Brufen SR tablets 800mg, No. 14

Symptomatic treatment as an anti-inflammatory and antipyretic agent:

• inflammatory and degenerative diseases of the joints and spine (including rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis),

• articular syndrome with exacerbation of gout,

• psoriatic arthritis,

• ankylosing spondylitis,

• tendinitis

• bursitis,

• radiculitis,

• traumatic inflammation of soft tissues and musculoskeletal system.

• Neuralgia,

• myalgia,

• pain syndrome in infectious and inflammatory diseases of the ENT organs,

• adnexitis,

• algodismenorrhea,

• headache and toothache.

• Fever in infectious and inflammatory diseases,

• with childhood infections,

• with post-vaccination reactions in children (in appropriate dosage forms)

Inside, after eating. The tablets should be swallowed whole, without chewing, washed down with plenty of water.

Adults and children 12 years of age and older: The recommended dose is 2 Brufen CP tablets once a day, preferably at bedtime. In severe and acute conditions, the maximum daily dose is 3 tablets taken separately. The maximum daily dose is 2,400 mg.

Elderly patients: with normal renal and hepatic function, adjustment of the dosage regimen in elderly patients is not required. In case of impaired renal and / or liver function, the dose should be selected individually. In this group of patients, dosing should be done with caution.

Active substance:

ibuprofen - 800 mg

Excipients: xanthan gum - 196.8 mg; povidone K-30 - 25.9 mg; stearic acid - 10.3 mg; anhydrous colloidal silicon dioxide - 3.0 mg.

• Hypersensitivity to ibuprofen;

• erosive and ulcerative lesions of the gastrointestinal tract in the acute phase or ulcerative bleeding in the active phase or in history (2 or more confirmed episodes of peptic ulcer or ulcer bleeding);

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

• severe heart failure (NYHA functional class IV);

• severe renal and / or liver dysfunction;

• diseases of the optic nerve, 'aspirin triad', hematopoiesis disorders;

• period after coronary artery bypass grafting;

• intracranial or other bleeding;

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

• proctitis (for rectal use);

• III trimester of pregnancy;

• child's body weight up to 6 kg (for all dosage forms);

• children under 6 years of age (orally - at a dose of 200 mg);

• children under 12 years of age (orally - at a dose of 400 mg).

Carefully:concomitant use of other NSAIDs; a history of a single episode of gastric ulcer and duodenal ulcer or gastrointestinal ulcer bleeding; gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in history; systemic lupus erythematosus or mixed connective tissue disease (Sharp's syndrome) - increased risk of aseptic meningitis; chickenpox; renal failure, incl. with dehydration (CC 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; peripheral arterial disease; smoking; frequent alcohol consumption; the simultaneous use of drugs that can increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram , fluoxetine, paroxetine, serratine) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); I-II trimester of pregnancy; breastfeeding period; elderly age; children under 12 years of age - for a dose of 200 mgoral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, serratine) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); I-II trimester of pregnancy; breastfeeding period; elderly age; children under 12 years of age - for a dose of 200 mgoral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, serratine) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); I-II trimester of pregnancy; breastfeeding period; elderly age; children under 12 years of age - for a dose of 200 mg

pharmachologic effect

NSAIDs, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic and antipyretic effects.

The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to both a peripheral (indirectly, through suppression of prostaglandin synthesis) and a central mechanism (inhibition of prostaglandin synthesis in the central and peripheral nervous system). Suppresses platelet aggregation.

Pharmacokinetics

When taken orally, ibuprofen is almost completely absorbed from the gastrointestinal tract. Simultaneous food intake slows down the rate of absorption. Metabolized in the liver (90%). T1 / 2 is 2-3 hours. 80% of the dose is excreted in the urine mainly in the form of metabolites (70%), 10% - unchanged; 20% is excreted through the intestines as metabolites.

Side effect

From the hematopoietic system: very rarely - hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).

