NEUROMAX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEUROMAX (NEUROMAX)

Composition:

Active substances: pyridoxine hydrochloride, benfotiamine;

1 tablet contains pyridoxine hydrochloride 100 mg, benfotiamine 100 mg;

Excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, talc, povidone, calcium stearate, maize starch, dry mixture "Opadry II white" containing titanium dioxide (E 171), talc, polyethylene glycol, polyvinyl alcohol.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets, white or almost white, round, biconvex.

Pharmacotherapeutic group. Vitamin B1 preparations in combination with vitamin B6.

ATC code A11D B.

Pharmacological properties.

Pharmacodynamics.

Neurotropic vitamins of group B exert a beneficial effect on the course of inflammatory and degenerative diseases of nerves and the musculoskeletal system. They should be used to correct deficiency conditions; in high doses, these vitamins possess analgesic properties, promote improvement of blood circulation, and normalize the function of the nervous system and hematopoiesis.

Pharmacokinetics.

Vitamin B6 and its derivatives are mostly rapidly absorbed in the upper gastrointestinal tract via passive diffusion and are excreted within 2–5 hours.

Clinical characteristics.

Indications.

Neurological disorders caused by proven deficiency of vitamins B1 and B6.

Contraindications.

Hypersensitivity to the components of the drug.

Vitamin B1 is contraindicated in allergic reactions.

Vitamin B6 is contraindicated in peptic ulcer disease of the stomach and duodenum during exacerbation (since it may increase gastric juice acidity).

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

Pyridoxine is incompatible with drugs containing levodopa, because simultaneous administration enhances peripheral decarboxylation of levodopa and thereby reduces its antiparkinsonian effect.

Benfotiamine is incompatible with oxidizing and reducing agents: mercury chloride, iodide, carbonate, acetate, tannic acid, iron-ammonium citrate, as well as with sodium phenobarbital, riboflavin, benzylpenicillin, glucose, and metabisulfite, since it is inactivated in their presence. Copper accelerates the degradation of benfotiamine; in addition, thiamine loses its activity at increased pH values (above 3).

Thiamine is inactivated by 5-fluorouracil, as the latter competitively inhibits phosphorylation of thiamine to thiamine pyrophosphate.

Antacids reduce thiamine absorption.

Loop diuretics (e.g., furosemide), which inhibit tubular reabsorption, during long-term therapy may cause increased excretion of thiamine and thus reduce thiamine levels.

Concomitant use of pyridoxine antagonists (e.g., isoniazid, hydralazine, D-penicillamine, or cycloserine), alcohol, as well as prolonged use of oral contraceptives containing estrogens, may lead to vitamin B6 deficiency.

Alcohol and black tea consumption reduces thiamine absorption.

Beverages containing sulfites (e.g., wine) enhance thiamine degradation.

Pyridoxine may reduce the efficacy of altretamine.

Special precautions for use.

The decision on the use of Neuromax in patients with severe or acute decompensated heart failure is made individually by a physician, taking into account the patient's condition.

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

Since Neuromax contains vitamin B6, this medicinal product should be prescribed with caution to patients with a history of peptic ulcer of the stomach and duodenum, or severe hepatic and renal insufficiency.

Neuromax must not be used in patients with neoplastic diseases, except in cases associated with megaloblastic anemia and vitamin B12 deficiency. The drug is not used in severe or acute forms of decompensated cardiac dysfunction or in angina pectoris.

If signs of peripheral sensory neuropathy (paresthesia) occur, the dosage should be reassessed and administration of Neuromax should be discontinued if necessary. Peripheral neuropathy has been observed with prolonged use (more than 6–12 months) of daily doses exceeding 50 mg of vitamin B6, as well as with short-term use (more than 2 months) of more than 1 g of vitamin B6 per day. Therefore, ongoing monitoring is recommended during long-term treatment.

Use during pregnancy or breastfeeding.

The daily requirement for vitamin B6 during pregnancy and breastfeeding is up to 2.5 mg.

During pregnancy or breastfeeding, the recommended daily intake is vitamin B1 in a dose of 1.4–1.6 mg and vitamin B6 in a dose of 2.4–2.6 mg.

There is no evidence supporting the use of higher doses compared to the recommended daily allowances.

Vitamins B1 and B6 are excreted into breast milk.

High doses of vitamin B6 may interfere with milk production.

The product contains 100 mg of vitamin B6; therefore, it should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Since the drug may cause adverse effects such as dizziness, headache, and tachycardia in some patients, caution should be exercised when driving or operating machinery.

Dosage and Administration.

Take orally, swallowing with sufficient amount of liquid.

The recommended dose is 1 tablet per day. In individual cases, the dose may be increased to 1 tablet three times a day.

Tablets should be taken whole, with liquid, after meals.

The duration of treatment is determined individually by a physician. After the maximum treatment period (4 weeks), a decision on dose adjustment and reduction should be made.

Children.

The efficacy and safety of the drug in children have not been established; therefore, it should not be prescribed to this age group of patients.

Overdose.

In case of overdose, symptoms of adverse drug reactions are intensified.

Treatment: gastric lavage, administration of activated charcoal. Symptomatic therapy.

With chronic use in high doses, impaired hepatic enzyme activity, cardiac pain, and hypercoagulability may occur.

Thiamine has a wide therapeutic range. High doses (more than 10 g) of vitamin B1 may produce a ganglionic blocking, curare-like effect and suppress nerve impulse conduction.

Continuous use of vitamin B6 in doses exceeding 1 g per day for longer than 2 months may lead to neurotoxic effects.

Long-term use (more than 6–12 months) in doses exceeding 50 mg of vitamin B6 daily may result in peripheral sensory neuropathy.

Long-term use of vitamin B1 in doses exceeding 2 g per day has been associated with neuropathy with ataxia and sensory disturbances, cerebral seizures with EEG changes, and in individual cases – hypochromic anemia and seborrheic dermatitis.

Adverse Reactions.

Gastrointestinal system: nausea, vomiting, diarrhea, abdominal pain, increased gastric juice acidity.

Cardiovascular system: tachycardia.

Immune system: hypersensitivity reactions, including anaphylactic shock; anaphylaxis; urticaria.

Skin: skin rashes, pruritus.

In very rare cases – shock.

Nervous system: long-term use (more than 6–12 months) at doses exceeding 50 mg of vitamin B6 daily may lead to peripheral sensory neuropathy, nervous excitement, dizziness, headache.

Endocrine system: inhibition of prolactin secretion.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Film-coated tablets, 30 (10×3), 60 (10×6) in blisters in a carton.

Dispensing category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business.

22 Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.