Translation of the instruction Mose

dragee HEXAVITUM

Instruction

On medical use of medicine

Hexavitum

(hexavit)

Ingredients:

Active ingredients, retinol (vit a), thiamine (vit b]), riboflavin (vit b2), pyridoxine (vit be), ascorbic acid (vit c), nicotinamide;

1 dragee substance — 1.72 mg (5000 ME), thiamine of a hydrochloride (B1 vitamin) in terms of 100% contains Retinolum of acetate (vitamin A) in terms of 100% substance — 2 mg, Riboflavinum ( _{2 vitamin B} ) in terms of 100% substance — 2 mg, a pyridoxine of a hydrochloride (B6 vitamin) in terms of 100% substance — 2 mg, ascorbic acid (vitamin C) in terms of 100% substance — 70 mg, niacinamide in terms of 100% substance — 15 mg; excipients: wheat flour, starch syrup, sugar, peppermint oil, wax yellow, sunflower oil, talc:.

Dosage form.

Dragee.

Main physical and chemical properties: a dragee from yellow till orange color, a sharopodobny form, with a surface, smooth, uniform in coloring. Existence of a specific smell is allowed.

Pharmacotherapeutic group.

Vitamins. polyvitaminic complexes without additives:.

ATX A11B A Code.

Pharmacological properties.

Pharmacological effect of medicament is defined by properties of the vitamins which are it a part. medicament regulates metabolic processes, normalizes a metabolism. pharmakodin amika.

Vitamin A (Retinolum acetate) plays a key role in synthesis of proteins-enzymes and structural components of fabrics, is necessary for forming of epithelial cells, bones and synthesis of rhodopsin, supports division of immunocompetent cells, synthesis of immunoglobulins and other factors of protection against infections:.

B Vitamin, (thiamine a hydrochloride) — the coenzyme in metabolism of carbohydrates, takes part in functioning of nervous system.

_{2 Vitamin B} (Riboflavinum) catalyst of processes of cellular respiration and visual perception.

Vitamin of Wb (a pyridoxine a hydrochloride) as the coenzyme takes part in protein metabolism and synthesis of neurotransmitters.

Vitamin C (ascorbic acid) takes part in oxidation-reduction processes of an organism, hemoglobin synthesis, influences exchange of amino acids, accelerates absorption of iron from digestive tract, increases nonspecific resistance of an organism, is necessary for growth and forming of bones, skins, teeth and for normal functioning of the nervous and immune system.

Niacinamide takes part in processes of tissue respiration, carbohydrate and lipidic metabolism.

Pharmacokinetics.

medicament is well absorbed by

After intake from a small intestine in a system blood stream, gets into all bodies and fabrics.

Clinical characteristics.

Indication.

• Prevention and treatment of hypovitaminoses; at long-term treatment by antibiotics; for strengthening of body resistance to infectious diseases.

Contraindication.

Hypersensitivity to separate components of drug, heavy renal failures, gout, a hyperuricemia, tendency to thromboses, thrombosis, thrombophlebitis, a thrombembolia, a sarcoidosis in the anamnesis, a nephrolithiasis, intolerance of fructose, a glucose galactose sprue, a hypervitaminosis and, a chronic glomerulonephritis, a peptic ulcer of a stomach and duodenum in an aggravation phase (in connection with possible increase in acidity of gastric juice), virazhenny abnormal liver functions, active hepatitis, arterial hypertension (severe forms), disturbance of exchange of iron or copper.

Interaction with other medicines and other types of interactions.

is not recommended to appoint Hexavitum together with other polyvitamins as the overdose of the last in an organism is possible.

Retinolum reduces protivospalitelny action of glucocorticoids. It is impossible to accept along with nitrites and holestiraminy because they break Retinolum absorption. It is not necessary to appoint vitamin A with retinoids as their combination is toxic.

Tiamin's

a hydrochloride, influencing processes of polarization in the field of neuromuscular synapses, can weaken kurarepodobny action of muscle relaxants.

Riboflavinum is incompatible

with streptomycin and reduces efficiency of antibacterial medicaments (Oxytetracyclinum, doxycycline, erythromycin, tetracycline and lincomycin). Tricyclic antidepressants, Imipraminum and amitriptyline inhibit Riboflavinum metabolism, especially in heart tissues.

