Nurofen Express forte capsules 400 mg No. 20
A country
Netherlands, United Kingdom
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Active substance
Ibuprofen
Compound
1 capsule contains: ibuprofen 400 mg.
Excipients: macrogol 600 - 335.3 mg, potassium hydroxide - 44.82 mg, water - 29.88 mg. Soft gelatin capsules, oval, translucent, red, with the identifying inscription “NUROFEN” in white. The contents of the capsules are a transparent liquid from colorless to light pink.
pharmachologic effect
The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks COX-1 and COX-2, as a result of which it inhibits the synthesis of prostaglandins. It has a rapid, targeted effect against pain (analgesic), antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.
Mode of application
Read the instructions carefully before taking the drug. For oral administration. For short term use only. Adults and children over 12 years of age: 200 mg orally (1 capsule) 3-4 times a day. The capsule is taken without chewing with water. The interval between doses of the drug should be 6-8 hours. To achieve a faster therapeutic effect in adults, the dose can be increased to 2 capsules (400 mg) up to 3 times a day. The maximum daily dose is 1200 mg. The maximum daily dose for children 12-17 years old is 1000 mg. If symptoms persist or worsen after taking the drug for 2-3 days, you should stop treatment and consult a doctor.
Interaction
The simultaneous use of ibuprofen with the following drugs Acetylsalicylic acid should be avoided: with the exception of low doses of acetylsalicylic acid (no more than 75 mg / day) prescribed by a doctor, since combined use may increase the risk of side effects. With simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting ibuprofen). Other NSAIDs, in particular selective COX-2 inhibitors: the simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increased risk of side effects. Use with caution concomitantly with the following drugs Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs. Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs. GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding. Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding. Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma. Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs. Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs. Cyclosporine: increased risk of nephrotoxicity when NSAIDs are administered concomitantly with cyclosporine. Mifepristone: NSAIDs should be started no earlier than 8 to 12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone. Tacrolimus: When NSAIDs and tacrolimus are coadministered, the risk of nephrotoxicity may increase. Zidovudine: Concomitant use of NSAIDs and zidovudine may result in increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received concomitant treatment with zidovudine and ibuprofen. Quinolone antibiotics: In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase. Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia. Drugs that block tubular secretion: decreased excretion and increased plasma concentrations of ibuprofen. Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of developing severe intoxications. Microsomal oxidation inhibitors: reducing the risk of hepatotoxicity. Oral hypoglycemic drugs, sulfonylurea derivatives and insulin: enhanced effect. Antacids and cholestyramine: decreased absorption. Caffeine: increased analgesic effect.
Side effect
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose required to eliminate symptoms. Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg/day (6 capsules). When treating chronic conditions and with long-term use, other adverse reactions may occur. The frequency of adverse reactions was assessed based on the following criteria: very often (?1/10), often (from?1/100 to From the blood and lymphatic system: very rarely - 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 symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology. From the immune system: - uncommon - hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), allergic rhinitis, eosinophilia; - very rarely - severe hypersensitivity reactions, including including swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock). From the digestive system: - uncommon - abdominal pain, nausea, dyspepsia (including heartburn, bloating); - rarely - diarrhea, flatulence, constipation, vomiting; - very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis; - frequency unknown - exacerbation of colitis and Crohn's disease. From the liver and biliary tract: very rarely - liver dysfunction (especially with long-term use), increased activity of liver transaminases, hepatitis and jaundice. From the urinary system: very rarely - acute renal failure (compensated and decompensated), especially with long-term use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis. From the nervous system: - infrequently - headache; - very rarely - aseptic meningitis. From the cardiovascular system: frequency unknown - heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction), increased blood pressure. From the respiratory system: frequency unknown - bronchial asthma, bronchospasm, shortness of breath. From the skin and subcutaneous tissues: infrequently - itching, urticaria, purpura, exfoliative and bullous dermatoses, incl. toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme. Other: very rarely - swelling, incl. peripheral. Laboratory parameters: - hematocrit or hemoglobin (may decrease); - bleeding time (may increase); - plasma glucose concentration (may decrease); — CC (may decrease); - serum creatinine concentration (may increase); - activity of liver transaminases (may increase). If side effects occur, you should stop taking the drug and consult a doctor.
