Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbsptablets, effervescent
    Composition:

    1 tablet effervescent contains:

    Active substance: ibuprofen 400.00 mg.

    Excipients: potassium carbonate 300.00 mg, sodium carbonate, anhydrous 10.00 mg, citric acid, anhydrous 330.00 mg,monosodium citrate 290.00 mg, sodium hydrogen carbonate 1340.00 mg, hypromellose 30.00 mg, sodium saccharinate 40.00 mg, sucrose palmitate 10.00 mg, flavoring menthol 10.00 mg, flavoring grapefruit 40.00 mg, magnesium stearate qs to obtain a tablet weighing 2800.00 mg.

    Description:Round flat tablets white or almost white with bevelled edges.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.01.A.E.01   Ibuprofen

    Pharmacodynamics:Ibuprofen is a derivative of phenylpropionic acid and has an analgesic, antipyretic and anti-inflammatory effect due to the indiscriminate blockade of cyclooxygenase 1 and 2 and has an inhibitory effect on the synthesis of prostaglandins. The analgesic effect is most pronounced for inflammatory pains. The analgesic activity of the drug does not apply to the narcotic type. The therapeutic effect of the drug lasts up to 8 hours. Like all NSAIDs, ibuprofen exhibits antiaggregant activity.
    Pharmacokinetics:
    Ibuprofen is easily absorbed from the stomach, especially in the form of effervescent tablets, in which Cmax on an empty stomach is reached within approx. 22 minutes, as opposed to tablets (about 90 minutes). It means that ibuprofen in this dosage form - effervescent tablets, is absorbed more than four times faster. Such rapid absorption of ibuprofen effervescent tablets is associated with a faster onset of analgesic effect compared to paracetamol (1000 mg), with significant pain the effect was achieved 28-35 minutes after taking and after the first palpable pain - after about 14 minutes. In addition, it has been demonstrated clinically that when taking 400 mg of ibuprofen in the form of effervescent tablets, analgesia is much quicker compared to a combination of acetylsalicylic acid (800 mg) and vitamin C (480 mg). The intake of 400 mg of ibuprofen in effervescent tablets demonstrated efficacy in migraine attacks and accompanying symptoms, such as photophobia, phonophobia and nausea, in clinical trials.
    Absorption slightly decreases when taking the drug after a meal. Ibuprofen approximately 99% is associated with plasma proteins. It is slowly distributed in the synovial fluid and is withdrawn from it more slowly than from the plasma. Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. The isozyme CYP2C9 is involved in the metabolism of the drug.After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly transformed into an active S-form. Ibuprofen has a two-phase kinetics of elimination. The half-life period (T1 / 2) from the plasma is 2-3 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and, to a lesser extent, with bile. Ibuprofen completely output in 24 hours.