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, dyspnoea), 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. edema of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).

From the digestive system: 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.

From the liver and biliary tract: very rarely - liver dysfunction, increased activity of hepatic transaminases, hepatitis and jaundice.

From the urinary system: very rarely - 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.

From the nervous system: infrequently - headache; very rarely - aseptic meningitis.

From the side of the cardiovascular system: the frequency is unknown - heart failure, peripheral edema; with prolonged use, the risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure is increased.

Respiratory system: frequency unknown - bronchial asthma; bronchospasm; dyspnea.

On the part of laboratory indicators: it is possible - a decrease in the content of hematocrit or hemoglobin, an increase in bleeding time, a decrease in the concentration of glucose in the blood plasma, a decrease in creatinine clearance, an increase in the concentration of creatinine in the blood plasma, an increase in the activity of hepatic transaminases.

Application during pregnancy and lactation

Use during pregnancy and during breastfeeding is contraindicated.

Application for violations of liver function

Contraindicated in severe liver dysfunction. Use with caution in case of concomitant liver diseases.

Application for impaired renal function

Contraindicated in severe renal impairment. Use with caution in case of concomitant kidney disease.

Application in children

Ibuprofen is contraindicated for rectal administration in children weighing up to 6 kg; for oral administration - in children under the age of 6 (at a dose of 200 mg), in children under the age of 12 (at a dose of 400 mg).

Use in elderly patients

Caution should be given to elderly patients in order to avoid worsening of the course of concomitant diseases.

In elderly patients, there is an increased frequency of adverse reactions associated with the use of NSAIDs, especially gastrointestinal bleeding and perforation, in some cases with a fatal outcome.

special instructions

It is recommended to prescribe ibuprofen in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. If you need systemic use for more than 10 days, you should consult your doctor.

During long-term treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, general blood count (hemoglobin determination), and fecal occult blood test.

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 ibuprofen for chickenpox.

Ibuprofen inhibits COX and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).

Influence on the ability to drive vehicles and mechanisms

Patients who report dizziness, drowsiness, lethargy or visual impairment while taking ibuprofen should avoid driving vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions.

Drug interactions

With the simultaneous use of ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).

With simultaneous use with anticoagulants, their effect may be enhanced.

With simultaneous use with GCS, the risk of developing side effects from the gastrointestinal tract increases.

With simultaneous use, ibuprofen can displace indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), oral hypoglycemic drugs, sulfonylurea derivatives from compounds with blood plasma proteins.

With simultaneous use with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid - the concentration of ibuprofen in the blood plasma decreases; with baclofen - a case of intensification of the toxic effect of baclofen is described.

With simultaneous use with warfarin, an increase in bleeding time is possible, microhematuria, hematomas were also observed; with captopril - it is possible to reduce the antihypertensive effect of captopril; with cholestyramine - a moderately pronounced decrease in the absorption of ibuprofen.

With simultaneous use with lithium carbonate, the concentration of lithium in the blood plasma increases.

With simultaneous use with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate - the toxicity of methotrexate increases.

The simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in the glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.

There is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma against the background of the use of NSAIDs.

With the simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.

NSAIDs can reduce the effectiveness of mifepristone, therefore NSAIDs should be started no earlier than 8-12 days after the end of mifepristone.

With the simultaneous use of NSAIDs and tacrolimus, an increase in the risk of nephrotoxicity is possible.

The simultaneous use of NSAIDs and zidovudine can lead to an increase in 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.

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

In patients receiving both NSAIDs and myelotoxic drugs, hematotoxicity increases.

With the simultaneous use of ibuprofen and cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin, the incidence of hypoprothrombinemia increases.

With the simultaneous use of ibuprofen and drugs that block tubular secretion, there is a decrease in excretion and an increase in the plasma concentration of ibuprofen.

With the simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), there is an increase in the production of hydroxylated active metabolites, an increase in the risk of severe intoxication.