INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PikoVit® Forte (Pikovit®Forte)

Composition:

Active ingredients: retinol, cholecalciferol, ascorbic acid, thiamine nitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, nicotinamide, folic acid, calcium pantothenate, α-tocopherol acetate.

One coated tablet contains:

retinol (vitamin A as retinyl 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 μg,

nicotinamide 20 mg,

folic acid 0.40 mg,

calcium pantothenate 10 mg,

α-tocopherol acetate (vitamin E) 15 mg;

Excipients: maltitol (E 965), maltitol liquid, mannitol (E 421), aspartame (E 951), mandarin flavor, polysorbate 80, glycerin, purified castor oil, magnesium stearate, Caprol 600 Pharma, povidone, colloidal anhydrous silicon dioxide, titanium dioxide (E 171), beta-carotene (E 160a).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: round, biconvex, coated tablets ranging from light to dark orange in color. The presence of dark and light specks is permitted.

Pharmacotherapeutic group. Multivitamin complexes without additional supplements. ATC code A11B A.

Pharmacological properties.

Pharmacodynamics.

Pikovit® Forte, coated tablets, contain a combination of vitamins.

Vitamins are substances involved in the regulation of many biochemical processes in the body. The effects of vitamins in the body are primarily physiological rather than pharmacodynamic.

Vitamins of group B (B1, B2, B6, B12, pantothenic acid, nicotinamide, and folic acid) participate in carbohydrate, protein, and fat metabolism and 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 essential for epithelial cell development and synthesis of visual pigment.

Vitamin D regulates calcium absorption and promotes proper mineralization of bones and teeth.

Vitamin C enhances iron absorption and participates in numerous redox processes in the body.

Vitamin E is a physiological antioxidant that protects cell membranes from damage and maintains cellular functions.

Pikovit® Forte, coated tablets, contain non-cariogenic sweeteners: maltitol, mannitol, and aspartame. Both polyols (maltitol and mannitol) are metabolized in very small amounts and very slowly by oral flora bacteria.

Pharmacokinetics.

Water-soluble vitamins (B-complex vitamins, vitamin C) are well absorbed in amounts corresponding to daily requirements. Excess amounts are excreted in urine, and in some cases, in feces. These vitamins are stored in the body only in limited quantities; therefore, they should be regularly administered to maintain adequate tissue concentrations.

In the presence of dietary fats, fat-soluble vitamins A and D are well absorbed in the small intestine. The absorption of vitamin E is relatively low (25–85% of the dose). When administered in large amounts, these vitamins accumulate in the liver and are therefore more toxic than water-soluble vitamins.

Clinical characteristics.

Indications.

The product is intended for children:

during physical and mental overloads in schoolchildren;
in developmental delay;
in seasonal deficiency of fruits and vegetables in the diet;
in decreased appetite;
as an adjunctive agent during antibiotic therapy.

Pikovit® Forte is not a substitute for a balanced and varied diet.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients of the product; hypervitaminosis of vitamins A and D; phenylketonuria; nephrolithiasis; renal insufficiency; 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; malignant anemias; malignant neoplasms; peptic ulcer of the stomach and duodenum (due to possible increase in gastric juice acidity); tuberculosis; concomitant use of retinoids.

Interaction with other medicinal products and other forms of interaction.

