Description
Latin name
Nurofen forte
release form coated tablets
packaging 12 pcs
Pharmacological action
Double concentration of active substance * for directed action against severe pain.
The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to the inhibition of prostaglandin synthesis of mediators of pain, inflammation and hyperthermia. Indirectly blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it inhibits prostaglandin synthesis. It has a quick directed action against pain (analgesic), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.
* Compared to Nurofen in the form of coated tablets (200 mg), RU N013012 / 01
Indications
Nurofen ® Forte is used for headaches, migraines, toothaches, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and joint pain, as well as for a febrile illness with the flu and colds.
Contraindications
Hypersensitivity to ibuprofen or any of the components that make up the drug.
Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including a history of).
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 the anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding).
History of bleeding or perforation of a gastrointestinal ulcer provoked by the use of NSAIDs.
Severe heart failure (NYHA Class IV – Classification of the New York Association of Cardiology).
Severe liver failure or liver disease in the active phase.
Severe renal failure (creatinine clearance <30 ml / min), confirmed hyperkalemia. Decompensated heart failure period after coronary artery bypass grafting. Cerebrovascular or other bleeding. Fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase deficiency. Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis. Pregnancy (III trimester). Children under 12 years old. Caution If you have the conditions mentioned 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 and duodenal ulcer or gastric ulcer, gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis bronchial asthma or an allergic disease in the acute stage or in the anamnesis – it is possible to develop bronchospasm systemic lupus erythematosus or mixed connective tissue disease (Sharpe syndrome) – the risk of aseptic meningitis chickenpox renal failure, including dehydration (creatinine clearance less than 30- 60 ml / min), nephrotic syndrome, liver failure, cirrhosis of liver with portal hypertension, hyperbilirubinemia, arterial hypertension and / or heart failure viability, cerebrovascular diseases, blood diseases of unknown etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, frequent alcohol use, simultaneous use of drugs, which may increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (in including acetylsalicylic acid, clopidogrel), pregnancy I-II trimester, breastfeeding, old age. Use during pregnancy and lactation The use of the drug in the third trimester of pregnancy is contraindicated. Avoid the use of the drug in the I-II trimesters of pregnancy, if necessary, take the drug should consult your doctor. There is evidence that small amounts of ibuprofen can pass into breast milk without any negative consequences for the health of the infant, therefore, usually with short-term use, the need to stop breastfeeding does not arise. If you need long-term use of the drug, you should consult a doctor to resolve the issue of stopping breastfeeding for the period of use of the drug. Composition One coated tablet contains the active ingredient – 400 mg ibuprofen and excipients: croscarmellose sodium, sodium lauryl sulfate, sodium citrate, stearic acid, silicon dioxide colloidal shell Composition: carmellose sodium, talc, acacia , titanium dioxide, macrogol 6000, red ink [Opakod S-1-15094]. Dosage and administration For oral administration. Patients with increased gastric sensitivity are recommended to take the drug with meals. For short-term use only. Read the instructions carefully before taking the drug. Adults and children 12 years of age and inside, take 1 tablet (400 mg) up to 3 times a day. Tablets should be washed down with water. The interval between taking the tablets should be at least 6 hours. The maximum daily dose is 1200 mg (3 tablets). The maximum daily dose for children from 12 to 18 years is 800 mg (2 tablets). If, after taking the drug for 2 3 days, symptoms persist or intensify, stop treatment and consult a doctor. Side effects The risk of side effects can be minimized by taking the drug in a short course, at the minimum effective dose needed to eliminate the symptoms. Elderly people have an increased frequency of adverse reactions with NSAIDs, especially gastrointestinal bleeding and perforations, in some cases fatal. Side effects are predominantly dose dependent. The following adverse reactions were noted with short-term use of ibuprofen in doses not exceeding 1200 mg / day (3 tablets). In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur. The frequency of adverse reactions was estimated based on the following criteria: very frequent ( 1/10), frequent (from 1/100 to <1/10), infrequent (from 1/1000 to <1/100), rare (from 1/10 000 to <1/1000), very rare (<1/10 000), the frequency is unknown (there is not enough data to estimate the frequency). Violations of the blood and lymphatic system · Very rare: hematopoiesis (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of these disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds, and subcutaneous hemorrhages, bleeding, and bruising of unknown etiology. Immune system disorders · Infrequent: hypersensitivity reactions – nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, dyspnea, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, in including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia. · Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke’s edema, or severe anaphylactic shock). Gastrointestinal disorders · Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, bloating). · Rare: diarrhea, flatulence, constipation, vomiting. · Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis. · Unknown