Inside. For short term use only.

Adults and children over 12 years old - 1 capsule each, without chewing. The capsule should be taken with water. The interval between doses of the drug should be at least 4 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children 12-17 years old is 800 mg.

If symptoms persist or worsen when taking the drug for 2-3 days, you must stop treatment and consult a doctor.

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 a 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 bleeding ulcer);

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 (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 12 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, 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 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; simultaneous use of drugs that can increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy, I – II trimester; period of breastfeeding; elderly age.

Use during pregnancy and children

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 you need to take the drug, you 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 an infant, so there is usually no need to stop breastfeeding with short-term use. If you need to use the drug for a long time, you should consult a doctor to decide whether to stop breastfeeding for the period of using the drug.

The risk of side effects can be minimized by taking the drug in a short course in the minimum effective dose necessary to eliminate symptoms.

Side effects are predominantly dose-dependent.

The following adverse reactions were observed with short-term administration of ibuprofen in doses not exceeding 1200 mg / day (3 caps.). In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur.

The assessment of the incidence of adverse reactions was made on the basis of the following criteria: very often (≥1 / 10); often (≥1 / 100 to <1/10); infrequently (from ≥1 / 1000 to <1/100); rarely (from ≥1 / 10,000 to <1/1000); very rare (<1/10000); frequency is unknown (data on frequency estimates are not available).

On the part of the blood and lymphatic system: very rarely - hematopoiesis 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: infrequently - 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: infrequently - abdominal pain, nausea, dyspepsia (including heartburn, bloating); rarely - diarrhea, flatulence, constipation, vomiting; very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis; frequency unknown - exacerbation of colitis and Crohn's disease.

Liver and biliary tract disorders: very rarely - liver dysfunction (especially with prolonged 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 CCC: the frequency is unknown - heart failure, peripheral edema, with prolonged use, the risk of thrombotic complications (for example, myocardial infarction or stroke), increased blood pressure is increased.

From the respiratory system, chest and mediastinal organs: the frequency is 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); hepatic transaminase activity (may increase).

If side effects appear, stop taking the drug and consult a doctor.

Simultaneous use of ibuprofen with the following drugs should be avoided

Acetylsalicylic acid: 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 the simultaneous use of 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 low doses of acetylsalicylic acid as an antiplatelet agent 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 the possible increase in the risk of side effects.

Use with caution simultaneously with the following drugs

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

Antihypertensive drugs (ACE inhibitors and ARA II) and diuretics: NSAIDs can reduce the effectiveness of drugs in these groups. Diuretics can increase the nephrotoxicity of NSAIDs.

GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Antiplatelet agents and SSRIs: increased risk of gastrointestinal bleeding.

Cardiac glycosides: The simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, decreased GFR, and an increase in the concentration of cardiac glycosides in blood plasma.

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.

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 with concomitant administration of NSAIDs and cyclosporine.

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

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

Zidovudine: Concomitant use of NSAIDs and zidovudine can lead to increased 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.

Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.

In children, symptoms of overdose may occur after taking a dose exceeding 400 mg / kg. In adults, the dose-dependent effect of overdose is less pronounced. T1 / 2 of the drug in case of an overdose is 1.5-3 hours.

Symptoms: 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 PT, acute renal failure, liver tissue damage, a decrease in blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, an aggravation of this disease is possible.

Treatment: symptomatic, with the mandatory provision of airway patency, ECG monitoring and vital signs until the patient's condition is normalized. Oral administration of activated charcoal or gastric lavage is recommended within one hour of 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 ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged convulsions should be treated with IV diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.