Ibuprofen-Hemofarm tablets coated.pl.ob. 400 mg 30 pcs. (ibuprofen)

packaging 30 pcs

Pharmacological action

The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia. Indirectly blocks cyclooxygenase 1 (COX-1) and cyclooxygenase II (COX-2), as a result of which it inhibits prostaglandin synthesis. It has a quick directed action against pain (analgesic), anti-inflammatory and antipyretic effect. In addition, ibuprofen reversibly inhibits platelet aggregation.

Pharmacokinetics

Absorption - 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 after 30-35 minutes. Taking the drug with food can increase the time to reach maximum concentration (TCmax).

Communication with plasma proteins more than 90%. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in blood plasma. After absorption, about 60% of the pharmacologically inactive R-form slowly transforms into the active S-form. It is metabolized in the liver. The half-life (T1 / 2) is 2 hours. It is excreted by the kidneys (unchanged no more than 1%) and, to a lesser extent, with bile.

In the elderly, there were no significant differences in the pharmacokinetic profile of ibuprofen compared to younger people.

In limited studies, ibuprofen was found in breast milk at very low concentrations.

Indications

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

Contraindications

Hypersensitivity to ibuprofen or to any of the components that make up the

preparation, complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid (including ASR) or other peptic ulcer of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in the anamnesis e (confirmed by two or more episodes of peptic ulcer or ulcer bleeding)

ulcer bleeding or perforation of the gastrointestinal tract in history, NSAID-induced

severe heart failure (class IV classification by the New York Association of Cardiology (NYHA))

severe liver failure or liver disease in the active phase

severe renal failure (creatinine clearance <30 ml / min), confirmed hyperkalemia srd decompensated heart failure, the period after coronary artery bypass grafting

cerebrovascular or other bleeding

hemophilia and other bleeding disorders (Including hypocoagulation), hemorrhagic diathesis

pregnancy (III trimester)

Children up to age 12 years.

Caution

If you have the conditions described 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 gastrointestinal ulcer bleeding, gastritis, enteritis, colitis, presence of Helicobacter pylori infection, ulcerative colitis, bronchial asthma or an allergic disease - possibly history lupus erythematosus or mixed connective tissue disease (Sharp syndrome) - increased risk of aseptic meningitis chickenpox renal failure, including with dehydration zhivanii (creatinine clearance of less than 30-60 ml / min), nephrotic syndrome, liver failure, cirrhosis with portal hypertension, hyperbilirubinemia, hypertension and / or heart failure, cerebrovascular disease, blood diseases of unclear etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, frequent drinking, and the simultaneous use of drugs that may increase the risk of ulcers or bleeding, in particular oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, steam ksetina, sertraline) or antiplatelet agents (including ACK, clopidogrel), pregnancy I-II trimester, during breastfeeding, older age.

Use during pregnancy and lactation

Contraindicated in the III trimester of pregnancy, in the I and II trimester - with caution. During breastfeeding, the use of the drug is possible (with caution).

Composition

1 film-coated tablet contains:

active substance: ibuprofen - 400 mg excipients: microcrystalline cellulose PH 101, sodium carboxymethyl starch, colloidal silicon dioxide, anhydrous, stearic acid film coating: methacrylic acid and ethyl acrylate copolymer (1: 1), talc, titanium dioxide E 171, polysorbate 80. Description: round, biconvex tablets, coated they are covered with a film membrane from white to yellowish-white in color, with a notch on one side, at a break from white to yellowish-white.

Side effects

The risk of side effects can be minimized by taking 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.

The following adverse reactions have been 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 in accordance with the following classification: very frequent (> 10%), frequent (> 1%, but <10%), infrequent (> 0.1%, but <1% ), rare (> 0.01%, but <0.1%), very rare (<0.01%), frequency unknown - it is not possible to estimate the frequency based on available data.

Disorders of the blood and lymphatic system

Very rare disorders of blood formation (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 etiology.

Immune system disorders

Infrequent hypersensitivity reactions - non-specific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including exacerbation, bronchospasm, shortness of breath, dyspnea), 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 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).

Disorders of the gastrointestinal tract

Infrequent 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, are very rare, especially in elderly patients, ulcerative stomatitis, gastritis.

Frequency of unknown exacerbation of colitis and Crohn's disease.

Violations of the liver and biliary tract

Very rare violations of the liver (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, combined with an increase in urea concentration in blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Disorders of the nervous system

Infrequent headache.

Very rare aseptic meningitis.

Disorders from 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 and mediastinal organs

Frequency unknown, bronchial asthma, bronchospasm, shortness of breath.

Laboratory indicators 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 “liver” transaminases (may increase).

If any of the side effects listed in the instructions get worse, or you notice any other side effects, not specified in the instructions, inform your doctor.

Medicationco-administration of

Concomitant use of ibuprofen with the following drugs should be avoided:

Acetylsalicylic acid: except for low doses of acetylsalicylic acid (not more than 75 mg per day) prescribed by the physician, as co-administration may increase the risk of adverse effects. When co-administered with ibuprofen, it reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (possibly increasing the incidence of acute coronary insufficiency in patients receiving low doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).

Other NSAIDs, including selective COX-2 inhibitors: two or more NSAIDs should be avoided at the same time because of the possible increased risk of side effects.

Use with caution with the following medicines:

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

Antihypertensive agents (angiotensin converting enzyme (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), simultaneous administration of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibiting agents, can lead to impaired renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients receiving coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the joint use of the above agents should be used with caution, especially in the elderly. It is necessary to prevent dehydration in patients, as well as to consider the possibility of monitoring renal function after the start of such combination treatment and periodically thereafter. ACE diuretics and inhibitors can increase the nephrotoxicity of NSAIDs.

Glucocorticosteroids: increased risk of gastrointestinal ulcer and gastrointestinal bleeding.

Antiaggregates and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Cardiac glycosides: the simultaneous administration of NSAIDs and cardiac glycosides may lead to a worsening of heart failure, a decrease in glomerular filtration rate, and an increase in the concentration of cardiac glycosides in blood plasma.

Lithium preparations have data on the likelihood of an increase in the concentration of lithium in blood plasma against the use of NSAIDs.

Methotrexate There is evidence of an increase in the concentration of methotrexate in blood plasma when NSAIDs are used.

Cyclosporine increases the risk of nephrotoxicity when co-administered with NSAIDs and cyclosporine.

Mifepristone NSAIDs should be initiated no earlier than 8-12 days after receiving mifepristone, since NSAIDs may reduce the effectiveness of mifepristone.

Tacrolimus may increase the risk of nephrotoxicity with the simultaneous administration of NSAIDs and tacrolimus.

Zidovudine concomitant use of NSAIDs and zidovudine can lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive hemophilia patients receiving concomitant treatment with zidovudine and ibuprofen.

Quinolone series antibiotics in patients receiving co-treatment with NSAIDs and quinolone series antibiotics may increase the risk of convulsions.

Myelotoxic drugs increase hematotoxicity.

Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: an increase in the incidence of hypoprothrombinemia.

Drugs blocking tubular secretion: decreased excretion and increased plasma concentrations of ibuprofen.

Inductors 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 Action.

Oral hypoglycemic drugs and insulin derivatives of sulfonylureas enhance the action of drugs.

Antacids and cholestyramine decrease absorption.

Uricosuric drugs decrease the effectiveness of drugs.

Estrogens, ethanol: an increased risk of side effects.

Caffeine: Enhancing analgesic effect.

Overdose

Overdose symptoms in children may occur after taking a dose greater than 400 mg / kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of drug 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 from the central nervous system: 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. Patients with bronchial asthma may have an exacerbation of this disease.

Treatment: symptomatic, with obligatory maintenance of airway patency, monitoring of electrocardiogram and basic indicators of vital activity up to normalization of a patient's condition. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour of receiving a potentially toxic dose of ibuprofen. 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 cramps should be stopped by intravenous diazepam or lorazepam. With worsening bronchial asthma, the use of bronchodilators is recommended.

Storage conditions

At a temperature not exceeding 25 ° C in consumer packaging.

Keep out of the reach of children.

Expiration

4 years.

Deystvuyuschee substances

Ibuprofen

ppt41 apfd41 p41

pharmacy leave terms without a prescription

tablet dosage form

Formulation

tablets



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