Vitamin the Wb weakens action of a levodopa and strengthens effect of diuretics, warns or reduces the toxic phenomena which take place at reception of an isoniazid and other antituberculous remedies.

Vitamin C strengthens action and toxicity of streptocides (possibility of a crystalluria), penicillin, increases iron absorption, aluminum absorption (to consider at simultaneous treatment by antacids which contain aluminum), reduces efficiency of heparin and indirect coagulants;. High doses of medicament reduce efficiency of tricyclic antidepressants, neuroleptics — derivatives of a fenotiazin, a canalicular reabsorption of amphetamine, break removal of a meksiletin kidneys.

Ascorbic acid can be accepted only in 2 hours after Deferoxaminum injection. Long reception of high doses of medicament reduces efficiency of treatment by Disulfiramum. Ascorbic acid increases the general clearance of alcohol. Ascorbic acid strengthens discharge of oxalates with urine and increases risk of a crystalluria at treatment by salicylates.

Absorption of vitamin C decreases at simultaneous use with oral contraceptives, the use of fruit or vegetable juice, alkaline drink:.

to

At use of niacinamide with lovastatiny it was reported about rhabdomyolysis cases.

Feature of use.

At use of medicament needs to adhere to a dosage and duration of a course of reception.

should appoint Medicine by

with care the patient with acute nephrite, an urolithiasis, at severe damages of a liver, in gastrointestinal diseases, a round ulcer of a stomach and duodenum in the anamnesis, coronary heart disease, at a decompensation of warm activity, dystrophic heart diseases, in diseases of bodies of a hemopoiesis, at iron metabolism disturbances (hemosiderosis, hemochromatosis, a thalassemia), cholelithiasis, in chronic pancreatitis, allergic diseases, an idiosyncrasy, in diabetes, in glaucoma, hemorrhages, arterial hypotension of moderate degree. At use of medicine the control of arterial blood pressure and a condition of kidneys is necessary:.

Should be taken in attention that use of ascorbic acid in high doses can change some laboratory indicators (glucose in blood, transaminases, uric acid, creatinine). The concomitant use of ascorbic acid with alkaline drink reduces its absorption therefore it is not necessary to wash down means with alkaline mineral water. Not to accept medicine with hot drinks (especially coffee), alcohol. It is not recommended to accept medicine at the end of the day as ascorbic acid has easy promoting effect. At medicament use, as well as other polyvitaminic drugs, the full-fledged proteinaceous diet which promotes the best digestion and exchange of vitamins, especially water-soluble is necessary.

to Women who accepted high doses of Retinolum (more than 10000 ME) can plan pregnancy not earlier than in 6–12 months as throughout this time there is a risk of maldevelopment of a fruit under the influence of the high content of vitamin A in an organism.

is not recommended to appoint Drug together with other medicines which contain vitamins as the overdose of the last in an organism is possible:.

Drug contains sugar that should be considered to patients, sick diabetes. Coloring of urine in yellow color is possible that is absolutely harmless factor and is explained by existence in Riboflavinum drug.

Use during pregnancy or feeding by a breast.

Use during pregnancy or feeding by a breast perhaps only in the preventive purposes after consultation of the doctor with strict observance of the recommended doses, taking into account advantage of advantage to mother over potential risk for the fruit/child. for prevention of risk of teratogenic effect in p-highway trimesters of pregnancy and during feeding by a breast Hexavitum can be used only with the preventive purpose, no more than 1 dragee a day are exclusive according to purpose and under control of the doctor in a dose.

Dose of vitamin A should not exceed

5000 ME for pregnant women and women who plan pregnancy.

should not accept high doses of Retinolum (more than 10000 ME) to women during feeding by a breast because of threat of development in babies of a hypervitaminosis And.

Ability to influence speed of response at control of motor transport or other mechanisms.

Data on influence on speed of response at control of motor transport or other mechanisms are absent, but drivers and operators of difficult mechanisms should consider a likelihood of development of such side effects as dizziness, drowsiness, a disorder of vision.

Route of administration and doses.

Hexavitum to accept

inside after a meal.

Adult

Treatment: on 1 dragee 3 times a day.

