Instructions for Decamevit film-coated tablets blister pack No. 20
Composition
active ingredients:
1 tablet contains
vitamin A 6600 IU,
vitamin E (a-tocopherol acetate)
or dry vitamin E 50% 10 mg,
vitamin B1 (thiamine hydrochloride) 20 mg,
vitamin B2 (riboflavin) 10 mg,
vitamin B6 (pyridoxine hydrochloride) 20 mg,
vitamin C (ascorbic acid) 200 mg,
folic acid (vitamin B) 2 mg,
nicotinamide (vitamin PP) 50 mg,
rutin (vitamin P) 20 mg,
methionine 200 mg,
vitamin B12 (cyanocobalamin) 0.1 mg;
excipients: croscarmellose sodium, mannitol (E 421), magnesium stearate;
shell: Opadry AMB II White film coating mixture: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaprate, sodium lauryl sulfate; Opadry II Yellow film coating mixture: polydextrose, talc, quinoline yellow aluminum lake (E 104), hypromellose, maltodextrin, medium chain triglycerides, titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a yellow film coating. They have a characteristic odor.
Pharmacotherapeutic group
Multivitamin preparations with various additives.
ATX code A11AB.
Pharmacological properties
Pharmacodynamics
A multivitamin drug, the properties of which are due to the vitamins that are part of it and take an active part in almost all biochemical reactions of the body. A rationally selected composition contributes to a more pronounced and versatile biological effect of the drug.
Vitamin A (retinol acetate) is necessary for the development of epithelial cells and the synthesis of visual pigment.
Vitamin E (a-tocopherol acetate) is a fat-soluble vitamin that has a pronounced antioxidant and radioprotective effect, participates in the biosynthesis of heme and proteins, cell proliferation and other important processes of cellular metabolism, improves oxygen consumption by tissues, and also has an angioprotective effect, affecting the tone and permeability of blood vessels, stimulating the formation of new capillaries.
Vitamin B1 (thiamine hydrochloride) normalizes the functional activity of the nervous, cardiovascular and digestive systems.
Vitamin B2 (riboflavin) plays an important role in protein, fat, and carbohydrate metabolism, participates in maintaining normal visual acuity, and normalizes skin functions.
Vitamin B6 (pyridoxine hydrochloride) is necessary for the regeneration of skin and liver cells, restoration of the nervous system, and improves fat metabolism in atherosclerosis.
Vitamin C (ascorbic acid) plays an important role in regulating redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, normal capillary permeability, the formation of steroid hormones and connective tissue components, and helps increase the body's resistance to infectious diseases.
Vitamin B (folic acid), in addition to its anti-anemic effect during pregnancy, protects the fetus from the effects of teratogenic factors and participates in the metabolism and synthesis of amino and nucleic acids.
Vitamin PP (nicotinamide) is a specific anti-pellagra agent that improves carbohydrate metabolism.
Vitamin P (rutin) – a P-vitamin-like water-soluble substance, a flavonoid. Rutin interacts with ascorbic acid, participates in the regulation of collagen formation in connective tissue, prevents the depolymerization of hyaluronic acid by hyaluronidase, and activates tissue respiration.
The essential amino acid methionine plays a role in the synthesis of a number of biologically important compounds, activates the effects of hormones, vitamins, and enzymes, and neutralizes toxic products.
Vitamin B12 (cyanocobalamin) affects the processes of normal maturation of all body cells, especially blood and liver cells, and has a positive effect on the functioning of the nervous system and liver.
Pharmacokinetics
Fat-soluble vitamins that are part of the drug (vitamin A, vitamin E) can be deposited in tissues. Water-soluble vitamins (vitamins B1, B2, B6, B12, C, PP) are converted into coenzymes and, combining with the apoenzyme, are part of complex enzymes. Since the life span of enzymes is limited, coenzymes break down and are excreted from the body in the form of various metabolites. Fat-soluble vitamins also undergo catabolism and are excreted from the body, although more slowly than water-soluble ones.
Indication
As a treatment for avitaminosis and hypovitaminosis, increased body need for vitamins in the following conditions:
with physical and mental exhaustion;
in old age to optimize metabolism;
for convalescence in the postoperative period, after serious illnesses, including intoxications of various origins;
with prolonged antibiotic therapy.
