Instructions for Pikovit syrup bottle 150 ml
Composition
active ingredients: 5 ml of syrup (1 measuring spoon) contain:
900 IU of retinol (vitamin A in the form of retinol palmitate),
100 IU cholecalciferol (vitamin D3),
50 mg of ascorbic acid (vitamin C),
1 mg of thiamine hydrochloride (vitamin B1),
1 mg riboflavin phosphate sodium salt (vitamin B2),
0.6 mg pyridoxine hydrochloride (vitamin B6),
1 mcg of cyanocobalamin (vitamin B12),
5 mg of nicotinamide,
2 mg of dexpanthenol (D-panthenol);
excipients: agar, tragacanth, sucrose, glucose solution, orange oil flavoring, grapefruit concentrate flavoring, orange concentrate flavoring, polysorbate 80, citric acid monohydrate, Ponceau 4R dye (E 124), sodium benzoate (E 211), purified water.
Dosage form
Syrup.
Main physicochemical properties: thick, viscous syrup from light yellow to brownish-orange color. Has a pleasant odor and sour taste.
Pharmacotherapeutic group
Multivitamin complexes without additives. ATX code A11B A.
Pharmacological properties
Pharmacodynamics.
Pikovit®, syrup, contains 9 essential vitamins that are involved in the regulation of many biochemical processes in the body. The effects of vitamins and minerals in the body are mainly physiological, not pharmacodynamic. They play an important role in maintaining vital functions and psychological health.
B vitamins (B1, B2, B6, pantothenic acid and nicotinamide) participate in the metabolism of carbohydrates, proteins and fats, and also play an important role in the functioning of the nervous system.
Vitamin B1 helps optimize cognitive activity, has a positive effect on growth and energy processes, normalizes appetite. It is also necessary for maintaining muscle tone in the gastrointestinal tract (GI) and heart.
Vitamin B2 contributes to the normal function of the organs of vision and normalizes the activity of the nervous system. It is involved in energy processes during the conversion of fats and carbohydrates.
Vitamin B6 is involved in amino acid metabolism. It is necessary for the conversion of tryptophan into niacin, glycogenolysis, the formation of antibodies and hemoglobin, and the metabolism of homocysteine.
Vitamin B12 prevents anemia, activates energy supply processes, improves concentration and memory, and supports the nervous system.
Vitamin A is necessary for the normal course of metabolic processes, including the regulation of growth and development of the body. It ensures the normal function of the organs of vision, the structural integrity of tissues, and increases the body's resistance to the effects of harmful environmental factors.
Vitamin D3 regulates calcium absorption and promotes proper mineralization of bones and teeth.
Vitamin C has strong reducing properties and is involved in redox processes, regulation of carbohydrate metabolism, affects amino acid metabolism, thyroxine metabolism, biosynthesis of catecholamines, steroid hormones and insulin; necessary for blood clotting, synthesis of collagen and procollagen, regeneration of connective and bone tissue. Normalizes capillary permeability. Vitamin C controls iron absorption. Promotes iron absorption in the intestine and participates in hemoglobin synthesis. Also increases the body's nonspecific resistance.
Pharmacokinetics.
There are no data on the pharmacokinetics of Pikovit® syrup. Water-soluble vitamins (B vitamins and vitamin C) are well absorbed in amounts corresponding to daily needs. Excess amounts are excreted in the urine, in some cases with feces. These vitamins are stored in the body in limited quantities, so they should be used regularly to maintain appropriate concentrations in the tissues.
In the presence of fat, orally administered fat-soluble vitamins A and D3 are well absorbed in the small intestine.
Indication
Pikovit®, syrup, mainly intended for children:
with reduced appetite;
during physical and mental overload in schoolchildren;
with developmental delay;
as an adjunct to antibiotic treatment;
with a seasonal deficit of fruits and vegetables in the diet.
Contraindication
Hypersensitivity to the components of the drug; hypervitaminosis A and D; nephrolithiasis; renal failure; severe renal dysfunction; gout; hyperuricemia; erythremia; erythrocytosis; thromboembolism; thrombophlebitis; fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency; iron or copper metabolism disorders; hypercalcemia; hypercalciuria; thyrotoxicosis; chronic glomerulonephritis; chronic heart failure; history of sarcoidosis; active peptic ulcer of the stomach and duodenum (due to a possible increase in the acidity of gastric juice); active pulmonary tuberculosis; simultaneous use of retinoids.
