Neovitam

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEOVITAM (NEOVITAM)

Composition:

Active substances:

One tablet contains: vitamin B1 (thiamine hydrochloride) 100 mg; vitamin B6 (pyridoxine hydrochloride) 200 mg; vitamin B12 (cyanocobalamin) 0.2 mg;

Excipients: microcrystalline cellulose, magnesium stearate, povidone;

Coating: Opadry II 57U White film-coating mixture: talc, maltodextrin, polidextrose, titanium dioxide (E 171), medium-chain triglycerides, hypromellose.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: white or almost white, round, biconvex tablets with a film coating.

Pharmacotherapeutic group. Vitamin B1 in combination with vitamin B6 and/or B12.

ATC code A11D B.

Pharmacological Properties

Pharmacodynamics

The medicinal product contains a combination of neurotropic active substances, the B vitamins complex: thiamine (B1), pyridoxine (B6), and cyanocobalamin (B12). These play an essential role as coenzymes in intermediate metabolism occurring in the central and peripheral nervous systems.

Like all other vitamins, they are essential nutrients that cannot be synthesized directly in the body.

Therapeutic administration of vitamins B1, B6, and B12 compensates for insufficient dietary intake, thus ensuring adequate levels of coenzymes in the body. Therapeutic use of these vitamins in various nervous system disorders aims, on one hand, to compensate for existing deficiencies (possibly due to increased bodily requirements caused directly by the disease) and, on the other hand, to stimulate natural recovery mechanisms.

Vitamins B1, B6, and B12 have very low toxicity and do not pose a potential risk to humans.

Pharmacokinetics

Thiamine. After oral administration, thiamine undergoes dose-dependent transport, a process with a dual mechanism: active absorption at concentrations up to 2 µmol and passive diffusion at concentrations exceeding 2 µmol. The elimination half-life is approximately 4 hours. The human body can store up to 30 mg of thiamine. However, due to rapid metabolism, vitamin reserves are very limited and are depleted within 4–10 days.

Pyridoxine. Pyridoxine is absorbed very rapidly, primarily in the upper gastrointestinal tract, and is excreted within a maximum of 2–5 hours.

The human body can store approximately 40–150 mg of the vitamin, with 1.7–3.6 mg excreted in urine per day.

Cyanocobalamin. Vitamin B12 is absorbed from the gastrointestinal tract via two mechanisms:

• release under the influence of gastric juice and rapid binding to intrinsic factor;
• independent of intrinsic factor, through passive entry into the bloodstream.

At doses exceeding 1.5 µg, the latter mechanism plays a significant role. Vitamin B12 is primarily stored in the liver. The rate of metabolism is 2.5 µg per day, or 0.05% of the stored amount. Vitamin B12 is mainly excreted in bile and is largely reabsorbed during enterohepatic circulation.

Clinical characteristics.

Indications.

As part of complex therapy for neurological disorders:

• Trigeminal neuralgia;
• Intercostal neuralgia;
• Ischialgia;
• Lumbar syndrome (lumbago);
• Plexitis (cervical and brachial plexus);
• Radicular neuritis due to degenerative spine diseases;
• Facial palsy (facial nerve damage).

Contraindications.

Hypersensitivity to any component of the drug.

Vitamin B1 is contraindicated in allergic diseases.

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

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

Interaction with other medicinal products and other forms of interactions.

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 that inhibit tubular reabsorption (e.g., furosemide), during long-term therapy, may increase thiamine excretion and thus reduce thiamine levels.

Concomitant use with pyridoxine antagonists (e.g., isoniazid, hydralazine, penicillamine, or cycloserine), or oral contraceptives may increase the requirement for vitamin B6. When used concomitantly, vitamin B6 may reduce the effectiveness of levodopa.

Alcohol and black tea consumption decreases thiamine absorption.

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

Special precautions for use.

The medicinal product should not be used in high doses for more than 4 weeks, as this may provoke neurological symptoms.

Alcohol and black tea consumption reduces thiamine absorption. Consumption of beverages containing sulfites (e.g., wine) increases thiamine degradation.

Since the medicinal product contains vitamin B6, it should be used with caution in patients with a history of peptic ulcer of the stomach and duodenum, and in those with pronounced renal or hepatic impairment.

When vitamin B12 is administered, the clinical picture as well as laboratory findings in funicular myelosis or pernicious anemia may lose their specificity. The medicinal product should not be used in patients with neoplasms, except in cases associated with megaloblastic anemia and vitamin B12 deficiency.

The medicinal product is contraindicated in severe or acute decompensated heart failure and in angina pectoris.

Use during pregnancy or breastfeeding.

Use of the medicinal product is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product does not affect the ability to drive a vehicle or operate machinery.

If dizziness occurs during treatment with the medicinal product, patients should refrain from driving or operating machinery.

Method of Administration and Dosage

Tablets should be taken after meals, without chewing, with a small 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.

The duration of treatment is determined individually by the physician. After a 4-week treatment period, the physician decides on dose adjustment and reduction.

Children.

The use of the medicinal product in children is contraindicated due to lack of clinical experience.

Overdose.

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

Vitamin B6: has very low toxicity. Neuropathies with ataxia and sensory disturbances, cerebral convulsions with ECG changes, as well as, in individual cases, hypochromic anemia and seborrheic dermatitis, have been reported after administration of more than 2 g per day.

Excessive use of vitamin B6 in doses exceeding 1 g per day over several months may lead to neurotoxic effects.

Vitamin B12. Allergic reactions, eczematous skin disorders, and benign forms of acne have been observed after parenteral administration (very rarely – after oral administration) of high doses.

Prolonged use of high-dose vitamin B12 may lead to impaired liver enzyme activity, chest pain, and hypercoagulability.

Side effects.

Central 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.

Gastrointestinal tract: gastrointestinal disturbances, including nausea, vomiting, diarrhea, abdominal pain, increased gastric acidity.

Renal and urinary tract: chromaturia.

Immune system: anaphylactic shock, anaphylaxis, skin reactions, including pruritus, urticaria, rash.

General disorders: chronic abuse of extremely high doses of vitamin B6 may cause sensory disturbances, increased sweating, tachycardia.

Shelf life. 3 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 pack; 3 blisters per carton.

Availability. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity.

38 Kopilivska St., Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua