Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbsp
    The tablets covered with a sugar cover.

    Composition:

    1 tablet, covered with sugar shell contains: active substance: diclofenac potassium - 12.5 mg, Excipients: calcium hydrophosphate - 85.00 mg, corn starch - 34.50 mg, sodium carboxymethyl starch (type A) - 12.60 mg, silicon dioxide colloid (anhydrous) - 2.80 mg, povidone 30 - 1.60 mg, magnesium stearate - 1.00 mg. Sugar shell composition: sucrose 41.83 mg, talc 24.28 mg, colourant Ponso E 124 9.64 mg, acacia gum 2.65 mg, povidone 25 0.78 mg, titanium dioxide E 171 0.70 mg , macrogol 6000 - 0.12 mg.

    Description:Round biconvex tablets covered with a sugar shell of red color, with small impregnations of a lighter color.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:Rapent Rapid, containing as active substance diclofenac potassium, is a non-steroidal anti-inflammatory drug (NSAID), has a strong anti-inflammatory, analgesic and antipyretic effect.It is caused by inhibition of the synthesis of prostaglandins, the main sources of pain, inflammation and fever, by inhibiting the activity of cyclooxygenases (types 1 and 2). Given the fact that diclofenac potassium is absorbed very quickly from the gastrointestinal tract, Rapent Rapid is most effective in the treatment of acute pain and inflammatory conditions, in which the rapid initial effect is most important. The drug relieves pain and lowers the temperature within the first 30 minutes after administration, and the effect lasts for 4-6 hours.
    Pharmacokinetics:
    The drug is quickly and completely absorbed when taken orally. Absorption begins in the stomach, the maximum concentration of the drug in the blood plasma is reached approximately 40 minutes after ingestion. The concentration in the plasma is linear in the dose of the drug administered. Changes in the pharmacokinetics of diclofenac against the background of repeated administration do not occur. When observing the recommended interval between meals, cumulation of the drug does not occur. The half-life of plasma is 1 -2 hours.

    Quickly distributed in the body for tissues and fluids.Penetrates into the synovial fluid. The maximum concentration of diclofenac in synovial fluid is noted 2-4 hours later than in plasma. The half-life period of diclofenac from the synovial fluid is 3-6 hours, and its concentration in the synovial fluid after 4-6 days after administration of the drug remains higher than in the plasma for another 12 hours. The connection with plasma proteins is high (up to 99%) and most of it is associated with albumins.

    The drug is metabolized in the liver: 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation. The enzyme system P450 CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.

    The drug is excreted mainly through the kidneys. Systemic clearance is 260 ml / min. About 60% of the administered dose is excreted through the kidneys in the form of metabolites and less than 1% - in unchanged form. The rest of the drug is excreted as metabolites with bile. It is noted that the pharmacokinetics of the drug does not change depending on the age of the patient.In patients with severe renal dysfunction (creatinine clearance less than 10 ml / min), the time for excretion of metabolites with bile is increased. At the same time, there is no increase in their concentration in the blood.

    In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac are the same as in patients who do not have liver disease.
    Indications:
    Pain syndrome of different origin:

    - Pain in muscles and joints (including pain in different parts of the spine, etc.),

    - Headache and toothache,

    - Pain during menstruation; Elimination of symptoms of colds and flu:

    - Pain in the muscles and joints, headache associated with colds and flu, sore throat.

    - Increased body temperature.
    Contraindications:
    Hypersensitivity to diclofenac and other components that make up the drug; attacks of bronchial asthma, urticaria, or acute rhinitis in history in response to taking acetylsalicylic acid or other NSAIDs (such as, for example, ibuprofen); period after aortocoronary shunting; a stomach ulcer,inflammatory bowel disease in the stage of exacerbation (nonspecific ulcerative colitis, Crohn's disease), ulcerous bleeding or perforation; III trimester of pregnancy; severe hepatic, renal (creatinine clearance less than 30 ml / min) or heart failure, progressive kidney disease, confirmed hyperkalemia, hematopoiesis disorder, various hemostatic disorders, bone marrow damage; children's age till 14 years.
    Carefully:ischemic heart disease (CHD), cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min. Amnestic data on the development of gastrointestinal ulcer, elderly age, prolonged use of NSAIDs, frequent use of alcohol, severe somatic diseases.
    Pregnancy and lactation:
    In the first and second trimesters of pregnancy, the drug is prescribed only if the potential benefit to the mother's health exceeds the risk to the fetus. The use of diclofenac, like other NSAIDs, is contraindicated in the third trimester of pregnancy because of possible atony of the uterus and / or premature closure of the ductus arteriosus.

    Diclofenac, like other NSAIDs, penetrates into breast milk in small amounts. Therefore Rapent Rapid is not recommended for breastfeeding to prevent unwanted effects in the child.
    Dosing and Administration:
    Inside adults and children over 14 years of age:

    - the initial dose is 2 tablets, and then, if necessary, 1-2 tablets every 4-6 hours.

