INSTRUCTIONS FOR MEDICAL USE PIKOVIT®

Compound

INSTRUCTIONS FOR MEDICAL USE PIKOVIT®

“APPROVED” State Unitary Enterprise “State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment” of the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan April 22, 2021 No. 9

Trade name of the drug: Pikovit® Dosage form: syrup Composition: 5 ml (1 spoon) of syrup contains: active substances:

excipients: agar, tragacanth, sucrose, liquid glucose, orange oil flavor, grapefruit flavor, orange flavor, polysorbate 80, citric acid monohydrate, Ponceau 4R dye (E124), sodium benzoate, purified water. Description: thick viscous liquid from light yellow to brownish-orange color with the permissible presence of barely visible inclusions. It has a pleasant smell and sour taste. Pharmacotherapeutic group: Vitamins. Multivitamins. ATX code: A11BA.

Pharmacological properties Pharmacodynamics Pikovit® syrup contains nine essential vitamins that take part in the regulation of many biochemical processes in the body. The effects of vitamins in the body are primarily physiological rather than pharmacodynamic. They play an important role in maintaining vital functions and good psychophysical condition. Vitamin A is involved in the synthesis of various substances (proteins, lipids, mucopolysaccharides) and ensures the normal function of the skin, mucous membranes, and the organ of vision. Vitamin D3 plays an important role in maintaining the balance of calcium and phosphorus in the body. With its deficiency in bone tissue, the calcium content decreases (osteoporosis). Vitamin B1 normalizes the activity of the heart and contributes to the normal functioning of the nervous system. Vitamin B2 promotes tissue regeneration processes, including skin cells. Vitamin B6 helps maintain the structure and function of bones, teeth, and gums; influences erythropoiesis and promotes the normal functioning of the nervous system. Vitamin B12 is involved in erythropoiesis and contributes to the normal functioning of the nervous system. B vitamins are involved in the formation of various enzymes that regulate metabolism in the body. Vitamin C is involved in the oxidation of a number of biologically active substances, regulation of metabolism in connective tissue, carbohydrate metabolism, blood clotting and tissue regeneration, stimulates the formation of steroid hormones, and normalizes capillary permeability. Vitamin C increases the body's resistance to infections and reduces inflammatory reactions. Vitamin PP and D-panthenol are coenzymes involved in protein metabolism, in the synthesis of fatty acids and cholesterol, in energy production and are necessary for the normal functioning of the central nervous system. Pharmacokinetics Pharmacokinetic data regarding Pikovit® syrup are not available. The purposes of individual vitamins in the body are known and described in the literature. Water-soluble vitamins (vitamins B and C) are very well absorbed in quantities that meet the daily needs of the body. Amounts exceeding tissue saturation levels are excreted in urine and sometimes in feces. They accumulate in the body only in limited quantities, so regular intake of these vitamins is important to maintain adequate tissue concentrations. After oral administration, fat-soluble vitamins A and D are well absorbed in the small intestine in the presence of fat. Higher amounts of fat-soluble vitamins accumulate in the liver.

Indications for use Pikovit® syrup is intended for children as a prophylactic agent: - in case of lack of appetite; - to increase the body's resistance to infectious and colds; - during the period of recovery after illnesses; - with insufficient physical development (stunted growth); - as a vitamin preparation in the daily diet, especially in winter and spring; — with increased physical and neuropsychic stress in school-age children; - in complex therapy when using antibiotics.

Directions for use and dosage: Pikovit® Syrup is taken orally. Children aged 1 to 3 years: 1 measuring spoon (5 ml) of syrup 2 times a day. Children aged 4 to 6 years: 1 measuring spoon (5 ml) of syrup 3 times a day. Children aged 7 to 14 years: 1 measuring spoon (5 ml) of syrup 3 times, maximum 4 times a day. The syrup can be given from a spoon or mixed with tea, juice or fruit puree. Do not exceed the recommended daily dose. If there is no appetite, the syrup should be given daily for 1 month. Repeated course of treatment after 1-3 months.

Side effects Hypersensitivity reactions are possible. If allergic reactions occur, you should stop treatment and consult your doctor.

Contraindications - hypersensitivity to active substances or auxiliary components of the drug - hypervitaminosis A and D

Drug interactions No interactions known.

