Neurobex-teva

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEUROBEX-TEVA

Composition:

Active substances: thiamine nitrate (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12);

1 tablet contains:

Excipients: lactose monohydrate, wheat starch, talc, magnesium stearate, colloidal silicon dioxide, povidone, Kollicoat Protect, titanium dioxide (E 171),
Ponceau 4R (E 124).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex, film-coated tablets. Color: pink.

Pharmacotherapeutic group. Vitamins. Vitamin B1 preparations in combination with vitamins B6 and B12. ATC code A11DB.

Pharmacological Properties

The action of the drug is determined by the vitamins contained in its composition.

Thiamine (vitamin B1) actively participates in carbohydrate and fat metabolism and is necessary for the synthesis of nucleic acids. It potentiates the action of acetylcholine, which is involved in nerve impulse transmission. It plays an important role in regulating the functions of the muscular and autonomic nervous systems. It enhances tissue respiration and improves oxygen delivery 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 cholesterol breakdown and in the synthesis and nourishment of the peripheral nerve's myelin sheath and axon. Vitamin B6 deficiency leads to the development of neuromuscular dystrophy and convulsions.

Cyanocobalamin (vitamin B12) participates in protein, fat, and carbohydrate metabolism. It prevents fatty degeneration of the liver. It promotes reduction of blood cholesterol levels and its elimination from blood vessels. By stimulating protein synthesis, it normalizes growth and development processes. It regulates hematopoietic processes. By increasing leukocyte phagocytic activity and activating the reticuloendothelial system, it enhances the body's immunological defense.

The components of Neurorubex-Teva are absorbed in the small intestine, bind to plasma proteins, and are distributed in all tissues. They undergo biotransformation in the body and are excreted primarily in the urine (both unchanged and as metabolites).

Clinical characteristics.

Indications.

In complex treatment of neuritis, polyneuritis, and neuralgias, such as:

• trigeminal neuralgia;
• intercostal neuralgia;
• sciatica;
• lumbar syndrome (lumbago);
• plexitis (cervical and brachial plexus);
• radicular neuritis due to degenerative spine diseases;
• facial palsy (facial nerve damage);
• post-infectious and toxic nerve tissue damage in alcoholism, diabetic polyneuropathy, drug intoxication.

Contraindications.

Hypersensitivity to thiamine nitrate, pyridoxine hydrochloride, cyanocobalamin, or to any other components of the drug.

Vitamin B1 is contraindicated in allergic diseases.

Vitamin B6 is contraindicated in peptic ulcer disease of the stomach and duodenum during exacerbation (due to possible increase in gastric juice acidity).

Vitamin B12 is contraindicated in erythremia, erythrocytosis, and thromboembolism.

Interaction with other medicinal products and other forms of interaction.

Ethanol markedly reduces thiamine absorption. The action of thiamine is inactivated by 5-fluorouracil, as the latter competitively inhibits phosphorylation of thiamine into thiamine pyrophosphate. Antacids reduce thiamine absorption. Loop diuretics, such as furosemide, which inhibit tubular reabsorption, may during long-term therapy cause increased excretion of thiamine and thus reduce thiamine levels.

Vitamin B1, by affecting polarization processes at neuromuscular synapses, may weaken the curare-like action of muscle relaxants.

Vitamin B6 is an antagonist of isoniazid and thiosemicarbazones and corrects sideroblastic anemia caused by these antituberculosis agents. Concomitant use with levodopa is contraindicated, as vitamin B6 may reduce the antiparkinsonian effect of levodopa (when used without a dopa-decarboxylase inhibitor) by enhancing peripheral decarboxylation of levodopa. Pyridoxine may reduce blood concentrations of anticonvulsant drugs, such as phenytoin and phenobarbital. Concurrent use with pyridoxine antagonists (e.g., isoniazid, hydralazine, penicillamine, or cycloserine) or oral contraceptives may increase the requirement for vitamin B6. Concurrent administration of vitamin B6 with hydralazine and cycloserine reduces the neurologic adverse reactions caused by these drugs. Pyridoxine may reduce the efficacy of altretamine.

Serum concentration of vitamin B12 may decrease when used concomitantly with oral contraceptives. The clinical significance of this interaction is unclear.

Colchicine, ethyl alcohol, aminoglycosides (neomycin), oral antidiabetic biguanides, aminosalicylic acid, antiepileptic drugs, chloramphenicol, cholestyramine, vitamin C, potassium salts, methyldopa, and antacids (e.g., omeprazole and cimetidine) reduce vitamin B12 absorption. The clinical significance of most of these interactions is likely minor.

