Vivacia Vitamin D3 2000 IU (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Vitamin D3 2000 IU

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

* recommended level of consumption according to TR TS 022/2011 “Food products regarding their labeling” (Appendix 2).

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

^# recommended daily intake.

Energy value (100 g): 209 kJ/49 kcal.

60 pcs. – bottles (1).

Therapeutic Category

Dietary supplement – source of vitamin D

Indications

• For the correction and prevention of vitamin D3 deficiency in adults and children over 12 years of age.
• As an adjunctive source of cholecalciferol to support bone health and mineral density, particularly in individuals with limited sun exposure.
• To support normal function of the immune system and contribute to the reduction of fatigue and exhaustion.
• For the maintenance of normal muscle function and healthy teeth.

It is important to note that this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease. The decision to use this product should be based on an individual assessment of nutritional status and, ideally, guided by a healthcare professional.

Contraindications

• Hypersensitivity or allergy to cholecalciferol (vitamin D3) or any of the auxiliary ingredients listed in the composition (microcrystalline cellulose, dicalcium phosphate, magnesium stearate).
• Conditions associated with hypercalcemia (elevated blood calcium levels) or hypercalciuria (elevated calcium in urine), such as sarcoidosis.
• Patients with severe renal impairment or end-stage renal disease not managed with appropriate medical therapy.
• Patients with active urolithiasis (kidney stones) related to calcium oxalate or phosphate.
• Children under 12 years of age, as the dosage is formulated for adult and adolescent requirements.

Concurrent use with other vitamin D-containing preparations or high-dose calcium supplements is not recommended without medical supervision due to the risk of additive effects and potential toxicity.

Dosage Regimen

The recommended dosage for adults and children over 12 years of age is one tablet (2000 IU) once daily, unless otherwise directed by a healthcare provider.

The tablet should be swallowed whole with a sufficient amount of water, preferably with a main meal to enhance absorption. Do not chew or crush the tablet. Adherence to the recommended dosage is crucial; do not exceed the stated dose.

The duration of use should be determined by a healthcare professional based on individual needs and serum 25-hydroxyvitamin D levels. Long-term supplementation at this dose should be monitored periodically. For individuals with severe deficiency, a healthcare provider may recommend a different, often higher, initial loading dose using a different pharmaceutical form before maintenance with this product.

Adverse Reactions

When used at the recommended dosage, Vivacia Vitamin D3 2000 IU is generally well tolerated. However, like any bioactive substance, adverse reactions may occur, primarily in cases of prolonged excessive intake.

The most significant adverse effects are related to vitamin D intoxication, which leads to hypercalcemia (elevated blood calcium). Early signs may include nausea, vomiting, constipation, anorexia (loss of appetite), polydipsia (excessive thirst), polyuria (excessive urination), dehydration, fatigue, and weakness.

Chronic hypercalcemia can result in vascular and soft-tissue calcification, as well as impaired renal function, potentially leading to nephrolithiasis (kidney stones). In rare cases, individuals may experience allergic reactions such as skin rash, itching, or urticaria. If any adverse reaction is suspected, discontinue use immediately and consult a physician.

Drug Interactions

Vitamin D3 can interact with several classes of medications, which may necessitate monitoring or dosage adjustments.

Thiazide diuretics (e.g., hydrochlorothiazide) can reduce urinary calcium excretion. Concurrent use with vitamin D may increase the risk of hypercalcemia. Patients on this combination should have their serum calcium levels monitored regularly.

Cardiac glycosides such as digoxin: Hypercalcemia can potentiate the effects of digoxin, increasing the risk of cardiac arrhythmias. Extreme caution and close monitoring are required if these are used together.

Anticonvulsants (e.g., phenobarbital, phenytoin) and antituberculosis drugs (e.g., rifampin) can increase the hepatic metabolism of vitamin D, leading to reduced serum levels and potentially requiring a higher dosage of vitamin D.

Systemic corticosteroids (e.g., prednisone) may antagonize the effects of vitamin D on calcium absorption. Orlistat and bile acid sequestrants (e.g., cholestyramine) can reduce the absorption of fat-soluble vitamins, including vitamin D, and it is advisable to separate the timing of administration by several hours.

Overdose

Vitamin D is fat-soluble and can accumulate in the body; therefore, overdose is a serious medical condition. The manifestations of vitamin D overdose are a consequence of hypercalcemia.

Symptoms of overdose include, but are not limited to: anorexia, nausea, vomiting, constipation, abdominal pain, pancreatitis, renal failure, hypertension, cardiac arrhythmias, psychosis, and in severe cases, coma. Long-term excessive intake leads to widespread calcification of blood vessels and tissues, causing irreversible damage to the cardiovascular system and kidneys.

In case of suspected overdose, discontinue the supplement immediately and seek urgent medical attention. Treatment involves withdrawal of vitamin D, a low-calcium diet, and measures to promote hydration. In severe hypercalcemia, hospitalization may be required for more aggressive treatment, which can include loop diuretics, bisphosphonates, glucocorticoids, and in extreme cases, hemodialysis.

Accidental ingestion of a very large number of tablets by a child constitutes a medical emergency.

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.