Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbsp
    Film coated tablets.
    Composition:

    One film-coated tablet contains:

    active substance: diclofenac potassium 25 mg or 50 mg;

    Excipients: lactose monohydrate 27.2 mg / 54.4 mg, corn starch 12.5 mg / 25 mg, microcrystalline cellulose 25 mg / 50 mg, magnesium stearate 0.3 mg / 0.6 mg, sodium carboxymethyl starch 7 mg / 14 mg; tablet coating composition: hypromellose 2.43 mg / 4.86 mg, macrogol-4000 0.27 mg / 0.54 mg, titanium dioxide (E171) 0.16 mg / 0.32 mg, talc 3.18 mg / 6.36 mg , iron dye oxide red (E172) 0.095 mg / 0.19 mg, simethicone (emulsion 30%) 0.05 mg / 0.10 mg (emulsion composition: 30% simethicone, stearin emulsifiers, sorbic acid, benzoic acid, macrogol stearate, macrogol, mono- and diglycerides C14-18, macrogol distearate, macrogol palmitate, octamethylcyclotetrasiloxane, water).

    Description:Dosage of 25 mg: Round biconvex tablets covered with a film coat of light pink color; The tablet is cross-sectional in white or almost white.

    Dosage 50 mg: Round biconvex tablets covered with a film coat of red-brown color; The tablet is cross-sectional in white or almost white.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug.
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:
    Non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid. Has a pronounced anti-inflammatory, analgesic and antipyretic effect. The mechanism of action is based on the inhibition of the synthesis of prostaglandins (which play a major role in the pathogenesis of inflammation, pain and fever) by inhibiting the enzyme cyclooxygenase (COX). In traumatic and postoperative conditions, the drug quickly reduces the severity of the pain syndrome (including pain when moving), as well as swelling of the tissues due to inflammation and trauma.
    With primary dysmenorrhea, the drug weakens the pain and reduces the intensity of bleeding. The drug may temporarily inhibit platelet aggregation.
    Pharmacokinetics:
    After oral administration diclofenac Potassium is rapidly absorbed from the gastrointestinal tract (GIT). The maximum concentration (Сmах) in blood plasma is reached in 40 minutes.
    The volume of the distribution (Vd) is 550 ml / g. Diclofenac potassium penetrates into the synovial fluid, excreted in breast milk.Metabolized with the formation of inactive metabolites (glucuronic and sulfate conjugates).
    More than 50% of the dose is excreted in the urine during the first 4 hours. With bile, 30-35% of the dose in the form of metabolites is excreted.
    Indications:
    For rapid relief of pain syndrome and short-term therapy of the following acute conditions:

    - pain syndrome and inflammation after trauma and surgical interventions;

    - primary and secondary algodismenorea;

    - adnexitis;

    - Pain in the spine;

    - Arthralgia;

    - in the combination therapy of infectious and inflammatory diseases of ENT organs with severe pain syndrome;

    - headache.
    Contraindications:Hypersensitivity (including other NSAIDs), complete or incomplete combination of bronchial asthma, recurrent polyposis of nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in history), erosive and ulcerative lesions of the stomach and duodenum, active gastrointestinal bleeding, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe hepatic and heart failure; period after aortocoronary shunting; Heavyrenal insufficiency (creatinine clearance less than 30 ml / min), progressive kidney disease, active liver disease, confirmed hyperkalemia, pregnancy (III trimester), lactation period, children under 15 years of age, hereditary lactose intolerance, glucose-galactose absorption impairment, lactase deficiency .
    Carefully:Stomach ulcer and duodenal ulcer, ulcerative colitis, Crohn's history, history of liver disease, hepatic porphyria, chronic hepatic insufficiency, chronic heart failure, arterial hypertension, a significant decrease in the volume of circulating blood (including after extensive surgical intervention) , elderly patients (including those receiving diuretics, weakened patients and with low body weight), bronchial asthma, simultaneous reception of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including ascorbic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), ischemic heart disease,cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (creatinine clearance of 30-60 ml / min), the presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic disorders.
    Pregnancy and lactation:
    Clinical studies to study the effect of diclofenac during pregnancy have not been conducted. Therefore, in the I and II trimesters of pregnancy, the drug is prescribed only if the potential benefit to the mother's health exceeds the risk to the fetus. Diclofenac contraindicated III trimester because of possible uterine atony and / or premature closure of the ductus arteriosus (ductus arteriosus).
    Diclofenac penetrates into breast milk in small amounts, so it is not recommended to use when breastfeeding to prevent unwanted side effects in the child.
    Dosing and Administration:

    Inside. The dose is set individually, depending on the severity of the pain syndrome. In order to quickly achieve the desired therapeutic effect, the drug is taken 30 minutes before meals.In other cases, take before, during or after eating, without chewing, squeezed with enough water.

    Adults appoint a daily dose of 75-150 mg, divided into 2-3 doses. For of adolescents over 14 years The daily dose is 75-100 mg in 2-3 doses.