    Indications:For relief of weak and moderate pains, such as: rheumatic and muscular, lumbar, dental, headaches, migraine (as well as concomitant symptoms like light and phobia, nausea), pain in osteoarthritis, joint pain, painful menstruation; and to relieve the symptoms of cold and flu, including fever.
    Contraindications:
    - Hypersensitivity to any of the ingredients that make up the drug. Hypersensitivity reactions to acetylsalicylic acid or other NSAIDs in history, especially those expressed by asthma, rhinitis or urticaria.
    - Concomitant erosive and ulcerative diseases or perforation of the organs of the gastrointestinal tract (including gastric ulcer and duodenal ulcer in the acute stage, Crohn's disease, nonspecific ulcerative colitis)
    - Pregnancy III trimester (see "Application in pregnancy and lactation").
    - Co-administration with other NSAIDs, including specific inhibitors of type 2 cyclooxygenase.
    - Diseases of the blood, including hemophilia and other disorders of coagulability (including hypocoagulation), hemorrhagic diathesis, gastrointestinal bleeding and cardiovascular hemorrhage.
    - Severe hepatic and renal failure (including hyperkalemia)
    - Severe uncontrolled heart failure.
    - Do not apply before or after heart surgery
    - Children under 12 years.
    Carefully:elderly age, heart failure, arterial hypertension, coronary heart disease, liver cirrhosis with portal hypertension, hepatic and / or renal failure, nephrotic cider, hyperbilirubinemia, stomach and duodenal ulcer (history), gastritis, enteritis, colitis, blood diseases unclear etiology (leukopenia and anemia), pregnancy (I-II trimester), lactation period, children's age, cerebrovascular diseases, islipidemia, hyperlipidemia, diabetes mellitus, peripheral arteries, smoking, creatinine clearance less than 60 ml / min, and other conditions.
    Pregnancy and lactation:
    Although the experience of studying the drug in animals indicates the lack of teratogenic effect in ibuprofen, nevertheless, if possible, it should be avoided during pregnancy.
    In the third trimester of pregnancy, the use of ibuprofen is contraindicated because of the risk of premature closure of the Botallov duct and subsequent pulmonary hypertension in the fetus. The delay in the onset of labor and the increase in their duration increase the risk of blood loss, which is dangerous for the mother and child (see "Contraindications"). In limited studies, ibuprofen is found in breast milk in very low concentrations. The minimum detectable dose (0.0008% of the dose received) in a small degree of probability can have an impact on the child during breastfeeding.
    See also section "Special instructions" for women's fertility.
    Dosing and Administration:
    Inside. The effervescent tablet must be dissolved in a glass of water and drunk immediately. Do not swallow the whole pill!
    Adults, seniors and children over 12 years of age - one fizzy pill. Admission should not be repeated more often than every 4 hours and should not take more than 3 tablets (1200 mg of ibuprofen) per day (24 hours). The drug is prescribed in minimal effective doses and as short as possible.If the symptoms persist or worsen during the course of 10 days, the patient should consult a doctor. Do not use in children under 12 years of age.
    Side effects:
    When ingestion of ibuprofen preparations, the following cases of adverse reactions are described (they are rare):
    Gastrointestinal tract (GIT)
    NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, dyspepsia, decreased appetite, diarrhea, flatulence, constipation, rarely - ulceration of the mucous membrane of the digestive tract, which in some cases are complicated by perforation and hemorrhage sometimes with fatal outcome (especially in the elderly ), exacerbation of chronic colitis and Crohn's disease); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis. Bloating, gastritis, hematemesis, melena.
    Hepatobiliary system
    Very rarely: a violation of liver function, hepatitis, jaundice and other liver diseases.
    Respiratory system
    Shortness of breath, bronchospasm, exacerbation of asthma, wheezing, stridor.
    Sense organs
    Hearing impairment: hearing loss, vertigo, ringing or tinnitus;
    visual impairment: toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).
    Central and peripheral nervous system
    Sometimes headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations; disturbance of cerebral circulation.
    The cardiovascular system
    Heart failure, stenocardia, tachycardia, increased blood pressure, swelling.
    The use of such drugs may be associated with a slight increase in the risk of developed acute cardiovascular disorders (myocardial infarction or stroke). The risk increases with high doses and a long time of taking the drug. Do not exceed the recommended dose (no more than 3 tablets per day) or duration of application (no more than 10 days).
    In the presence of cardiovascular disease, a previous stroke or having risk factors (for example, high blood pressure, diabetes, high cholesterol,smoking) should discuss the drug with the doctor.
    urinary system
    Acute renal failure, papillary necrosis, especially with prolonged
    application, accompanied by an increase in the level of urea in the serum and edema, peripheral edema, allergic nephritis, nephrotic syndrome, interstitial nephritis, polyuria, cystitis, hematuria, proteinuria.
    Allergic reactions
    Hypersensitivity reactions: skin rash (usually erythematous or urticaria), face swelling, rash, maculopapular rash, itchy skin; extremely rare: angioedema (Quincke), anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, bullous dermatitis, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), allergic rhinitis.
    Organs of hematopoiesis
    Anemia (including hemolytic, aplastic), leukopenia, thrombocytopenia and thrombocytopenic purpura, pancytopenia; agranulocytosis, eosinophilia.
    The first symptoms: fever, sore throat, superficial ulceration of the oral mucosa, influenza-like symptoms, severe fatigue, bleeding and bruising of unknown origin;
    The immune system
    In patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue diseases) during the treatment with ibuprofen, symptoms of aseptic meningitis such as cramps spasm, headache, nausea, vomiting, fever, loss of orientation may occur.
    Other violations:
    Absence of effect when taking the drug
    Laboratory indicators:
    - time of bleeding (may increase)
    - the concentration of glucose in the serum (may decrease)
    - clearance of creatinine (may decrease)
    - Hematocrit or hemoglobin (may decrease)
    - serum creatinine concentration (may increase)
    - activity of "liver" transaminases (may increase)
    Overdose:
    In case of an unexpected overdose (in children receiving a dose exceeding 400 mg / kg), discontinue use and seek professional help immediately.
    The following signs or symptoms may be associated with an overdose of ibuprofen:
    Hearing and ear damage: dizziness.
    Gastrointestinal disorders: abdominal pain, nausea and vomiting. Violations of the hepatobiliary system: a violation of the liver.