Contraindication
Hypersensitivity to any of the components of the drug, severe renal dysfunction, gout, hyperuricemia, erythremia, erythrocytosis, thromboembolism, fructose intolerance, hypervitaminosis A and E, thyrotoxicosis, chronic glomerulonephritis, chronic heart failure, history of sarcoidosis, active peptic ulcer of the stomach and duodenum, disorders of iron or copper metabolism, thrombosis, tendency to thrombosis, thrombophlebitis, urolithiasis, untreated cobalamin deficiency, pernicious anemia, malignant neoplasms.
Interaction with other medicinal products and other types of interactions
The drug is not recommended to be prescribed together with other multivitamins, as an overdose of the latter in the body is possible.
High doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, and disrupt the excretion of mexiletine by the kidneys.
Due to the possibility of developing hypervitaminosis A, concomitant use of the drug with other drugs containing vitamin A or with oral retinoids is not recommended.
Retinol reduces the anti-inflammatory effect of glucocorticoids. It should not be used simultaneously with nitrites and cholestyramine, as they impair the absorption of retinol.
Iron-containing drugs inhibit the action of vitamin E. Vitamin E should not be used together with iron drugs, silver, alkaline agents (such as sodium bicarbonate, trisamine), indirect anticoagulants (such as dicoumarin, neodicoumarin). Alpha-tocopherol acetate enhances the effect of steroidal and non-steroidal anti-inflammatory drugs (such as diclofenac sodium, ibuprofen, prednisolone).
Thiamine hydrochloride, by affecting the polarization processes in the area of neuromuscular synapses, can weaken the curare-like effect of muscle relaxants.
Pyridoxine hydrochloride weakens the effect of levodopa, prevents the occurrence or reduces the toxic manifestations of isoniazid and other anti-tuberculosis drugs.
When using short-acting sulfonamides with ascorbic acid, the risk of crystalluria increases. When used simultaneously, it enhances the effect of penicillin, increases iron absorption, reduces the effectiveness of heparin and indirect anticoagulants, increases aluminum absorption (consider when using antacids containing aluminum). Absorption of ascorbic acid decreases when used simultaneously with oral contraceptives, drinking fruit or vegetable juices, and drinking alkaline drinks. Ascorbic acid can be used only 2 hours after the injection of deferoxamine. Long-term use of large doses of ascorbic acid reduces the effectiveness of disulfiram treatment. Ascorbic acid increases the total clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylates, tetracyclines, and corticosteroids reduce the reserves of ascorbic acid in the body with long-term use. Ascorbic acid enhances the excretion of oxalates in the urine and increases the risk of crystalluria during treatment with salicylates.
Riboflavin is incompatible with streptomycin and reduces the effectiveness of antibacterial drugs (oxytetracycline, doxycycline, erythromycin, tetracycline and lincomycin). Tricyclic antidepressants, imipramine and amitriptyline inhibit riboflavin metabolism, especially in heart tissues.
Folic acid reduces plasma concentrations of phenytoin and other antiepileptic drugs, including phenobarbital, which causes a mutual decrease in clinical efficacy.
Ethanol, cycloserine, glutethimide, and methotrexate may affect folate metabolism.
The absorption of folic acid is reduced when used simultaneously with analgesics, anticonvulsants, antacids, sulfonamides, antibiotics, cytostatics. Absorption may decrease or change when used simultaneously with cholestyramine and folic acid. 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, reducing agents, as folic acid is inactivated.
Application features
Women who have used high doses of retinol (over 10,000 IU) should not plan pregnancy until 6–12 months after the start of treatment. This is because during this time there is a risk of abnormal fetal development due to the high levels of vitamin A in the body.
The urine may turn yellow, which is a completely harmless factor and is explained by the presence of riboflavin in the drug.
Use with caution in patients with kidney disease, severe liver damage, history of gastric and duodenal ulcer, acute nephritis, cardiac decompensation, cholelithiasis, chronic pancreatitis, ischemic heart disease, diabetes mellitus; in diseases accompanied by loss of calcium in the body.
The drug is prescribed with caution to patients with anemia of unknown etiology, since folic acid may interfere with the diagnosis of pernicious anemia by improving hematological parameters, while allowing neurological complications to progress.