Due to the possibility of developing hypervitaminosis A, concomitant use of Pikovit® Forte, film-coated tablets, with other products containing vitamin A or with oral retinoids is not recommended, as their combination may be toxic. Retinol may reduce the anti-inflammatory effect of glucocorticoids. It is not allowed to take it simultaneously with nitrates and cholestyramine, as they impair retinol absorption. When treating with sulfonamides, high doses of vitamin C should be avoided to prevent crystalluria. Vitamin C enhances iron absorption, but slows down the absorption of beta-adrenergic blockers and indirect-acting anticoagulants. Concurrent use of vitamin C and deferoxamine increases tissue iron toxicity, especially in the myocardium, which may lead to circulatory decompensation. Vitamin C may be used only 2 hours after deferoxamine injection. Prolonged use of high doses of ascorbic acid (more than 1 g, corresponding to the content of 17 tablets of Pikovit® Forte) by patients treated with disulfiram inhibits the disulfiram-alcohol reaction. Calcium chloride, salicylates, and corticosteroids, when used long-term, reduce ascorbic acid reserves in the body. Absorption of ascorbic acid is reduced when taken simultaneously with fruit or vegetable juices or alkaline drinks, or when Pikovit® Forte is used by adults concurrently with oral contraceptives. Pyridoxine reduces the efficacy of levodopa if the patient is taking levodopa alone, and also prevents or reduces toxic manifestations observed during treatment with isoniazid and other antituberculosis drugs. Thiamine may weaken curare-like effects. PAS, cimetidine, potassium preparations, and alcohol reduce vitamin B12 absorption. Riboflavin is incompatible with streptomycin and reduces the efficacy of antibacterial agents (oxytetracycline, doxycycline, erythrocycline, tetracycline, and lincomycin). It should be taken at least 3 hours before or 3 hours after the dose of antibiotic. Tricyclic antidepressants, imipramine, and amitriptyline inhibit riboflavin metabolism, especially in cardiac tissues. When used concurrently with quinine, hemorrhages may be intensified. Concurrent use of certain drugs (e.g., tetracyclines, quinolones, cholestyramine) may lead to interaction with calcium ions. The simultaneous use of vitamin D3 and thiazide diuretics increases the risk of hypercalcemia. Ion-exchange resins such as cholestyramine and laxative agents (paraffin oil) may reduce vitamin D3 absorption. Due to metabolic activation, vitamin D3 activity may be reduced when used concurrently with phenytoin or barbiturates. Therefore, the product is recommended to be taken 2 hours before or 2 hours after taking other medicinal products. Since concomitant oral administration of products containing calcium and vitamin D3 enhances the effect of cardiac glycosides, medical supervision and ECG monitoring are required when they are used simultaneously. In patients with folate deficiency, folic acid use may reduce plasma phenobarbital levels and trigger epileptic seizures. Ethanol, cycloserine, glutethimide, and methotrexate may affect folate metabolism. Folic acid absorption is reduced when used concomitantly with analgesics, anticonvulsants, antacids, sulfonamides, antibiotics, and cytostatics. Cases of reduced or altered absorption may occur when cholestyramine and folic acid are used simultaneously. Therefore, the product should be taken 1 hour before or 4–6 hours after cholestyramine administration. It should not be used together with mineral acids, alkaline substances, or reducing agents, as folic acid inactivation occurs.

Special precautions.

If skin hypersensitivity reactions (rash, itching) occur, administration of Pиковіt® Forte should be discontinued. The drug should not be prescribed together with other multivitamins, as this may lead to overdose. The recommended dose should not be exceeded.

Use with caution in patients with liver disease, acute nephritis, cardiac decompensation, cholelithiasis, chronic pancreatitis, allergic disorders, idiopathic conditions, neoplasms, predisposition to thrombosis and bleeding (hemophilia, thrombocytopenia, thrombopathies).

Women during pregnancy or breastfeeding may take vitamins and minerals only after mandatory consultation with a physician. 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 caused by high vitamin A levels in the body. A change in urine color to yellow may occur due to riboflavin content. This effect is harmless. Absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia. Since ascorbic acid enhances iron absorption, its use in high doses may be hazardous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. As a reducing agent, ascorbic acid may interfere with laboratory test results, such as glucose, bilirubin, transaminase activity, and lactate dehydrogenase levels. The drug should be administered with caution to patients with anemia of unknown etiology, as folic acid may mask the hematological manifestations of pernicious anemia, potentially allowing progression of neurological complications. Blood analysis should be performed systematically during folic acid treatment of anemias. Long-term use of the drug is not recommended (especially in high doses) due to the possible decrease in vitamin B12 concentration.

Prior to concomitant use of other vitamin or vitamin-mineral preparations, consultation with a physician is mandatory.

Patients with diabetes mellitus may use Pиковіt® Forte, but they should be aware that 1 coated tablet contains 0.84 g of maltitol. Insulin is required for maltitol metabolism; however, insulin requirements are minimal due to the slow hydrolysis and absorption of the drug in the gastrointestinal tract. In addition, the energy value of maltitol (10 kJ/g or 2.4 kcal/g) is significantly lower than that of sucrose.

Special information about certain excipients

Pиковіt® Forte contains maltitol (E 965) and liquid maltitol. Patients with known sugar intolerances should consult their physician before taking this medicinal product.

Aspartame is a derivative of phenylalanine and poses a risk for patients with phenylketonuria.

Use during pregnancy or breastfeeding.

The drug is intended for use in children.

Ability to influence reaction rate while driving or operating machinery.

The drug is intended for use in children.

Method of Administration and Dosage.

For children aged 7 years and older, for the treatment of hypovitaminosis: 1 tablet once daily after meals; for prophylaxis: 1 tablet every other day.

Pikovit® Forte, coated tablets, should be chewed in the mouth.

In cases of reduced appetite, the tablets are recommended to be taken for 2 months; for other indications and if necessary – depending on the duration and frequency of symptoms, following consultation with a physician.

Children.

The product is intended for children aged 7 years and older.

Overdose.