Contraindications
- hypersensitivity to ibuprofen or any of the components included in the drug;
- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including a history); - erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding); - a history of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs; - severe liver failure or active liver disease; - severe renal failure (KK - decompensated heart failure; - period after coronary artery bypass grafting; - cerebrovascular or other bleeding; - fructose intolerance; - hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; - III trimester of pregnancy - children under 12 years of age Precautions for use If you have the conditions listed in this section, you should consult your doctor before using the drug - concomitant use of other NSAIDs, a history of a single episode of gastric ulcer or gastrointestinal ulcer bleeding ; - gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; - bronchial asthma or allergic diseases in the acute phase or in history - bronchospasm may develop; - systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; - renal failure, incl. with dehydration (creatinine clearance less than 30-60 ml/min), nephrotic syndrome, liver failure, liver cirrhosis with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, cerebrovascular diseases, blood diseases of unknown etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol consumption, phenylketonuria or phenylalanine intolerance, concomitant use of medications that may increase the risk of ulcers or bleeding, in particular oral corticosteroids (including prednisolone ), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel), I-II trimesters of pregnancy , breastfeeding period, old age. Use during pregnancy and breastfeeding The use of the drug in the third trimester of pregnancy is contraindicated. You should avoid using the drug in the first and second trimesters of pregnancy; if you need to take the drug, you should consult your doctor. There is evidence that ibuprofen can pass into breast milk in small quantities without any adverse effects on the health of the nursing infant, so there is usually no need to stop breastfeeding when taken for a short period of time. If long-term use of the drug is necessary, you should consult a doctor to decide whether to stop breastfeeding for the period of use of the drug. Information for women planning pregnancy: these drugs suppress COX and prostaglandin synthesis, affect ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).
Overdose
In children, overdose symptoms may occur after ingestion of more than 400 mg/kg body weight of vine. In adults, the dose-dependent effect of overdose is less pronounced. T1/2 of the drug in case of overdose is 1.5-3 hours. Symptoms: nausea, vomiting, pain in the epigastric region or, less commonly, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are observed: drowsiness, rarely - agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is possible. Treatment: symptomatic, with mandatory maintenance of airway patency, monitoring of ECG and vital signs until the patient’s condition is normalized. Oral use of activated charcoal or gastric lavage is recommended within 1 hour after taking a potentially toxic dose of ibuprofen. If ibuprofen has already been absorbed, an alkaline drink may be prescribed in order to eliminate the acidic derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be treated with IV diazepam or lorazepam. If bronchial asthma worsens, the use of bronchodilators is recommended.
special instructions
It is recommended to take the drug for the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, ethanol intake is not recommended. Patients with renal failure should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys. Patients with arterial hypertension, incl. history, and/or chronic heart failure, you should consult your doctor before using the drug, since the drug may cause fluid retention, increased blood pressure and edema. Effects on the ability to drive vehicles and operate machinery Patients who experience dizziness, drowsiness, lethargy, or visual disturbances when taking ibuprofen should avoid driving vehicles or operating machinery.
Nurofen Express forte, 10 pcs., 400 mg, capsules
The risk of side effects can be minimized if the drug is taken in a short course at the minimum effective dose required to eliminate symptoms.
Side effects are predominantly dose-dependent.
The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg/day (3 caps.). When treating chronic conditions and with long-term use, other adverse reactions may occur.
The incidence of adverse reactions was assessed based on the following criteria: very often (≥1/10); often (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10,000 to <1/1000); very rare (<1/10000); frequency unknown (no frequency estimates available).
From the blood and lymphatic system:
very rarely - hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
From the immune system:
uncommon - hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath), skin reactions (itching, urticaria, purpura, Quincke's edema, exfoliative and bullous dermatoses , including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rarely - severe hypersensitivity reactions, incl. swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).
From the gastrointestinal tract:
uncommon - abdominal pain, nausea, dyspepsia (including heartburn, bloating); rarely - diarrhea, flatulence, constipation, vomiting; very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis; frequency unknown - exacerbation of colitis and Crohn's disease.
From the liver and biliary tract:
very rarely - liver dysfunction (especially with long-term use), hepatitis, jaundice.
From the kidneys and urinary system:
very rarely - acute renal failure, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.
From the nervous system:
infrequently - headache; very rarely - aseptic meningitis (isolated cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever and disorientation, were observed during treatment with ibuprofen in patients with autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).
From the SSS side:
frequency unknown - heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction or stroke), increased blood pressure.
From the respiratory system, chest and mediastinal organs:
frequency unknown - bronchial asthma, bronchospasm, shortness of breath.
Laboratory indicators:
hematocrit or hemoglobin (may decrease); bleeding time (may increase); plasma glucose concentration (may decrease); creatinine clearance (may decrease); plasma creatinine concentration (may increase); liver transaminase activity (may increase).
If side effects occur, you should stop taking the drug and consult a doctor.
