Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbspCapsules
    Composition:
    One capsule contains active substance - ibuprofen 400 mg, Excipients: macrogol-600 335.3 mg, potassium hydroxide 44.82; water 29.88 mg; shell capsules: gelatin 197 mg, sorbitol (partially dehydrated) 95.68 mg,Water 25.02 mg, Crimson Crude [Ponso 4J] (E124) 0.79 mg, White Inks [Opacode WB NS-78-18011] (water 48%, titanium dioxide (E171) 29%, propylene glycol 10%, isopropanol 8 %, hypromellose 3cP 5%).

    Description:Oval capsules with a red translucent gelatin shell, with an identifying inscription of white NUROFEN, containing a clear liquid from colorless to light pink.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    M.01.A.E.01   Ibuprofen

    Pharmacodynamics:The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (H11VP), is caused by inhibition of the synthesis of prostaglandins - mediators of pain, inflammation of hyperthermic reaction. Non-selectively blocks cyclooxygenase (COX-1) and cyclooxygenase 2 (COX-2), which inhibits the synthesis of prostaglandins. Has a quick directional action against pain (analgesic), antipyretic and anti-inflammatory action. Besides, ibuprofen reversibly inhibits platelet aggregation.
    Pharmacokinetics:
    Absorption is high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach, ibuprofen is detected in the blood plasma after 15 minutes, the maximum concentration (Cmax) of ibuprofen in the blood plasma is reached after 30-40 m, which is twice as fast as after taking an equivalent dose of Nurofen®, in the form of a tablet coated with 200 mg. Taking the drug along with food can increase the time reached by the maximum concentration (TCmax). Connection with plasma proteins over 90 half-life (T1 / 2) -2 hours Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating in it a greater concentration than in the blood plasma. After absorbing about 60 pharmacologically inactive R-form, the active S-form is slowly transformed. It is metabolized in the liver. It is excreted by the kidneys unchanged not more than 1%) and, to a lesser extent, with bile.
    In the elderly, there were no significant differences in the pharmacokinetic profile of the drug compared to younger people.
    In limited studies ibuprofen was found in breast milk at very low concentrations.

    Indications:Nurofen® Express Forte is used for headache, migraine, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pain; at feverish conditions at a flu and cold diseases.
    Contraindications:
    - Hypersensitivity to ibuprofen or any of the components that make up the drug.
    - The presence in the history of episodes of hypersensitivity (attacks of bronchial obstruction, bronchial asthma, rhinitis, Quincke's edema or urticaria) in response to the use of acetylsalicylic acid (salicylates) or other NSAIDs; complete or incomplete syndrome of acetylsalicylic acid intolerance (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma).
    - Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of stomach and duodenum, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in the anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding); bleeding or perforation of an ulcer of the gastrointestinal tract in an anamnesis, provoked by the use of NSAIDs.
    - Pronounced hepatic insufficiency or liver disease in the active phase.
    - Severe renal insufficiency (creatinine clearance <30 ml / min), confirmed hyperkalemia.
    - Decompensated heart failure; period after aortocoronary bypass surgery.
    - Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.
    - Intolerance to fructose.
    - Intracranial hemorrhages.
    - Pregnancy (III trimester).
    - Children under 12 years.
    Carefully:
    In the presence of conditions specified in this section, before using the drug should consult a doctor.
    Bronchial asthma or allergic disease in the acute stage, or a history of a single episode of erosive and ulcerative diseases of the gastrointestinal tract in history (including gastric ulcer and duodenal ulcer); gastritis, enteritis, colitis; renal failure (creatinine clearance of 30-60 ml / min), hepatic failure, arterial hypertension and / or heart failure, ischemic heart disease, peripheral artery disease, cerebrovascular disease, hyperlipidemia, diabetes, smoking and frequent use of alcohol, cirrhosis with portal hypertension, nephrotic syndrome, hyperbilirubinemia, blood diseases of unknown etiology (leucopenia and anemia), prolonged use of NSAIDs, severe somatic disorders,systemic lupus erythematosus or other autoimmune diseases of connective tissue (increased risk of developing aseptic meningitis), simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid clopidogrel), selective inhibitors of re-uptake serotonin (including citalopram, fluoxetine, paroxetine, sertraline), pregnancy I trimester, period of breastfeeding, elderly age.
