Neurodiclovit caps. 30 pc

Description

Composition
Active substance:
1 capsule contains: 50.0 mg of diclofenac sodium; vitamin mixture: Thiamine hydrochloride 50.0 mg; pyridoxine hydrochloride 50.0 mg; cyanocobalamin 0.25 mg ;.
Excipients:
Povidone K 25 8.42 mg of methacrylic acid ethyl acrylate copolymer (1: 1) 30% dispersion, 5.60 mg triethyl citrate 0.60 mg talc 3.08 mg; capsule shell: a housing: titanium dioxide (E 171) 0.9240 mg, colorant ferric oxide red (E 172) 0.0061 mg ferric oxide yellow dye (E 172) 0.0924 mg, 45.1775 mg of gelatin; cap: titanium dioxide (E 171) 0.7186 mg, colorant red ferric oxide (E 172) 0.5144 mg Gelatin 29.5670 mg.
Description:
Hard gelatin capsules № 1, housing: pale pinkish-yellow, transparent, lid: pinkish brown, opaque. The contents of the capsules: white-colored granules mixture (sodium diclofenac) and pink powder (thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin).
Product form:
Capsules modified release.
10 capsules in blister PVC / PE / PVDC / AI.
3 blisters together with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to the drug (including to other nonsteroidal anti-inflammatory drugs or vitamins), erosive and ulcerative lesions of the gastrointestinal tract (exacerbation), bleeding from the gastrointestinal tract, intracranial bleeding, the complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and the intolerance of acetylsalicylic acid (ASA) and other nonsteroidal anti-inflammatory drugs (NSAIDs) (including history), hematopoietic disorders , Hemostatic disorders (including hemophilia), inflammatory bowel disease, severe liver and heart failure, since the aortocoronary bypass, severe renal impairment (creatinine clearance less than 30 mL / min), progressive kidney disease, active liver disease, confirmed hyperkalemia, infancy, pregnancy, lactation.
Carefully
Peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn’s disease, a history of liver disease, hepatic porphyria, chronic liver failure, chronic heart failure, arterial hypertension, a significant reduction in circulating blood volume (including after extensive surgery), mature patients (including receiving diuretics and debilitated patients with low body weight), bronchial asthma, simultaneous glucocorticosteroids (including prednisone), anticoagulants (in including warfarin), antiplatelet agents (including ACK, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (creatinine clearance 30 – 60 ml / min), the presence of Helicobacterpylori infection, prolonged use of NSAIDs, alcoholism, severe somatic disorders.
Indications
Pain in inflammation of non-rheumatic nature after injuries, surgical and dental procedures; gynecological diseases – primary algomenorrhea, adnexitis; inflammatory diseases of the ENT sphere – pharyngitis, tonsillitis, otitis media
Inflammatory and degenerative joint and spine diseases (chronic polyarthritis, osteoarthritis, spondilartroz)
Neuritis and neuralgia (cervical syndrome, lumbago, lumbar ischialgia)
Acute gouty arthritis.
Interaction with other drugs
The preparation increases the concentration of digoxin in plasma of methotrexate drugs lithium and cyclosporine.
Reduces the effect of diuretics, potassium-sparing diuretics in the background increases the risk of hyperkalemia; against the background of anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase) – The risk of bleeding (usually from the gastrointestinal tract).
Reduces the effect of antihypertensive and hypnotic drugs.
Increases the likelihood of side effects and other NSAIDs glucocorticosteroid means (bleeding in the gastrointestinal tract), the toxicity of methotrexate and cyclosporine nephrotoxicity. Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Concomitant use of paracetamol with increased risk of nephrotoxic effects of diclofenac.
Reduces the effect of hypoglycemic agents.
Cefamandole, cefoperazone, cefotetan, valproic acid and increase the incidence plicamycin hypoprothrombinemia.
Cyclosporine and preparations of gold increases the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which increases the nephrotoxicity.
The simultaneous use of ethanol, colchicine, corticotropin, serotonin reuptake inhibitors and drugs St. John’s wort increases the risk of bleeding in the gastrointestinal tract.
Diclofenac enhances the action of drugs that cause photosensitization.
Antibacterial drugs from the group of quinolone – the risk of seizures.
Drugs that block tubular secretion, increase the concentration of diclofenac in plasma, thereby increasing its toxicity.
The drug reduces the effectiveness of anti-levodopa.
