Vivacia Vitamin B Complex (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Vitamin B Complex

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 150 mg.

^# recommended norm of consumption.

60 pcs. – bottles (1) – packs cardboard.

Therapeutic Category

Dietary supplement for maintenance of function of nervous system

Indications

• Vivacia Vitamin B Complex is indicated as a dietary supplement to provide essential B vitamins for individuals whose dietary intake may be insufficient.
• It is used to support the normal functioning of the nervous system, helping to maintain energy-yielding metabolism and reduce feelings of tiredness and fatigue.
• The supplement aids in the maintenance of normal psychological functions, including cognitive performance and emotional well-being.
• It contributes to the protection of cells from oxidative stress and supports the health of the skin, hair, and mucous membranes.

This product is not intended to diagnose, treat, cure, or prevent any disease and should be used as part of a balanced and varied diet and a healthy lifestyle.

Contraindications

• Hypersensitivity to any of the components of the dietary supplement. Individuals with a known allergy to any B vitamin or excipient in the formulation should not use this product.
• Patients with Leber’s disease (hereditary optic neuropathy) should avoid high doses of cyanocobalamin (Vitamin B12) as it may lead to severe and rapid optic atrophy.
• Individuals with a history of oxalate kidney stones should use caution with high-dose pyridoxine, though the dose in this formulation is within typical dietary supplement levels.
• Use during pregnancy and lactation should only be undertaken under the direct supervision of a healthcare professional, as individual vitamin requirements can vary significantly during these periods.

It is strongly recommended to consult with a physician or qualified healthcare provider before starting any new dietary supplement, especially if you have pre-existing medical conditions.

Dosage Regimen

The recommended dosage for adults and children over 12 years of age is one tablet daily, taken with a meal and a full glass of water.

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

The duration of use is not limited, but it is recommended to take breaks, for example, after one month of use, take a one-week break, unless otherwise advised by a healthcare professional. Do not exceed the stated recommended daily dose.

For children under 12 years of age, use is not recommended unless directed by a physician, as safety and efficacy have not been established in this population group.

Adverse Reactions

Vivacia Vitamin B Complex is generally well-tolerated when taken at the recommended dosage. However, as with any supplement, adverse reactions may occur in some individuals.

The most commonly reported reactions are gastrointestinal disturbances, such as mild nausea, abdominal discomfort, or diarrhea, which are usually transient and resolve with continued use or upon discontinuation.

High doses of certain B vitamins can cause specific effects. Niacin (Vitamin B3) may cause a temporary, harmless flushing of the skin, a sensation of warmth, tingling, or itching, which typically subsides within 30 to 60 minutes. Riboflavin (Vitamin B2) may cause a bright yellow discoloration of the urine, which is harmless and indicates the body is excreting excess vitamin.

In rare cases, allergic reactions such as skin rash, urticaria, itching, or swelling may occur. If any adverse reaction is severe or persistent, discontinue use and consult a healthcare professional.

Drug Interactions

B vitamins can interact with certain medications, which may alter the effectiveness of either the supplement or the drug. It is crucial to inform your healthcare provider about all the products you are taking.

Levodopa: High doses of Pyridoxine (Vitamin B6) can reduce the efficacy of levodopa, a medication used for Parkinson’s disease. The dose in this supplement is relatively low, but caution is advised.

Isoniazid and Cycloserine: These anti-tuberculosis drugs can increase the excretion of Pyridoxine (Vitamin B6), potentially leading to a deficiency. Supplementation may be necessary under medical supervision.

Phenytoin and Phenobarbital: High doses of Folic Acid (Vitamin B9) may decrease serum levels of these anticonvulsant drugs, potentially increasing the risk of seizures. The dose in this formulation is not considered high-risk, but monitoring is recommended.

Methotrexate: This medication can interfere with the metabolism of folic acid. While folic acid supplementation is often prescribed with methotrexate, it should only be done under strict medical guidance.

Proton Pump Inhibitors (e.g., Omeprazole) and H2-Receptor Antagonists (e.g., Ranitidine): Long-term use of these medications can reduce the absorption of Cyanocobalamin (Vitamin B12) from food; supplementation may be beneficial, but a healthcare provider should determine this.

This is not an exhaustive list of all possible drug interactions. Always consult your doctor or pharmacist for personalized advice.

Overdose

While the risk of acute overdose with water-soluble vitamins like the B-complex is low due to renal excretion, excessively high single doses or prolonged intake of doses significantly above the recommended level can lead to adverse effects.

Symptoms of acute overdose are unlikely but may include severe gastrointestinal upset, such as nausea, vomiting, and diarrhea. In cases of extremely high doses of specific vitamins, neurological symptoms such as peripheral neuropathy (associated with very high doses of pyridoxine over long periods) or hepatotoxicity (associated with high-dose niacin) could occur, though these are not expected from this formulation at the recommended dose.

In case of suspected overdose, discontinue use immediately and seek medical attention or contact a Poison Control Center. Treatment is generally supportive and symptomatic, as there is no specific antidote. Provide the medical professional with the product packaging.

To avoid the potential for chronic overdose, do not exceed the recommended daily intake and be mindful of other dietary sources of B vitamins, including fortified foods and other supplements.

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.