Instructions Neovitam film-coated tablets blister pack No. 30
Composition
active ingredients:
1 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;
shell: Opadry II 57U White film coating mixture (talc, maltodextrin, polydextrose, titanium dioxide (E 171), medium chain triglycerides, hypromellose).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a white or almost white film coating.
Pharmacotherapeutic group
Vitamin B1 in combination with vitamin B6 and/or B12.
ATX code A11D B.
Pharmacological properties
Pharmacodynamics
The drug contains a combination of neurotropic active substances of the B vitamin complex: thiamine (B1), pyridoxine (B6) and cyanocobalamin (B12) are of particular importance as coenzymes in the intermediate metabolism that occurs in the central and peripheral nervous system.
Like all other vitamins, they are essential nutrients that cannot be synthesized directly in the body.
Therapeutic administration of vitamins B1, B6 and B12 into the body replenishes the insufficient intake of vitamins with food, which ensures the presence of the necessary amount of coenzymes in the body. Therapeutic use of these vitamins in various diseases of the nervous system is aimed, on the one hand, at compensating for the simultaneously existing deficiency (possibly due to an increase in the body's needs caused directly by the disease) and, on the other hand, at stimulating natural recovery mechanisms.
Vitamins B1, B6, and B12 have very low toxicity and do not pose a potential risk to humans.
Pharmacokinetics
Thiamine. After internal administration, it undergoes dosed transport, the mechanism of which is dual in nature: active absorption up to a concentration of 2 μmol and passive diffusion at concentrations greater than 2 μmol. The half-life is approximately 4 hours. The human body can accumulate up to 30 mg of thiamine. Due to rapid metabolism, the reserve reserves of the vitamin are very limited and are consumed after 4-10 days.
Pyridoxine. Pyridoxine is absorbed very quickly, mainly in the upper gastrointestinal tract, and is excreted after a maximum of 2-5 hours.
The human body can store approximately 40-150 mg of the vitamin, and 1.7-3.6 mg is excreted in the urine per day.
Cyanocobalamin. Vitamin B12 is absorbed from the gastrointestinal tract by two mechanisms:
release under the action of gastric juice and rapid combination with the intrinsic factor; independent of the intrinsic factor due to passive entry into the blood.
At doses above 1.5 μg, the latter mechanism plays a significant role. Vitamin B12 accumulates mainly in the liver. The metabolic rate is 2.5 μg per day or 0.05% of the stored amount. Vitamin B12 is mainly excreted in the bile and is largely reabsorbed in the enterohepatic circulation.
Indication
As part of the complex therapy of neurological diseases:
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).
Contraindication
Hypersensitivity to any 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
The action of thiamine is inactivated by 5-fluorouracil, as the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.
Antacids reduce thiamine absorption. Loop diuretics that inhibit tubular reabsorption (e.g., furosemide) may, during long-term therapy, cause increased 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 need for vitamin B6. Concomitant use of vitamin B6 may reduce the effectiveness of levodopa.
Application features
The drug should not be used in high doses for more than 4 weeks, as this may provoke neurological symptoms.
Consumption of alcohol and black tea reduces thiamine absorption. Consumption of beverages containing sulfites (e.g. wine) increases thiamine degradation.
When vitamin B12 is administered, the clinical picture, as well as laboratory tests in funicular myelosis or pernicious anemia, may lose their specificity. Patients with neoplasms, except in cases accompanied by megaloblastic anemia and vitamin B12 deficiency, should not use the drug.
The drug is not used in severe or acute forms of cardiac decompensation and angina pectoris.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine does not affect the ability to drive a car or operate other mechanisms.
In cases where dizziness is observed during treatment with the drug, you should refrain from driving vehicles and working with mechanisms.
Use during pregnancy or breastfeeding
The use of the drug is not recommended during pregnancy or breastfeeding.
Method of administration and doses
The 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 can be increased and taken 1 tablet 3 times a day.
The duration of the course of treatment is determined by the doctor individually in each case. After a treatment period of 4 weeks, the doctor decides on adjusting and reducing the doses of the drug.
Children
The use of the drug in children is contraindicated due to the lack of clinical experience.
Overdose
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. Neuropathies with ataxia and sensory disturbances, cerebral convulsions with ECG changes, and, in isolated cases, hypochromic anemia and seborrheic dermatitis have been described after administration of more than 2 g per day.
Excessive use of vitamin B6 in doses of more than 1 g per day for several months can lead to neurotoxic effects.
Vitamin B12: After parenteral administration (very rarely after oral administration) of high doses, 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.
Adverse reactions
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.
Gastrointestinal: gastrointestinal disorders, including nausea, vomiting, diarrhea, abdominal pain, increased acidity of gastric juice.
Immune system disorders: anaphylactic shock, anaphylaxis, skin reactions, including itching, urticaria.
General disorders: chronic abuse of extremely high doses of vitamin B6 can cause sensitivity disorders, increased sweating, tachycardia.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister, 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
