Nurofen express capsules 200mg, No. 8

NurofenЃ Express is used for such diseases and conditions as:

• headache;

• migraine;

• toothache;

• painful periods;

• neuralgia;

• back pain, muscle pain, rheumatic pain;

• fevers with flu and colds.

Inside. For short term use only. Read the instructions carefully before taking the drug.

Adults and children over 12 years old - 1 caps. (200 mg), without chewing, up to 3-4 times a day. The capsule should be taken with water. The interval between doses of the drug should be 6-8 hours.

To achieve a faster therapeutic effect in adults, a single dose can be increased to 2 caps. (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 when taking the drug for 2-3 days, you must stop treatment and consult a doctor.

One capsule contains the active ingredient - ibuprofen 200 mg,

excipients: macrogol-600 218.33 mg, potassium hydroxide 25.6 mg, water 17.07 mg;

capsule shell: gelatin 119.8 mg, sorbitol 76% solution 58.19 mg, crimson dye [Ponso 4R] (E124) 0.485 mg, water 15.02 mg, white ink [Opakod WB NS-78-18011] (water 48 %, titanium dioxide (E171) 29%, propylene glycol 10%, isopropanol 8%, hypromellose 5%).

Х Hypersensitivity to ibuprofen or any of the components that make up the drug.

Х Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including a history).

Х Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer and duodenal ulcer, 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).

Х Bleeding or perforation of gastrointestinal ulcers in history, provoked by the use of NSAIDs.

Х Severe heart failure (NYHA class IV - NYHA classification).

Х Severe liver failure or active liver disease.

Х Renal failure of severe severity (creatinine clearance <30 ml / min), confirmed hyperkalemia.

Х Decompensated heart failure; period after coronary artery bypass grafting.

Х Cerebrovascular or other bleeding.

Х Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.

Х Fructose intolerance.

Х Pregnancy (III trimester).

Х Children under 12 years of age.

Carefully:

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 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; chickenpox; renal failure, including dehydration (creatinine clearance less than 30-60 ml / min), nephrotic syndrome, hepatic 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, concomitant use of drugs that can increase the risk of ulcers or bleeding, in particular , oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid), clopidine II trimester, breastfeeding period, old age.dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol consumption, concomitant use of drugs that may increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin) , selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel), pregnancy I-II trimester, breastfeeding period, old age.dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol consumption, concomitant use of drugs that may increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin) , selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel), pregnancy I-II trimester, breastfeeding period, old age.oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid I), clopidogram II trimester, breastfeeding period, old age.oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid I), clopidogue trimester, breastfeeding period, old 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.

Pharmacokinetics:

Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking 2 capsules of the drug on an empty stomach, ibuprofen is detected in the blood plasma after 10 minutes, the maximum concentration (Cmax) of ibuprofen in the blood plasma is reached after 30-40 minutes, which is two times faster than after taking an equivalent dose of NurofenЃ, in the tablet dosage form coated 200 mg. Taking the drug with food may increase the time to reach maximum concentration (TCmax). The connection with blood plasma proteins is more than 90%, the half-life (T1 / 2) is 2 hours. It slowly penetrates into the joint cavity, retains in the synovial fluid, creating higher concentrations in it than in the 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. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, with bile. In the elderly, there were no significant differences in the pharmacokinetic profile of the drug compared with younger people. 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. 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 count (hemoglobin determination), and 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 hypertensionincluding a history of and / or chronic heart failure, you should consult your 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 artery disease, peripheral arterial disease and / or cerebrovascular disease should be prescribed ibuprofen only after careful assessment of the benefit-risk ratio, and high doses of ibuprofen (? 2400 mg / day). 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 a pregnancy: these drugs suppress cyclooxygenase and prostaglandin synthesis, affect ovulation, disrupting female reproductive function (reversible after discontinuation of treatment). Patients who report dizziness, drowsiness, lethargy, or visual impairment while taking ibuprofen should avoid driving or operating machinery.retardation or visual impairment while taking ibuprofen, you should avoid driving or operating machinery.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 dysfunction (especially with prolonged use), 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.

Other

Х Very rare: edema, including peripheral edema.

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 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 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, forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.

Interaction with other medicinal products:

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 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 small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen). Х Other NSAIDs, including 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 in conjunction 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. 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 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: increased effect.

Х Antacids and cholestyramine: decreased absorption.

Х Caffeine: enhances the analgesic effect.