No intoxication is expected when the recommended doses are taken. In case of overdose, the likelihood of adverse reactions increases, possibly causing abdominal bloating (meteorism). Prolonged intake of very high doses may lead to hypervitaminosis of vitamins A and D, although the risk of overdose with Pikovit® Forte tablets is low. Overdose of vitamin D3 may cause weakness, anorexia, nausea, vomiting, diarrhea, weight loss, fever, convulsions, and disturbances of the cardiovascular system and kidneys. Hypercalcemia due to hypersensitivity to vitamin D3 may develop. Symptoms of hypercalcemia include anorexia, polyuria, nausea, vomiting, general weakness, headache, apathy, and thirst. Overdose of vitamin A may lead to headache, dizziness, sleep disturbances, nausea, vomiting, drowsiness, photophobia, and convulsions. If the above symptoms occur, the use of the drug should be discontinued and immediate medical advice sought. Prolonged use of high doses of ascorbic acid may suppress the function of the islet apparatus of the pancreas; therefore, its functional capacity should be monitored. Overdose may lead to changes in renal excretion of ascorbic and uric acids during urine acidification, increasing the risk of oxalate stone formation. High-dose ascorbic acid intake may cause heartburn. Significant exceeding of recommended doses may result in renal failure, sleep disturbances, sensation of heat, increased fatigue, disturbances in zinc and copper metabolism, increased excitability, erythrocytopenia, and neutrophilic leukocytosis. If symptoms of overdose occur, the drug should be discontinued and treatment initiated. Induce vomiting and ensure adequate hydration. In cases of diagnosed hypercalcemia, a diet restricted in calcium and vitamin D3 should be followed. Further treatment is symptomatic. Very high doses of folic acid may increase central nervous system excitability and provoke convulsions.

The sweeteners mannitol and maltitol are poorly absorbed in the gastrointestinal tract. Therefore, intake of doses exceeding the recommended amounts may cause diarrhea and meteorism.

Side effects

Immune system disorders: Possible hypersensitivity reactions to the components of the medicine, including anaphylactic reaction (frequency unknown), anaphylactic shock, bronchospasm, Quincke's edema (angioedema).

If hypersensitivity reactions (allergic reactions) occur, treatment should be discontinued and medical advice should be sought. In case of anaphylactic reaction, immediate emergency medical assistance should be sought.

Metabolism and nutrition disorders: Hypercalcaemia, calcinosis.

Nervous system disorders: Headache, dizziness, drowsiness, increased excitability.

Eye disorders: Visual disturbances.

Gastrointestinal disorders: Dyspepsia, nausea, vomiting, belching, stomach pain, constipation, diarrhoea, increased gastric juice secretion, heartburn.

Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus, erythema, eczema.

Renal and urinary disorders: Change in urine color, hypercalciuria, glomerular kidney damage.

General disorders and administration site conditions: Hyperthermia, irritability, hyperhidrosis.

With prolonged use at high doses, the following adverse effects may occur.

Metabolism and nutrition disorders: Hyperuricaemia; impaired glucose tolerance, hyperglycaemia, impaired glycogen synthesis, anorexia.

Nervous system disorders: Paraesthesia.

Cardiac disorders: Arrhythmia, arterial hypertension, myocardial dystrophy, arterial hypotension.

Blood and lymphatic system disorders: Thrombocytosis, hyperprothrombinaemia, thrombosis. High doses of ascorbic acid (more than 1 g, equivalent to 17 tablets of Pиковіт® Forte) may cause haemolysis (haemolytic anaemia) in patients with glucose-6-phosphate dehydrogenase deficiency.

Gastrointestinal disorders: Gastrointestinal disturbances, irritation of the gastrointestinal mucosa, flatulence, bitter taste in mouth.

Skin and subcutaneous tissue disorders: Hair loss, seborrhoea, dryness and cracking of palms and soles.

Renal and urinary disorders: Renal failure, crystalluria, formation of urate, cystine and/or oxalate calculi.

Investigations: Transient increases in aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase; increased levels of calcium in blood and urine, glucosuria.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance System at: https://aisf.dec.gov.ua.

Shelf life: 3 years.

Storage conditions

Store at temperatures not exceeding 25 °C, in the original packaging to protect from light and moisture.

Keep out of reach of children.

Packaging

15 tablets per blister; 2 blisters per cardboard box.

Release classification: Over-the-counter (without prescription).

Manufacturer

KRKA, d.d., Novo mesto / KRKA, d.d., Novo mesto.

Manufacturer's address and place of business

Smarjeska cesta 6, 8501 Novo mesto, Slovenia / Smarjeska cesta 6, 8501 Novo mesto, Slovenia.

Pikovit® forte