    Pregnancy and lactation:Contraindicated use of the drug in the III trimester of pregnancy. If possible, the use of ibuprofen in I-II trimesters of pregnancy should be avoided. There is evidence that ibuprofen in small quantities can penetrate into breast milk without any negative consequences for the health of the infant.
    Dosing and Administration:Read the instructions carefully before taking the drug. For oral administration. Only for short-term use. Adults and children over 12 years: inside by 1 capsule, without chewing. Capsule should be washed down with water.The interval between doses should be at least 4 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children 12-17 years is 800 mg. If the symptoms persist or worsen during 2-3 days, stop treatment and consult a doctor.
    Side effects:
    The risk of side effects can be minimized if you take the drug with a short course, at the lowest effective dose needed to eliminate the symptoms.
    Side effects are predominantly dose-dependent. The following adverse reactions were noted with a short-term intake of ibuprofen in doses not exceeding 1200 mg / day (3 capsules). In the treatment of chronic conditions and with prolonged use, other side reactions may occur.
    The incidence of adverse reactions was estimated on the basis of the following criteria: very frequent (> 1/10), frequent (> 1/100 to <1/1 infrequent (> 1/1000 to <1/100), rare (> 1/10 000 to <1/1000), very rare (<1/10 000).
    Violations of the blood and lymphatic system
    - Very rare: hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like syndrome, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
    Immune system disorders
    - Infrequent: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its aggravation, bronchospasm, dyspnea, dyspnea), skin reactions (itching, urticaria, Quincke's edema, exfoliative and bullous dermatoses, toxic epidermal necrolysis, erythema multiforme), allergic rhinitis, eosinophilia.
    - Very rare: aseptic meningitis (in patients with autoimmune disorders: systemic lupus erythematosus, mixed connective tissue disease), severe hypersensitivity reactions.
    Disorders from the gastrointestinal tract
    - Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, decreased appetite), gastritis, bloating.
    - Rare: diarrhea, flatulence, constipation and vomiting.
    - Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, exacerbation of colitis and Crohn's disease.
    Disorders from the urinary system and liver
    - Rare: papillonecrosis, nephritic syndrome, especially with prolonged use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, hematuria and proteinuria.
    - Very rare: violations of the liver (especially with prolonged treatment), hepatitis and jaundice, nephrotic syndrome, acute renal failure (compensated and decompensated), interstitial nephritis, cystitis.
    Disturbances from the nervous system
    - Infrequent: dizziness, headache.
    - Very rare: aseptic meningitis, stroke.
    Disorders from the psyche
    - Very rare: insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations.
    Impaired sensory organs
    - Hearing impairment: hearing loss,ringing or noise in the ears; visual impairment: toxic damage to the optic nerve, blurred vision and, double vision, scotoma, dry eye irritation, edema of the conjunctiva and in (allergic genesis).
    Disorders from the cardiovascular system
    - Very rare: heart failure, increased arterial pressure, tachycardia.
    Disturbances from the respiratory system and mediastinal organs
    - Very rare: bronchial asthma, bronchospasm, shortness of breath and wheeze.
    Disturbances from the skin and subcutaneous tissues
    - Infrequent: various types of skin rashes.
    - Very rare: severe forms of skin reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis (Lyell's syndrome).
    Other
    - Very rare: edema, including peripheral.
    Laboratory indicators
    - hematocrit or hemoglobin (may decrease)
    - bleeding time (may increase)
    - the concentration of glucose in the blood plasma (may decrease)
    - clearance of creatinine (may decrease)
    - plasma creatinine concentration (may increase)
    - activity of "liver" transaminases (may increase)
    If side effects occur, stop taking the medication and consult a doctor.
    Overdose:
    In children, overdose symptoms may occur after taking a dose exceeding 400 mg / kg body weight. In adults, the dose-dependent effect of an overdose is less pronounced. The half-life of the drug with an overdose is 1.5-3 hours.