Prevention of hypovitaminoses: on 1 dragee a day.

Children since 14 years.

Treatment of hypovitaminoses: on 1 dragee a day.

Pregnant women and women during feeding by a breast

Prevention of hypovitaminoses: in ІІ-ІІІ pregnancy trimesters and also during feeding a breast to appoint 1 dragees a day (maximum daily dose). Duration of a preventive course is determined by the doctor individually. The pregnant women and mothers nursing cannot apply medical doses.

can use Drug within 30 days. To repeat a course of treatment 2–3 times a year. Duration of reception and repeatability of courses of therapy depends on specific indications, expressivenesses and forms of pathological process, age of the patient.

Children.

to Children up to 14 years the use of medicament is contraindicated to

.

Overdose.

Symptoms: the dispepsichesky phenomena (nausea, vomiting, pain in a stomach, an eructation, a constipation, diarrhea), allergic reactions (itching, skin rashes), changes from skin and hair, an abnormal liver function, drowsiness, slackness, irritability, a headache, hyperaemia of the person. in such cases the administration of medicament should be stopped.

Treatment: symptomatic therapy, gastric lavage, sorbents.

At prolonged use of vitamin C in high doses the oppression of function of the insulyarny device of a pancreas, change of renal secretion of ascorbic and uric acids is possible

during acetylation of urine with risk of settling out of oxalic concrements.

Side reactions.

At use of medicament in the recommended doses side reactions are very seldom possible

:

from the immune system, at persons with hypersensitivity to components of medicine allergic reactions, including an acute anaphylaxis, a Quincke's edema, a hyperthermia are possible

• , it is rare — a bronchospasm at persons with hypersensitivity to vitamins A, With, group B vitamins;
• from a cardiovascular system: arterial hypertension;
• from skin and hypodermic fabrics: skin rashes, urticaria, feeling of an itching, erubescence, xeroderma;
• from digestive tract: stomach ache, eructation, constipation, increase in secretion of gastric juice, dispepsichesky disorders, nausea, vomiting, diarrhea;
• from nervous system: headache, dizziness, hyperexcitability, drowsiness, perspiration, sleep disorder; inflows which are followed by heart consciousness; increased fatigue, irritability;
• from organs of sight: disorder of vision, dryness of a mucous membrane of eyes;
• from outside, metabolism: kristash_uriya, glucosuria;
• from the system of blood and lymphatic system: disturbance of blood clotting, hemolysis of erythrocytes at patients with insufficiency glyukozo-6-fosfatdegidrogenazy;
• datas of laboratory: disturbance of blood clotting, crystalluria, glucosuria;
• others: coloring of urine in yellow color is possible’.

during long reception of high doses the following side reactions can arise:

• from a metabolism: decrease in tolerance to glucose, a hyperglycemia, disturbance of exchange of zinc, copper;
• from nervous system: paresthesias, spasms, anorexia;
• from a cardiovascular system: arrhythmias, arterial hypotension;
• from the system of blood and lymphatic system: erythrocytopenia, neutrophylic leukocytosis;
• from outside, digestive tract: gastrointestinal disturbances, irritation of a mucous membrane of a gastric path, tranzitorny increase in activity of aspartate aminotransferase (ACT), lactate dehydrogenase (LDG), alkaline phosphatase;
• from skin and hypodermic fabrics: hair loss, seborrheal rashes, dryness and cracks of a pas palms and stupnyakh, hyperpegmentation;
• from kidneys and lyuchevyvodyashchy ways: renal failure, renal failure;
• from a liver and biliary tract: jaundice, fat dystrophy of a liver;
• from musculoskeletal and connecting fabrics: myalgia, myopathy;
• datas of laboratory: disturbance of electrolytic balance, hyperuricemia.

Expiration date.

1 year.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Packing

On 50 dragees in a container.

On 50 dragees in a container, on 1 container in a pack.

Category of release.

Without prescription.

Producer.

PJSC vitaminy.

Location of the producer and its address of location of activity.

20300, Ukraine, Cherkassk Region, Uman, st. of a Lenin spark, 31.

Applicant.

PJSC vitaminy.

Location of the applicant and/or applicant's representative.

20300, Ukraine, the Cherkassk Region, at. man, st. of a Lenin spark, 31.