Neomagb6

Patient Information Leaflet

NeomagB6, 100 mg Mg + 10 mg, 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 taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 30 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What NeomagB6 is and what it is used for
2. What you need to know 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 NeomagB6 is and what it is used for

NeomagB6 contains two active substances: magnesium ions and vitamin B6 (pyridoxine hydrochloride). This medicine helps correct magnesium deficiency, while vitamin B6 enhances its absorption 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 deficiency may lead to disorders in the muscular and central nervous systems. Vitamin B6 increases gastrointestinal absorption of magnesium by 20–40%.
This medicine 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-related symptoms such as gastrointestinal spasms or palpitations (without heart disorders);
• Muscle cramps, tingling sensations, eyelid twitching.

Supplementing magnesium may help alleviate the above-mentioned deficiency symptoms. NeomagB6 should be used only after excluding other potential causes of these symptoms besides magnesium deficiency, and when adequate dietary intake cannot correct or increase magnesium levels.
If no improvement occurs after 30 days of treatment with NeomagB6, continued use 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 insufficiency (creatinine clearance less than 30 mL/min);
• if the patient is concurrently taking levodopa (a medicine used in Parkinson's disease);
• if the patient has been diagnosed with hypermagnesemia (increased magnesium levels in 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 body weight below 21 kg).

Warnings and precautions
Before starting to take NeomagB6, discuss this with your doctor or pharmacist.

• If the patient has concomitant magnesium and calcium deficiency, magnesium deficiency should be corrected first.
• If the patient has severe magnesium deficiency and absorption disorders, treatment should begin with intravenous administration of magnesium.
• If the patient has moderate renal insufficiency, exercise special caution due to the risk of elevated magnesium levels in blood.

Taking this medicine in doses higher than recommended may cause diarrhea.
Long-term use of magnesium may lead to increased potassium levels in blood,
especially in patients with restricted potassium intake and impaired kidney function.
When high doses of the drug (referring to vitamin B ) are taken for a prolonged period,
neurological problems such as tingling sensations may occur (see section 3: "If you take more NeomagB6 than you should").

Children
NeomagB6 must not be used in children under 6 years of age (with body weight below 21 kg).

NeomagB6 and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 things,
increasing their excretion from the body or impairing their absorption:

• amphotericin B (a medicine used to treat severe systemic fungal infections);
• bisphosphonates (medicines used in the treatment of osteoporosis);
• isoniazid, cycloserine (medicines used in the treatment of tuberculosis);
• penicillamine (a medicine used in the treatment of 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 in cancer treatment);
• 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;
• contraceptive medicines;
• laxatives;
• aminoglycoside antibiotics (gentamicin, tobramycin);
• DNA virus polymerase inhibitors.

Quinolone antibiotics (such as ciprofloxacin) should be taken at least
2 hours before or 6 hours after taking NeomagB6.
Inform your doctor or pharmacist if you are taking levodopa (a medicine used
in the treatment of Parkinson's disease), as vitamin B may inhibit its effect.
Do not take simultaneously medicines containing magnesium and certain antibiotics
(fluoroquinolones - levofloxacin, 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 NeomagB6.
Concomitant use of magnesium preparations with lithium carbonate, potassium-sparing diuretics
(such as amiloride and spironolactone), or other medicines containing
magnesium, such as laxatives or antacids, may increase
the risk of hypermagnesemia and magnesium toxicity. The risk is particularly high in patients
with renal insufficiency.

NeomagB6 with food and drink
Take this medicine during meals, with a large amount of water.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child,
you should consult your doctor or pharmacist before using this medicine.

Pregnancy
This medicine may be used during pregnancy only after consultation with a doctor.
Clinical experience has not shown harmful effects of magnesium during pregnancy.

Breastfeeding
This medicine may be used during breastfeeding only after consultation with a doctor.
It is recommended that during breastfeeding, the dose of vitamin B does not exceed 20 mg per day.

Fertility
Studies on vitamin B have shown effects on male fertility. However, such an effect occurs
only at very high doses. The safety of NeomagB6 is very high due to its low vitamin B content.

Driving and operating machinery
NeomagB6 has no effect on the ability to drive or operate machinery.

NeomagB6 contains 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 take NeomagB6

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
Recommended dose:

• Adults and adolescents aged 14 years and above (with body weight greater than or equal to 40 kg): 3 to 4 tablets per day, divided into 2 or 3 doses, taken with meals.
• Children aged 6 years and older (with body weight greater than or equal to 21 kg) and adolescents:

Use in children
The medicine should not be used in children under 6 years of age (with body weight below 21 kg).
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
If you feel that the effect of NeomagB6 is too strong or too weak, consult your doctor.

Taking more than the recommended dose of NeomagB6
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.
Oral magnesium overdose does not cause toxic reactions in patients with normal kidney function.
In patients with renal insufficiency, magnesium poisoning may occur, manifested by:
nausea, vomiting, facial flushing, urinary retention, intestinal obstruction, low blood pressure, drowsiness, absence of tendon reflexes (in neurological examination), heart rhythm disturbances (complete heart block), paralysis, respiratory depression (slowed breathing), and weakness syndrome.
Long-term use of high doses of vitamin B6 (for several months, and in some cases even years) may lead to damage of sensory nerves.
Symptoms may include: numbness, reduced sensation in hands and feet, and progressively worsening coordination problems (sensory ataxia). Nerve damage is usually reversible after discontinuation of 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, nor take two doses within a short interval.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with NeomagB6:
Rare (may occur in less than 1 in 1,000 patients):

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

Very rare (may occur in less than 1 in 10,000 patients):

• allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 helps to provide more information on the safety of the medicine.

5. How to store NeomagB6

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
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 packaging and other information

What NeomagB6 contains

• The active substances in 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.
• Other ingredients are: lactose, macrogol 6000, magnesium stearate.

What NeomagB6 looks like and contents of the pack
NeomagB6 is an oval, biconvex tablet, white or almost white, with a division line on one side,
measuring 17.0 mm x 8.5 mm. The division line on the tablet is intended only to facilitate breaking the tablet
for easier swallowing and does not allow for dividing it into equal doses.
The medicine pack contains 60, 90, 105 or 108 tablets packed in blisters made of
PVDC/PE/PVC/Aluminium, placed in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. +48 42 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów