NEUROBEX 15mg/10mg/0.02mg x 60 tabl
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Neurobex 15 mg/10 mg/0.02 mg film-coated tablets
Neurobex 15 mg/10 mg/0.02 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg thiamine nitrate (vitamin B1), 10 mg pyridoxine hydrochloride (vitamin B6) and 0.02 mg cyanocobalamin (vitamin B12).
Excipients with known effect:
Each film-coated tablet contains 35 mg lactose monohydrate, 22 mg wheat starch and colouring agent E124.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Pink, round, biconvex film-coated tablets
4. CLINICAL DATA
4.1 Therapeutic indications
In the complex treatment of the following diseases and conditions:
Inflammatory and degenerative processes affecting the peripheral nerves - neuritis, polyneuritis (alcoholic, post-infectious and toxic, in diabetes), neuralgia, myalgia, paresthesia;
States of prolonged convalescence, chronic alcoholism, intoxications, asthenia;
Vitamin B hypovitaminosis, dermatitis, eczema, psoriasis, exudative diathesis, acne.
4.2 Dosage and administration
It is administered in a dose of 2-3 film-coated tablets 3-4 times daily. The tablets are taken during or after meals, without chewing, with sufficient liquid.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;
Acute thromboembolism;
Erythrosis and erythremia.
4.4 Special warnings and precautions for use
Use with caution in patients with severe and acute forms of decompensated heart failure and angina.
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Excipients
Lactose
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption should not take this medicine.
Wheat starch
The wheat starch in this medicinal product contains very small amounts of gluten (considered to be gluten-free) and is very unlikely to cause problems in patients with coeliac disease. One tablet contains no more than 2.2 micrograms of gluten. Patients with a wheat allergy (other than coeliac disease) should not take this medicinal product.
Colouring agent E124
May cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
Ethanol significantly reduces the absorption of thiamine.
Vitamin B6 affects the metabolism of some drugs. High doses of vitamin B6 reduce the antiparkinsonian effect of levodopa. This vitamin increases the peripheral decarboxylation of levodopa and thus reduces its effectiveness in the treatment of Parkinson's disease. It antagonizes the action of isoniazid and thiosemicarbazones; corrects sideroblastic anemia caused by antituberculosis drugs. Long-term use of penicillamine can cause vitamin B6 deficiency. Hydralazine and cycloserine are also its antagonists and its simultaneous use with them reduces the undesirable neurological reactions associated with their use. The amount of vitamin B6 decreases when taken simultaneously with oral contraceptives.
The absorption of vitamin B12 is inhibited by colchicine, ethanol and neomycin. Oral antidiabetic agents of the biguanide type and p-aminosalicylic acid, as well as chloramphenicol and vitamin C affect the absorption of the vitamin.
4.6 Fertility, pregnancy and lactation
There is no evidence of harm to the fetus when using Neurobex during pregnancy or to the newborn during breastfeeding. Due to insufficient data in pregnant women, it is recommended to use it only if necessary.
4.7 Effects on ability to drive and use machines
It does not affect the ability to drive or use machines.
4.8 Adverse drug reactions
Neurobex is well tolerated by patients. In rare cases, increased sweating, tachycardia, itching, urticaria may be observed. In isolated cases, allergic reactions, rash, shortness of breath, anaphylactic shock may be observed.
Severe sensory neuropathy has been described in patients receiving high doses of pyridoxine (2 g to 6 g daily) for a period of 2 to 40 months. Sensory peripheral neuropathy may occur in cases of prolonged administration of daily doses of 200 mg or less.
Reporting suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of a medicinal product is important. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any
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suspected adverse reaction through the Bulgarian Medicines Executive Agency, 8 Damyan Gruev Str., 1303 Sofia, tel.: 02 8903417, website: www.bda.bg.
4.9 Overdose
In case of overdose, the side effects associated with the use of the product are intensified, and nervous excitement, tachycardia, and pain in the heart area may also occur. Treatment includes gastric lavage, activated charcoal, and symptomatic agents. Isoniazid is an antidote to vitamin B6.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vitamins, Vitamin B1 in combination with vitamin B6 and/or vitamin B12, ATC code: A11DB00
Mechanism of action and pharmacodynamic effects:
The combination of neurotropic B vitamins in the product Neurobex is used to influence a number of important processes and functions in the body and mainly to influence inflammatory and degenerative diseases of the nerves and the musculoskeletal system. B vitamins are part of enzymes that catalyze reactions in the metabolism of carbohydrates, fats and proteins.
The physiological functions of vitamin B1 are multifaceted. After its absorption, it is converted in the body into thiamine pyrophosphate, which is a cofactor of the carboxylase enzyme involved in the decarboxylation of pyruvic and -ketoglutaric acid. This is the reason why vitamin B1 is consumed intensively when consuming carbohydrates. It is related to the activity of the nervous and neuromuscular systems, facilitating the processes of biosynthesis of the main mediator acetylcholine and suppressing the activity of the cholinesterase enzyme, which breaks it down. Its deficiency leads to the accumulation of lactic and pyruvic acid, which can cause polyneuritis, beriberi, Wernicke's encephalopathy and Korsakoff's syndrome, polyneuropathy, cardiac disorders, gastrointestinal disorders (ulcerative colitis, chronic diarrhea).
The physiological functions of vitamin B6, as a coenzyme, include its participation in several metabolic transformations of amino acids - decarboxylation, transamination and racemization, as well as enzymatic transformations in the metabolism of sulfate-containing and hydroxyamino acids. It takes part in the conversion of tryptophan into 5-hydroxytryptamine, in the synthesis of dopamine, noradrenaline, adrenaline, histamine and GABA. The conversion of methionine into cysteine also depends on the vitamin. It is involved in the regulation of liver and nervous system function, enhances erythropoiesis in some forms of anemia. Vitamin B6 deficiency can develop with insufficient intake with food, with impaired intestinal resorption, when taken with drugs that are its antagonists, with radiation therapy. Symptoms of deficiency are manifested by seborrheic lesions in the area of the eyes, nose, glossitis, stomatitis; peripheral neuritis, seizures (from low concentration of gamma-aminobutyric acid), very rarely anemia.
The physiological role of the active coenzymes of vitamin B12 methylcobalamin and 5-deoxyadenosylcobalamin is essential for cell growth and replication. Methylcobalamin is necessary for the formation of methionine and its derivative S-adenoylmethionine from homocysteine. It participates in the processes of transmethylation and hydrogen cation transfer in the synthesis of choline, methionine, creatinine and nucleic acids. Vitamin B12 plays an important role in the processes of hematopoiesis (especially in the maturation of
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erythrocytes). In case of vitamin deficiency, folates are taken up by methyltetrahydrofolate and a folate deficiency is created for the other intracellular forms of folic acid, necessary for erythrocyte maturation. It has a beneficial effect on the functions of the liver and the nervous system. Vitamin B12 deficiency manifests itself with symptoms from the hematopoietic and nervous systems. Hematopoiesis becomes ineffective, with erythropoiesis being megaloblastic, and in severe cases pancytopenia develops. Irreversible damage can occur in the nervous system - demyelination, death of neurons in the spinal cord and cerebral cortex, manifested by paresthesia in the limbs, instability in gait, impaired certain reflexes and in a late stage mental confusion, hallucinations, easy mood swings, loss of memory, vision, even psychosis.
5.2 Pharmacokinetic properties
Vitamin B1 is absorbed in the small intestine and distributed evenly throughout the body. Most of it is phosphorylated in the liver. There it undergoes reabsorption, as it is also excreted through the bile ducts. It is excreted in the urine in unchanged form or as inactive metabolites.
Vitamin B6 is well absorbed after oral administration. It is partially metabolized in the liver.
The absorption of vitamin B12 when taken orally is limited. In the stomach it binds to gastromucoprotein (“intrinsic factor”) and is absorbed in the small intestine. When taken orally, a large percentage of it (70-75%) is not absorbed, and in pernicious patients it is almost not absorbed. Administration of amounts above 100 g is excreted unabsorbed. Its intestinal absorption is improved when administered with folic acid.
5.3 Preclinical safety data
Toxicity
Vitamin B1 (thiamine):
LD50 when administered orally to rats - 3710 mg/kg; to mice - 8224 mg/kg.
Vitamin B6 (pyridoxine hydrochloride):
LD50 when administered orally to rats - 4000 mg/kg.
Vitamin B12 (cyanocobalamin):
LD50 when administered orally to mice - 5000 mg/kg.
Carcinogenicity/mutagenicity
There is no evidence of carcinogenic effect or mutagenic effect.
Reproductive
Studies with the use of vitamin B6 in animals show that it causes malformations of the central nervous system of the fetus and changes in the reproductive system affecting the testicles, epididymis, seminal ducts, prostate, and spermatogenesis.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate
Wheat starch
Talc
Magnesium stearate
Colloidal anhydrous silica
Povidone
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Film coating:
Coliquot protect
Titanium dioxide
Talc
Colorant E 124
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years
6.4 Special storage conditions
Store below 25°C.
6.5 Nature and contents of container
10 film-coated tablets in a blister.
3 blisters per box.
30 film-coated tablets in a blister.
1 or 2 blisters per box.
14 film-coated tablets in a blister.
2 blisters per box.
90 or 150 film-coated tablets in a polyethylene tablet packaging, with a desiccant cap.
1 polyethylene tablet pack per box.
6.6 Special precautions for disposal and handling
There are no special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Teva Pharma EAD
9 Lyuba Velichkova Street
1407 Sofia, Bulgaria
8. MARKETING AUTHORISATION NUMBER
Reg. No. 20000698
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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorization: 31.05.1968
Date of last renewal: 12.04.2011
10. DATE OF TEXT UPDATE
05.01.2021
