Vitrum^® Beauty Luxe (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Vitrum® Beauty Luxe

Film-coated tablets: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light gray to dark gray in color, round, biconvex; a specific odor is allowed.

Excipients: magnesium stearate – 3 mg, silicon dioxide – 8 mg, croscarmellose sodium – 5.5 mg, microcrystalline cellulose – 16.2 mg, stearic acid – 16.57 mg.

Shell composition: hypromellose – 3.89 mg, opadry II gray dye (titanium dioxide, polydextrose, hypromellose, triacetin, macrogol, indigotine dye (E132), sunset yellow FCF dye (E110), allura red AC dye (E129)) – 16.11 mg.

30 pcs. – blisters (1) – cardboard packs.
30 pcs. – blisters (2) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements and plant components

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

A vitamin-mineral complex with plant components, developed taking into account the physiological needs of older people. Lutein, which is part of the preparation, is necessary for the prevention of age-related eye diseases; the medicinal plant ginkgo biloba improves cerebral and peripheral circulation, promotes stimulation of brain activity, and is effective for memory impairment.

Vitamin A – normalizes the function of epithelial cells of the skin and mucous membranes of the eyes, respiratory tract, digestive tract, participates in the metabolism of amino acids, carbohydrates, in the formation of protein in tissues, and activates the body’s defenses.

Vitamin D – participates in the mineralization of bone tissue, affects general metabolism during calcium and phosphorus metabolism.

Vitamin E – maintains the stability of cell membranes, protecting them from destruction, and is a strong natural antioxidant. It slows down the aging of body tissues.

Vitamin C – participates in metabolic processes, strengthens the vascular wall, participates in the process of regeneration of bones and cartilage tissue, and stimulates the activity of the endocrine glands.

Vitamin B₁ – normalizes the activity of the central and peripheral nervous systems, cardiovascular and endocrine systems; participates in carbohydrate metabolism.

Vitamin B₂ – participates in energy metabolism and biological oxidation processes, protects the retina from excessive exposure to ultraviolet radiation, and improves the function of the nervous system, skin, and mucous membranes.

Vitamin B₆ – necessary for the normal functioning of the central and peripheral nervous systems.

Vitamin B₁₂ – participates in the synthesis of nucleic acids, affects hematopoiesis processes, affects the functioning of the nervous system; has a beneficial effect on fat metabolism in the liver.

Biotin – participates in metabolic processes, plays an important role in the reactions of glucose synthesis, fatty acids, steroid compounds, and amino acids.

Folic acid – participates in hematopoiesis processes, has a positive effect on fat metabolism in the liver, and the metabolism of cholesterol and a number of vitamins.

Nicotinamide – regulates redox processes in the body, participates in the regulation of cellular respiration processes, improves the metabolism of the heart muscle, and enhances myocardial contractility.

Pantothenic acid – participates in the metabolism of fatty acids, normalizes lipid metabolism, and ensures the development and differentiation of tissues.

Vitamin K – necessary for the blood clotting process, helps increase the resistance of blood vessel walls.

Calcium – forms and maintains bone tissue, ensures neuromuscular conduction, rhythmicity of heart contractions, and vascular tone. It promotes iron metabolism in the body.

Copper – promotes the transport of oxygen to tissues, is responsible for the formation of hemoglobin and the formation of red blood cells, stimulates the absorption of proteins and carbohydrates, is necessary for the conversion of iron entering the body into hemoglobin, and improves thyroid function.

Iodine – ensures the synthesis of thyroid hormones, participates in the growth and differentiation of cells of all tissues, and the metabolism of all types.

Iron – responsible for the transport of electrons, oxygen, ensures redox reactions, and is part of hemoglobin.

Magnesium – restores the structure of bone tissue, enhances the body’s defenses, and reduces blood cholesterol levels.

Phosphorus – participates in energy transfer, is part of DNA and RNA, regulates carbon metabolism, and, together with vitamin D and calcium, participates in bone formation.

Zinc – stimulates the synthesis of insulin and other hormones, and has a positive effect on the functioning of the central nervous system.

Chromium – participates in the regulation of blood sugar levels.

Manganese – promotes the formation and mineralization of bone and cartilage tissue, is responsible for normal fat metabolism, and the synthesis of cholesterol and nucleotides (DNA).

Molybdenum – ensures the metabolism of purines and the production of uric acid.

Potassium – transports amino acids and glucose into cells, is responsible for the conduction of nerve impulses, controls muscle contractions (including the myocardium), and ensures stable blood pressure.

Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid – an antioxidant, stimulates the body’s defenses.

Tin – affects the activity of enzymes involved in iron metabolism.

Nickel – enhances oxidative processes in tissues, and participates in carbohydrate and lipid metabolism.

Silicon – plays an important role in the formation of the skeletal system.

Vanadium – participates in the regulation of carbohydrate metabolism, stimulates glucose utilization, increasing insulin activity.

Ginkgo biloba – improves cerebral circulation and the supply of oxygen and glucose to the brain, dilates small arteries, increases venous tone, regulating vascular blood filling.

Lutein – slows down dystrophic processes in the retina, and neutralizes the damaging effects of ultraviolet radiation.

Indications

• Prevention of hypovitaminosis and mineral deficiency conditions in elderly people, developing against the background of: convalescence after long-term illnesses, including seasonal illnesses, in the postoperative period, after antibiotic therapy; increased physical and mental stress; unbalanced or inadequate nutrition;
• Recommended for persons living in environmentally unfavorable areas.

ICD codes

Dosage Regimen

Administer the drug orally.

Take one tablet per day.

Ingest the tablet after a meal with a sufficient amount of water.

Do not chew the tablet; swallow it whole.

The standard course of treatment is one month.

Adhere strictly to the once-daily dosing schedule.

Do not exceed the recommended daily dose.

Initiate a repeated course only on the recommendation of a physician.

Consult a doctor if you miss a dose.

Store the packaging in a dry place at room temperature, away from children.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Childhood;
• Hypersensitivity to the components of the drug;

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Pediatric Use

The use of the drug is contraindicated in childhood.

Special Precautions

The recommended dosage should not be exceeded.

Effect on the ability to drive vehicles and operate machinery

No data.

Overdose

In case of accidental overdose, a doctor should be consulted.

Treatment: oral administration of activated charcoal, gastric lavage, symptomatic therapy.

Drug Interactions

Concomitant use with other preparations containing vitamins A, E, and D is not recommended to avoid overdose.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.