Ethanol dramatically reduces the absorption of thiamine (blood levels may be reduced by 30%). Prolonged treatment with anticonvulsant drugs may lead to a deficiency of thiamine. The use of colchicine and biguanide reduces the absorption of cyanocobalamin. During the drug is not recommended intake multivitamin complexes comprised of the vitamins of group B.
Overdose
Symptoms: vomiting, bleeding from the gastrointestinal tract (GIT)
epigastric pain, diarrhea, dizziness, tinnitus, lethargy, convulsions; rarely – increased blood pressure, acute renal failure, hepatotoxicity, respiratory depression, coma.
Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating the increase in blood pressure, renal dysfunction, seizures, gastrointestinal irritation, respiratory depression. Forced diuresis, hemodialysis ineffective (due to significant bond and intense protein metabolism).
pharmachologic effect
Pharmacological group:
Analgesic combined (non-narcotic analgesic agent vitamin +).
Pharmacodynamics:
Diclofenac has antiinflammatory, analgesic, antipyretic, and antiplatelet properties. Non-selectively inhibiting cyclooxygenase 1 and 2, it gives the arachidonic acid metabolism, reduces the amount of prostaglandins in inflammation.
In rheumatic diseases inflammatory and analgesic effect of diclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. When trauma, postoperative diclofenac reduces pain and inflammatory edema.
Thiamine (vitamin B1) in the human body as a result of phosphorylation processes is converted into kokarboksilazu, which is a coenzyme of many enzyme reactions. Vitamin V1igraet an important role in carbohydrate, protein and fat metabolism. Actively involved in the processes of neural excitation at synapses.
Pyridoxine (vitamin B6) is required for normal functioning of the central and peripheral nervous system. The phosphorylated form is a coenzyme in the metabolism of amino acids (decarboxylation, transamination, etc.). It acts as a coenzyme essential enzymes active in nerve tissues. Involved in the biosynthesis of many neurotransmitters – such as dopamine, serotonin, noradrenaline, adrenaline, histamine, and gamma-aminobutyric acid (GABA).
Cyanocobalamin (vitamin B12) is necessary for normal hematopoiesis and maturation of red blood cells and is also involved in a number of biochemical reactions that provide vital functions of the body – in the transfer of methyl groups in the synthesis of nucleic acid, protein, metabolism of amino acids, carbohydrates, lipids. It has a beneficial effect on the processes of the nervous system (synthesis of nucleic acids, and lipid composition of phospholipids and cerebrosides). Coenzyme form cyanocobalamin – methylcobalamin and adenosyl necessary for replication and cell growth.
The combination of B vitamins potentiates the analgesic effect of diclofenac.
Pharmacokinetics:
Absorption of diclofenac – rapid and complete, food slows the rate of absorption for 1 – 4 hours or reducing the maximum concentration of 40%. After oral administration of 50 mg maximum concentration (Cmax) – 1.4 g / ml is achieved through -. 2-3 h plasma concentration is in linear dependence on the magnitude of the dose administered.
Changes in the pharmacokinetics of diclofenac on the background of multiple doses is not marked, not accumulates.
Bioavailability – 50%. Relationship to plasma proteins – more than 99% (most associated with albumin). Penetrates into the synovial fluid; maximum concentration observed in the synovial fluid for 2-4 hours later than in plasma. The half-life of 3-6 hours synovial fluid (the concentration of active agent in the synovial fluid after 4-6 h after administration is higher than in the plasma, and remains higher for a further 12 hours). The relationship of drug concentration in synovial fluid from the clinical efficacy of the drug is not clear. Metabolism: 50% of the active substance is metabolised during the “first pass” through the liver. Metabolism occurs as a result of single or multiple hydroxylation and conjugation with glucuronic acid. The metabolism of the drug is involved enzyme system P450 CYP2C9. The pharmacological activity of the metabolites is lower than diclofenac.
Systemic clearance is 350 ml / min, the volume of – 550 ml / kg. . The half-life of plasma -2 h 65% of the administered dose excreted by the kidneys as metabolites; less than 1% is excreted in unaltered form, the remainder of the dose excreted in bile as metabolites. In patients with renal failure (less than 10 ml / min creatinine clearance) increases the excretion of metabolites in the bile, thus increasing their concentration in the blood is not observed.
In patients with chronic hepatitis or compensated cirrhosis pharmacokinetic parameters of diclofenac are not changed.
Diclofenac passes into breast milk.
