Nurofen Intensive painkiller tablets 200 mg + 500 mg 12 pcs. (Ibuprofen, Paracetamol)

Release form

Film-coated tablets.

For 6 or 12 tablets per blister (PVC / PVDC / aluminum). 1 blister together with instructions for use in a cardboard box.

Pharmacological action

Combined drug whose action is due to its constituent components. It has a directed action against pain (analgesic), antipyretic and anti-inflammatory effect. Ibuprofen and paracetamol differ in the mechanism and place of action. As a result of their mutually reinforcing action, a more pronounced decrease in pain sensitivity and increased antipyretic effect are achieved than individually.

Ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs), has anti-inflammatory, decongestant, analgesic and antipyretic effects. The mechanism of action of ibuprofen is due to the inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia, through the indiscriminate inhibition of the activity of cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2). The analgesic effect of ibuprofen is provided by its inhibitory effect at the peripheral level. The antipyretic effect of ibuprofen is associated with a central inhibition of prostaglandin synthesis in the hypothalamus. Ibuprofen inhibits the migration of leukocytes into the focus of inflammation. In addition, ibuprofen reversibly inhibits platelet aggregation.

Paracetamol is an analgesic non-narcotic drug that has analgesic, antipyretic and mild anti-inflammatory effects. Indirectly blocks COX-2, primarily in the central nervous system. Paracetamol can also stimulate the activity of the descending pathways of serotonin, which leads to stopping the transmission of pain impulse in the spinal cord. At the peripheral level, paracetamol has a mild effect on COX-1 and COX-2.

The drug has a faster therapeutic effect and a more pronounced analgesic effect than ibuprofen and paracetamol separately. After taking one tablet of the drug, the analgesic effect is observed on average after 15 minutes, the clinically significant analgesic effect is achieved after 40 minutes and lasts for 8 hours. After taking two tablets of the drug, the analgesic effect is observed on average after 18 minutes, the clinically significant analgesic effect is achieved after 45 minutes and lasts for 9 hours.

Ibuprofen pharmacokinetics

: Absorption is high, rapidly and almost completely absorbed from the gastrointestinal tract (GIT). Communication with blood plasma proteins - 90%. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in blood plasma. It is found in blood plasma 5 minutes after taking the drug on an empty stomach, the maximum concentration (Cmax) in blood plasma is reached after 1-2 hours. Concomitant use with food can reduce the concentration of ibuprofen in blood plasma and increase the time to reach maximum concentration (Tmax). The degree of absorption of ibuprofen is independent of food intake. It is metabolized in the liver. After absorption, about 60% of the pharmacologically inactive R-form slowly transforms into the active S-form. The half-life (T1 / 2) is 2 hours. It is excreted by the kidneys mainly in the form of metabolites (unchanged no more than 1%) and, to a lesser extent, with bile in the form of metabolites. In the elderly, no significant differences were found in the pharmacokinetic profile of ibuprofen compared to younger people. There is evidence that ibuprofen was found in breast milk in low concentrations.

Paracetamol: absorption is high, quickly absorbed from the digestive tract. Communication with blood plasma proteins is insignificant when taken in therapeutic doses, slightly increased with an overdose. It is found in blood plasma 5 minutes after taking the drug on an empty stomach, Cmax in blood plasma is reached 30-40 minutes after administration. Concomitant use with food can reduce the concentration of paracetamol in blood plasma and increase Tmax. The degree of absorption of paracetamol is independent of food intake. It is metabolized in the liver and excreted mainly in the form of glucuronides and sulfated conjugates with the formation of glutathione conjugates (about 10%). It is excreted by the kidneys. In the form of unchanged paracetamol, less than 5% of the dose taken is excreted. The half-life (T1 / 2) is 3 hours. Hydroxylated metabolite N-acetyl-p-benzoquinoneimine, which is formed in small quantities in the liver and kidneys under the influence of mixed oxidases and is usually detoxified by binding to glutathione, can accumulate with an overdose of paracetamol and cause damage to liver tissue. The elderly did not show significant differences in the pharmacokinetic profile of paracetamol compared to younger people. The bioavailability and pharmacokinetic parameters of ibuprofen and paracetamol, taken as part of this combined preparation, do not change both with single and multiple use.

Indications

Back pain, joint pain, muscle and rheumatic pain, neuralgia, headache, migraine, toothache, painful menstruation, sore throat, fever, symptoms of a cold and flu.

