Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbspcapsules
    Composition:
    Each capsule contains:
    Active substance: ibuprofen 400.00 mg,
    Excipients: macrogol 600 - 240.00 mg; potassium hydroxide 50% solution (in water purified) - 80.00 mg; capsule shell (wet): liquid sorbitol, partially dehydrated - 114.08 mg; gelatin - 198.72 mg; purified water - 147.20 mg;
    printing: Opacode black NSP-78-17827 [alcohol SDA 35 A (ethanol, ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropanol, macrogol 400, ammonium hydroxide 28%] - q.s.

    Description:Yellowish translucent soft oval capsules containing a colorless transparent viscous liquid, with the inscription "400" in black ink on one side.
    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:
    Capsules Advil® Liquvi-Jels contain a water-soluble form of ibuprofen, which is quickly absorbed after ingestion on an empty stomach. Comparative studies show that the water soluble form of ibuprofen is absorbed more quickly (Tmax 35 minutes) compared with ibuprofen tablets.
    After taking during meals, the time to reach the maximum concentration (TCmax) is reached after 1-2 hours.
    Ibuprofen is approximately 99% bound to 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 It is slowly distributed in the synovial fluid and is withdrawn from it more slowly than from the plasma.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 fully output in 24 hours.

    Indications:For relief of mild and moderate pains, such as: rheumatic and muscular, lumbar, dental, headache, migraine, pain in osteoarthritis, painful menstruation; and to relieve the symptoms of cold and flu, including fever.
    Contraindications:
    - Hypersensitivity to ibuprofen or any of the other ingredients that make up the drug. Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance of ASA or other NSAIDs (including in the anamnesis).
    - Concomitant or preceding 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, ulcerative
    colitis); bleeding or perforation of a gastrointestinal ulcer in an anamnesis, provoked by the use of NSAIDs.
    - Pregnancy III trimester (see "Application during pregnancy and during breastfeeding").
    - Joint use with other NSAIDs, including specific inhibitors of cyclooxygenase type 2.
    - Diseases of the blood,including hemophilia and other disorders of coagulability (including hypocoagulation), hemorrhagic diathesis, gastrointestinal bleeding and cardiovascular hemorrhage.
    - Severe hepatic and renal insufficiency (QC less than 30 ml / min) (including confirmed hyperkalemia).
    - Severe decompensated heart failure.
    - Do not use before or after aortocoronary bypass surgery.
    - Children under 12 years.
    - Intolerance to fructose.
    - Intracranial hemorrhages.
    Carefully:Elderly, heart failure, arterial hypertension, ischemic heart disease, liver cirrhosis with portal hypertension, hepatic and / or renal insufficiency (CK = 30-60 ml / min), nephrotic cider, hyperbilirubinemia, stomach and duodenal ulcer ), gastritis, enteritis, colitis, blood diseases of unclear etiology (leukopenia and anemia), pregnancy (I-II trimester), the period of breastfeeding, children over 12 years of age, cerebrovascular diseases, dyslipidemia, hyperlipidemia, sa ary diabetes, peripheral arterial disease, smoking, frequent alcohol use,severe somatic diseases, prolonged use of NSAIDs, systemic lupus erythematosus or other autoimmune diseases of connective tissue (increased risk of aseptic meningitis), simultaneous use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents ( including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
    Pregnancy and lactation:
    Although the experience of the study of the drug in animals indicates the lack of teratogenic effect in ibuprofen, nevertheless, whenever possible, it should be avoided during pregnancy. If necessary, use the drug in the I-II trimesters of pregnancy only if the potential benefit to the mother exceeds the potential risk to the fetus.
    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. However, it is necessary to stop breastfeeding at the time of application.
    See also section "Special instructions" for women's fertility.
    Dosing and Administration:Inside, washing down with water. Adults, seniors and children over 12 years of age - 1 capsule each. Admission should not be repeated more often than every 4 hours and should not take more than 3 capsules (1200 mg of ibuprofen) per day (24 hours). The maximum daily dose for children 12-18 years is 800 mg. The drug is prescribed in minimal effective doses and as short as possible. If after 3 days of taking the drug the symptoms of fever worsen or persist, the patient should stop taking the drug and consult a doctor. You should stop taking and consult with your doctor if the pain is worse and persists for more than 5 days. Do not use in children under 12 years of age.
    Side effects:
    Qualification incidence of side effects produced on the basis of the following criteria: very frequent (> 1/10 destinations), frequent (from 1/10 to 1/100 destinations), infrequent (from 1/100 to 1/1000 destinations), rare (from 1/1000 to 1/10 000 appointments), very rare (<1/10 000 appointments).
    When ingestion of ibuprofen preparations, the following cases of side effects are described:
    - Disorders from the gastrointestinal tract
    NSAID-gastropathy (infrequent: abdominal pain, nausea, heartburn, dyspepsia, anorexia, rare diarrhea, bloating, constipation, vomiting, very rare: ulceration of the gastrointestinal mucosa, 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), very rare: irritation or dryness of mucous membranes of the mouth, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, abdominal distention , gastritis, vomiting with blood, melena.
    - Disturbances from the liver and bile ducts
    Very rare: a violation of liver function, hepatitis, jaundice and other liver diseases.
    - Disturbances from the respiratory system. organs of the chest and mediastinum
    Very rare: shortness of breath, bronchospasm, exacerbation of bronchial asthma, wheezing, stridor.
    - Hearing disorders and labyrinthine disorders
    Very rare: hearing loss, vertigo, ringing or noise in the ears.
    - Disturbances on the part of the organ of sight
    Very rare: visual disturbances: 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).
    - Disturbances from the nervous system
    Infrequent: headache, dizziness, impaired cerebral circulation.
