Vivacia Immune Flash - Orange (Powder) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Immune Flash – Orange

Powder for oral suspension preparation: sticks 2.2 g 10 pcs.

Dosage Form, Packaging, and Product Composition

Powder for preparation of suspension for oral administration with a mass of 2.2 mg.

* Orange tree fruit extract (Citrus sinentis) from 50 mg of extract 2:1.
** Elderberry extract (Sambucus nigra) from 35.714 mg of extract 7:1.

Auxiliary substances : Ascorbic acid, bulking agent (maltodextrin), acidity regulator (sodium citrate), natural flavor, sweetener (sucralose).

^# recommended daily intake.

Energy value (100 g): 767 kJ/183 kcal.

2.2 g – sticks (10) – carton packs.

Indications

• For use as a dietary supplement to the diet as an additional source of vitamin C, vitamin D₃, zinc, and bioflavonoids from orange and elderberry extracts.
• To support the normal function of the immune system and contribute to the reduction of the severity and duration of cold and flu symptoms.
• For the prevention of seasonal colds and acute respiratory viral infections (ARVI), including influenza, particularly during periods of increased epidemiological risk and seasonal immune system stress.
• To help compensate for micronutrient deficiencies that may arise from an unbalanced diet or increased physiological need for vitamins and minerals.

Contraindications

• Individual hypersensitivity to any of the components of the dietary supplement, including the active ingredients or auxiliary substances such as maltodextrin or sucralose.
• Pregnancy and breastfeeding due to the lack of sufficient clinical data on the safety of the specific extract combination and high-dose vitamins in these populations. Consultation with a healthcare professional is mandatory before considering use.
• Severe renal impairment or a history of oxalate kidney stones, given the high dose of ascorbic acid which can increase oxalate excretion and potentially exacerbate these conditions.
• Patients with hemochromatosis, thalassemia, or other disorders of iron metabolism, as high-dose vitamin C can enhance non-heme iron absorption and lead to iron overload.
• Children under 14 years of age, as the safety and efficacy profile for this specific formulation and dosage have not been established in pediatric populations.

Dosage Regimen

For adults and children over 14 years of age: The contents of one stick (2.2 g) should be dissolved in 150-200 ml (approximately 5-7 oz) of water at room temperature. Stir thoroughly until the powder is completely dissolved and drink immediately. It is recommended to take one serving per day, preferably with a meal to enhance tolerance and absorption.

The duration of use is typically 2 to 4 weeks for preventive purposes during periods of increased risk of infection. For use during an active cold or flu, the duration may be continued for the entire symptomatic period, but generally should not exceed 4 consecutive weeks without consulting a physician. Do not exceed the recommended daily dose. The product is not intended for use as a substitute for a varied and balanced diet and a healthy lifestyle.

Adverse Reactions

Adverse reactions are generally rare and mild, typically associated with the high doses of specific ingredients. Gastrointestinal disturbances such as nausea, abdominal discomfort, diarrhea, or heartburn may occur, primarily due to the high concentration of ascorbic acid. These symptoms are often dose-dependent and may be mitigated by taking the supplement with food.

Allergic reactions are possible, though uncommon, and may include skin rash, itching, or urticaria, particularly in individuals with known sensitivities to citrus fruits, elderberry, or other botanical ingredients. In cases of prolonged use of high-dose vitamin C, rebound scurvy has been reported upon abrupt discontinuation. High doses of zinc can lead to copper deficiency with long-term use, manifesting as neurological symptoms or anemia. If any adverse reactions occur, discontinuation of the product is recommended.

Drug Interactions

The high doses of active ingredients in this formulation have the potential for significant drug interactions. Ascorbic acid (Vitamin C) may decrease the serum concentration and efficacy of fluphenazine and other antipsychotic medications. It can also increase the absorption of iron supplements and certain antibiotics like tetracyclines, potentially increasing both their efficacy and risk of side effects.

Zinc can form insoluble complexes with quinolone and tetracycline antibiotics (e.g., ciprofloxacin, doxycycline), as well as with bisphosphonates (e.g., alendronate), significantly reducing their absorption. To avoid this interaction, the supplement should be taken at least 2 hours before or 4-6 hours after taking these medications. Long-term, high-dose zinc supplementation can reduce copper levels, which may necessitate monitoring. Colecalciferol (Vitamin D₃) should be used with caution in patients taking cardiac glycosides (e.g., digoxin), as hypercalcemia, which can be potentiated by vitamin D, may increase the risk of cardiac arrhythmias. Concomitant use with thiazide diuretics may increase the risk of hypercalcemia. Patients on any long-term medication should consult their physician or pharmacist before starting this supplement.

Overdose

Acute overdose with a single large ingestion is unlikely to cause severe toxicity in healthy adults but may result in pronounced gastrointestinal upset, including severe diarrhea, nausea, and abdominal cramps, primarily due to the osmotic effect of unabsorbed vitamin C and other components.

Chronic overdose from prolonged intake of doses exceeding the recommendation is of greater concern. Symptoms of chronic vitamin C overdose may include gastrointestinal disturbances, a significant increase in the risk of oxalate nephrolithiasis (kidney stones), and rebound scurvy upon cessation. Chronic zinc overdose can lead to copper deficiency, resulting in neutropenia, microcytic anemia, and neurological impairments. Chronic vitamin D overdose can cause hypercalcemia, manifesting as nausea, vomiting, constipation, weakness, and in severe cases, renal calcification and impaired renal function. In case of suspected overdose, discontinue use immediately and seek medical attention. Treatment is supportive and symptomatic; forced diuresis may be beneficial.

Therapeutic Category

Dietary supplement for prevention of colds, ARVI, incl. flu

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.