Nurofen tablets 200mg, No. 10

• Headache;

• migraine;

• toothache;

• painful periods;

• neuralgia;

• back pain, muscle pain, rheumatic pain;

• fevers with flu and colds.

For oral administration.

Patients with hypersensitivity of the stomach are advised to take the drug with meals. For short term use only. Read the instructions carefully before taking the drug.

Adults and children over 12 years of age: orally 1 tablet (200 mg) up to 3-4 times a day.

The tablets should be taken with water.

To achieve a faster therapeutic effect in adults, the dose can be increased to 2 tablets (400 mg) up to 3 times a day.

Children from 6 to 12 years old: 1 tablet (200 mg) up to 3-4 times a day; the drug can be taken only if the child's body weight is more than 20 kg. The interval between taking the pills should be at least 6 hours. The maximum daily dose for adults is 1200 mg (6 tablets). Maximum daily dose for children from 6 to 18 years old: 800 mg (4 tablets). If, when taking the drug for 2-3 days, the symptoms persist or worsen, it is necessary to stop treatment and consult a doctor.

Coated tablets of white or off-white color, round, biconvex, overprinted in black 'Nurofen' on one side; on a cross-section of a tablet, the core is white or almost white, the shell is white or almost white.

1 tab.

ibuprofen 200 mg

Excipients: croscarmellose sodium - 30 mg, sodium lauryl sulfate - 0.5 mg, sodium citrate dihydrate - 43.5 mg, stearic acid - 2 mg, colloidal silicon dioxide - 1 mg.

• Hypersensitivity to ibuprofen or any of the components that make up 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 history);

• erosive and ulcerative diseases of the gastrointestinal tract in the acute stage (including peptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding);

• a history of bleeding or perforation of a gastrointestinal ulcer, provoked by the use of NSAIDs;

• severe renal failure (Cl creatinine <30 ml / min), confirmed hyperkalemia;

• decompensated heart failure; period after coronary artery bypass grafting;

• cerebrovascular or other bleeding;

• intolerance to fructose;

• hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

• pregnancy (III trimester);

• children under 6 years of age.

With caution: in the presence of the conditions specified in this section, before using the drug, you should consult a doctor - concurrent 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 stage of exacerbation or in history - the development of bronchospasm is possible; systemic lupus erythematosus or mixed connective tissue disease (Sharp's syndrome) increased risk of aseptic meningitis; renal failure, incl. with dehydration (Cl creatinine less than 30-60 ml / min); nephrotic syndrome; liver failure; cirrhosis of the liver 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; peripheral arterial disease; smoking; frequent alcohol consumption; phenylketonuria or phenylalanine intolerance; the simultaneous use of drugs that can increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy, I Ц II trimester; breastfeeding period; elderly age.peripheral arterial disease; smoking; frequent alcohol consumption; phenylketonuria or phenylalanine intolerance; the simultaneous use of drugs that can increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy, I Ц II trimester; breastfeeding period; elderly age.peripheral arterial disease; smoking; frequent alcohol consumption; phenylketonuria or phenylalanine intolerance; the simultaneous use of drugs that can increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy, I Ц II trimester; breastfeeding period; elderly age.sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy, I Ц II trimester; breastfeeding period; elderly age.sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy, I Ц II trimester; breastfeeding period; elderly age.

Pharmacology

The mechanism of action of ibuprofen, a propionic acid derivative 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 cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it inhibits the synthesis of prostaglandins. It has a fast directed action against pain (analgesic), antipyretic and anti-inflammatory action. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.

Pharmacokinetics:

Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach, the maximum concentration (Cmax) of ibuprofen in the blood plasma is reached after 45 minutes. Taking the drug with food can increase the time to reach the maximum concentration (TCmax) up to 1-2 hours. Communication with blood plasma proteins - 90%. It slowly penetrates into the joint cavity, retains in the synovial fluid, creating higher concentrations in it than in the blood plasma. In the cerebrospinal fluid, lower concentrations of ibuprofen are found compared to blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. The half-life (T1 / 2) is 2 hours. It is excreted by the kidneys (not more than 1% unchanged) and,to a lesser extent, with bile. In limited studies, ibuprofen has been found in breast milk at very low concentrations.

Special instructions:

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. If you need to take the drug for more than 10 days, you must consult a doctor. In patients with bronchial asthma or an allergic disease in the acute stage, as well as in patients with a history of bronchial asthma / allergic disease, the drug can provoke bronchospasm. The use of the drug in patients with systemic lupus erythematosus or mixed connective tissue disease is associated with an increased risk of aseptic meningitis. During long-term treatment, it is necessary to monitor the peripheral blood picture and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy,general blood test (determination of hemoglobin), fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. Patients with renal insufficiency should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys. Patients with hypertension, including a history of and / or chronic heart failure, should consult a doctor before using the drug, as the drug can cause fluid retention, increased blood pressure and edema. Patients with uncontrolled arterial hypertension, NYHA class II-III congestive heart failure, coronary heart disease,for peripheral arterial disease and / or cerebrovascular disease, ibuprofen should be prescribed only after careful assessment of the benefit-risk ratio, and high doses of ibuprofen (? 2400 mg / day) should be avoided. The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid the use of the drug for chickenpox. Information for women planning pregnancy: the drug inhibits cyclooxygenase and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment). Patients who report dizziness, drowsiness,retardation or visual impairment while taking ibuprofen, you should avoid driving or operating machinery.

