Instructions Neurobex film-coated tablets, can No. 90
Composition
active ingredients: thiamine nitrate (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12);
1 tablet contains: thiamine nitrate (vitamin B1) 15 mg; pyridoxine hydrochloride (vitamin B6) 10 mg; cyanocobalamin (vitamin B12) 0.02 mg;
excipients: lactose monohydrate, wheat starch, talc, magnesium stearate, colloidal silicon dioxide, povidone, Kollicoat Protect, titanium dioxide (E 171),
Ponceau 4R (E 124).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, film-coated. Color – pink.
Pharmacotherapeutic group
Vitamins. Vitamin B1 preparations in combination with vitamins B6 and B12. ATX code A11D B.
Pharmacological properties
Pharmacodynamics
The effect of the drug is determined by the vitamins that are part of it.
Thiamine (vitamin B1) takes an active part in the metabolism of carbohydrates and fats, is necessary for the synthesis of nucleic acids. Potentiates the action of acetylcholine, which is involved in the transmission of nerve impulses. Plays an important role in regulating the functions of the muscular and autonomic nervous systems. Enhances tissue respiration, improves the supply of oxygen to skin cells.
Pyridoxine (vitamin B6) is a component necessary for the metabolism of amino acids, fats and carbohydrates, as well as for the synthesis of physiological regulators such as serotonin and histamine. It participates in the breakdown of cholesterol, the synthesis and nutrition of the myelin sheath of the peripheral nerve and axon. Vitamin B6 deficiency leads to the development of neuromuscular dystrophy and seizures.
Cyanocobalamin (vitamin B12) participates in protein, fat and carbohydrate metabolism. Prevents fatty degeneration of the liver. Helps reduce cholesterol levels in the blood and its removal from blood vessels. Stimulating protein synthesis, normalizes growth and development processes. Regulates hematopoiesis processes. Increasing the phagocytic activity of leukocytes and activating the activity of the reticuloendothelial system, strengthens the body's immunological defenses.
The components of the Neurobex-Teva complex are absorbed in the small intestine, bind to blood plasma proteins, and are distributed in all tissues. They undergo biotransformation in the body and are excreted mainly in the urine (both unchanged and in the form of metabolites).
Indication
In the complex treatment of neuritis, polyneuritis and neuralgia, such as:
trigeminal neuralgia; intercostal neuralgia; sciatica; lumbar syndrome (lumbago); plexitis (cervical and brachial plexuses); radicular neuritis due to degenerative diseases of the spine; prosoplegia (facial nerve damage); post-infectious and toxic lesions of nervous tissue in alcoholism, diabetic polyneuropathy, drug intoxication.
Contraindication
Hypersensitivity to thiamine nitrate, pyridoxine hydrochloride, cyanocobalamin and any other components of the drug.
Vitamin B1 is contraindicated for use in allergic diseases.
Vitamin B6 is contraindicated for use in cases of gastric and duodenal ulcers in the acute stage (since increased acidity of gastric juice is possible).
Vitamin B12 is contraindicated for use in erythremia, erythrocytosis, and thromboembolism.
Interaction with other medicinal products and other types of interactions
Ethanol sharply reduces the absorption of thiamine. The action of thiamine is inactivated by 5-fluorouracil, since the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate. Antacids reduce the absorption of thiamine. Loop diuretics, such as furosemide, which inhibit tubular reabsorption, during long-term therapy can cause increased excretion of thiamine and, thus, reduce the level of thiamine.
Vitamin B1, by influencing the polarization processes in the areas of neuromuscular synapses, can weaken the curare-like effect of muscle relaxants.
Vitamin B6 is an antagonist of isoniazid and thiosemicarbazones, corrects sideroblastic anemia caused by these antituberculosis drugs. Concomitant use with levodopa is contraindicated, since vitamin B6 may reduce the antiparkinsonian effect of levodopa (when used without a dopa decarboxylase inhibitor) by increasing peripheral decarboxylation of levodopa. Pyridoxine may reduce the blood concentration of anticonvulsants, such as phenytoin, phenobarbital. Concomitant use with pyridoxine antagonists (such as isoniazid, hydralazine, penicillamine or cycloserine), oral contraceptives may increase the need for vitamin B6. Concomitant use of vitamin B6 with hydralazine and cycloserine reduces the neurological adverse reactions caused by these drugs. Pyridoxine may reduce the effectiveness of altretamine.
