Nurofen forte tablets 400mg, No. 12

NurofenЃ Forte 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.

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 inside 1 tablet (400 mg) up to 3 times a day. The tablets should be taken with water. The interval between taking the pills 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 old is 800 mg (2 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.

One coated tablet contains:

active substance: ibuprofen 400 mg;

excipients: croscarmellose sodium 60 mg, sodium lauryl sulfate 1 mg, sodium citrate 87 mg, stearic acid 4 mg, colloidal silicon dioxide 2 mg. shell composition: carmellose sodium 1.4 mg, talc 66 mg, acacia gum 1.2 mg, sucrose 232.2 mg, titanium dioxide 2.8 mg, macrogol 6000 0.4 mg, red ink [Opakod S-1-15094 ] (shellac 41.49%, iron dye red oxide (E172) 31%, butanol * 14%, isopropanol * 7%, propylene glycol 5.5%, aqueous ammonia 1%, simethicone 0.01%). * Solvents evaporated after the printing process.

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.

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 the drug on an empty stomach, ibuprofen is found in the blood plasma after 15 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 dosage form of a tablet, 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, is retained 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.

Carefully:

If you have the conditions listed in this section, you should consult a 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 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 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), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors ( including citalopram, fluoxetine, paroxetine, sertraline); pregnancy I-II trimester, breastfeeding period, old age.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), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors ( including citalopram, fluoxetine, paroxetine, sertraline); pregnancy I-II trimester, breastfeeding period, old age.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), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors ( including citalopram, fluoxetine, paroxetine, sertraline); pregnancy I-II trimester, breastfeeding period, old age.in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, sertraline, paroxetine); pregnancy I-II trimester, breastfeeding period, old age.in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, sertraline, paroxetine); pregnancy I-II trimester, breastfeeding period, old age.

Application during pregnancy and breastfeeding:

The use of the drug in the third trimester of pregnancy is contraindicated. Avoid the use of ibuprofen 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.

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 arterial hypertension,including 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. Information for women planning pregnancy: the drug inhibits cyclooxygenase and prostaglandin synthesis and can affect ovulation, disrupting female reproductive function (reversible after discontinuation of treatment). 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. Patients with uncontrolled blood pressure,congestive heart failure NYHA class II-III, coronary heart disease, peripheral arterial disease and / or cerebrovascular disease, ibuprofen should be prescribed only after a careful assessment of the benefit / risk ratio, and high doses of ibuprofen (? 2400 mg / day) should be avoided. 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 Uncommon: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its aggravation, 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.

Х Very rare: severe hypersensitivity reactions, including edema 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, dyspepsia (including heartburn, bloating).

Х Rarely: diarrhea, flatulence, constipation, vomiting.

Х Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases 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, jaundice.

Kidney and urinary tract disorders

Х Very rare: acute renal failure, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

Х Uncommon: headache.

Х Very rare: aseptic meningitis (isolated cases of symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever and disorientation, have been observed with ibuprofen treatment in patients with autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease) ).

Cardiovascular disorders

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

Respiratory, Chest 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, acute 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 within one hour of taking a potentially toxic dose of ibuprofen is recommended. 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 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, including selective cyclooxygenase-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. Diuretics 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: the simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, decreased glomerular filtration rate and increased plasma concentration 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 use of NSAIDs and cyclosporine.

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

Х Tacrolimus: with the simultaneous use 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.