    When primary dysmenorrhea the initial daily dose is 50-100 mg, the average daily dose is 50-150 mg, the maximum daily dose is 200 mg. For elderly patients, especially for the exhausted and weakened, the use of the drug in the minimum effective dose is recommended.

    The drug Tabuk-Di should be taken no more than 5 days to relieve pain without consulting a doctor. If the pain persists during the specified time, you should immediately call your doctor.

    Side effects:

    Very frequent -> 10%; frequent -> 1% and <10%; not frequent -> 0,1% and <1%; rare -> 0.01% and <0.1%; very rare - <0.01%.

    From the digestive system: often - epigastric pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases; rarely gastritis, proctitis, gastrointestinal bleeding (vomiting with blood, melena, diarrhea with blood impurity), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, liver dysfunction; very rarely - stomatitis, glossitis, esophagitis,nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis, fulminant hepatitis.

    From the side of the nervous system, often - headache, dizziness; rarely - drowsiness; very rarely - a violation of sensitivity, including paresthesia, memory disorders, tremors, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmares, irritability, mental disorders.

    From the sense organs: often - vertigo; very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, a violation of taste sensations.

    From the side of the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis,

    nephrotic syndrome, papillary necrosis.

    On the part of the organs of hematopoiesis: very rarely - thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis. Allergic reactions: rarely - anaphylactic / anaphylactoid reactions, including marked decrease in blood pressure and shock; very rarely - angioedema (including face).

    From the cardiovascular system: very rarely - palpitations, chest pain, increased blood pressure, vasculitis, myocardial infarction.

    From the respiratory system: rarely - bronchial asthma (including dyspnea); very rarely - pneumonia.

    From the skin: often - skin rash; rarely - hives; very rarely - bullous eruptions, eczema, including multiform and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, itching, hair loss, photosensitivity, purpura, including allergic.

    Overdose:

    Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, convulsions, with a significant overdose - acute renal failure, hepatotoxic effect.

    Treatment: gastric lavage, Activated carbon, symptomatic therapy aimed at eliminating the increase in blood pressure, impaired renal function, seizures, irritation of the gastrointestinal tract, respiratory depression. Forced diuresis, hemodialysis are ineffective (due to the significant connection with proteins and intensive metabolism).

    Interaction:
    Increases the concentration in the blood plasma digoxin, methotrexate, lithium and cyclosporine.

    Reduces the effect of diuretics, against the background of potassium-sparing diuretics increases the risk of hyperkalemia; on the background of anticoagulants, antiplatelet agents and thrombolytic drugs (alteplase, streptokinase, urokinase) increases the risk of bleeding. Reduces the effect of hypotensive and hypnotic drugs. Increases the likelihood of side effects of other NSAIDs and glucocorticosteroids (gastrointestinal bleeding), toxicity of methotrexate and nephrotoxicity of cyclosporine.

    Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac. Reduces the effect of hypoglycemic drugs.

    Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.

    Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.

    Selective serotonin reuptake inhibitors increase the risk of developing gastrointestinal bleeding. Simultaneous administration with ethanol, colchicine, corticotropin and preparations of St. John's wort increases the risk of developing gastrointestinal bleeding.

    Medicines that cause photosensitivity, increase the sensitizing effect of diclofenac to UV irradiation. Drugs that block tubular secretion, increase the concentration in the blood plasma diclofenac, thereby increasing its effectiveness and toxicity.

    Antibacterial drugs from the quinolone group - risk development of seizures.
    Special instructions:
    Because of the important role of prostaglandins in maintaining renal blood flow, caution should be exercised in appointing patients with cardiac or renal insufficiency, and also in the treatment of elderly patients taking diuretics and patients who for any reason have a decrease in circulating blood volume (in including after extensive surgical intervention). If in such cases appoint diclofenac, recommend as a precautionary measure to monitor kidney function.In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis), the kinetics and metabolism do not differ from similar processes in patients with normal liver function. When performing long-term therapy, it is necessary to monitor liver function, the picture of peripheral blood, the analysis of feces for latent blood. In connection with the negative effect on fertility, women who want to become pregnant, the drug is not recommended. In patients with infertility (including undergoing examination) it is recommended to cancel the drug.
    To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from driving transport and occupations with other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Film coated tablets 25 mg and 50 mg.
    Packaging:For 10, 20 tablets in a blister, made of PVC-HDTV film and aluminum foil. For 1, 2, 3, 4 blisters together with instructions for use are placed in a cardboard box.
    Storage conditions:In dry, dark place at a temperature of 15 ° C to 30 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000861
    Date of registration:14.10.2011
    Date of cancellation:2016-10-14
    The owner of the registration certificate:Tabuk Pharmaceutical Mfg. Co.Tabuk Pharmaceutical Mfg. Co. Saudi Arabia
    Manufacturer: & nbsp
    Representation: & nbspPharmaReg Ltd.PharmaReg Ltd.Russia
    Information update date: & nbsp12.02.2016
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