Vivacia Vitamin D3 500 IU (Tablets) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Maryvery, Limited (UK)

Dosage Form

Vivacia Vitamin D3 500 IU

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Tablets mass of 215 mg.

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

^# recommended daily intake.

Energy value (100 g): 16.26 kJ/3.87 kcal.

60 pcs. – bottles (1) – carton packs.

Therapeutic Category

Dietary supplement – source of vitamin D

Indications

• For the prevention of vitamin D deficiency in children over 11 years of age and adults, particularly in individuals with reduced dietary intake, limited sun exposure, or impaired absorption.
• As a supplementary source of colecalciferol (Vitamin D3) to support bone health and calcium metabolism, contributing to the maintenance of normal bones and teeth.
• To support normal function of the immune system and muscle function as part of a balanced diet and healthy lifestyle.

Contraindications

• Hypersensitivity to colecalciferol (Vitamin D3) or any of the auxiliary ingredients, such as dicalcium phosphate, microcrystalline cellulose, or magnesium stearate.
• Conditions associated with hypercalcemia (elevated blood calcium levels) or hypercalciuria (elevated calcium in urine), including but not limited to certain types of cancer, sarcoidosis, and primary hyperparathyroidism.
• Patients with severe renal impairment or end-stage renal disease requiring medical supervision, due to the risk of altered calcium and phosphate metabolism.
• Concomitant use with prescription-strength Vitamin D or calcium supplements or medications that can cause hypercalcemia, unless specifically directed by a healthcare professional.

Dosage Regimen

The recommended dosage for adults and children over 11 years of age is one tablet (500 IU) per day, unless otherwise advised by a healthcare provider.

The tablet should be swallowed whole with a glass of water, preferably with a meal to enhance absorption. Do not exceed the stated recommended daily intake unless under medical supervision.

For specific population groups, such as the elderly, individuals with malabsorption syndromes, or those with diagnosed vitamin D deficiency, a healthcare professional may recommend a different dosage based on individual needs and serum 25-hydroxyvitamin D levels.

The duration of use is not limited; however, it is advisable to periodically consult with a doctor or pharmacist for long-term supplementation.

Adverse Reactions

When taken at the recommended dosage, adverse reactions are uncommon. However, in cases of individual hypersensitivity or significant overdose, the following may occur due to the pharmacological effects of vitamin D.

Gastrointestinal disturbances such as constipation, flatulence, nausea, abdominal pain, or diarrhea have been rarely reported and are typically mild and transient.

Allergic reactions, including skin rash, pruritus, and urticaria, are possible but very rare. Discontinue use immediately if any signs of hypersensitivity appear.

Long-term intake of excessively high doses far exceeding the recommended intake can lead to hypervitaminosis D, characterized by hypercalcemia and hypercalciuria. Symptoms may include fatigue, weakness, headache, loss of appetite, dry mouth, metallic taste, nausea, vomiting, bone pain, muscle pain, and in severe cases, cardiac arrhythmias or renal impairment.

Drug Interactions

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

Thiazide diuretics (e.g., hydrochlorothiazide) may reduce urinary calcium excretion. Concomitant use with vitamin D can increase the risk of hypercalcemia.

Cardiac glycosides (e.g., digoxin): Hypercalcemia may potentiate the therapeutic and toxic effects of digoxin, increasing the risk of cardiac arrhythmias. Close monitoring of serum calcium and digoxin levels is recommended.

Anticonvulsants (e.g., phenobarbital, phenytoin) and rifampicin can increase the metabolism of vitamin D via induction of hepatic enzymes, potentially reducing its efficacy and leading to lower serum levels.

Systemic corticosteroids (e.g., prednisone) may antagonize the effects of vitamin D on calcium absorption. Orlistat and bile acid sequestrants (e.g., cholestyramine) may reduce the absorption of fat-soluble vitamins, including vitamin D, and it is advisable to separate the time of administration by at least 2 hours.

Overdose

Acute overdose with a single dose is unlikely to cause severe symptoms; however, chronic intake of excessively high doses can lead to vitamin D intoxication.

The primary manifestation of overdose is hypercalcemia. Early signs include nausea, vomiting, constipation, anorexia, weakness, fatigue, and mental confusion. Prolonged hypercalcemia can lead to calcium deposition in soft tissues, such as the kidneys and blood vessels, and potentially cause impaired renal function and nephrolithiasis (kidney stones).

In case of suspected overdose, discontinue the supplement immediately and seek medical attention. Treatment is symptomatic and supportive and may include measures to reduce serum calcium levels, such as hydration, dietary calcium restriction, and in severe cases, the administration of corticosteroids or bisphosphonates under medical supervision. Specific treatment should be determined by a physician based on the clinical presentation.

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.