frequency: exacerbation of colitis and Crohn’s disease. Disorders from the liver and biliary tract · Very rare: impaired liver function, increased activity of hepatic transaminases, hepatitis and jaundice. Disorders of the kidneys and urinary tract · Very rare: acute renal failure (compensated and decompensated) especially with prolonged use, combined 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. Disorders of the nervous system · Infrequent: headache. · Very rare: aseptic meningitis. Cardiovascular disorders · Frequency unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (eg, myocardial infarction), increased blood pressure. Disorders of the respiratory system and mediastinal organs · Frequency unknown: bronchial asthma, bronchospasm, shortness of breath. Laboratory readings · hematocrit or hemoglobin (may decrease) · bleeding time (may increase) · plasma glucose concentration (may decrease) · creatinine clearance (may decrease) · plasma creatinine concentration (may increase) activity of hepatic transaminases (may increase) If side effects occur, you should stop taking the drug and consult a doctor. Drug Interaction Concomitant use of ibuprofen with the following drugs should be avoided: · Acetylsalicylic acid: except for low doses of acetylsalicylic acid (not more than 75 mg per day) When co-administered with ibuprofen, it reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (possibly increasing the incidence of acute coronary insufficiency in patients receiving low doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen). · Other NSAIDs, including selective COX-2 inhibitors: two or more NSAIDs should be avoided at the same time because of the possible increased risk of side effects. Use with caution with the following medicines: · Anticoagulants and thrombolytic agents: NSAIDs may potentiate the effect of anticoagulants, in particular warfarin and thrombolytic agents. · Antihypertensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of these groups. In some patients with impaired renal function (eg, in patients with dehydration or in elderly patients with impaired renal function), concomitant administration of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibiting agents may result in including the development of acute renal failure (usually reversible). These interactions should be considered in patients receiving coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the joint use of the above agents should be used with caution, especially in the elderly. It is necessary to prevent dehydration in patients, as well as to consider the possibility of monitoring renal function after the start of such combination treatment and periodically thereafter. ACE diuretics and inhibitors can increase the nephrotoxicity of NSAIDs. · Glucocorticosteroids: increased risk of gastrointestinal ulcer and gastrointestinal bleeding. · Antiaggregants and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding. · Cardiac glycosides: concomitant administration of NSAIDs and cardiac glycosides can lead to a worsening of heart failure, a decrease in glomerular filtration rate, and an increase in the concentration of cardiac glycosides in the blood plasma. · Lithium drugs: There is evidence of an increase in the concentration of lithium in blood plasma when NSAIDs are used. · Methotrexate: There is evidence of an increase in the concentration of methotrexate in blood plasma when NSAIDs are used. · Cyclosporine: Increase the risk of nephrotoxicity when co-administered with NSAIDs and cyclosporine. · Mifepristone: NSAIDs should be initiated no earlier than 8-12 days after receiving Mifepristone, as NSAIDs may reduce the effectiveness of Mifepristone. · Tacrolimus: increased risk of nephrotoxicity may be associated with the administration of NSAIDs and tacrolimus. · Zidovudine: Co-administration of NSAIDs with zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive hemophilia patients receiving concomitant treatment with zidovudine and ibuprofen. · Quinolone series antibiotics: Patients receiving co-treatment with NSAIDs and quinolone series antibiotics may have an increased risk of seizures. · Myelotoxic drugs: increased hematotoxicity. · Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: an increase in the incidence of hypoprothrombinemia. · Drugs blocking tubular secretion: decreased excretion and increased plasma concentrations of ibuprofen. · Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication. · Microsomal Oxidation Inhibitors: Reducing the Risk of Hepatotoxic Action. · Oral hypoglycemic drugs and insulin derivatives of sulfonylureas: enhancement of drug action. · Antacids and cholestyramine: decrease in absorption. · Uricosuric drugs: reduced effectiveness of drugs. · Estrogens, ethanol: an increased risk of side effects. · Caffeine: Enhances analgesic effect. Overdose Overdose symptoms in children may occur after taking a dose greater than 400 mg / kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of drug overdose is 1.5-3 hours. Symptoms: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely – excitement, cramps, 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. Patients with bronchial asthma may have an exacerbation of this disease. Treatment: symptomatic, with obligatory maintenance of airway patency, monitoring of ECG and basic indicators of vital activity up to normalization of the patient’s condition. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour of receiving a potentially toxic dose of ibuprofen. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged cramps should be stopped by intravenous diazepam or lorazepam. With worsening bronchial asthma, the use of bronchodilators is recommended. Storage conditions Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. Expiration 3 years. Deystvuyuschee substances Ibuprofen Terms of delivery from pharmacies Without a prescription dosage form dosage form tablets Reckitt Benckiser, UK