Colchicine, ethanol, aminoglycosides (neomycin), oral antidiabetic agents from the biguanide group, aminosalicylic acid, antiepileptic agents, chloramphenicol, cholestyramine, vitamin C, potassium salts, methyldopa and antacids (e.g. omeprazole and cimetidine) reduce the absorption of vitamin B12. The clinical significance of most interactions is probably small.
Nitrous oxide and general anesthetics can also lower vitamin B12 levels in the blood.
Application features
When using vitamin B12, the clinical picture, as well as laboratory tests in funicular myelosis or pernicious anemia, may lose their specificity.
Drinking alcohol and black tea reduces the absorption of thiamine.
Consumption of beverages containing sulfites (e.g. wine) increases the degradation of thiamine.
Since Neurobex-Teva contains vitamin B6, which can cause increased acidity of gastric juice, the drug should be used with caution in patients with a history of peptic ulcer of the stomach and duodenum, with severe renal and hepatic dysfunction.
Patients with neoplasms, except for cases accompanied by megaloblastic anemia and vitamin B12 deficiency, should not use the drug. The drug should not be used in severe or acute forms of cardiac decompensation and angina pectoris.
Since Neurobex-Teva contains lactose as an excipient, it should not be used in patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome. The preparation contains wheat starch, therefore patients with wheat allergy (different from celiac disease) should not use this medicine. Neurobex-Teva can be used in patients with celiac disease.
Ponceau 4R dye (E 124) may cause allergic reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or operate complex mechanisms. If dizziness occurs during treatment with the drug, you should refrain from driving or operating mechanisms.
Use during pregnancy or breastfeeding
The drug should be prescribed only after careful assessment of the benefit-risk ratio for the mother, as there is insufficient data on the safety of the drug during pregnancy.
Vitamins B1, B6 and B12 are excreted in breast milk. High concentrations of vitamin B6 may inhibit lactation. Studies on the extent of secretion of vitamins into breast milk have not been conducted. The decision to discontinue breastfeeding or use of the drug should be made taking into account the need for the drug to the mother. If necessary, breast-feeding should be discontinued for this period.
Method of administration and doses
Neurobex-Teva should be taken orally, during or after meals, without chewing, with water.
Adults should be prescribed 2-3 tablets 3-4 times a day for 30 days.
The individual dose and duration of treatment is determined by the doctor.
Children
The drug should not be prescribed to children.
Overdose
In case of overdose, adverse reactions associated with the use of the drug are intensified. Nervous excitement, tachycardia, and pain in the heart area may occur.
Vitamin B1: has a wide therapeutic range. Very high doses (more than 10 g) exhibit a curare-like effect, inhibiting the conduction of nerve impulses.
Vitamin B6: has very low toxicity. Long-term use (over 6-12 months) in doses greater than 50 mg of vitamin B6 daily may lead to peripheral sensory neuropathy.
Excessive use of vitamin B6 in doses greater than 1 g per day for several months can lead to neurotoxic effects.
Neuropathies with ataxia and sensory disturbances, cerebral convulsions with EEG changes, and in isolated cases hypochromic anemia and seborrheic dermatitis have been described after administration of vitamin B6 in excess of 2 g per day.
Vitamin B12: After parenteral administration (in rare cases, after oral administration) of more than recommended doses of the drug, allergic reactions, eczematous skin disorders, and benign acne have been observed.
Prolonged use of vitamin B12 in high doses may cause liver enzyme abnormalities, pain in the heart area, and hypercoagulation.
Treatment: Gastric lavage, administration of activated charcoal and symptomatic agents. Isoniazid should be used as an antidote to vitamin B6.
Adverse reactions
Side effects are unlikely when taking the drug. In some cases, the following side effects are possible when taking the drug in this dosage form.
On the part of the nervous system: long-term use (over 6-12 months) in doses exceeding 50 mg of vitamin B6 daily can lead to peripheral sensory neuropathy, nervous excitement, malaise, dizziness, and headache.
On the part of the digestive tract: gastrointestinal disorders, including nausea, vomiting, diarrhea, abdominal pain, increased acidity of gastric juice.
On the part of the endocrine system: high concentrations of vitamin B6 may suppress lactation.
Cardiovascular system: tachycardia, collapse.
Skin: allergic reactions, including itching, rash, urticaria.
Expiration date
2 years.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
90 tablets in a plastic jar. 1 jar in a cardboard box.
Vacation category
Without a prescription.
Producer
Balkanfarma-Dupnytsia JSC.
Location of the manufacturer and its business address
3 Samokovskoe Shose St., Dupnitsa, 2600, Bulgaria.
