NEUROBEX 15mg/10mg/0.02mg x 60 tabl
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BRIEF DESCRIPTION OF THE PRODUCT
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 action:
Each film-coated tablet contains 35 mg of lactose monohydrate, 22 mg of wheat starch and coloring 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 peripheral nerves - neuritis, polyneuritis (alcoholic, post-infectious and toxic, in diabetes), neuralgia, myalgia, paresthesias;
Conditions of prolonged convalescence, chronic alcoholism, intoxications, asthenia;
Vitamin B hypovitaminoses, dermatitis, eczema, psoriasis, exudative diathesis, acne.
4.2 Dosage and method of administration
It is administered in a dose of 2-3 film-coated tablets 3-4 times a day. The tablets are taken during or after a meal, without chewing, with a sufficient amount of liquid.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in point 6.1;
Acute thromboembolism;
Erythrosis and erythremia.
4.4 Special warnings and precautions for use
To be used with caution in patients with severe and acute forms of decompensated heart failure and angina pectoris.
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Excipients
Lactose
Patients with rare hereditary problems of galactose intolerance, the total 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 gluten-free) and is very unlikely to cause problems in celiac patients. One tablet contains no more than 2.2 micrograms of gluten. Patients with wheat allergy (other than celiac disease) should not take this medicinal product.
Colorant 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 medicinal products. 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. Antagonizes the action of isoniazid and thiosemicarbazones; corrects sideroblastic anemia caused by antituberculosis agents. 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 adverse neurological reactions associated with their use. The amount of vitamin B6 decreases with simultaneous use with oral contraceptives.
Absorption of vitamin B12 is inhibited by colchicine, ethanol and neomycin. Oral antidiabetic agents of the biguanidine 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 Neurobex is administered during pregnancy and 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 the ability to drive and use machines
Does not affect the ability to drive and operate machinery.
4.8 Adverse drug reactions
Neurobex is well tolerated by patients. In rare cases, it is possible to observe an increased tendency to sweating, tachycardia, itching, urticaria. It is possible in isolated cases to observe the occurrence of allergic reactions, rash, shortness of breath, anaphylactic shock.
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 of suspected adverse reactions
Post-marketing reporting of suspected adverse reactions is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Medical professionals are required to report any
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suspected adverse reaction through the Medicines Executive Agency, 8 Damyan Gruev St., 1303 Sofia, phone: 02 8903417, website: www.bda.bg.
4.9 Overdose
In case of overdose, there is an increase in adverse reactions related to the application of the product, and the appearance of nervous excitement, tachycardia, pain in the heart area is also possible. Treatment includes gastric lavage, activated charcoal, 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 the neurotropic vitamins of group B in the product Neurobex is used to affect a number of important processes and functions in the body and primarily to affect inflammatory and degenerative diseases of the nerves and motor apparatus. Group 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 resorption, it is converted in the body into thiamine pyrophosphate, which is a cofactor of the carboxylase enzyme involved in the decarboxylation of pyruvate and -ketoglutaric acid. This is the reason why vitamin B1 is used up heavily when consuming carbohydrates. It is related to the activity of the nervous and neuromuscular system, facilitating the processes of biosynthesis of the main mediator acetylcholine and suppressing the activity of the enzyme cholinesterase, which breaks it down. Its deficiency leads to the accumulation of lactic and pyruvic acid, which can cause polyneuritis, beriberi disease, Wernicke's encephalopathy and Korsakoff's syndrome, polyneuropathy, cardiac activity 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 conversions 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, norepinephrine, adrenaline, histamine and GABA. The conversion of methionine to cysteine is also dependent on the vitamin. It participates in the regulation of liver and nervous system function, enhances erythropoiesis in some forms of anemia. A deficiency of vitamin B6 can develop with insufficient food intake, with impaired intestinal absorption, with taking drugs that are its antagonists, with radiation therapy. Deficiency symptoms are manifested by seborrhea-like lesions in the area of the eyes, nose, glossitis, stomatitis; peripheral neuritis, convulsions (from low concentration of gamma-aminobutyric acid), very rarely anemia.
The physiological role of the active vitamin B12 coenzymes methylcobalamin and 5-deoxyadenosylcobalamin is essential for cell growth and replication. Methylcobalamin is required for the formation of methionine and its derivatives S-adenoylmethionine from homocysteine. It participates in the processes of transmethylation and transfer of hydrogen cations in the synthesis of choline, methionine, creatinine and nucleic acids. Vitamin B12 plays an important role in blood formation processes (especially in the maturation of
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erythrocytes). With a deficiency of the vitamin, folates are taken up by methyltetrahydrofolate and a folate deficiency is created for the other intracellular forms of folic acid required 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, erythropoiesis is 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 the gait, violation of some reflexes and in the late stage mental confusion, hallucinations, easy change of mood, memory loss, vision loss, 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 is reabsorbed as it is also emitted through the bile ducts. It is excreted in the urine unchanged or as inactive metabolites.
Vitamin B6 is well absorbed after oral administration. It is partially metabolized in the liver.
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 terminally ill patients it is almost not absorbed. Application of amounts above 100 g are discarded unabsorbed. Its intestinal absorption is improved when administered with folic acid.
5.3 Preclinical safety data
Toxicity
Vitamin B1 (thiamine):
LD50 upon oral administration to rats - 3710 mg/kg; on mice – 8224 mg/kg.
Vitamin B6 (pyridoxine hydrochloride):
LD50 when administered orally to rats - 4000 mg/kg.
Vitamin B12 (cyanocobalamin):
LD50 upon oral administration to mice - 5000 mg/kg.
Carcinogenicity/mutagenicity
There are no data on carcinogenic effect and mutagenic effect.
Reproducibility
Studies with the administration of vitamin B6 in animals show that malformations of the central nervous system of the fetus and changes in the reproductive system are caused, affecting the testes, epididymis, seminal ducts, prostate and spermatogenesis.
6. PHARMACEUTICAL DATA
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 Expiry Date
2 years
6.4 Special storage conditions
To be stored below 25°C.
6.5 Type and contents of packaging
10 film-coated tablets in a blister.
3 blisters in a box.
30 film-coated tablets in a blister.
1 or 2 blisters in a box.
14 film-coated tablets in a blister.
2 blisters in a box.
90 or 150 pieces of film-coated tablets in a polyethylene package for tablets, with a cap with a desiccant.
1 polyethylene package for tablets in a box.
6.6 Special precautions for disposal and handling
There are no special requirements.
Any unused medicinal product or waste materials derived from it should be disposed of in accordance with local requirements.
7. HOLDER OF THE USE AUTHORIZATION
Teva Pharma EAD
9 Lyuba Velichkova St
1407 Sofia, Bulgaria
8. USE AUTHORIZATION NUMBER
Reg. No. 20000698
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9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE MARKETING AUTHORIZATION
Date of first authorisation: 31/05/1968
Date of last renewal: 04/12/2011
10. TEXT UPDATE DATE
01/05/2021