    Symptoms: nausea, vomiting, epigastric pain or, more rarely, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely - excitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, damage to liver tissue, lowering blood pressure, respiratory depression and cyanosis may develop. Patients with bronchial asthma may exacerbate this disease.
    Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic indicators of vital activity, up to the normalization of the patient's condition.Recommended oral administration of activated carbon or gastric lavage within one hour after taking a potentially toxic dose of ibuprofen. If ibuprofen already absorbed, alkaline drink may be prescribed to excrete the acid derivative of ibuprofen by the kidneys, forced diuresis.
    Interaction:
    It should be avoided simultaneous use of ibuprofen with the following medicines:
    - Acetylsalicylic acid (aspirin): with the exception of low doses of aspirin (not more than 75 mg per day) prescribed by a doctor, since
    joint use may increase the risk of side effects. With simultaneous application ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as antiplatelet agent after the onset of ibuprofen administration).
    - Other NSAIDs, including selective inhibitors of cyclooxygenase: simultaneous use of two or more drugs from the NSAID group should be avoided because of the possible increased risk ofside effects.
    Use with caution simultaneously with the following medicines:
    - Anticoagulants: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin.
    - Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of these drugs, lead to impaired renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, use the above tools with ibuprofen should be done with caution, especially in the elderly.
    It is necessary to prevent dehydration in patients with mandatory monitoring of kidney function during the entire period of this combined treatment. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs.
    - Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
    - Antiaggregants and selective serotonin reuptake inhibitors: an increased risk of gastrointestinal bleeding.
    - Cardiac glycosides: simultaneous use of NSAIDs and cardiac glycosides may lead to worsening of heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in blood plasma.
    - Lithium preparations: an increase in the concentration of lithium in blood plasma against the background of the use of NSAIDs.
    - Methotrexate: an increase in the concentration of methotrexate in the blood plasma on the background of the use of NSAIDs.
    - Cyclosporine: increased risk of nephrotoxicity with simultaneous use of NSAIDs and cyclosporine.
    - Mifepristone: NSAIDs should be started no earlier than 8-12 days after the end of mifepristone, because NSAIDs may reduce the effectiveness of mifepristone.
    - Tacrolimus: with the simultaneous use of NSAIDs and tacrolimus, an increased risk of nephrotoxicity may occur.
    - Zidovudine: simultaneous use of NSAIDs and zidovudine coins lead to an increase in hematotoxicity in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen: the risk of hemarthrosis and formation of hematoma.
    - Antibiotics of the quinolone series: in patients receiving co-treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.
    Special instructions:It is recommended to take the drug as quickly as possible short courses and in the minimum effective dose necessary to eliminate symptoms. Agents that inhibit cyclooxygenase and the synthesis of prostaglandins can affect ovulation, disrupting female reproductive function (reversible after withdrawal of treatment). During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin a), and analysis of feces for latent blood are shown. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. During the period of treatment, ethanol is not recommended.
    Effect on the ability to drive transp. cf. and fur:
    Under the recommended dosage regimen and timing of application, the drug does not affect the ability to drive vehicles and mechanisms, as well as to engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.
    Patients reporting dizziness, drowsiness, blocking, or visual impairment when taking ibuprofen should avoid driving vehicles or controlling mechanisms.

    Form release / dosage:
    Capsules 400 mg.
    Packaging:For 4, 8 or 10 capsules in the blister of PVC / PVDC / Aluminum. 1 blister (4, 8 or 10 capsules) or 2 blisters (4, 8 or 10 capsules) or 3 blisters (10 capsules each) are placed in a cardboard box together with instructions for use.
    Storage conditions:In a dry place at a temperature of no higher than 25 ° C. Keep the drug out of the reach of children.
    Shelf life:
    3 years.
    Do not use after the date shown on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-005587/10
    Date of registration:18.06.2010
    The owner of the registration certificate:Rekitt Benckiser Helsar International Ltd.Rekitt Benckiser Helsar International Ltd. United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspREKITT BENKIZER HELSKER LTD. REKITT BENKIZER HELSKER LTD. United Kingdom
    Information update date: & nbsp04.08.2014
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