    The maximum daily dose is 6 tablets per day (75 mg). Tablets should be taken whole, not liquid, squeezed with water.

    To achieve maximum therapeutic effect, the drug should be taken before meals.

    Without consulting a doctor, the drug should be taken no more than 3 days to reduce body temperature and not more than 5 days for the treatment of pain. If the temperature does not decrease within the specified time and the pain persists, you should immediately call your doctor!
    Side effects:

    Frequent adverse reactions - develop in more than 1 case for 100 appointments, infrequent - the incidence of less than 1 case per 100, but more than 1 case per 1000 prescriptions, and rare - the incidence of less than 1 case per 1000 prescriptions, but more than 1 per 10,000, very rare - frequency is less than 1 per 10000.

    On the part of the blood and lymphatic system

    very rare: thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.

    From the immune system

    - rare, hypersensitivity, anaphylactic and anaphylactoid reactions (including arterial hypotension and shock);

    - very rare: angioedema (including swelling of the face).

    - Psychoemotional disorders

    - very rare: loss of orientation, depression, insomnia, nightmares, irritability, psychotic disorders.

    Violations of the function of the nervous system

    - frequent: headache, dizziness;

    - rare, drowsy;

    - very rare, paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular disorders.

    From the side of the vision system

    - very rare, visual disturbances (blurred vision, diplopia).

    - From the side of AOP-organ

    - frequent, dizziness;

    - very rare: ringing in the ears, hearing impairment.

    - From the side of the cardiovascular system

    - very rare, heart palpitations, chest pain, heart failure, myocardial infarction, hypertension, vasculitis.

    On the part of the respiratory system

    - rare: bronchial asthma (including dyspnea);

    - very rare: pneumonia.

    From the gastrointestinal tract

    - frequent: nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, anorexia, increased levels of hepatic transaminases;

    - rare: gastritis, gastrointestinal bleeding, bloody vomiting, diarrhea, melena with blood, stomach ulcers or intestines (with or without bleeding or perforation), hepatitis, jaundice;

    - very rare: colitis (including blood, exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal pathology, esophageal aperture structure, pancreatitis, fulminant hepatitis.

    From the skin and subcutaneous tissues

    - frequent: rash;

    - rare: urticaria;

    - very rare: a rash in the form of blisters, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), hair loss. Photosensitive reactions; purpura, including allergic purpura.

    From the side of the kidneys and urinary tract

    very rare: acute renal failure, hematuria and proteinuria, interstitial nephritis; nephrotic syndrome; papillary necrosis.

    Common violations

    rare: edema.

    Overdose:
    Symptoms: symptomatology from the gastrointestinal tract, arterial hypotension, nephrotoxicity (up to acute renal failure), dizziness, headache, hyperventilation of the lungs, clouding of consciousness; in children, there are myoclonic cramps, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.

    Treatment: symptomatic and supportive, aimed at eliminating symptoms. Forced diuresis, hemodialysis are ineffective.
    Interaction:

    Lithium, digoxin: with simultaneous application diclofenac can increase the concentration of lithium or digoxin in the blood plasma.

    Diuretic and antihypertensive agents: diclofenac, as well as other NSAIDs, when taken with diuretic or antihypertensive agents (eg beta-blockers, angiotensin converting enzyme inhibitors) can reduce the severity of antihypertensive action. Simultaneous use of potassium-sparing diuretics can lead to an increase in serum potassium levels.

    NSAIDs and corticosteroids. simultaneous application of diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of adverse events from the gastrointestinal tract.

    Anticoagulants and inhibitors of platelet aggregation: special care is required, since with the simultaneous administration of diclofenac with these drugs, the risk of bleeding increases.

    Antidiabetic drugs, in clinical studies it has been established that simultaneous use of diclofenac and oral antidiabetic drugs is possible, while the efficacy of the latter does not change. However, there are individual cases of development, both hypoglycemia and hyperglycemia, which required a change in the dose of antidiabetic drugs during diclofenac administration.

    Methotrexate: caution should be exercised in prescribing NSAIDs less than 24 hours before or after taking methotrexate, as in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may increase.

    Cyclosporin: the effect of NSAIDs on the synthesis of prostaglandins in the kidneys can enhance the nephrotoxicity of cyclosporine.

    Antibacterial agents, derivatives of quinolone: there are some reports of the development of seizures in patients receiving concurrently derivatives of quinolone and NSAIDs. Antacids, as for example. aluminum hydroxide and magnesium, can slow the absorption of diclofenac, but do not affect the total amount of the absorbed drug.

    Selective serotonin reuptake inhibitors: concomitant therapy with selective serotonin reuptake inhibitors: (eg, citalopram, fluoxetine, paroxetine, sertraline), accompanied by an increased risk of developing gastrointestinal bleeding.

