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Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-UfaVITA OJSC (Russia)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Complivit® “Mama” for pregnant and nursing women

Film-coated tablets: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from yellow-brown to light brown with a pinkish tint, biconvex, oblong; the fracture appearance is yellow-gray with inclusions of different colors.

Excipients: colloidal silicon dioxide, talc, potato starch, citric acid, povidone, calcium stearate, stearic acid, sucrose, hypromellose, macrogol 4000, titanium dioxide, dye azorubine (E122), tropaeolin O.

30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

A combined multivitamin preparation with micro- and macroelements, the action of which is due to the effects of its constituent components.

Compatibility of components in one tablet is ensured by a special technology for the production of vitamin-mineral complexes.

α-Tocopherol acetate (vitamin E) has antioxidant properties, maintains erythrocyte stability, prevents hemolysis; has a positive effect on the functions of the gonads, nervous and muscle tissue. Vitamin E deficiency in early pregnancy can cause miscarriage.

Retinol acetate (vitamin A) plays an important role in redox processes, participates in the synthesis of mucopolysaccharides, proteins, lipids. Promotes normal spermatogenesis and oogenesis, placental development, growth, normal development and differentiation of embryonic tissues, including epithelial structures and bone tissue. Participates in the formation of visual pigments necessary for normal twilight and color vision, ensures the integrity of epithelial tissues, and regulates bone growth.

Thiamine hydrochloride (vitamin B₁) as a coenzyme participates in carbohydrate metabolism and the functioning of the nervous system.

Riboflavin (vitamin B₂) is a key catalyst for cellular respiration and visual perception processes.

Pyridoxine hydrochloride (vitamin B₆) as a coenzyme participates in protein metabolism and the synthesis of neurotransmitters. During pregnancy, it is necessary for women who have previously taken oral contraceptives that deplete pyridoxine reserves in the body.

Cyanocobalamin (vitamin B₁₂) participates in the synthesis of nucleotides, is an important factor for normal growth, hematopoiesis and development of epithelial cells; necessary for the metabolism of folic acid and the synthesis of myelin.

Nicotinamide (vitamin PP) participates in the processes of tissue respiration, fat and carbohydrate metabolism.

Ascorbic acid (vitamin C) ensures the synthesis of collagen, participates in the formation and maintenance of the structure and function of cartilage, bone and teeth, affects hemoglobin formation and erythrocyte maturation. Vitamin C increases the body’s resistance to infections and reduces inflammatory reactions.

Calcium pantothenate (vitamin B₅) as a component of coenzyme A plays an important role in acetylation and oxidation processes; promotes the construction and regeneration of epithelium and endothelium.

Folic acid (vitamin B_c) participates in the synthesis of amino acids, nucleotides, nucleic acids; necessary for normal erythropoiesis. In the early stages of pregnancy, it reduces the risk of neural tube defects in the fetus, as well as the risk of developing maxillofacial defects.

Iron participates in erythropoiesis, as part of hemoglobin it ensures oxygen transport to tissues; prevents the development of anemia in pregnant women, especially in the II and III trimesters of pregnancy.

Copper prevents anemia and oxygen deprivation of organs and tissues, helps prevent osteoporosis, and strengthens blood vessel walls.

Manganese has anti-inflammatory properties and prevents the development of osteoarthritis.

Zinc is necessary for the normal formation of the fetal skeleton and tissue regeneration, participates in the formation of some hormones, including insulin; reduces the likelihood of a number of intrauterine anomalies. In combination with retinol, it promotes the formation of normal twilight and color vision.

Magnesium normalizes blood pressure, has a sedative effect, and reduces the likelihood of developing preeclampsia, spontaneous abortion, and premature birth.

Calcium participates in the formation of bone tissue, promotes normal blood clotting, participates in the transmission of nerve impulses, contractions of skeletal and smooth muscles, and in the regulation of cardiac activity.

Phosphorus strengthens bone tissue and teeth, enhances mineralization, and is part of ATP, the energy source of cells.

Pharmacokinetics

The action of the drug is the combined action of its components, therefore conducting kinetic observations is not possible; all components together cannot be traced using markers or bioassays.

Indications

Prevention and treatment of hypovitaminosis and mineral deficiency

• During pregnancy planning;
• During pregnancy and breastfeeding.

ICD codes

Dosage Regimen

Take one tablet once daily.

Administer the tablet during or immediately after breakfast.

Swallow the tablet whole with a full glass of water; do not chew or crush.

Initiate therapy during the preconception period to prepare the body for pregnancy.

Continue administration throughout all trimesters of pregnancy to support maternal health and fetal development.

Maintain intake during the entire period of breastfeeding to ensure adequate nutrient content in breast milk.

The duration of treatment is determined individually by a physician based on nutritional status and clinical need.

Avoid concomitant use with other multivitamin or mineral supplements to prevent overdose.

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

Adverse Reactions

Possible allergic reactions to the components of the drug.

Contraindications

• Hypervitaminosis A;
• Increased content of calcium and iron in the body;
• Urolithiasis;
• Pernicious B₁₂-deficiency anemia;
• Childhood;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is used during pregnancy and lactation according to indications in recommended doses.

Use in Renal Impairment

The drug is contraindicated for use in urolithiasis.

Special Precautions

It is not recommended to take this drug simultaneously with other multivitamin preparations to avoid overdose.

When prescribing the drug, it should be taken into account that the daily dose of retinol acetate during pregnancy should not exceed 5000 IU.

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

Overdose

The patient should be informed that in case of overdose, a doctor should be consulted.

Treatment: temporary discontinuation of the drug, gastric lavage, administration of activated charcoal; if necessary, symptomatic therapy is carried out.

Drug Interactions

The drug contains Iron and Calcium, therefore, when used concomitantly with antibiotics of the tetracycline and fluoroquinolone groups, their absorption from the gastrointestinal tract is slowed down.

Ascorbic acid enhances the pharmacological action and side effects of antimicrobial agents from the sulfonamide group (including an increased risk of crystalluria).

With the simultaneous use of antacid preparations containing aluminum, Calcium, Magnesium, as well as cholestyramine, the absorption of iron is reduced.

When used concomitantly with thiazide diuretics, the risk of hypercalcemia increases.

Storage Conditions

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