Side effect:

Blood and lymphatic system disorders

Х Very rare: 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.

Immune system disorders

Х Infrequent: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its aggravation, bronchospasm, shortness of breath, dyspnea), skin reactions (pruritus, urticaria, purpura, Quincke's edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.

Х 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

Х Uncommon: abdominal pain, nausea, indigestion (including heartburn, bloating).

Х Rare: diarrhea, flatulence, constipation, vomiting.

Х Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, sometimes fatal, especially in elderly patients, ulcerative stomatitis, gastritis.

Х Frequency not known: exacerbation of colitis and Crohn's disease.

Liver and biliary tract disorders

Х Very rare: liver dysfunctions, increased activity of 'hepatic' transaminases, hepatitis and jaundice.

Kidney and urinary tract disorders

Х Very rare: acute renal failure (compensated and decompensated), 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, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

Х Uncommon: headache.

Х Very rare: aseptic meningitis.

Cardiovascular disorders

Х Frequency unknown: heart failure, peripheral edema, with prolonged use, the risk of thrombotic complications (eg, myocardial infarction), increased blood pressure is increased.

Respiratory and mediastinal disorders

Х Frequency unknown: bronchial asthma, bronchospasm, shortness of breath.

Laboratory indicators

Х hematocrit or hemoglobin (may decrease)

Х bleeding time (may increase)

Х concentration of glucose in blood plasma (may decrease)

Х creatinine clearance (may decrease)

Х plasma creatinine concentration (may increase)

Х activity of 'hepatic' transaminases (may increase)

If side effects appear, you should stop taking the drug 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 overdose is less pronounced. The half-life of the drug in case of overdose is 1.5-3 hours. Symptoms include nausea, vomiting, epigastric pain 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, an exacerbation of this disease is possible. Treatment: symptomatic,with the obligatory provision of airway patency, monitoring of the ECG and vital signs until the patient's condition is normalized. Oral administration 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 to eliminate the acidic ibuprofen derivative by the kidneys, and forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.Oral administration 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 to eliminate the acidic ibuprofen derivative by the kidneys, and forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.Oral administration 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 to eliminate the acidic ibuprofen derivative by the kidneys, and forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.When bronchial asthma worsens, the use of bronchodilators is recommended.When bronchial asthma worsens, the use of bronchodilators is recommended.

Interaction with other medicinal products:

The simultaneous use of ibuprofen with the following drugs should be avoided:

Х Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by your doctor, since combined use may increase the risk of side effects. With the simultaneous use of ibuprofen, it 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 an antiplatelet agent after starting ibuprofen).

Х 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 the possible increase in the risk of side effects. Use with caution simultaneously with the following drugs:

Х Anticoagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.

Х Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous administration of ACE inhibitors or angiotensin II antagonists and drugs that inhibit cyclooxygenase can lead to deterioration of renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concurrently with ACE inhibitors or angiotensin II antagonists. In this regard, the joint use of the above funds should be prescribed with caution, especially in the elderly. It is necessary to prevent dehydration in patientsand consider monitoring renal function after initiation of such combination therapy and periodically thereafter. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs.

Х Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Х Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Х Cardiac glycosides: Concomitant administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, decreased glomerular filtration rate, and increased plasma levels of cardiac glycosides.

Х Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma with the use of NSAIDs.

Х Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in blood plasma with the use of NSAIDs.

Х Cyclosporine: increased risk of nephrotoxicity with concomitant administration of NSAIDs and cyclosporine.

Х Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs can reduce the effectiveness of mifepristone.

Х Tacrolimus: concomitant administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Х Zidovudine: Concomitant use of NSAIDs and zidovudine may increase hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.

Х Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, there may be an increased risk of seizures.

Х Myelotoxic drugs: increased hematotoxicity.

Х Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin: an increase in the incidence of hypoprothrombinemia.

Х Medicines that block tubular secretion: a decrease in excretion and an increase in the plasma concentration of ibuprofen.

Х Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication.

Х Inhibitors of microsomal oxidation: reducing the risk of hepatotoxic effects.

Х Oral hypoglycemic drugs and insulin, sulfonylurea derivatives: enhancement of drug action.

Х Antacids and cholestyramine: decreased absorption. Х Uricosuric drugs: reduced effectiveness of drugs.

Х Caffeine: enhances the analgesic effect.