    Metabolic and nutritional disorders: hyperkalemia, metabolic acidosis. Nervous system disorders: dizziness, drowsiness, headache, loss of consciousness and convulsions.
    Renal and urinary disorders: renal insufficiency.
    Respiratory, thoracic and mediastinal disorders: dyspnea and respiratory depression.
    Vascular disorders: hypotension.
    Interaction:
    In connection with the description of a number of clinical observations, care should be taken when prescribing to patients taking any of the following drugs.
    Acetylsalicylic acid or other NSAIDs may increase the risk of side effects. Care should be taken if acetylsalicylic acid is taken with coronary artery disease or cerebral circulation disorders, because ibuprofen can reduce the therapeutic effect of acetylsalicylic acid.
    Antihypertensive drugs: ibuprofen weaken the effect of antihypertensive drugs (including slow calcium channel blockers and ACE inhibitors).
    Lithium: ibuprofen slows the excretion of lithium.
    Cardiac glycosides: NSAIDs can enhance the phenomena of heart failure, reduce the rate of glomerular filtration and cause an increase in the level of glycosides in the blood plasma.
    Methotrexate: Methotrexate excretion is slowed. Patients with reduced renal function have a high risk of developing hepatotoxic reactions, even if low doses of methotrexate (<20 mg / week) are used.
    Some antacids may reduce the absorption of ibuprofen from the gastrointestinal tract, which may be important with prolonged administration of ibuprofen.
    Corticosteroids, serotonin reuptake inhibitors: the risk of gastrointestinal bleeding increases.
    Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increased risk of nephrotoxicity.
    Mifepristone: Do not prescribe NSAIDs for 8-12 days after mifepristone therapy, since NSAIDs may reduce the effect of mifepristone.
    Diuretics: the effect of thiazide diuretics is reduced.
    An increased risk of hemarthrosis and hematomas in HIV-positive patients and patients with hemophilia simultaneously receiving zidovudine and ibuprofen.
    Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites,increasing the risk of developing severe hepatotoxic reactions.
    Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action
    Caffeine increases the analgesic effect.
    Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.
    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
    Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.
    Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.
    Reduces the effectiveness of uricosuric medicines, increases the effect of antiplatelet agents, fibrinolytic agents, thrombolytic drugs (alteplase, stektokinase, urokinase) (increased risk of hemorrhagic complications), enhances the effect of oral hypoglycemic drugs and insulin. Kolestyramine reduces the absorption of ibuprofen.
    Simultaneous reception with serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing gastrointestinal bleeding.
    Special instructions:
    The use of ibuprofen may cause severe allergic reactions, including redness of the skin, the appearance of rashes or blisters, toxic
    epidermal necrolysis.
    In patients with bronchial asthma or allergic diseases in the history of the drug can cause the development of an attack or bronchospasm. The risk of unwanted effects can be minimized by using the lowest effective dose and short duration of therapy.
    Ibuprofen should not be prescribed in the last trimester of pregnancy (see the sections on "Application in pregnancy and lactation" and "Contraindications").
    It is necessary to consult a doctor before taking another drug from the NSAID group.
    During treatment with any drugs of the NSAID group, cases
    bleeding from the gastrointestinal tract, ulcerative lesions or perforation with a fatal outcome, regardless of the presence or absence of previous symptoms or the presence in the patient's history of serious diseases of the gastrointestinal tract.
    Patients, especially the elderly, should always report all symptoms (especially bleeding from the gastrointestinal tract),
    arising during therapy. The drug should be discontinued and
    It is necessary to consult a doctor in case of vomiting with blood or the presence of blood in the feces. In elderly patients, the risk of serious adverse reactions is increased.
    Precautions should be taken when prescribing ibuprofen to patients taking drugs that increase the risk of developing
    complications of the gastrointestinal tract (including bleeding), such as
    glucocorticosteroids or anticoagulants (warfarin, acetylsalicylic acid) (see section "Interactions with other drugs").
    With the development of symptoms of bleeding GIT or ulcerative lesions in patients taking ibuprofen, the drug should be discontinued.
    Systemic lupus erythematosus and systemic connective tissue diseases - the risk of developing aseptic meningitis increases (see section "Side effect").
    Ibuprofen, due to its pharmacological action, can reduce the diagnostic significance of such symptoms as fever and inflammation and affect the diagnosis of the disease.
    There is limited information that preparations inhibiting the synthesis
    cyclooxygenase / prostaglandins, can cause fertility decline in women through exposure to ovulation. When the drug is canceled, the function is restored.
    During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.
    When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.
    To prevent the development of NSAIDs, gastropathy is recommended to be combined with preparations of prostaglandins (misoprostol).
    If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.
    Before starting therapy for patients with a history of arterial hypertension and / or heart failure, care should be taken and consulted with a specialist, since such patients were noted for fluid retention, hypertension, and swelling associated with NSAID administration.
    Long-term use may increase the risk of acute coronary disease or stroke.
    During the period of treatment, ethanol is not recommended.
    Patients taking the drug should refrain from activities that require increased concentration of attention and rapid mental and motor reactions.

    Effect on the ability to drive transp. cf. and fur:Patients taking the drug should refrain from activities that require increased concentration of attention and rapid mental and motor reactions.
    Form release / dosage:
    Tablets effervescent, 400 mg.
    Packaging:By 2, 8, 10, 20 tablets into strips of film laminated (aluminum foil / paper / PE / ionomer). 1 or 5 strips (2 tablets each); 2 or 5 strips (4 tablets each) together with instructions for use are placed in a cardboard box.
    Storage conditions:
    In the original packaging, at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001362
    Date of registration:15.12.2011
    Expiration Date:15.12.2016
    The owner of the registration certificate:Pfizer Corporation Austria GmbHPfizer Corporation Austria GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation
    Information update date: & nbsp23.01.2017
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