Complivit^® for women 45 plus (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-UfaVITA OJSC (Russia)

ATC Code

A11AB (Multivitamins in combination with other drugs)

Dosage Form

Complivit® for women 45 plus

Film-coated tablets: 30, 60, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets green in color, round, biconvex, with a characteristic odor.

Excipients: talc, potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), magnesium stearate, ludipress (lactose monohydrate 93%, povidone 3.5%, crospovidone 3.5%), microcrystalline cellulose.

Film coating composition: hypromellose (hydroxypropyl methylcellulose), povidone (low molecular weight medical polyvinylpyrrolidone), titanium dioxide, talc, macrogol (polyethylene oxide 4000), quinoline yellow dye (E104), indigo carmine (indigotine) dye (E132).

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements and plant components

Pharmacotherapeutic Group

Multivitamin agent + other drugs

Pharmacological Action

A combined multivitamin preparation containing the minerals Magnesium and Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid, as well as extracts of the medicinal plants Leonurus cardiaca and Cimicifuga.

The vitamin complex replenishes vitamin deficiency, taking into account the daily requirement in women during the period of age-related hormonal changes (perimenopause). Additional components of the complex have an adaptogenic effect (Leonurus cardiaca), a metabolic effect (L-carnitine), and a regulatory effect on the hormonal balance of the female body (Cimicifuga).

Compatibility of components in 1 tablet is ensured by a special production technology for vitamin preparations.

The pharmacological action of the drug is due to the properties of its constituent components.

Ascorbic acid (vitamin C) – activates the activity of the endocrine glands, regulates all types of metabolism, blood clotting, tissue regeneration, steroid hormone synthesis, collagen synthesis, capillary permeability. It has a stimulating effect on the body as a whole, increases its adaptive capabilities, resistance to infections and adverse effects, and helps prevent aging processes.

Thiamine (vitamin B₁) – plays a key role in energy production processes, participates in carbohydrate metabolism, and is a necessary component of the impulse transmission process along the nerve fiber.

Riboflavin (vitamin B₂) – is part of many enzymes and performs the functions of a catalyst for cellular respiration processes. It participates in carbohydrate, protein, and fat metabolism, in the synthesis of hemoglobin and erythropoietin. It is necessary for maintaining normal visual function and the integrity of red blood cells.

Pyridoxine (vitamin B₆) – participates in the metabolism of amino acids and carbohydrates. It ensures the normal functioning of the central and peripheral nervous system and normalizes lipid metabolism. It has a mild diuretic effect. It helps reduce the risk of developing cardiovascular diseases.

Pantothenic acid (vitamin B₅) – plays an important role in acetylation and oxidation processes; promotes the regeneration of epithelium and endothelium. It improves the energy supply of the heart muscle and eliminates intestinal atony. It participates in maintaining the body’s resistance to infections.

Folic acid (vitamin B_c) – is included in various metabolic processes necessary for the synthesis of nucleic acids. It has an anti-anemic effect and increases the thromboresistance of the endothelium.

Cyanocobalamin (vitamin B₁₂) – participates in the synthesis of nucleotides, is an important factor in hematopoiesis and normal growth of epithelial cells; it is necessary for the metabolism of folic acid and the synthesis of myelin. It has a beneficial effect on processes in the nervous system.

Nicotinamide (vitamin PP) – participates in the processes of tissue respiration, fat and carbohydrate metabolism. It prevents the development of chronic fatigue syndrome. It helps reduce the cholesterol content in the blood.

Rutoside (vitamin P) – participates in redox processes, has antioxidant properties, prevents oxidation and promotes the deposition of ascorbic acid in tissues. It strengthens the walls of capillaries by regulating their permeability.

Retinol (vitamin A) – participates in the processes of synthesis, growth, and maintenance of the vital activity of the skin and mucous membranes. Vitamin A is important for vision as a component of the visual pigment rhodopsin and for skeletal development processes. It is necessary for maintaining immunity and has antioxidant properties.

α-Tocopherol acetate (vitamin E) – has antioxidant properties, maintains the stability of red blood cells, prevents hemolysis; has a positive effect on the functions of the gonads, nervous and muscle tissue, and helps slow down the aging processes of body tissues.

L-carnitine – improves the functioning of the immune system, has a beneficial effect on the cardiovascular system, participates in protein metabolism and the synthesis of muscle tissue. It stimulates regeneration, activates fat metabolism, and mobilizes fat from fat depots. It restores the structure of nervous tissue. It increases tolerance to physical activity and restores performance after prolonged physical exertion. It helps reduce the level of cholesterol and triglycerides in the blood, the excess of which is a potential risk factor for the development of a number of vascular diseases.

Cimicifuga – normalizes the balance of estrogens and LH, has a mild sedative, muscle relaxant, antispasmodic and hypotensive effect, increases myocardial contractility, exhibits hypolipidemic, antioxidant and angioprotective activity, and eliminates perimenopausal symptoms.

Leonurus cardiaca – reduces the pressor effect of adrenaline on blood vessels, lowers blood pressure, normalizes the activity of the central nervous system, eliminates tachycardia, and has a calming effect.

Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid – a natural antioxidant that increases immunity. In combination with vitamins A, E, and C, it has a pronounced antioxidant effect and improves the body’s adaptive capabilities under conditions of exposure to adverse factors (stress, smoking, environmental pollution).

Magnesium – necessary for the heart, has antispasmodic vasodilating action, helps lower blood pressure. It is necessary for the normal activity of the nervous system and has a calming effect.

As a result, the drug provides a balanced intake of components necessary to maintain the optimal functioning of the body during the period of hormonal changes.

Pharmacokinetics

Pharmacokinetic data are not provided.

Indications

• Prevention of hypovitaminosis in women during the period of age-related hormonal changes (perimenopause).

ICD codes

Dosage Regimen

Take this medication orally after a meal to minimize potential gastrointestinal discomfort.

Swallow one tablet once daily with a sufficient amount of liquid; do not chew.

For specific clinical indications, a physician may increase the daily dose to two tablets.

The minimum course duration is three to four months for optimal effect.

Continue treatment or initiate repeated courses only based on a physician’s recommendation.

Do not exceed the prescribed daily dosage.

Consult a physician before concomitant use with other multivitamin preparations.

Discontinue use and seek medical advice if severe adverse reactions occur.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Pregnancy;
• Lactation period (breastfeeding);
• Childhood;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication: childhood.

Special Precautions

Do not exceed the recommended dose.

It is recommended to use the drug with caution in patients with liver diseases, as well as simultaneously with potentially hepatotoxic drugs.

Intense yellow coloration of urine is possible, which is due to the presence of riboflavin in the drug composition and is not dangerous.

Overdose

In case of overdose, the patient should consult a doctor.

Treatment: activated charcoal orally, gastric lavage, symptomatic therapy.

Drug Interactions

Concomitant use of other multivitamin preparations is not recommended.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 1.5 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.