There is also a risk of developing neuropsychiatric disorders (such as depression, anxiety, and mood swings).
When using high doses or long-term use of the drug, it is necessary to monitor blood pressure. Simultaneous use of the drug with alkaline drinks reduces the absorption of ascorbic acid, so you should not drink it with alkaline mineral water. Also, the absorption of ascorbic acid may be impaired in intestinal dyskinesias, enteritis and achilia. Use with caution in the treatment of patients with glucose-6-phosphate dehydrogenase deficiency. Ascorbic acid may affect the results of laboratory tests. For example, when determining the content of glucose, bilirubin, transaminase activity, lactate dehydrogenase in the blood.
Large doses of the drug should not be prescribed to patients with increased blood clotting.
Since ascorbic acid increases iron absorption, use in high doses may be dangerous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Patients with high iron levels in the body should use the drug in minimal doses.
Since ascorbic acid has a mild stimulating effect, it is not recommended to use the medicine at the end of the day.
Use during pregnancy or breastfeeding
The drug is not used during pregnancy.
The dose of vitamin A should not exceed 5,000 IU for pregnant women and women planning to become pregnant.
During breastfeeding, use only on the recommendation of a doctor.
Large doses of retinol (over 10,000 IU) should not be used by women during breastfeeding due to the risk of developing hypervitaminosis A in infants.
Ability to influence reaction speed when driving vehicles or other mechanisms
Drivers and operators of complex mechanisms should consider the possibility of side effects such as dizziness and drowsiness.
Method of administration and doses
The drug is prescribed for adults. Take orally, after meals, 1 tablet 1–2 times a day. The course of treatment is usually 20 days. Depending on the indications, repeated courses are possible with breaks of 2–3 months between them.
Children.
Due to the lack of data on safety and efficacy, the drug should not be used in children.
Overdose
Symptoms. In case of an overdose of the drug, dyspeptic phenomena (nausea, vomiting, diarrhea, epigastric pain), allergic reactions (itching, skin rashes), changes in the skin and hair, liver dysfunction, headache, drowsiness, lethargy, facial flushing, irritability, increased excitability of the central nervous system, which can cause convulsions, may be observed.
Treatment: Discontinue the drug. Symptomatic therapy.
With prolonged use in high doses, inhibition of the function of the insular apparatus of the pancreas is possible, which requires monitoring of the condition of the latter. Overdose can lead to changes in the renal excretion of ascorbic and uric acids during urine acetylation with the risk of precipitation of oxalate stones.
Side effects
The drug is usually well tolerated, but sometimes adverse reactions may occur, mainly when used in high doses.
On the part of the immune system: in individuals with hypersensitivity, allergic reactions are possible, including anaphylactic shock, angioedema, hyperthermia; rarely - bronchospasm in individuals with hypersensitivity to vitamins A, C, group B.
On the part of the endocrine system: damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the appearance of diabetes mellitus.
Skin and subcutaneous tissue disorders: rash, urticaria, itching, redness of the skin, eczema.
Cardiovascular system: arterial hypertension/hypotension, myocardial dystrophy.
Nervous system: headache, dizziness, increased excitability, fatigue, sleep disturbances, drowsiness, feeling hot, depression, anxiety and mood changes.
On the part of the gastrointestinal tract: dyspeptic disorders, heartburn, bitter taste in the mouth, nausea, vomiting, diarrhea, anorexia; rarely - increased secretion of gastric juice is possible.
On the part of the kidneys and urinary system: damage to the glomerular apparatus of the kidneys, crystalluria, formation of urate, cystine and/or oxalate stones in the kidneys and urinary tract, renal failure.
Metabolic disorders: zinc and copper metabolism disorders.
From the blood and lymphatic system: thrombocytosis, hyperprothrombinemia, thrombocytopenia, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency of blood cells, hemolysis of erythrocytes, hemolytic anemia may occur.
With prolonged use of the drug in large doses, the following are possible: irritation of the gastrointestinal mucosa, paresthesia, hyperuricemia, transient increase in the activity of aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, decreased glucose tolerance, hyperglycemia, impaired renal function, dryness and cracks on the palms and soles, hair loss, seborrheic rashes, tachycardia, arrhythmia.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Address
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua
