Lavita^® (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharmaceuticals, PJSC (Russia)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Lavita®

Film-coated tablets: 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink in color, capsule-shaped, biconvex; on the cross-section, light yellow in color with white and reddish-brown microgranules.

Excipients: microcrystalline cellulose up to 0.6 g, Ludipress LCE (lactose monohydrate 94.7-98.3%, povidone 3-4%) 0.3135 g, pregelatinized starch 0.0525 g, copovidone 0.0525 g, croscarmellose sodium 0.0210 g, calcium stearate 0.0105 g.

Coating composition Opadry II (series 85) 0.05 g.

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

The mechanism of action of the drug is determined by the vitamins and minerals that are part of its composition, which are involved in the regulation of metabolic processes and the normalization of tissue trophism, the formation of enzymes and structural components of tissues, and the normal functioning of the body’s organs and systems.

Retinol (vitamin A) is involved in the synthesis of proteins, lipids, and mucopolysaccharides, and is necessary for normal eye function.

Thiamine (vitamin B₁) is necessary for the synthesis of the neurotransmitter acetylcholine.

Riboflavin (vitamin B₂) is involved in the processes of biological oxidation and energy metabolism.

Pyridoxine (vitamin B₆) is involved in carbohydrate, lipid, and protein metabolism. Impaired metabolism and a decrease in pyridoxine hydrochloride in the body occurs with long-term use of oral contraceptives by women of childbearing age.

Cyanocobalamin (vitamin B₁₂) is involved in the synthesis of nucleic acids, affecting hematopoiesis processes. Impaired metabolism and a decrease in cyanocobalamin in the body occurs with long-term use of oral contraceptives by women of childbearing age.

Ascorbic acid (vitamin C) is involved in the oxidation of biologically active substances, regulates metabolism in connective tissue, carbohydrate metabolism, stimulates the formation of steroid hormones, and increases the absorption of iron in the intestine.

Alpha-tocopherol (vitamin E) is a natural antioxidant, maintains the stability of cell membranes, protecting them from damage.

Folic acid (vitamin B₉) stimulates erythropoiesis and is involved in the synthesis of amino acids and nucleic acids.

Biotin (vitamin B₇, vitamin H) is part of enzymes that regulate protein and fat metabolism and is involved in the synthesis of glucokinase.

Betacarotene is an antioxidant from the group of carotenoids – natural retinol-like substances. Beta-carotene has pronounced antioxidant properties and protects cells from damage by active oxygen and free radicals (by fixing active oxygen, it interrupts chain free radical reactions and protects macromolecules and cell biomembranes from damage, thereby increasing the body’s resistance to various pathogenic influences). It is also a precursor of vitamin A.

Magnesium is a co-factor of many enzymes and is necessary for maintaining the homeostasis of calcium, potassium, and sodium.

Zinc is part of many enzyme systems, ensures the synthesis of insulin and other hormones, is necessary for tissue regeneration, and is involved in the metabolism and stabilization of cell membranes.

Selenium is a trace element that is part of all cells of the body, the most important element of antioxidant protection, has an immunomodulatory effect, and is involved in the regulation of the action of thyroid hormones.

Indications

Hypovitaminosis and deficiency of macro- and microelements (prevention and treatment).

Conditions associated with an increased need for vitamins and minerals

• Insufficient and unbalanced nutrition;
• Intense mental and physical exertion;
• Antibiotic therapy;
• Convalescence period after illnesses;
• Long-term use of oral contraceptives by women of childbearing age.

ICD codes

Dosage Regimen

Administer the tablets orally.

Take after breakfast with a small amount of water.

Do not chew the film-coated tablet; swallow it whole.

The standard dosage for adults is one tablet once daily.

The recommended treatment course is 30 days.

Any repeated courses of therapy must be initiated and supervised by a physician.

Do not exceed the stated daily dose to avoid the risk of hypervitaminosis, particularly of vitamin A.

If you miss a dose, take it as soon as remembered on the same day; do not double the dose the next day.

Concurrent use with other multivitamin preparations is not recommended due to an increased risk of overdose.

When taking other medications, maintain an interval of approximately two hours between their intake and Lavita^® to prevent potential interactions.

Adverse Reactions

Allergic reactions: possible – urticaria.

From the gastrointestinal tract: nausea, diarrhea or constipation, discomfort in the epigastrium are possible, which do not require discontinuation of the drug.

Contraindications

• Hypervitaminosis of vitamin A;
• Lactase deficiency;
• Lactose intolerance;
• Glucose-galactose malabsorption;
• Children under 18 years of age;
• Increased individual sensitivity to the components of the drug.

Use with caution in severe liver damage, gastric and duodenal ulcers.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in severe liver damage.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Urine may turn intense yellow, which is explained by the presence of riboflavin in the drug.

Do not take simultaneously with other vitamin preparations (increases the risk of overdose).

Effect on the ability to drive vehicles and perform work requiring increased concentration

Does not affect the ability to drive vehicles and perform work requiring increased concentration.

Overdose

When exceeding the indicated dose of the drug, symptoms of retinol hypervitaminosis are clinically significant.

Symptoms of overdose severe headache, dizziness, facial flushing, nausea, vomiting, decreased heart rate, possible visual impairment.

Treatment: gastric lavage, oral administration of activated charcoal.

Drug Interactions

Vitamin C enhances the action and side effects of antimicrobial agents from the sulfonamide group (including the appearance of crystals in the urine).

Vitamin B₆ reduces the severity of the action of levodopa.

If it is necessary to take other drugs in combination with Lavita^®, an interval of about 2 hours should be observed between doses.

Storage Conditions

Store in a dry place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

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.