Vivacia Multi Eye (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Multi Eye

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 675 mg.

* extract of seeds of grape cultural (Vitis vinifera L.) from 30 mg of extract 20:1.
** from flowers of calendula.
*** from buds of sophora Japanese (Sophorae japonica L.).
^# recommended norm of consumption.

Auxiliary substances : volume-forming agents (dicalcium phosphate, cellulose microcrystalline (MCC)), anti-caking agents (magnesium stearate, silicon dioxide).

60 pcs. – bottles (1).

Therapeutic Category

Dietary supplement for maintenance of function of organ of vision

Indications

• As a dietary supplement to the diet, Vivacia Multi Eye is indicated to provide additional nutritional support for the eyes.
• It is specifically formulated to help maintain visual function and support the health of the retina and macula.
• The product may be used to assist in protecting ocular tissues from oxidative stress caused by exposure to blue light and other environmental factors.
• It is intended for adults experiencing eye strain associated with prolonged computer use, reading, or other activities requiring intense visual concentration.
• The supplement can be used as part of a comprehensive approach to eye health, particularly for individuals concerned about age-related decline in visual acuity.

Contraindications

• Hypersensitivity to any component of the dietary supplement, including the active ingredients or auxiliary substances such as dicalcium phosphate or magnesium stearate.
• Pregnancy and breastfeeding due to the high concentration of retinyl acetate (Vitamin A), which can be teratogenic and is excreted in breast milk, posing a risk to the infant.
• Patients with severe liver or kidney disease, as impaired organ function may affect the metabolism and excretion of the product’s components, particularly fat-soluble vitamins and minerals.
• Individuals with hemochromatosis or other conditions involving iron overload, as the zinc content may interfere with iron absorption and metabolism.
• Concomitant use with isotretinoin, acitretin, or other systemic retinoid therapies, due to the risk of additive vitamin A toxicity and hypervitaminosis A.

Dosage Regimen

The recommended adult dosage is one tablet daily, taken with a meal. Taking the tablet with food, particularly a meal containing some fat, can enhance the absorption of the fat-soluble components like retinyl acetate and lutein.

The tablet should be swallowed whole with a full glass of water; it should not be chewed, crushed, or broken. The duration of use is not limited, but it is advisable to consult a healthcare professional for prolonged continuous use beyond 3-6 months to assess ongoing need and suitability.

Do not exceed the stated recommended daily dose. Exceeding the recommended dose will not provide additional benefits and may increase the risk of adverse effects. This product is intended for use by adults only and is not recommended for children or adolescents under the age of 18.

Adverse Reactions

Vivacia Multi Eye is generally well-tolerated when taken at the recommended dosage. However, like any supplement, it has the potential to cause adverse reactions in some individuals.

The most commonly reported adverse reactions are gastrointestinal in nature and may include mild and transient symptoms such as nausea, epigastric discomfort, bloating, or changes in bowel habits. These effects are often dose-related and may be minimized by taking the tablet with a meal.

Due to the high dose of retinyl acetate (Vitamin A), there is a potential risk of hypervitaminosis A with long-term use at or above the recommended dose. Symptoms of Vitamin A toxicity can include dizziness, headache, blurred vision, drowsiness, nausea, vomiting, skin dryness and peeling, and joint pain. Chronic, excessive intake can lead to more serious conditions such as liver damage and increased intracranial pressure.

Allergic reactions, though rare, are possible. Signs of an allergic reaction may include skin rash, pruritus (itching), urticaria (hives), and facial swelling. Discontinue use immediately and seek medical attention if any signs of a severe allergic reaction, such as difficulty breathing or swelling of the throat, occur.

Drug Interactions

Retinoid Medications (e.g., Isotretinoin, Acitretin, Tretinoin): Concomitant use with Vivacia Multi Eye is contraindicated due to the additive risk of vitamin A toxicity. The combined intake can lead to hypervitaminosis A, characterized by severe headache, blurred vision, and hepatotoxicity.

Anticoagulants (e.g., Warfarin): Vitamin K plays a crucial role in blood clotting. While this supplement does not contain high doses of Vitamin K, the presence of other antioxidants could theoretically influence anticoagulant control. It is recommended to monitor International Normalized Ratio (INR) levels more closely when initiating or discontinuing this supplement in patients on warfarin therapy.

Zinc-Absorption Inhibitors (e.g., Tetracycline, Quinolone Antibiotics, Bisphosphonates): The zinc in this supplement can chelate with these medications in the gastrointestinal tract, forming insoluble complexes that reduce the absorption and efficacy of both the drug and the mineral. To avoid this interaction, take Vivacia Multi Eye at least 2 hours before or 4-6 hours after taking these medications.

Cholestyramine and Mineral Oil: These agents can reduce the absorption of fat-soluble vitamins, including Vitamin A (retinyl acetate) and lutein. A significant time interval (several hours) should be maintained between the dose of this supplement and the administration of these drugs.

Copper Absorption: Long-term, high-dose zinc supplementation (significantly above the recommended daily intake) can interfere with copper absorption, potentially leading to copper deficiency. While the zinc dose in this product is at 100% RNP, prolonged use in individuals with marginal copper intake should be monitored.

Overdose

In the event of an acute overdose, which would involve the ingestion of a large number of tablets at once, the primary concerns are related to Vitamin A (retinyl acetate) toxicity and gastrointestinal irritation.

Symptoms of acute Vitamin A overdose can manifest within hours and may include severe headache, dizziness, blurred or double vision, nausea, vomiting, diarrhea, irritability, and drowsiness. In severe cases, peeling of the skin, particularly around the mouth, and increased intracranial pressure (pseudotumor cerebri) may occur, leading to persistent headache and visual changes.

There is no specific antidote for an overdose of this dietary supplement. Management is symptomatic and supportive. Gastric lavage or administration of activated charcoal may be considered if the overdose is recent. Due to the fat-soluble nature of Vitamin A, its effects can be prolonged. Immediate medical attention should be sought, and the patient should be advised to bring the product container to the healthcare facility.

Chronic overdose results from prolonged intake of doses exceeding the recommended daily amount. This can lead to chronic hypervitaminosis A, which is characterized by a wide range of symptoms including bone and joint pain, hair loss, dryness and fissuring of the lips, liver toxicity (elevated liver enzymes, hepatomegaly), and visual disturbances. Discontinuation of the supplement is the primary treatment, with symptoms potentially taking weeks or months to resolve completely.

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.