Special instructions If a hypersensitivity reaction occurs, the drug should be discontinued. Before simultaneous use with other vitamins and vitamin-mineral preparations, you should consult your doctor or pharmacist. Due to the riboflavin content, yellow coloration of urine may occur. This effect is safe. Pikovit® syrup is not recommended for use in patients with diabetes mellitus, since 5 ml of syrup (1 scoop) contains 3 g of sugar. Children under 1 year of age should only be given syrup on the recommendation and under the supervision of a doctor. Use during pregnancy and lactation Pregnant and lactating women can take vitamins and minerals as recommended by a doctor. Doses of vitamins in the drug Pikovit® syrup are intended for children. Effect on the ability to drive a car and operate complex mechanisms The effect of the drug on the ability to drive vehicles and operate machinery has not been reported. The drug does not affect the motor function of children. Special information about some ingredients Pikovit® syrup contains sucrose, glucose and Punceau 4R dye (E124). Patients with rare hereditary forms of fructose intolerance, glucose/galactose malabsorption or sucrase-isomaltase deficiency should not use this drug. Dye Punceau 4R (E124) may cause allergic reactions.

Overdose At recommended doses, intoxication is not expected. Long-term use in very large doses can lead to hypervitaminosis A and D, although the risk of overdose is minimal. Symptoms of hypervitaminosis A after short-term use of large doses of vitamin A include abdominal pain, anorexia, vomiting, blurred vision, headache, uncoordinated movements and redness of the skin. Long-term use of large doses of vitamin A can cause thinning and itching of the skin, cracked lips, inflammation of the conjunctiva, eye damage, joint pain, chronic headaches and repeated vomiting. Symptoms of hypervitaminosis D that may occur after taking large doses of vitamin D include anorexia, weight loss, fatigue, confusion, vomiting, constipation or diarrhea, metallic taste in the mouth, dry mouth and thirst.

Release form 150 ml of syrup in a dark glass bottle, sealed with a plastic stopper with first opening control. 1 bottle along with a dosing spoon and instructions for medical use are placed in a cardboard box.

Storage conditions Store at a temperature not exceeding 25 ºС, in a place protected from light. Keep out of the reach of children.

Shelf life: 2 years. The syrup should be used within 2 months after opening the bottle. Should not be used after the expiration date.

Conditions for dispensing from pharmacies Without a prescription.

Manufacturer KRKA, d.d. Novo Mesto, Slovenia, Šmarješka 6, 8501 Novo Mesto, Slovenia

Name and address of the organization that accepts claims (suggestions) on the quality of medicines on the territory of the Republic of Uzbekistan Representative office of “KRKA, d.d., Novo mesto” in the Republic of Uzbekistan 100015, Republic of Uzbekistan, Tashkent, st. Afrosiab, 14 Tel.: +99871 150 2828, +99871 150 2929, Fax: +99871 150 1044

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Pharmacodynamics

Pikovit® syrup for children contains a complex of vitamins that are important factors in metabolic processes in the body.

Vitamin A is involved in the synthesis of various substances (proteins, lipids, mucopolysaccharides) and ensures the normal function of the skin, mucous membranes, and the organ of vision.

Vitamin D3 plays an important role in maintaining the balance of calcium and phosphorus in the body. With its deficiency in bone tissue, the calcium content decreases (osteoporosis).

Vitamin B1 normalizes the activity of the heart and contributes to the normal functioning of the nervous system.

Vitamin B2 promotes tissue regeneration processes, incl. skin cells.

Vitamin B6 helps maintain the structure and function of bones, teeth, and gums; influences erythropoiesis and promotes the normal functioning of the nervous system.

Vitamin B12 is involved in erythropoiesis and contributes to the normal functioning of the nervous system. B vitamins are involved in the formation of various enzymes that regulate metabolism in the body.

Vitamin C is involved in the oxidation of a number of biologically active substances, regulation of metabolism in connective tissue, carbohydrate metabolism, blood clotting and tissue regeneration, stimulates the formation of steroid hormones, and normalizes capillary permeability. Vitamin C increases the body's resistance to infections and reduces inflammatory reactions.

