Instructions for Pikovit forte film-coated tablets, blister pack No. 30
Composition
active ingredients: retinol, cholecalciferol, ascorbic acid, thiamine nitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, nicotinamide, folic acid, calcium pantothenate, α-tocopherol acetate.
1 film-coated tablet contains:
retinol (vitamin A in the form of retinol palmitate) - 5000 IU; cholecalciferol (vitamin D3) - 400 IU; ascorbic acid (vitamin C) - 60 mg; thiamine nitrate (vitamin B1) - 1.50 mg; riboflavin (vitamin B2) - 1.70 mg; pyridoxine hydrochloride (vitamin B6) - 2 mg; cyanocobalamin (vitamin B12) - 6 mcg; nicotinamide - 20 mg; folic acid - 0.40 mg; calcium pantothenate - 10 mg; α-tocopherol acetate (vitamin E) - 15 mg.
excipients: maltitol (E 965), liquid maltitol, mannitol (E 421), aspartame (E 951), tangerine flavor, polysorbate 80, glycerin, purified castor oil, magnesium stearate, capol 600 pharma, povidone, colloidal anhydrous silicon dioxide, titanium dioxide (E 171), beta-carotene (E 160a).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated, light to dark orange in color. Dark and light inclusions are allowed.
Pharmacotherapeutic group
Multivitamin complexes without additives. ATX code A11B A.
Pharmacological properties
Pharmacodynamics
Pikovit Forte, film-coated tablets, contain a combination of vitamins.
Vitamins are substances that participate in the regulation of many biochemical processes in the body. The effects of vitamins in the body are mainly physiological, not pharmacodynamic.
B vitamins (B1, B2, B6, B12, pantothenic acid, nicotinamide and folic acid) participate in the metabolism of carbohydrates, proteins and fats, and also play an important role in the functioning of the nervous system.
Folic acid is necessary for the normal formation, regeneration, and functioning of blood cells.
Vitamin A is necessary for the development of epithelial cells and the synthesis of visual pigment.
Vitamin D regulates calcium absorption and promotes proper mineralization of bones and teeth.
Vitamin C controls iron absorption and participates in many redox processes in the body.
Vitamin E is a physiological antioxidant that protects cell membranes from damage and preserves cellular functions.
Pikovit Forte, film-coated tablets, contain the non-cariogenic sweeteners maltitol, mannitol and aspartame. Both polyols (maltitol and mannitol) are metabolized in very small amounts and very slowly by bacteria of the oral flora.
Pharmacokinetics
Water-soluble vitamins (B vitamins, vitamin C) are well absorbed in amounts corresponding to daily needs. Excess amounts are excreted in the urine, and in some cases in the feces. These vitamins are stored in the body in limited quantities, so they must be regularly administered to maintain appropriate concentrations in the tissues.
In the presence of fat, when taken orally, the fat-soluble vitamins A and D are well absorbed in the small intestine. Absorption of vitamin E is relatively low (25-85% of the dose). When taken in large amounts, these vitamins accumulate in the liver and are therefore more toxic than water-soluble vitamins.
Indication
The drug is intended for children:
with physical and mental overload in schoolchildren; with developmental delay; with seasonal deficiency of fruits and vegetables in the diet; with reduced appetite; as an adjuvant in antibiotic treatment.
Pikovit Forte is not a substitute for a balanced and varied diet.
Contraindication
Hypersensitivity to the active substances or to any of the excipients of the drug; hypervitaminosis with vitamins A and D; phenylketonuria; nephrolithiasis; renal failure; gout; hyperuricemia; erythremia; erythrocytosis; thrombophlebitis; thromboembolism; disorders of iron and copper metabolism; untreated cobalamin deficiency; hypercalcemia; hypercalciuria; thyrotoxicosis; chronic glomerulonephritis; chronic heart failure; history of sarcoidosis; pernicious anemia; malignant neoplasms; gastric and duodenal ulcers (due to the possibility of increased acidity of gastric juice); 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 Forte, film-coated tablets, with other preparations containing vitamin A, or with oral retinoids is not recommended, as their combination may be toxic.
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 the content of 17 tablets of the drug Pikovit Forte) 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 use of fruit or vegetable juices, alkaline drinks or in the case of the use of the drug Pikovit Forte by adults with concomitant use of oral contraceptives. Pyridoxine reduces the effectiveness of levodopa if the patient takes only levodopa, and also prevents or reduces toxic manifestations observed with the use of isoniazid and other anti-tuberculosis drugs. Thiamine can weaken the curare-like effect. PAS, 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 cardiac tissues. With simultaneous use with quinine, hemorrhages may increase. Concomitant use of some drugs (e.g. tetracyclines, quinolines, cholestyramine) may lead to interaction with calcium ions. With simultaneous use of vitamin D3 and thiazide diuretics, the risk of hypercalcemia increases. 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 be reduced when used simultaneously with phenytoin or barbiturates. In this regard, it is recommended to take the drug 2 hours before or 2 hours after taking other drugs. Since the concomitant oral administration of calcium-containing drugs and vitamin D3 enhances the effect of cardiac glycosides, medical supervision and electrocardiogram monitoring are necessary in case of their simultaneous use. In patients with folate deficiency, the use of folic acid may reduce the level of phenobarbital in the blood plasma and cause an epileptic seizure.