    Interactions with food products: the level of absorption of diclofenac is reduced when taken with food. For this reason, it is not recommended to take the drug during or immediately after a meal.

    Special instructions:
    When taking non-steroidal anti-inflammatory drugs, there is a possibility of developing gastrointestinal bleeding, gastrointestinal ulcers sometimes complicated by perforation, without previous symptoms or having similar attacks in the patient's history. These complications can have serious consequences especially for the elderly. If these symptoms occur, the drug should be immediately discontinued.The risk of developing gastrointestinal bleeding increases with increasing doses of NSAIDs in patients with a history of peptic ulcer, especially if the disease is complicated by bleeding and perforation, as well as in elderly patients. To reduce the risk of complications, therapy should be initiated and maintained at the lowest effective dose level, taking into account the possibility of using combination therapy with protector drugs (eg, proton pump inhibitors or misoprostol).

    When prescribing diclofenac to patients with an existing pathology of the gastrointestinal tract (ulcer, bleeding, perforation) in a history, it is necessary to conduct therapy with careful medical supervision and observance of special care.

    Caution is recommended for patients who simultaneously take medications that may increase the risk of ulcers or bleeding of the gastrointestinal tract, such as systemic corticosteroids, anticoagulants, platelet aggregation inhibitors, or selective serotonin reuptake inhibitors. Patients suffering from ulcerative colitis or Crohn's disease,Therapy should be carried out under close medical supervision, as the diclofenac administration may exacerbate these diseases.

    The use of diclofenac should be discontinued at the first signs of skin rash, mucosal lesions and other signs of hypersensitivity.

    During the application of diclofenac, as well as other NSAIDs, in rare cases, allergies may occur, including anaphylactic / anaphylactoid reactions in patients who have not previously used diclofenac.

    Diclofenac, as well as other NSAIDs, in connection with its pharmacological properties, can mask the symptoms characteristic of infectious diseases. The simultaneous use of diclofenac with systemic NSAIDs (including selective inhibitors of cyclooxygenase-2) should be avoided, since there is no evidence of a beneficial effect as a result of synergism, and there are no data on possible side effects.

    Care should be taken when using the drug in elderly patients. Weak or low-fat elderly people are recommended to prescribe the drug at the lowest effective dose.

    In patients with bronchial asthma, seasonal allergic rhinitis, nasal mucosa edema (polygous nasal mucosa), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially associated with allergic rhinitis-like symptoms), reactions to drugs from the NSAID group in the form of seizures Asthma, Quincke's edema or urticaria develop more often than usual. Such patients are advised to take special care (readiness for urgent medical measures).

    When diclofenac is prescribed, patients with impaired liver function should be closely monitored, as the condition of such patients may worsen. During the application of Rapent Rapid, as well as other NSAIDs, the level of one or more hepatic enzymes may increase. Therefore, long-term therapy with the drug shows a regular study of liver function.

    If abnormalities from the liver function indicators persist or worsen, or if complaints or symptoms that indicate liver disease develop, and if other side effects (eg, eosinophilia, rash, etc.) occur, the drug should cancel.It should be borne in mind that hepatitis against diclofenac may occur without prodromal phenomena. Care should be taken in patients with hepatic porphyria, as taking diclofenac can provoke an attack.

    Since the use of NSAIDs has been reported on fluid retention and the appearance of edema, special care should be taken in patients with impaired renal and cardiac function, history of arterial hypertension, elderly patients, concomitant diuretics or drugs that have a significant effect on kidney function, and also patients who have a significant decrease in the volume of circulating blood plasma of any etiology, for example, before or after extensive surgical interventions. In such cases, when using diclofenac as a precautionary measure, monitoring of renal function is recommended. After discontinuing therapy, the baseline parameters are usually restored.

    Rapent Rapid is recommended for several days. With the appointment of the drug for a long time, systematic monitoring of the pattern of peripheral blood, the function of the liver, kidneys,feces for blood.

    Rapent Rapid, as well as other NSAIDs, can temporarily inhibit platelet aggregation. Therefore, patients with hemostasis disorders need careful monitoring of relevant laboratory parameters.

    Diclofenac can have a negative effect on female fertility, so it is not recommended to use the drug for women planning a pregnancy.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, there may be some decrease in the rate of psychomotor reactions. In this regard, patients taking the drug should refrain from activities that require increased attention and rapid mental and motor reactions, as well as the use of alcohol.
    Form release / dosage:Tablets coated with sugar shell 12.5 mg.
    Packaging:For 10 tablets in a PVC / AL blister. 1 blister together with instructions for use in a pack of cardboard.
    Storage conditions:
    List B.

    Store in a dry, dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children!

    Shelf life:
    2 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-002354/08
    Date of registration:02.04.2008
    The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia
    Manufacturer: & nbsp
    Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia
    Information update date: & nbsp05.03.2016
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