Interaction with other medicinal products and other types of interactions
Due to the possibility of developing hypervitaminosis A, the concomitant use of Pikovit® syrup with other drugs containing vitamin A or oral retinoids is not recommended. Vitamin A is not recommended to be prescribed together with oral retinoids, since their combination may be toxic. Retinol may reduce the anti-inflammatory effect of glucocorticoids. It should not be taken simultaneously with nitrites and cholestyramine, since they impair the absorption of retinol.
During sulfonamide therapy to prevent crystalluria, large amounts of vitamin C should be avoided. Vitamin C increases iron absorption, but slows down the absorption of beta-blockers and indirect anticoagulants. Simultaneous use of vitamin C and deferoxamine increases tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. Vitamin C can be used only 2 hours after the injection of deferoxamine. Long-term use of large doses of ascorbic acid (more than 1 g, which corresponds to 100 ml of Pikovit® syrup) by persons treated with disulfiram inhibits the disulfiram-alcohol reaction. Calcium chloride, salicylates, corticosteroids, with prolonged use, reduce the reserves of ascorbic acid in the body. Absorption of ascorbic acid is reduced with simultaneous consumption of fruit or vegetable juices, alkaline drinks, and in the case of Pikovit® syrup use by adults, with concomitant use of oral contraceptives.
Vitamin B6 weakens the effect of levodopa if the patient takes only levodopa, prevents or reduces toxic manifestations observed with the use of isoniazid and other anti-tuberculosis drugs. Thiamine can weaken the curare-like effect. Para-aminosalicylic acid (PASA), cimetidine, potassium preparations, alcohol reduce the absorption of vitamin B12. Riboflavin is incompatible with streptomycin and reduces the effectiveness of antibacterial drugs (oxytetracycline, doxycycline, erythromycin, tetracycline and lincomycin). It should be taken at least 3 hours before or 3 hours after taking a dose of the antibiotic. Tricyclic antidepressants, imipramine and amitriptyline inhibit riboflavin metabolism, especially in heart tissues. With simultaneous use with quinine, hemorrhages may increase.
The risk of hypercalcemia increases with the simultaneous use of vitamin D3 and thiazide diuretics. Ion exchange resins such as cholestyramine and laxatives (paraffin oil) may reduce the absorption of vitamin D3. Due to metabolic activation, the activity of vitamin D3 may decrease when used simultaneously with phenytoin or barbiturates. In this regard, it is recommended to take the drug during or 2 hours after taking other medications. Since the concomitant oral administration of calcium and vitamin D3 preparations enhances the effect of cardiac glycosides, medical supervision and electrocardiogram monitoring are necessary during their simultaneous use.
Application features
If hypersensitivity reactions to the components of the drug occur, it should be discontinued.
Use with caution in patients with liver damage, patients with acute nephritis, cardiac decompensation, allergic diseases, idiosyncrasy, with a history of peptic ulcer of the stomach and duodenum, cholelithiasis, chronic pancreatitis, patients with neoplasms, with a history of kidney disease, a tendency to thrombosis and bleeding (hemophilia, thrombocytopenia, thrombocytopathy).
Absorption of ascorbic acid may be impaired in intestinal dyskinesias, enteritis, and achilia. Since ascorbic acid increases iron absorption, its use in high doses may be dangerous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Ascorbic acid as a reducing agent may affect the results of laboratory tests, for example, when determining the content of glucose, bilirubin, transaminase activity, and lactate dehydrogenase.
The urine may turn yellow, which is a completely harmless factor and is explained by the presence of riboflavin in the preparation.
The drug is not recommended to be prescribed together with other multivitamins, as overdose is possible.
Do not exceed the recommended dose.
Special information about some of the excipients
Pikovit® syrup contains sucrose, glucose, therefore patients with rare hereditary forms of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. If the patient has been diagnosed with intolerance to some sugars, consult a doctor before use. Pikovit® syrup should be used with caution in patients with diabetes mellitus, since 5 ml of syrup (1 measuring spoon) contain 3.3 g of sucrose and 0.7 g of glucose.
The azo dye Ponceau 4R (E 124) may cause allergic reactions.
Use during pregnancy or breastfeeding
Women during pregnancy or breastfeeding can take vitamins and minerals after mandatory consultation with a doctor. Pregnancy should not be planned earlier than 6–12 months after high-dose retinol therapy (over 10,000 IU), due to the risk of embryonic abnormalities due to the high content of vitamin A in the body at this time.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no reports of the drug's effect on the ability to drive or use other (potentially dangerous) mechanisms. The doses of vitamins in Pikovit® syrup are adapted for children.
