Vivacia Zinc, Magnesium & Vitamin B6 (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Zinc, Magnesium and Vitamin B6

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 1210 mg.

Auxiliary substances : bulking agent (microcrystalline cellulose (MCC), dicalcium phosphate), anti-caking agent (magnesium stearate).

^# recommended daily intake.

Energy value (100 g): 95.04 kJ/22.7 kcal.

60 pcs. – bottles (1) – carton packs.

Therapeutic Category

Dietary supplement – additional source of vitamins and minerals

Indications

• For use as a dietary supplement to provide additional magnesium, zinc, and vitamin B6 to the daily diet.
• To help support normal metabolic function, including protein synthesis and carbohydrate metabolism.
• To contribute to the reduction of tiredness and fatigue and to support normal energy-yielding metabolism.
• To support the normal function of the nervous system and psychological function.
• To contribute to the maintenance of normal bones and teeth.
• To support normal muscle function, including the relaxation and contraction of muscles.
• To contribute to the protection of cells from oxidative stress.
• To support normal cognitive function and normal synthesis of DNA.
• To aid in the maintenance of normal testosterone levels in the blood and normal fertility and reproduction.
• To support normal acid-base metabolism and normal macronutrient metabolism.

It is important to note that this product is a dietary supplement and is not intended to diagnose, treat, cure, or prevent any disease. The indications are based on the established physiological roles of the included minerals and vitamin.

Dosage Regimen

The recommended dosage for adults is one tablet per day, taken with a meal and a full glass of water.

The tablet should be swallowed whole and should not be chewed or crushed. To ensure consistent levels of the nutrients in the body, it is best to take the supplement at approximately the same time each day.

Do not exceed the recommended daily dose. The duration of use should be discussed with a healthcare professional, as individual nutritional needs may vary. Continuous long-term use without medical supervision is not generally recommended.

For populations with specific needs or conditions, such as the elderly or those with gastrointestinal disorders, a healthcare provider should be consulted to determine the appropriateness and duration of use. This product is not intended for use by children or adolescents under the age of 18 unless specifically advised by a healthcare professional.

Contraindications

• Hypersensitivity to any of the components of the dietary supplement, including the active ingredients or any of the auxiliary substances (microcrystalline cellulose, dicalcium phosphate, magnesium stearate).
• Patients with severe renal impairment (e.g., end-stage renal disease) or acute renal failure, due to the risk of hypermagnesemia and hyperzincemia.
• Individuals with myasthenia gravis or other conditions where high doses of magnesium may exacerbate symptoms.
• Patients with hypoparathyroidism, as magnesium can further alter calcium metabolism.
• Concomitant use with levodopa without the concomitant administration of a peripheral decarboxylase inhibitor, as vitamin B6 can reduce its efficacy.
• Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, due to the potential presence of excipients.

This supplement should be used with caution and only under medical supervision in patients with pre-existing electrolyte imbalances or heart conditions. It is not recommended for use during pregnancy or breastfeeding unless directed by a physician.

Adverse Reactions

Adverse reactions to Vivacia Zinc, Magnesium & Vitamin B6 are generally mild and transient, particularly when taken at the recommended dosage. The most commonly reported reactions are related to the gastrointestinal system.

Gastrointestinal disturbances may include diarrhea, abdominal cramps, and nausea. These effects are often dose-dependent and are frequently associated with the magnesium component, which can have a laxative effect, especially at higher doses. Taking the supplement with food can help minimize these effects.

Less frequently, allergic-type skin reactions such as rash or itching have been reported in individuals with hypersensitivity. In rare cases, high doses of pyridoxine (vitamin B6) over prolonged periods can lead to sensory neuropathy, characterized by numbness and tingling; however, this is highly unlikely at the dose contained in this formulation.

If any adverse reaction is severe, persistent, or concerning, discontinuation of the product is recommended, and a healthcare professional should be consulted. It is important to report any suspected adverse reactions to your pharmacist or doctor.

Drug Interactions

Vivacia Zinc, Magnesium & Vitamin B6 may interact with several prescription medications, potentially altering their effectiveness or increasing the risk of adverse effects.

Magnesium can form insoluble complexes with several drugs in the gastrointestinal tract, impairing their absorption. A minimum separation of 2-4 hours is recommended between taking this supplement and the following medications: tetracycline antibiotics (e.g., doxycycline, minocycline), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), bisphosphonates (e.g., alendronate), thyroid hormones (e.g., levothyroxine), and penicillamine.

Concomitant use with potassium-sparing diuretics (e.g., spironolactone, amiloride) or ACE inhibitors may increase the risk of hypermagnesemia. Zinc may reduce the absorption of copper and certain antibiotics, such as quinolones and tetracyclines, similarly to magnesium. Long-term zinc supplementation can lead to copper deficiency.

Vitamin B6 (Pyridoxine) can antagonize the therapeutic effect of levodopa when it is administered without a decarboxylase inhibitor (e.g., carbidopa). It may also interact with phenobarbital and phenytoin, potentially reducing their serum concentrations and efficacy in some cases. Conversely, certain drugs like isoniazid, cycloserine, penicillamine, and oral contraceptives may increase the requirement for vitamin B6.

Patients taking any of these medications, or other prescription drugs, should consult their doctor or pharmacist before starting this supplement to manage potential interactions.

Overdose

In the event of an acute overdose, the clinical manifestations will primarily be related to the magnesium and zinc components. Symptoms of magnesium overdose may include severe diarrhea, nausea, vomiting, lethargy, muscle weakness, blurred vision, flushing, and hypotension. In severe cases, particularly in individuals with renal impairment, it can progress to cardiac arrhythmias, respiratory depression, and coma.

Symptoms of zinc overdose can involve gastrointestinal irritation, nausea, vomiting, loss of appetite, abdominal cramps, diarrhea, and headaches. Chronic excessive intake of zinc can lead to copper deficiency, which may manifest as neurological symptoms and hematological changes such as microcytic anemia.

While the risk from a single tablet is low, ingestion of a large number of tablets requires immediate medical attention. Treatment is primarily supportive and symptomatic. Gastric lavage may be considered if performed soon after ingestion. In cases of severe hypermagnesemia, administration of calcium gluconate intravenously can be an antidote. Hemodialysis may be effective in removing magnesium, especially in patients with renal failure. There is no specific antidote for zinc overdose; management involves discontinuation of the source and supportive care. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.