exceeding 25°C.
Keep in the original packaging to protect from light and moisture.
Do not use Asmag B Forte after the expiry date stated on the packaging after: EXP. 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Asmag B6 Forte contains

The active substances are: magnesium citrate and pyridoxine hydrochloride (vitamin B6). Each 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: lactose, macrogol 6000, magnesium stearate. Film-coat composition: hypromellose, macrogol 6000, talc.

What Asmag B6 Forte looks like and contents of the pack
Asmag B6 Forte is a white, oval, film-coated tablet, biconvex on both sides.
Available pack: 50 film-coated tablets in an HDPE container with an LDPE cap, inside a cardboard box.

Marketing Authorisation Holder and Manufacturer
Farmapol Pharmaceutical Company sp. z o.o.
Święty Wojciech 29, 61-749 Poznań, Poland
Tel.: +48 61 852 63 53
Email: [email protected]
For further information, please contact the Marketing Authorisation Holder.

Information for blind and partially sighted people: the package leaflet content is available free of charge by calling 0800 706 848.