Nitrous oxide and general anesthetics may also reduce blood levels of vitamin B12.

Special precautions for use

When vitamin B12 is administered, the clinical picture as well as laboratory findings in funicular myelosis or pernicious anemia may lose their specificity.

Alcohol consumption and black tea reduce thiamine absorption.

The intake of beverages containing sulfites (e.g. wine) increases thiamine degradation.

Since Neurexact-Teva contains vitamin B6, which may increase gastric juice acidity, the drug should be used with caution in patients with a history of peptic ulcer of the stomach and duodenum, and in those with pronounced impairment of renal and hepatic function.

The drug should not be administered to patients with neoplastic diseases, except in cases associated with megaloblastic anemia and vitamin B12 deficiency. The drug is contraindicated in severe or acute forms of cardiac decompensation and angina pectoris.

Since Neurexact-Teva contains lactose as an excipient, it should not be administered to patients with lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome. The drug contains wheat starch; therefore, it should not be administered to patients with wheat allergy (other than celiac disease). Neurexact-Teva can be used in patients with celiac disease.

The dye Ponceau 4R (E 124) may cause allergic reactions.

Use during pregnancy or breastfeeding

The drug should be prescribed only after careful assessment of the benefit-risk ratio for the mother and the fetus, 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 suppress lactation. Studies on the extent of vitamin secretion into breast milk have not been conducted. The decision whether to discontinue breastfeeding or to refrain from using the drug should be based on the necessity of treatment for the mother. If use of the drug is necessary, breastfeeding should be discontinued during this period.

Ability to affect reaction speed when driving or operating machinery

The drug does not affect the ability to drive or operate complex machinery. However, if dizziness occurs during treatment with the drug, patients should refrain from driving vehicles or operating machinery.

Dosage and Administration.

Neurobex-Teva should be taken orally, during or after meals, without chewing, with water.

For adults: 2-3 tablets 3-4 times daily for 30 days.

The individual dose and duration of treatment should be determined by a physician.

Children.

The drug should not be administered to children.

Overdose.

Overdose leads to intensification of adverse reactions associated with the use of the drug. Nervous excitement, tachycardia, and chest pain may occur.

Vitamin B1: has a wide therapeutic range. Very high doses (over 10 g) may produce a curare-like effect, suppressing the conduction of nerve impulses.

Vitamin B6: has very low toxicity. Prolonged use (over 6–12 months) at doses exceeding 50 mg of vitamin B6 daily may lead to peripheral sensory neuropathy.

Excessive use of vitamin B6 at doses over 1 g per day for several months may result in neurotoxic effects.

Neuropathies with ataxia and sensory disturbances, cerebral seizures with EEG changes, and in isolated cases hypochromic anemia and seborrheic dermatitis have been reported after administration of vitamin B6 exceeding 2 g per day.

Vitamin B12: after parenteral administration (rarely after oral use), exceeding the recommended doses of the drug has been associated with allergic reactions, eczematous skin disorders, and benign forms of acne.

Prolonged use of vitamin B12 in high doses may lead to impaired liver enzyme activity, chest pain, and hypercoagulation.

Treatment. Gastric lavage, administration of activated charcoal, and symptomatic therapy. Isoniazid should be used as an antidote for vitamin B6 overdose.

Adverse reactions.

Adverse effects are unlikely when taking this medication. However, in individual cases when using the drug in this pharmaceutical form, the following adverse effects are possible.

From the nervous system: prolonged use (over 6–12 months) at doses exceeding 50 mg of vitamin B6 daily may lead to peripheral sensory neuropathy, nervous excitement, malaise, dizziness, headache.

From the gastrointestinal tract: gastrointestinal disturbances, including nausea, vomiting, diarrhea, abdominal pain, increased gastric juice acidity.

From the immune system: hypersensitivity reactions; excessive sweating, dyspnea, anaphylactic shock, anaphylaxis.

From the endocrine system: high concentrations of vitamin B6 may suppress lactation.

From the cardiovascular system: tachycardia, collapse.

From the skin: allergic reactions, including pruritus, rash, urticaria.

Shelf life. 2 years.

Storage conditions.

Store in a dry, light-protected place at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

60, 90, or 150 tablets in a plastic bottle. One bottle per cardboard box.

Availability.

Over-the-counter.

Manufacturer.

Balkanpharma-Dupnitsa AD;
Balkanpharma-Razgrad AD.

Manufacturer's address and location of business activity.

3 Samokovsko Shose Str., Dupnitsa, 2600, Bulgaria;
68 Aprilsko Vastanie Blvd., Razgrad, 7200, Bulgaria.