Method of administration and doses
For the prevention of hypovitaminosis
Children aged 1 to 3 years - 0.5 measuring spoon (2.5 ml) of syrup per day.
Children aged 4 to 6 years – 1 measuring spoon (5 ml) of syrup per day.
Children aged 7 to 14 years - 1.5 measuring spoons (7.5 ml) of syrup per day.
For the treatment of hypovitaminosis
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 should be given to the child after meals, using a measuring spoon, and can also be added to tea, juice or fruit puree. Shake before use.
If the child has a reduced appetite, the syrup should be given for 1 month, for other indications - as needed, depending on the duration and frequency of symptoms, after consulting a doctor.
Children. The drug should be used in children over 1 year of age.
Overdose
When taking the recommended doses, no intoxication is expected. The probability of overdose is minimal. In case of overdose, the probability of the listed adverse reactions increases, bloating (flatulence) may occur.
Prolonged use of high doses can cause hypervitaminosis A and D3, although an overdose of Pikovit® syrup is unlikely. An overdose of vitamin D3 causes weakness, anorexia, nausea, vomiting, diarrhea, weight loss, fever, convulsions, disorders of the cardiovascular system and kidneys. Hypercalcemia may develop due to hypersensitivity to vitamin D3. Symptoms of hypercalcemia are anorexia, polyuria, nausea, vomiting, general weakness, headache, apathy, thirst. An overdose of vitamin A can lead to headache, dizziness, sleep disturbances, nausea, vomiting, drowsiness, photophobia and convulsions. If the above symptoms appear, you should stop taking the drug and immediately consult a doctor.
With prolonged use of ascorbic acid in high doses, inhibition of the function of the insular apparatus of the pancreas is possible, therefore it is necessary to monitor its functional capacity. Overdose can lead to changes in the renal excretion of ascorbic and uric acids during urine acetylation with the risk of oxalate stone formation. The use of large doses of ascorbic acid can lead to heartburn. If the recommended doses are significantly exceeded (if the dose of vitamin C exceeds 1 g per day, which corresponds to 100 ml of Pikovit® syrup), renal failure, sleep disturbances, feeling of heat, increased fatigue, impaired zinc and copper metabolism, increased excitability, erythrocytopenia, neutrophilic leukocytosis are possible.
If signs of overdose appear, the drug should be discontinued. If possible, treatment should be initiated. Vomiting should be induced and the body should be hydrated. If hypercalcemia is detected, a diet with a limited amount of calcium and vitamin D3 should be followed. Further treatment is symptomatic.
Side effects
The use of recommended doses of Pikovit® syrup does not cause side effects, however, adverse reactions may occur in individuals with hypersensitivity.
On the part of the immune system: in individuals with hypersensitivity, allergic reactions are possible, including anaphylactic shock, angioedema, bronchospasm.
Skin and subcutaneous tissue disorders: skin rash, urticaria, itching, redness of the skin, eczema.
Metabolism and nutrition disorders: hypercalcemia, calcinosis.
Gastrointestinal: dyspeptic disorders, nausea, vomiting, belching, stomach pain, constipation, diarrhea, increased secretion of gastric juice, heartburn.
From the nervous system: headache, dizziness, drowsiness, increased excitability.
On the part of the organs of vision: visual impairment.
Kidney and bladder: urine discoloration, hypercalciuria, damage to the glomerular apparatus of the kidneys.
Others: hyperthermia, increased sweating.
With prolonged use in high doses, the following side effects may occur.
Metabolism and nutrition disorders: hyperuricemia, decreased glucose tolerance, hyperglycemia, impaired glycogen synthesis.
Nervous system: paresthesia.
On the part of the heart: cardiac arrhythmias, arterial hypertension, myocardial dystrophy.
From the blood: thrombocytosis, hyperprothrombinemia, thrombosis.
Gastrointestinal: irritation of the mucous membrane of the digestive tract.
Skin and subcutaneous tissue disorders: dryness and cracks on the palms and soles, hair loss, seborrheic rashes.
Kidney and bladder disorders: renal failure, crystalluria, formation of urate, cystine and/or oxalate stones.
According to studies: transient increase in the activity of aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, increased calcium levels in the blood and urine, glycosuria.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions after the marketing authorisation of a medicinal product is of great importance. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
2 years.
After opening the bottle, the syrup should be used within 2 months.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging to protect from light.
Keep out of reach of children.
Packaging
150 ml of syrup in a bottle; 1 bottle together with a measuring spoon in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto/ KRKA, dd, Novo mesto.
Address
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
