Neomagb6

Package Leaflet: Information for the Patient

NeomagB6, 100 mg Mg + 10 mg, Tablets

Magnesium Citrate + Pyridoxine Hydrochloride

Read the package 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 package leaflet for the patient 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 30 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is NeomagB6 and what is it used for
• 2. Important information before taking NeomagB6
• 3. How to take NeomagB6
• 4. Possible side effects
• 5. How to store NeomagB6
• 6. Contents of the pack and other information

1. What is NeomagB6 and what is it used for

NeomagB6 contains two active substances: magnesium ions and vitamin B (pyridoxine hydrochloride). The medicine supplements magnesium deficiency, and vitamin B increases its absorption in the body.
Magnesium is a cation necessary for the proper course of many biochemical processes in the body. Its biological role involves the activation of a series of enzymes.
Magnesium plays an important role in the process of cardiac muscle contraction, affects the state of nervous-muscular excitability. Magnesium deficiency can cause disorders in the muscular and central nervous systems. Vitamin B increases magnesium absorption from the gastrointestinal tract by 20-40%.
The medicine is indicated for use in case of magnesium deficiency.
The occurrence of the following symptoms may indicate magnesium deficiency:

• nervousness, irritability, mood swings, mild anxiety, restlessness, transient feeling of fatigue, drowsiness, 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. The medicine should be used after excluding other causes of these symptoms, other than magnesium deficiency, and when it is not possible to achieve improvement or increase magnesium intake through a suitable diet.
If after 30 days of taking NeomagB6 there is no improvement, continuing treatment is not recommended.

2. Important information before taking NeomagB6

When not to take NeomagB6

• 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 is taking levodopa (a medicine used in the treatment of Parkinson's disease);
• if the patient has been diagnosed with hypermagnesemia (elevated magnesium levels in the blood);
• 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);
• in children under 6 years of age (with a body weight below 21 kg).

Warnings and precautions

Before starting to take NeomagB6, discuss it with your doctor or pharmacist.

• If the patient has a concurrent magnesium and calcium deficiency, magnesium deficiency should be supplemented first.
• If the patient has severe magnesium deficiency and malabsorption, treatment should be started with intravenous magnesium administration.
• If the patient has moderate renal impairment, special caution should be exercised due to the risk of elevated magnesium levels in the blood.

Taking the medicine in a higher dose than recommended may cause diarrhea.
Long-term use of magnesium may lead to increased potassium levels in the blood, especially in patients with controlled potassium intake and impaired renal function.
When taking high doses of the medicine (regarding vitamin B) for a long time, nerve problems may occur, such as tingling (see section 3: "Taking a higher dose of NeomagB6 than recommended").

Children

The medicine should not be used in children under 6 years of age (with a body weight below 21 kg).

NeomagB6 and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, 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 increasing their excretion from the body or impairing absorption:

• amphotericin B (a medicine used to treat severe systemic fungal infections);
• bisphosphonates (medicines used to treat osteoporosis);
• isoniazid, cycloserine (medicines used to treat tuberculosis);
• penicillamine (a medicine used to treat rheumatoid arthritis and heavy metal poisoning);
• cyclosporine A, rapamycin (medicines used in transplantology);
• diuretics (e.g., thiazides or furosemide);
• cisplatin, 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 pneumonia);
• hydralazine (a medicine used to lower blood pressure);
• phosphates, iron compounds, or calcium salts;
• contraceptives;
• laxatives;
• aminoglycoside antibiotics (gentamicin, tobramycin);
• DNA virus polymerase inhibitors.

Quinolone antibiotics (such as ciprofloxacin) should be taken at least 2 hours before taking NeomagB6 or 6 hours after taking it.
Tell your doctor or pharmacist if you are taking levodopa (a medicine used to treat Parkinson's disease), as vitamin B may inhibit its action.
Do not take medicines containing magnesium and certain antibiotics (fluoroquinolones - levofloxacin, tetracyclines) or medicines used to treat osteoporosis (bisphosphonates) at the same time, as magnesium may decrease their absorption from the gastrointestinal tract.
Keep a gap of at least 2-3 hours between taking these medicines and taking NeomagB6.
Concomitant use of magnesium preparations with lithium carbonate, potassium-sparing diuretics (such as amiloride and spironolactone), or other magnesium-containing medicines, such as laxatives or antacids, may increase the risk of hypermagnesemia and magnesium poisoning. The risk is particularly high in patients with renal impairment.

NeomagB6 with food and drink

The medicine should be taken during meals, with a large amount of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only after consulting a doctor. Clinical trials have not shown any harmful effects of magnesium during pregnancy.
Breastfeeding
The medicine may be used during breastfeeding only after consulting a doctor. It is recommended that the daily dose of vitamin B should not exceed 20 mg during breastfeeding.
Fertility
Studies on vitamin B have shown an effect on male fertility. However, this effect occurs only at very high doses. The safety of NeomagB6 is very high due to its low vitamin B content.

Driving and using machines

NeomagB6 does not affect the ability to drive and use machines.

NeomagB6 contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take NeomagB6

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine should be taken orally.

Recommended dose is

• Adults and adolescents over 14 years of age (with a body weight of 40 kg or more): 3 to 4 tablets per day, in 2 or 3 divided doses, taken during meals.
• Children over 6 years of age (with a body weight of 21 kg or more) and adolescents:

Use in children

The medicine should not be used in children under 6 years of age (with a body weight below 21 kg).
The dividing line on the tablet facilitates only its breaking, for easier swallowing, and not dividing into equal doses.
If you feel that the effect of NeomagB6 is too strong or too weak, consult your doctor.

Taking a higher dose of NeomagB6 than recommended

If you have taken more than the recommended dose of the medicine, consult your 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, which is characterized by: nausea, vomiting, facial flushing, urinary retention, intestinal obstruction, decreased blood pressure, drowsiness, lack of tendon reflexes (in neurological examination), cardiac arrhythmia (complete heart block), paralysis, respiratory depression (slow breathing), and a condition of powerlessness.
Long-term intake of high doses of vitamin B (for several months, and in some cases even years) may lead to damage to the sensory nerves.
Symptoms may include: numbness, impaired sensation in the hands and feet, and increasing problems with movement coordination (sensory ataxia). Nerve damage is usually reversible after stopping the medicine.

Missing a dose of NeomagB6

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed tablet or take two doses in a short period of time.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NeomagB6 can cause side effects, although not everybody gets them.
The following side effects may occur when taking NeomagB6:
Rare(may affect up to 1 in 1000 people):

• abdominal pain, loose stools, or diarrhea at the beginning of treatment (these symptoms are harmless and transient);

• skin flushing.

Very rare(may affect up to 1 in 10,000 people):

• allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Phone: +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 NeomagB6

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing this medicine.
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 pack and other information

What NeomagB6 contains

• The active substances of the medicine are: magnesium ions (in the form of magnesium citrate) and pyridoxine hydrochloride. Each tablet contains 100 mg of magnesium ions in the form of magnesium citrate and 10 mg of pyridoxine hydrochloride.
• The other ingredients are: lactose, macrogol 6000, magnesium stearate.

What NeomagB6 looks like and contents of the pack

NeomagB6 is an oval, biconvex, white or almost white tablet with a dividing line on one side, measuring 17.0 mm x 8.5 mm. The dividing line on the tablet facilitates only its breaking, for easier swallowing, and not dividing into equal doses.
The pack contains 60, 90, 105, or 108 tablets packaged in PVDC/PE/PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: