Magne B6^® forte (Tablets) Instructions for Use

Marketing Authorization Holder

Opella Healthcare Commercial, Ltd. (Hungary)

Manufactured By

Opella Healthcare International, SAS (France)

Or

Opella Healthcare Hungary, Ltd. (Hungary)

Contact Information

OPELLA HEALTHCARE LLC (Russia)

ATC Code

A11JB (Vitamins in combination with minerals)

Dosage Form

Magne B6® forte

Film-coated tablets, 100 mg+10 mg: 20, 30, 40, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oval, biconvex. The cross-section shows two layers: a white coating and a white tablet core.

Excipients

Tablet core: lactose, macrogol-6000, magnesium stearate.

Tablet coating: hypromellose 6 mPa.s, macrogol-6000, titanium dioxide (E171), talc.

15 pcs. – blisters made of PVC-PE-PVX/aluminum foil (2) – cardboard packs.
15 pcs. – blisters made of PVC-PE-PVX/aluminum foil (4) – cardboard packs.
20 pcs. – blisters made of PVC-PE-PVX/aluminum foil (1) – cardboard packs.
20 pcs. – blisters made of PVC-PE-PVX/aluminum foil (2) – cardboard packs.
20 pcs. – blisters made of PVC-PE-PVX/aluminum foil (3) – cardboard packs.
20 pcs. – blisters made of PVC-PE-PVX/aluminum foil (5) – cardboard packs.

Not all package sizes may be marketed.

Clinical-Pharmacological Group

Magnesium preparation

Pharmacotherapeutic Group

Magnesium preparation

Pharmacological Action

Magnesium is a vital element that is necessary for the normal functioning of cells and is involved in most metabolic reactions. In particular, it participates in the regulation of nerve impulse transmission and muscle contraction. 1/3 of the amount of magnesium in the body accumulates in bone tissue. The body receives magnesium from food. Magnesium deficiency in the body can be observed with dietary restrictions (diet), with an increased need for magnesium, or with an imbalance of magnesium intake (including indirectly due to decreased magnesium levels in food), impaired metabolism and excretion of magnesium (for example, with increased physical and mental stress, stress, during pregnancy, when using diuretics).

Pyridoxine (vitamin B₆) participates in many metabolic processes, promotes the absorption of magnesium from the gastrointestinal tract and its penetration into cells.

Magnesium and Pyridoxine have synergistic effects.

Preclinical safety data

In preclinical data obtained from standard studies of pharmacological safety, repeated dose toxicity, genotoxicity, carcinogenic potential, and reproductive and ontogenetic toxicity, no particular risk to humans was identified.

Pharmacokinetics

Absorption

The absorption of magnesium from the gastrointestinal tract is no more than 50% of the orally administered dose.

Distribution

99% of magnesium in the body is inside the cells. Approximately 2/3 of the intracellular magnesium is distributed, and 1/3 is located in smooth and striated muscle tissue.

Excretion

Magnesium is excreted mainly in the urine (at least 1/3 of the administered dose of magnesium).

Indications

For use in adults and children over 6 years of age with established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as

• Increased irritability;
• Increased fatigue;
• Minor sleep disturbances;
• Gastrointestinal cramps;
• Palpitations;
• Muscle pain and cramps, sensation of muscle tingling.

ICD codes

Dosage Regimen

The drug Magne B6^® Forte is intended for oral administration with meals. The tablets should be swallowed whole with a glass of water.

Adults are recommended to take 3-4 tablets/day. The daily dose should be divided into 2-3 doses (for example, 1 tablet 3 times a day or 2 tablets 2 times a day).

Children over 6 years of age (with body weight >20 kg) – 2-4 tablets/day (10-30 mg/kg/day (0.4-1.2 mmol/kg/day)). The daily dose should be divided into 2-3 doses (for example, 1 tablet 3 times a day or 1-2 tablets 2 times a day).

The usual duration of treatment is 1 month.

Adverse Reactions

According to WHO, adverse effects are classified according to their frequency of occurrence as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency not known (frequency cannot be estimated from the available data).

Children

The frequency, type, and severity of adverse reactions in children and adults are the same, and are expected to be the same.

Contraindications

• Hypersensitivity to the active substances or any other component of the drug;
• Severe renal failure (CrCl < 30 ml/min);
• Children under 6 years of age (efficacy and safety not established);
• Hereditary galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency (due to the presence of lactose in the drug);
• Concomitant use of levodopa (see section “Drug Interactions”).

With caution

Moderate renal failure (risk of hypermagnesemia).

Use in Pregnancy and Lactation

Pregnancy

Clinical experience with the drug in a sufficient number of pregnant women has not revealed any adverse effects on the occurrence of fetal malformations or fetotoxic effects.

Magne B6^® forte can be used during pregnancy only if necessary, on the recommendation of a doctor.

Breastfeeding period

Magnesium passes into breast milk; if it is necessary to take the drug during lactation, it is recommended to stop breastfeeding.

Use in Renal Impairment

Contraindicated in severe renal failure (CrCl <30 ml/min).

The drug should be prescribed with caution in moderate renal failure (risk of hypermagnesemia).

Pediatric Use

The drug in tablet form is intended only for adults and children over 6 years of age. For younger children (over 1 year old), it is recommended to use the drug in the form of an oral solution.

Special Precautions

In moderate renal failure, the drug should be taken with caution due to the risk of hypermagnesemia.

In case of simultaneous deficiency of calcium and magnesium, the magnesium deficiency should be corrected before starting calcium preparations or dietary supplements containing calcium.

When using pyridoxine in high doses (more than 200 mg/day) for a long time (for several months or years), sensory axonal neuropathy may develop (the main symptom of chronic pyridoxine overdose), which is accompanied by symptoms such as numbness, impaired proprioceptive sensitivity, tremor of the distal extremities and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and disappear after discontinuation of pyridoxine.

Use in pediatrics

The drug in tablet form is intended only for adults and children over 6 years of age. For younger children (over 1 year old), it is recommended to use the drug in the form of an oral solution.

Effect on ability to drive vehicles and mechanisms

The drug Magne B6^® does not affect the ability to drive vehicles and work with mechanisms.

Overdose

Symptoms with normal renal function, overdose of magnesium when taken orally usually does not lead to toxic reactions. However, in case of renal failure, magnesium poisoning may develop. Symptoms of overdose, the severity of which depends on the concentration of magnesium in the blood: decreased blood pressure, nausea, vomiting, depression of the central nervous system, decreased reflexes, ECG changes, respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome.

Treatment rehydration, forced diuresis. In renal failure, hemodialysis or peritoneal dialysis is necessary.

Drug Interactions

With levodopa

With simultaneous use of the drug Magne B6^® forte and levodopa at a dose of 5 mg or more, the effects of levodopa are reduced. Therefore, in patients taking levodopa, the drug Magne B6^® forte should be prescribed simultaneously with peripheral dopa decarboxylase inhibitors.

With drugs containing phosphates, calcium salts or iron ions

Simultaneous use of drugs containing phosphates, calcium salts or iron ions is not recommended, as such drugs reduce the absorption of magnesium in the intestine.

With tetracyclines (for oral administration)

The drug Magne B6^® forte should be prescribed no earlier than 3 hours after oral administration of tetracycline (because magnesium preparations reduce the absorption of tetracyclines).

With quinolones

Quinolones should be prescribed at least 2 hours before or 6 hours after taking the drug Magne B6^® forte in order to avoid impaired absorption of quinolones.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.