    - Disorders of the psyche
    Very rare: insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations.
    - Heart Disease
    Very rare: heart failure, angina, tachycardia. Vascular disorders
    Very rare: increased blood pressure, swelling.
    - Disorders from the kidneys and urinary tract
    Very rare: acute renal failure, papillary necrosis of the kidneys, especially with prolonged use,accompanied by increased urea concentration in the serum and edema, peripheral edema, allergic nephritis, nephrotic syndrome, interstitial nephritis, polyuria, cystitis, hematuria, proteinuria.
    - Immune system disorders
    Infrequent: hypersensitivity reactions: skin rash (usually erythematous or urticaria), face swelling, rash, maculopapular rash, itchy skin;
    very 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.
    Very rare: in patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen may cause symptoms of aseptic meningitis, such as spasm of the neck muscles, headache, nausea, vomiting, fever, loss of orientation.
    - Violations of the blood and lymphatic system
    Very rare: anemia (including hemolytic, aplastic), leukopenia, thrombocytopenia and thrombocytopenic purpura,pancytopenia, agranulocytosis, eosinophilia.
    - Other violations:
    Absence of effect when taking the drug
    - Laboratory and instrumental data:
    - bleeding time (may increase)
    - serum glucose concentration (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 the event of an unforeseen overdose, discontinue use and seek professional help immediately.
    In children, taking a dose exceeding 400 mg / kg may cause overdose symptoms. In adults, the symptoms of an overdose are less pronounced. The half-life for an overdose is 1.5-3 hours.
    Symptoms
    In most patients who have taken clinically significant overestimated doses of NSAIDs, symptoms such as nausea, vomiting, epigastric pain, and diarrhea may develop. Noises in the ears, dizziness, headache and bleeding of the gastrointestinal tract are also possible. In more serious cases of intoxication, there are symptoms from the CNS, manifested in drowsiness,marked dizziness, sometimes can be observed excitation, disorientation, coma, blocking, depression, acute renal failure, lowering blood pressure. In some cases, patients have convulsions. In severe cases of intoxication, metabolic acidosis and an increase in prothrombin time may be observed, an increase in the MHO (International Normalized Ratio) index. Also, acute violations of kidney and liver function, hyperkalemia, bradycardia, tachycardia, atrial fibrillation, dyspnoea, oppression and respiratory arrest are possible. Patients with bronchial asthma may exacerbate this disease. Therapy
    Standard measures are taken for symptomatic and maintenance therapy, including maintenance of respiratory function, as well as monitoring of cardiac activity and other vital functions. If no more than 1 hour has passed since the potentially toxic dose was taken, gastric lavage and Activated carbon Inside, then alkaline drink, forced diuresis. With frequent or prolonged convulsions it is recommended to inject intravenously diazepam or lorazepam. When bronchial asthma attacks bronchodilators are recommended.
    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.
    - Hypotensive drugs: ibuprofen weakens the effect of antihypertensive drugs (including blockers of slow calcium channels 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 concentration 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.
    - Glucocorticosteroids, 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, cefoperazone, 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, enhances 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.
    - With the simultaneous use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
    - In patients receiving co-treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.
    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 during pregnancy and during breastfeeding" and "Contraindications").
    - It is necessary to consult a doctor before taking another drug from the NSAID group.
    - During the treatment with any drugs of the NSAID group, there were cases of 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) that occur during therapy.The drug should be discontinued and the doctor should be consulted 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 in prescribing ibuprofen to patients taking medications that increase the risk of complications from 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 of cyclooxygenase / prostaglandins,can cause a decline in fertility 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 edema associated with NSAID use. Long-term use may increase the risk of acute coronary disease or stroke.
    During the period of treatment, ethanol is not recommended.
    The use of such drugs may be associated with a slight increase in the risk of developing 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 the duration of use (no more than 5 days).
    In the presence of cardiovascular disease, a previous stroke or having risk factors (eg, high blood pressure, diabetes, high cholesterol, smoking), you should discuss taking the drug with your doctor. The first symptoms of hemopoiesis: fever, sore throat, superficial ulceration of the oral mucosa, influenza-like symptoms, severe fatigue, bleeding and bruising of unknown origin.
    - 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,requiring increased concentration of attention and rapid mental and motor reactions.
    Form release / dosage:Capsules, 400 mg each.
    Packaging:By 2, 4, 8, 10 capsules in a blister of aluminum foil and PVC / PE / PVDNH. 1 blister (4, 8, 10 capsules) or 2 blisters (20 capsules) together with instructions for use in a cardboard box. Sample not for sale: 1 blister (2 capsules each) together with instructions for use in a cardboard box.
    Storage conditions:At a temperature of no higher than 25 ° C.

    Keep out of the reach of children!
    Shelf life:
    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007575/08
    Date of registration:19.09.2008/27.05.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Pfizer Corporation Austria GmbHPfizer Corporation Austria GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspPfizer LtdPfizer LtdUSA
    Information update date: & nbsp23.01.2017
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