Vivacia Calcium Plus (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Calcium Plus

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 1210 mg.

^# recommended norm of consumption.

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

Therapeutic Category

Dietary supplement for strengthening bone tissue and prophylaxis of osteoporosis

Indications

• As a dietary supplement to provide additional calcium, vitamin D₃, and vitamin K for individuals whose dietary intake may be insufficient.
• To support and maintain bone health and to help in the maintenance of normal bone mineral density.
• For the prophylaxis of calcium and vitamin D deficiency in individuals with an identified inadequate dietary intake or an increased requirement, such as during periods of reduced sun exposure.
• As a supportive measure for bone strengthening in postmenopausal women and older adults who are at risk of decreased bone mass.

It is important to note that this product is not intended to diagnose, treat, cure, or prevent any disease. The combined action of calcium, vitamin D, and vitamin K is aimed at supporting the body’s natural bone remodeling processes.

Dosage Regimen

The recommended dosage for adults and children over 12 years of age is one tablet twice daily, preferably with a meal.

Tablets should be swallowed whole with a full glass of water; do not crush or chew. To ensure optimal absorption, it is advisable not to take the tablet while lying down and to remain in an upright position for a few minutes after ingestion.

The duration of use should be determined by a healthcare professional based on individual needs and dietary assessment. Do not exceed the stated recommended daily dose. Excessive consumption of this product may cause adverse effects.

For children under 12 years of age, use should only be under the advice and supervision of a physician, as the dosage requirements and safety profile may differ.

Contraindications

• Hypersensitivity to any of the active substances (calcium, colecalciferol, menaquinone, phylloquinone) or to any of the excipients listed in the full product composition.
• Conditions associated with hypercalcemia (elevated blood calcium levels) and/or hypercalciuria (elevated calcium in urine), such as sarcoidosis, certain malignancies, or primary hyperparathyroidism.
• Patients with severe renal impairment or a history of kidney stones (nephrolithiasis or urolithiasis).
• Concomitant use with high doses of vitamin D from other sources, as this increases the risk of hypercalcemia.
• Patients receiving therapeutic anticoagulant therapy, particularly vitamin K antagonists like warfarin, due to the potential for phylloquinone and menaquinone to interfere with the anticoagulant effect. Use requires strict medical supervision and frequent monitoring of INR levels.

This product is contraindicated in individuals with known allergic reactions to soy, as the formulation may contain soy-derived excipients.

Adverse Reactions

Adverse reactions are generally uncommon and mild when the product is used at the recommended dosage. The most frequently reported adverse effects are related to the gastrointestinal system.

These may include constipation, flatulence, bloating, nausea, or abdominal discomfort. Taking the tablet with meals can often help to minimize these gastrointestinal effects.

In rare cases, allergic skin reactions such as rash, pruritus (itching), or urticaria (hives) may occur. Discontinue use immediately and seek medical attention if any signs of a serious allergic reaction appear, including difficulty breathing or swelling of the face, lips, tongue, or throat.

With long-term use at doses exceeding recommendations, there is a potential risk of hypercalcemia and hypercalciuria. Symptoms of hypercalcemia may include nausea, vomiting, loss of appetite, constipation, abdominal pain, fatigue, muscle weakness, excessive thirst, frequent urination, and mental confusion. If any of these symptoms occur, discontinue use and consult a physician.

Drug Interactions

Calcium can interfere with the absorption of several medications. It is recommended to take Vivacia Calcium Plus at least 2 hours before or 4 hours after taking other oral medications to minimize potential interactions.

Bisphosphonates (e.g., alendronate), tetracycline antibiotics (e.g., doxycycline), and fluoroquinolone antibiotics (e.g., ciprofloxacin): Calcium significantly reduces their absorption, leading to decreased effectiveness. A prolonged interval between doses is crucial.

Levothyroxine: Calcium carbonate can impair its absorption, potentially reducing its efficacy in managing hypothyroidism. These medications should be taken several hours apart.

Cardiac glycosides (e.g., digoxin): Hypercalcemia may potentiate the therapeutic and toxic effects of digoxin, increasing the risk of cardiac arrhythmias. Serum calcium and digoxin levels should be monitored regularly in patients on concomitant therapy.

Thiazide diuretics (e.g., hydrochlorothiazide): These agents can reduce calcium excretion by the kidneys, which may increase the risk of hypercalcemia, especially in patients with impaired renal function or hyperparathyroidism.

Vitamin K antagonists (e.g., warfarin): The vitamin K content in this supplement can antagonize the anticoagulant effect, potentially leading to a decrease in INR and an increased risk of thrombotic events. This combination is generally contraindicated unless under strict medical supervision with frequent INR monitoring and possible warfarin dose adjustment.

Overdose

Acute overdose with a single, very high dose is unlikely to cause severe symptoms beyond gastrointestinal upset. However, chronic excessive intake is dangerous and can lead to hypercalcemia and hypercalciuria.

Symptoms of severe hypercalcemia include pronounced nausea and vomiting, dehydration, lethargy, confusion, and in extreme cases, coma. Long-term hypercalcemia can result in vascular and soft tissue calcification and nephrocalcinosis (calcium deposits in the kidneys), leading to irreversible renal damage.

In case of suspected overdose, discontinue the product immediately. Treatment involves rehydration, dietary calcium restriction, and investigation of the cause. In severe cases, hospitalization may be required for more aggressive management, which can include loop diuretics (e.g., furosemide), corticosteroids, calcitonin, or bisphosphonates to rapidly lower serum calcium levels.

Patients with accidental ingestion of a large quantity should contact a poison control center or seek immediate medical attention, even in the absence of immediate symptoms.

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.