Vitamins that are part of Neyrodiklovita, are water soluble, eliminating the possibility of accumulation in the body. Thiamine and pyridoxine are absorbed in the upper small intestine are metabolized by the liver and excreted by the kidneys (approximately 8-10% – unchanged). The degree of absorption depends on the dose, increases significantly with an overdose of thiamine and pyridoxine excretion through the intestine. Absorption of cyanocobalamin depends heavily on the presence of intrinsic factor in the body (in the stomach and upper small intestine), further delivery of vitamin in the tissue is determined by the transport protein transcobalamin. After hepatic metabolism cyanocobalamin derived mainly in the bile, the extent of renal excretion variable – from 6 to 30%.
Pregnancy and breast-feeding
Do not use this drug during pregnancy and lactation.
Conditions of supply of pharmacies
On prescription.
side effects
Gastrointestinal tract: more than 1% – epigastric pain, a feeling of bloating, diarrhea, nausea, constipation, flatulence, increased aminotransferase activity, peptic ulcer with possible complications (bleeding, perforation), gastrointestinal bleeding; less than 1% – vomiting, jaundice, melena, blood in stool, esophageal lesion, aphthous stomatitis, dryness of mucous membranes (including the mouth), hepatitis (possibly fulminant course), necrosis of the liver, cirrhosis, hepatorenal syndrome, appetite change, pancreatitis , holetsistopankreatit colitis.
Nervous system: more than 1% – headache, dizziness; less than 1% – insomnia, drowsiness, depression, irritability, aseptic meningitis (usually in patients with systemic lupus erythematosus and other connective tissue diseases), cramps, weakness, disorientation, nightmares, feeling of fear.
Senses: more than 1% – tinnitus; less than 1% – blurred vision, diplopia, impaired sense of taste, reversible or irreversible hearing loss, scotoma.
Kozhye covers: more than 1% – itching, skin rash; less than 1% – areata, urticaria, eczema, chronic dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), increased photosensitivity melkotochechnye hemorrhage, bullous eruptions.
Urogenital: more than 1% – fluid retention; less than 1% – nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia.
Bodies of hematopoiesis and immune system: less than 1% – anemia (including haemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, worsening of infectious processes (including the development of necrotising fasciitis).
Respiratory system: less than 1% – cough, bronchospasm, laryngeal edema, pneumonia.
Cardiovascular system: less than 1% – increase in blood pressure; heart failure, beats, chest pain, myocardial infarction.
Allergic reaction: less than 1% – anaphylactoid reaction, anaphylactic shock (usually develops rapidly), swelling of the lips and tongue, allergic vasculitis.
special instructions
The period of treatment should be systematic monitoring of peripheral blood picture, liver function, kidney, examination of feces for the presence of blood.
To reduce the risk of adverse effects on the gastrointestinal tract should use the lowest effective dose of the lowest possible short course. In order to quickly achieve the desired therapeutic effect tablets taken 30 minutes before a meal. In other cases take before, during or after a meal with liquid, squeezed with sufficient water. Due to the importance of prostaglandins in maintaining renal blood flow should be particularly careful when administered to patients with cardiac or renal insufficiency as well as in the treatment of elderly patients taking diuretics, and patients who for any reason, a decrease in blood volume is observed (in including after major surgery). If in such cases, prescribe diclofenac, is recommended as a precautionary measure to monitor renal function. If during treatment increase in “liver” transaminases maintained or increased if the clinical symptoms observed hepatotoxicity (including nausea, fatigue, lethargy, diarrhea, itching, jaundice), treatment should cease. Diclofenac (and other NSAIDs) can cause hyperkalemia. Due to the adverse effect on fertility, women planning to become pregnant, the drug is not recommended. At infertile patients (including undergoing examination) it is recommended to cancel the drug.
The effect on the ability of control of vehicles and mechanisms
The treatment period may reduce the rate of mental and motor reactions, so you must refrain from driving vehicles and other classes of potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In dry the dark place at a temperature not higher than 25 C.
Keep out of the reach of children!.
Dosing and Administration
The capsules should be taken orally during meal time, not liquid and abundantly with some liquid.
Usually the drug is administered 1 capsule 1-3 times a day.
Adults Neurodiclovit 1 capsule – at the beginning of the treatment 3 times a day as a maintenance dose – 1-2 times per day. The duration of therapy depends on the nature and severity of the disease.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist