Ibuprofen-Chemopharm, pills 400mg 30pcs

Composition

1 film-coated tablet contains: Active ingredient: ibuprofen-400 mg; excipients: microcrystalline cellulose PH 101, sodium carboxymethyl starch, colloidal silicon dioxide, anhydrous, stearic acid; film-coated: methacrylic acid and ethyl acrylate copolymer (1: 1), talc, titanium dioxide E 171, polysorbate 80. Description: round, biconvex tablets, film-coated from white to yellowish-white, with a risk on one side, on the break from white to yellowish-white.

Pharmacological action

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis — mediators of pain, inflammation and hyperthermic reaction. It selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase II (COX-2), thereby inhibiting prostaglandin synthesis. It has a rapid directed action against pain (analgesic), anti-inflammatory and antipyretic effects. In addition, ibuprofen reversibly inhibits platelet aggregation. Pharmacokineticabsorption — high, rapidly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach, the maximum concentration (Cmax) of ibuprofen in blood plasma is reached in 30-35 minutes. Taking the drug with food may increase the time to reach the maximum concentration (TMAX). Binding to plasma proteins is more than 90%. Slowly penetrates the joint cavity, lingers 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. The elimination half-life (T 1/2) is 2 hours. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile. There were no significant differences in the pharmacokinetic profile of ibuprofen in older people compared to younger people. In limited studies, ibuprofen has been detected in breast milk at very low concentrations.

Indications

Headache, toothache, migraines, painful menstruation, neuralgia, back pain, joint pain, muscle and rheumatic pain, fever with flu and colds.

Use during pregnancy and lactation

Contraindicated in the third trimester of pregnancy, in the first and second trimester – with caution.

During breast-feeding, the drug may be used (with caution).

Contraindications

• Hypersensitivity to ibuprofen or any of the components included in the composition of the drug;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid (ASA) or other NSAIDs (including in the anamnesis);
• erosive and ulcerative diseases of the gastrointestinal tract (including stomach ulcer and duodenal ulcer, Crohn’s disease, ulcerative colitis) ulcer or bleeding in the active phase or in history (two or more episodes of confirmed peptic ulcer or ulcer bleeding);
• a bleeding or perforated ulcer of the gastrointestinal tract in history, triggered by the use of NSAIDs;
• severe heart failure (class IV according to the classification of new York heart Association (NYHA));
• severe liver failure or liver disease in the active phase;
• renal failure of severe degree of impairment (creatinine clearance < 30 ml/min), confirmed hyperkalemia;
• decompensated heart failure, since the coronary artery bypass surgery;
• cerebrovascular or other bleeding;
• hemophilia and other blood clotting (including anticoagulation), hemorrhagic diathesis;
• pregnancy (III trimester);
• children up to age 12 years.

Caution: If you have any of 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 and duodenal ulcer or ulcerative bleeding of the gastrointestinal tract; gastritis, enteritis, colitis, Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the anamnesis — may develop bronchospasm; systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) — increased risk aseptic meningitis; chickenpox; renal failure, including dehydration (creatinine clearance 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 mellitus, peripheral artery disease, smoking, frequent alcohol consumption, concomitant use of medications that may increase the risk of ulceration or bleeding, in particular, oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including including ASA, clopidogrel), pregnancy I-II trimester, breast-feeding period, elderly age.

Side effects

The risk of side effects can be minimized by taking the drug in a short course, at the minimum effective dose necessary to eliminate symptoms. In the elderly, there is an increased frequency of adverse reactions associated with NSAID use, especially gastrointestinal bleeding and perforation, in some cases with a fatal outcome. Side effects are mostly dose-dependent. The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg / day (6 tablets). In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur. The frequency of adverse reactions (HP) listed below is given according to the following classification: very frequent (> 10%), frequent (>>1%, but >>< 10%), infrequent (> 0.1%, but < 10%), infrequent (>< 1%), rare (> 0.01%, but < 1%), rare (>< 0.1%), very rare (Blood and lymphatic system disorders Very rare hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology. Immune system disorders Frequent hypersensitivity reactions — non-specific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its exacerbation, 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 syndrome-Johnson’s disease, erythema multiforme), allergic rhinitis, eosinophilia. Very rare severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock). Disorders of the gastrointestinal tract: Frequent abdominal pain, nausea, dyspepsia (including heartburn, bloating). Rare diarrhea, flatulence, constipation, vomiting. Peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis are very rare. Frequency unknown exacerbation of colitis and Crohn’s disease. Liver and biliary tract disorders Very rare liver function disorders (especially with prolonged use), increased activity of “liver” transaminases, hepatitis and jaundice. Renal and urinary tract disorders very rare acute renal failure (compensated and decompensated) especially with prolonged use, in combination with increased urea concentration in blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis. Nervous system disorders: Frequent headache. Very rare aseptic meningitis. Disorders of the cardiovascular system Frequency unknown heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (for example, myocardial infarction), increased blood pressure. Respiratory and mediastinal disorders Frequency unknown, bronchial asthma, bronchospasm, shortness of breath. Laboratory parameters: hematocrit or hemoglobin (may decrease); bleeding time (may increase); plasma glucose concentration (may decrease); creatinine clearance (may decrease); plasma creatinine concentration (may increase); activity of “hepatic” transaminases (may increase). If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use of ibuprofen with the following medications should be avoided:Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a doctor, since co-use may increase the risk of side effects. When used concomitantly, ibuprofen reduces the anti-inflammatory and antiplatelet effects 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: concomitant use of two or more NSAID drugs should be avoided due to the possible increased risk of side effects. Use with caution at the same time as the following medications::Anticoagulants and thrombolytics: NSAIDs may increase the effect of anticoagulants, particularly warfarin and thrombolytics. Antihypertensive agents (angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in 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 use of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to deterioration of renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the combined use of the above drugs should be prescribed with caution, especially in elderly patients. Patients should be prevented from becoming dehydrated, and renal function monitoring should be considered after starting this combination treatment and periodically thereafter. Diuretics and ACE inhibitors may 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 use of NSAIDs and cardiac glycosides may worsen heart failure, reduce 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 against the background of NSAID use. Methotrexate there is evidence for the likelihood of an increase in the concentration of methotrexate in blood plasma against the background of NSAID use. Cyclosporine increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine. Mifepristone NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as 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 lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia treated with zidovudine and ibuprofen. Quinolone antibiotics patients receiving co – treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures. Myelotoxic drugs increased hematotoxicity. Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia. Drugs that block tubular secretion: decreased excretion and increased plasma concentrations of ibuprofen. Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication. Microsomal oxidation inhibitors: reducing the risk of hepatotoxic effects. Oral hypoglycemic drugs and insulin, sulfonylurea derivatives enhance the effect of drugs. Antacids and colestyramine decrease absorption. Uricosuric drugs decrease the effectiveness of drugs. Estrogens, ethanol: increased risk of side effects. Caffeine: increases the analgesic effect.

How to take, course of use and dosage

Inside, after eating, take both effervescent tablets (in the form of a solution) and film-coated tablets. Ibuprofen doses are selected individually so as to obtain the desired therapeutic effect by using the lowest possible dose. An effervescent tablet of Ibuprofen-Chemopharm is completely dissolved in a glass (200 ml) of water, and the resulting solution is immediately drunk. Effervescent tablets should not be swallowed, chewed, or sucked in the mouth. Effervescent tablets are prescribed for children over 6 years of age and adults. Adults — a single dose of ibuprofen is 1-2 effervescent tablets (200-400 mg); the daily dose is 4-6 effervescent tablets (800-1200 mg), in divided doses with an interval of 4-6 hours. Petya aged from 6 to 12 years: a single dose is 1 effervescent tablet (200 mg); the therapeutic dose is 1 effervescent tablet at intervals of 4-6 hours,2-4 times a day. The maximum daily dose is 4 effervescent tablets (800 mg / day). Fly over the age of 12 years: a single dose is 1-2 effervescent tablets (200-400 mg); a therapeutic dose of 1-2 tablets with an interval of 4-6 hours. The maximum daily dose is 5 effervescent tablets (1000 mg). Pills. film-coated tablets are prescribed for adults and children over 12 years of age, inside after meals, tablets should be swallowed whole, washed down with a small amount of liquid. Adults and children over 12 years of age-inside 1 tablet (400 mg). Repeat reception no earlier than 4 hours later. Adults should not take more than 3 tablets in 24 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children from 12-18 years is 1000 mg. If symptoms persist after taking the drug for 2-3 days, you should stop treatment and consult a doctor.

Overdose

In children, overdose symptoms may occur after taking a dose exceeding 400 mg / kg of 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: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely-agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis can develop. Patients with bronchial asthma may have an exacerbation of this disease. Treatment: symptomatic, with mandatory provision of airway patency, monitoring of the electrocardiogram and basic vital signs until the patient’s condition normalizes. Oral use of activated charcoal or gastric lavage within 1 hour of taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous use of diazepam or lorazepam. In case of worsening of bronchial asthma, the use of bronchodilators is recommended.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. If you need to take the drug for more than 10 days, you should consult a doctor. In patients with acute bronchial asthma or allergic disease, as well as in patients with a history of bronchial asthma/allergic disease, the drug may 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 aseptic meningitis. During long-term treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and a fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, 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 of the functional state of the kidneys. Patients with hypertension, including in the anamnesis and / or chronic heart failure, should consult a doctor before using the drug, since the drug can cause fluid retention, increased blood pressure and edema.Patients with uncontrolled hypertension, NYHA class H-W congestive heart failure, coronary artery disease, peripheral artery disease, and/or cerebrovascular disease should only be prescribed ibuprofen after careful benefit-risk assessment, and high doses of ibuprofen (>2400 mg/day) should be avoided. 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 using the drug for chickenpox. Information for women planning pregnancy: ibuprofen suppresses cyclooxygenase and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment). Effects on the ability to drive vehicles and mechanisms When taking ibuprofen, driving vehicles or operating mechanisms should be avoided.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 25 °C in consumer packaging. Keep out of reach of children.

Shelf

life is 4 years.

Active ingredient

Ibuprofen

Dosage form

Tablets