The drug is especially indicated for the symptomatic treatment of pain requiring a more pronounced analgesic effect than ibuprofen or paracetamol alone.

Contraindications

· Hypersensitivity to ibuprofen, paracetamol or other components of the drug.

· Concomitant use of other medications containing paracetamol.

· 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 of).

· Erosive and peptic ulcer of the gastrointestinal tract (including peptic 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 peptic ulcer bleeding).

· A history of bleeding or perforation of a gastrointestinal ulcer, provoked by the use of NSAIDs.

· Severe heart failure (NYHA Class IV - Classification of the New York Association of Cardiology).

· Severe liver failure or liver disease in the active phase.

· Severe renal failure (creatinine clearance

< 30 ml / min), confirmed hyperkalemia.

· Decompensated heart failure after coronary artery bypass grafting.

· Cerebrovascular or other bleeding.

· Pregnancy (III trimester).

· Age to 18 years.

· Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.

· Genetic absence of glucose-6-phosphate dehydrogenase.

Caution

If you have the conditions mentioned in this section, you should consult your doctor before using the drug.

Concomitant use of other NSAIDs, history of a single episode of gastric ulcer or gastrointestinal ulcer, gastritis, enteritis, colitis, Helicobacter pylori infection, ulcerative colitis bronchial asthma or an allergic disease in the acute stage or in the anamnesis - it is possible to develop bronchospasm systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis chickenpox renal failure, including dehydration (creatinine clearance less than 30- 60 ml / min) nephrotic syndrome, liver failure, frequent alcohol consumption, arterial hypertension and / or heart failure, cerebrovascular disease the simultaneous use of drugs that can increase the risk of ulcers or bleeding, in particular oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel) pregnancy I-II trimester, breast-feeding, old age liver cirrhosis with portal hypertension, hyperbilirubinemia of blood disease of unclear etiology (leukopenia and anemia,) peripheral artery disease.

Special instructions

It is recommended that you take the drug as soon as possible and in the minimum effective dose necessary to eliminate the symptoms.

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 developing aseptic meningitis.

During prolonged treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), fecal occult blood analysis. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Ethanol is not recommended during treatment.

Patients with renal failure should consult a doctor before using the drug, since there is a risk of impaired renal function.

Patients with hypertension, including a history of and / or chronic heart failure, should consult a doctor before using the drug, since the drug can cause fluid retention, increased blood pressure and swelling.

Patients with uncontrolled blood pressure, NYHA class II-III congestive heart failure, coronary heart disease, peripheral arterial disease, and / or cerebrovascular disease should be prescribed ibuprofen only after a careful assessment of the benefit / risk ratio, while taking high doses of ibuprofen should be avoided ( 2400 mg / day).

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 (e.g. 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, act on ovulation, disrupting female reproductive function (reversible after withdrawal of treatment).

Should not be taken with any other drugs containing paracetamol. If this happens, you must urgently seek medical help, even with satisfactory health, because this can lead to an overdose.

Effect on the ability to drive vehicles, mechanisms

Subject to the recommended dosage regimen and timing of use, the drug does not affect the ability to drive vehicles and mechanisms, as well as to engage in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Composition

One film-coated tablet contains:

active ingredients: ibuprofen 200 mg and paracetamol 500 mg

excipients: croscarmellose sodium 30 mg, microcrystalline cellulose 120 mg, colloidal silicon dioxide 3 mg, 5 mg magnesium acid 4 mg.

Shell composition: white film coat 13 mg (polyvinyl alcohol 40%, titanium dioxide 25%, macrogol 20.2%, talc 14.8%), film shell with pearlescent effect 7 mg (polyvinyl alcohol 47%, talc 27%, macrogol 13.3%, pearlescent pigment based on mica 10% (titanium dioxide 28%, potassium aluminosilicate (E555) 72%), polysorbate 2.7%).

Dosage and administration

Carefully read the instructions before taking the drug.

For oral administration, before or 2-3 hours after eating. For short-term use only.

Take 1 tablet up to three times a day with water. The interval between doses of the drug should be at least 6 hours.

Maximum single dose: 2 tablets (corresponding to 400 mg ibuprofen, 1000 mg paracetamol).

Maximum daily dose: 6 tablets (corresponding to 1200 mg of ibuprofen, 3000 mg of paracetamol).

Recommended treatment duration is not more than 3 days. If the symptoms persist or intensify when taking the drug for 2-3 days, it is necessary to stop treatment and consult a doctor.

Side effects

The risk of side effects can be minimized if you take the drug in a short course, at the minimum effective dose needed to eliminate the symptoms.

Elderly people have an increased frequency of adverse reactions with NSAIDs, especially gastrointestinal bleeding and perforations, in some cases fatal.

Side effects are predominantly dose dependent. In particular, the risk of developing gastrointestinal bleeding depends on the dose range and on the duration of treatment.

The following adverse reactions were noted with short-term use of ibuprofen at doses of 1200 mg / day, paracetamol at doses of 3000 mg / day (6 tablets). In the treatment of chronic conditions and with prolonged use, other side effects may occur.

The frequency of adverse reactions was estimated based on the following criteria: very frequent (? 1/10), frequent (from? 1/100 to <1/10), infrequent (from? 1/1000 to <1/100), rare (from? 1/10 000 to <1/1000), very rare (? 1/10 000), frequency is unknown (data on frequency estimation are not available).

Disorders of the blood and lymphatic system:

Very rare: hematopoiesis (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of these disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds, and subcutaneous hemorrhages, bleeding, and bruising of unknown origin.

Immune system disorders:

Infrequent: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, skin reactions (itching, urticaria), allergic rhinitis, eosinophilia.

Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, low blood pressure (anaphylaxis, Quincke's edema, or severe anaphylactic shock).

Disorders of the nervous system:

Infrequent: headache.

Very rare: aseptic meningitis. In patients with autoimmune disorders, such as systemic lupus erythematosus, a mixed connective tissue disease, during treatment with ibuprofen, isolated cases of the appearance of symptoms of aseptic meningitis were observed: stiff neck, headache, nausea, vomiting, fever and disorientation, confusion, depression, hallucinations.

Disorders of the cardiovascular system:

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

Disorders of the respiratory system, chest and mediastinal organs:

Frequency unknown: bronchial asthma, including its exacerbation, bronchospasm, shortness of breath.

Disorders of the gastrointestinal tract:

Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, bloating).

Rare: diarrhea, flatulence, constipation, vomiting.

Very rare: 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.

Disorders from the liver and biliary tract:

Very rare: impaired liver function (especially with prolonged use), increased activity of “liver” transaminases, hepatitis and jaundice.

Disorders of the kidneys and urinary tract:

Very rare: acute renal failure (compensated and decompensated), especially with prolonged use, in combination with an increase in urea concentration in blood plasma and the appearance of edema, papillary necrosis, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, interstitial nephritis, cystitis.

Disorders of the skin and subcutaneous tissue:

Frequent: hyperhidrosis (excessive sweating).

Infrequent: Skin rash and acute generalized exanthematous pustulosis.

Very rare: Exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme.

Laboratory parameters:

Frequent: increased levels of alanine aminotransferase, gamma-glutamyl transpeptidase, increased plasma concentrations of creatinine and urea, liver function indicators are outside the normal range.

Infrequent: increased levels of aspartate aminotransferase, alkaline phosphatase, creatinine phosphokinase, lowering hemoglobin levels, increased platelet counts.

If side effects occur, you should stop taking the drug and consult a doctor.

Drug interactions

Paracetamol

· Antiemetics: decrease the absorption rate of paracetamol while using metoclopramide or domperidone.

· Anticoagulants: prolonged use of drugs containing paracetamol may enhance the effect of anticoagulants, in particular warfarin, and increase the risk of bleeding.

· Colestyramine: a decrease in the rate of absorption of paracetamol while co-administration with colestyramine.

Paracetamol falsely enhances the Continuous Blood Sugar Monitoring System (CGM) compared to a glucometer. This applies to patients using CGM devices that may or may not have an automatic insulin pump, i.e. with type I diabetes.

Caution should be exercised with the simultaneous use of paracetamol and fluloxacillin, which is associated with an increased risk of developing metabolic acidosis with a high anionic difference, especially in patients with a risk factor for glutathione deficiency (including patients with severe renal failure, sepsis, malnutrition and chronic alcoholism). Careful monitoring is recommended to detect signs of an acid-base balance disturbance, namely metabolic acidosis with a high anionic difference, including the determination of 5-oxoproline in urine.

Ibuprofen

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

· Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (not more than 75 mg per day) prescribed by a doctor, as 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).

· Other NSAIDs, in particular selective COX-2 inhibitors: the simultaneous use of two or more drugs from the NSAID group should be avoided because of the possible increased risk of side effects.

Use with caution simultaneously with the following medicines:

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

· Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of 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 agents that inhibit cyclooxygenase can lead to impaired 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 combined use of the above funds should be prescribed with caution, especially in the elderly. It is necessary to prevent dehydration in patients, as well as to consider the monitoring of renal function after the start of such combined treatment and periodically in the future. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs.

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

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

· Cardiac glycosides: concomitant administration of NSAIDs and cardiac glycosides can aggravate heart failure, decrease glomerular filtration rate and increase 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 blood plasma during the use of NSAIDs.

· Methotrexate: there is evidence of a likelihood of an increase in plasma concentration of methotrexate with NSAIDs.

· Cyclosporine: increased risk of nephrotoxicity while prescribing NSAIDs and cyclosporine.

· Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, since NSAIDs may reduce the effectiveness of mifepristone.

· Tacrolimus: concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

· 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, receiving joint treatment with zidovudine and ibuprofen.

· Quinolone-type antibiotics: Patients receiving co-treatment with NSAIDs and quinolone-type antibiotics may increase the risk of seizures.

· Myelotoxic drugs increase the hematotoxicity of the drug.

· Caffeine enhances the analgesic effect.

Overdose of

Paracetamol

Symptoms: symptoms of an overdose of paracetamol during the first 24 hours: pallor of the skin, nausea, vomiting, anorexia, and abdominal pain. Damage to the liver can occur 12-48 hours after administration, therefore it is necessary to consult a doctor even in the absence of symptoms. Possible impaired glucose metabolism and metabolic acidosis. In severe poisoning, liver failure can progress with complications such as encephalopathy, hemorrhage, hypoglycemia, cerebral edema, and death. Acute renal failure with acute tubular necrosis (defined by lower back pain, hematuria and proteinuria) can develop even in the absence of severe liver damage. There are reports of heart rhythm disturbances and pancreatitis.

Treatment: immediate treatment is needed in case of an overdose of paracetamol. Despite the failure of significant early symptoms, patients should be urgently taken to hospital for immediate medical examination. Symptoms may be limited to nausea or vomiting and may not match

severity of overdose or risk of organ damage. Activated carbon treatment should be considered if the excessive dose was taken less than 1 hour ago. Plasma paracetamol concentration should be measured 4 hours or more after administration (earlier concentrations are unreliable). Treatment with N-acetylcysteine ​​can be carried out up to 24 hours after taking paracetamol, however, the maximum protective effect is achieved after about 8 hours after taking the drug. The effectiveness of the antidote gradually decreases after this time. If necessary, N-acetylcysteine ​​is administered intravenously in accordance with the established regimen. Outside the hospital, if there is no vomiting, you can use methionine inside. Patients who have severe hepatic dysfunction 24 hours after taking the drug should be referred to a poisoning specialist.

Additional information on special patient groups

An increased risk of liver damage due to an overdose of paracetamol is most likely in:

· patients who are receiving long-term treatment with enzyme-inducing agents (such as carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin and hypericum perforated) drinking more than recommended

in patients with glutathione depletion (e.g., patients with eating disorders, cystic fibrosis, HIV infection, cachexia, starving).

Ibuprofen

In adults, the dose-dependent effect does not have a clear threshold. The half-life of the drug with 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 prothrombin time, renal failure, damage to liver tissue, lowering blood pressure, respiratory depression and cyanosis can develop. In patients with bronchial asthma, an exacerbation of this disease is possible.

Treatment: symptomatic, with mandatory airway management, ECG monitoring and basic vital signs up to the normalization of the patient's condition. Oral administration of activated charcoal or gastric lavage within 1 hour after taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to excrete the acid derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by the intravenous administration of diazepam or lorazepam. If bronchial asthma worsens, the use of bronchodilators is recommended.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

The Expiration of

is 3 years.



pharmacy terms and conditions without a prescription

Form of Treatment

tablets

Appointment

Children over 12 years, Adults7dfp16ro16161616 tyam over 12 years, For Adults, Detyam to doctor appointments Appointment

Indications

Dislocations and sprains, From neuritis, From migraine, From arthrosis and arthritis, From osteochondrosis, Colds, Influenza

Possible product names srenlp. 200 mg + 500 mg 12 pcs.



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