Vitamin PP and D-panthenol are coenzymes involved in protein metabolism, in the synthesis of fatty acids and cholesterol, in energy production, and are necessary for the normal functioning of the central nervous system.

Pikovit

Pikovit is a vitamin and mineral complex to compensate for the deficiency of vitamins and minerals in children aged 4 years and older. Created taking into account the increased need of the child's body for essential nutritional components. After reaching the age of four, intensive growth of bones and muscles begins in the body, for which Pikovit is enriched with calcium and phosphorus. The drug is indicated for inadequate and unbalanced diets, poor appetite, increased fatigue in schoolchildren, and in the complex treatment of diseases for which antibacterial drugs are used. Retinol is an active participant in the synthesis of many vital substances (proteins, fats, glycosaminoglycans), and maintains the normal condition of the skin, eyes, and mucous membranes. Cholecalciferol maintains a physiological balance between the levels of calcium and phosphorus in the body. Thiamine controls the functioning of the heart muscle and ensures neuromuscular transmission. Riboflavin helps restore damaged tissues, incl. epithelial. Pyridoxine ensures the structural integrity and stability of bone tissue, teeth, periodontal tissue, stimulates the formation of red blood cells, and regulates the functioning of the nervous system. Cyanocobalamin is in demand in erythropoiesis and the functioning of the nervous system. Ascorbic acid is an integral participant in redox reactions, a regulator of connective tissue metabolism and glucose metabolism. It controls the functioning of the blood coagulation system, promotes reparative processes, activates the process of synthesis of steroid hormones, normalizes the condition of the walls of blood vessels of the capillary bed, increases the body's resistance to the penetration of infectious agents, and eliminates inflammation.

Pantothenic acid is involved in oxidative reactions, acetylation, and metabolic processes. Folic acid promotes the formation of red blood cells. Calcium is a structure-forming component for bones; it is involved in the blood coagulation system, neuromuscular transmission, and muscle contraction. Phosphorus is involved in the formation of bone tissue and teeth, and takes part in the breakdown reactions of organic substances, accompanied by the release of energy. Pikovit has good organoleptic properties: the pleasant taste of the tablets ensures high compliance (patient adherence to taking the drug), and therefore the effectiveness of treatment. Pikovit is recommended for use by the Russian Union of Pediatricians. Contraindications to the use of the drug are individual intolerance to one or more of its components, as well as hypervitaminosis of retinol and cholecalciferol. Pikovit tablets are dissolved in the mouth or chewed. Single dose - 1 tablet. Frequency of administration: 4-5 times a day (up to 6 years), 5-7 times a day (from 6 years and older). The duration of the medication course is from 20 days to 1 month. In agreement with the doctor, a repeat course may be given. If you have a weak appetite, you can use Pikovit for 2 months. Possible unwanted side effects are allergic reactions. Cases of drug overdose have not been described in the medical literature; their risk is minimal. Pikovit can delay the absorption of tetracycline and fluoroquinolone antibacterial agents from the gastrointestinal tract (this is due to the presence of calcium in Pikovit). Ascorbic acid potentiates undesirable reactions of antibacterial agents of the sulfonamide group.

Indications of the drug Pikovit®

Pikovit® syrup for children is used as a prophylactic agent for conditions accompanied by an increased need for vitamins:

overwork in school-age children;

increased physical and neuropsychic stress;

lack of appetite and irregular, inadequate or monotonous diet;

recovery period after illnesses;

increasing the body's resistance to infectious and colds;

complex therapy when using chemotherapeutic agents.

special instructions

It is possible that the urine may turn yellow - this is completely harmless and is explained by the presence of riboflavin in the drug.

It is not recommended to take Pikovit® together with other medications containing vitamins.

5 ml of Pikovit® syrup contains 3.3 g of sucrose, 0.7 g of glucose, therefore the drug is not recommended for children with congenital intolerance to glucose and fructose, glucose/galactose malabsorption syndromes and sucrose/isomaltose deficiency.

The drug contains azo dye E124, which can cause a hypersensitivity reaction with an asthmatic component. Such reactions are more often observed in patients with hypersensitivity to acetylsalicylic acid.

Benzoic acid has a mild irritant effect on the skin and mucous membranes.