Ethanol, cycloserine, glutethimide and methotrexate can affect folate metabolism. Folic acid absorption is reduced when used simultaneously with analgesics, anticonvulsants, antacids, sulfonamides, antibiotics, cytostatics. Cases of reduction or change in absorption may occur when using cholestyramine and folic acid simultaneously. Therefore, the drug should be taken 1 hour before or 4-6 hours after taking cholestyramine. It should not be used together with mineral acids, alkaline substances, reducing agents, since folic acid is inactivated.
Application features
In case of hypersensitivity reactions on the skin (rash, itching), the use of Pikovit Forte should be discontinued. It is not recommended to prescribe the drug together with other multivitamins, as overdose is possible. Do not exceed the recommended dose.
It is prescribed with caution to patients with liver disease, acute nephritis, cardiac decompensation, cholelithiasis, chronic pancreatitis, allergic diseases, idiosyncrasies, neoplasms, predisposition to thrombosis and bleeding (hemophilia, thrombocytopenia, thrombopathies).
Before taking other vitamin and mineral supplements, you should definitely consult a doctor.
Patients with diabetes can use Pikovit Forte, but they should take into account that 1 film-coated tablet contains 0.84 g of maltitol. Insulin is required for the metabolism of maltitol, but these insulin requirements are insignificant due to the slow hydrolysis and absorption of the drug in the digestive tract. In addition, the energy value of maltitol (10 kJ/g, or 2.4 kcal/g) is significantly lower than the energy value of sucrose.
Special information about some of the excipients
Pikovit Forte contains maltitol (E 965) and liquid maltitol. Patients with known intolerance to some sugars should consult their doctor before taking this medicinal product.
Aspartame is a derivative of phenylalanine, which is dangerous for people with phenylketonuria.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug is intended for use in children.
Use during pregnancy or breastfeeding
The drug is intended for use in children.
Method of administration and doses
Children aged 7 and over are given 1 tablet once a day after meals for the treatment of hypovitaminosis, and 1 tablet every other day for the prevention.
Pikovit Forte, film-coated tablets, should be dissolved in the mouth.
For reduced appetite, the tablets are recommended to be used for 2 months, for other indications and as needed - depending on the duration and frequency of symptoms after consulting a doctor.
Children
The drug is used in children aged 7 years and older.
Overdose
When taking the recommended doses, no intoxication is expected. In case of overdose, the likelihood of adverse reactions increases, bloating (flatulence) is possible. Taking very large doses for a long time can cause hypervitaminosis of vitamins A and D, however, the likelihood of overdose when using Pikovit Forte tablets is small.
Overdose of vitamin D3 leads to 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 ability.
Overdose may lead to changes in 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 may cause heartburn. If the recommended doses are significantly exceeded, renal failure, sleep disturbances, feeling of heat, increased fatigue, zinc and copper metabolism disorders, increased excitability, erythrocytopenia, neutrophilic leukocytosis are possible. If signs of overdose appear, the use of the drug should be discontinued and treatment should be initiated. Vomiting should be induced and the body hydrated. If hypercalcemia is detected, a diet with a limited amount of calcium and vitamin D3 should be followed. Further treatment is symptomatic. Very high doses of folic acid can increase the excitability of the CNS and cause convulsions.
The sweeteners mannitol and maltitol are poorly absorbed in the digestive tract. Therefore, taking doses exceeding the recommended ones can cause diarrhea and flatulence.
Adverse reactions
On the part of the immune system: possible hypersensitivity reactions to the components of the drug, including anaphylactic shock, bronchospasm, Quincke's edema.
Metabolism and nutrition disorders: hypercalcemia, calcinosis.
From the nervous system: headache, dizziness, drowsiness, increased excitability.
On the part of the organs of vision: visual impairment.
Gastrointestinal: dyspepsia, nausea, vomiting, belching, stomach pain, constipation, diarrhea, increased secretion of gastric juice, heartburn.
Skin and subcutaneous tissue disorders: rash, urticaria, itching, redness, eczema.
On the part of the kidneys and urinary tract: urine discoloration, hypercalciuria, damage to the glomerular apparatus of the kidneys.
General disorders and administration site conditions: hyperthermia, irritability, hyperhidrosis.
With prolonged use in high doses, the following side effects may occur.
Metabolism and nutrition: hyperuricemia; impaired glucose tolerance, hyperglycemia, impaired glycogen synthesis, anorexia.
Nervous system: paresthesia.
Blood disorders: thrombocytosis, hyperprothrombinemia, thrombosis. Large doses of ascorbic acid (more than 1 g, which corresponds to 17 Pikovit Forte tablets) can cause hemolysis (hemolytic anemia) in patients with glucose-6-phosphate dehydrogenase deficiency.
Gastrointestinal disorders: gastrointestinal disorders, irritation of the gastrointestinal mucosa, flatulence, bitter taste in the mouth.
Skin and subcutaneous tissue disorders: hair loss, seborrhea, dryness and cracks on the palms and soles.
Kidney and urinary tract disorders: renal failure, crystalluria, formation of urate, cystine and/or oxalate stones.
According to studies: temporary increase in aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, increased calcium levels in the blood and urine, glycosuria.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging to protect from light and moisture.
Keep out of reach of children.
Packaging
15 tablets in a blister, 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, PhD, Novo mesto.
Location of the manufacturer and its business address
Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
