Ibuprofen D susp.d / ext. 200mg / 5ml in vial 100g in pack No. 1

NameIbuprofen D susp.d/in.prim.200mg/5ml in vial 100g in pack No. 1 Release form suspension Dosage 100 g Indications for use IBUPROFEN D is recommended for use in the following cases: Elevated body temperature of various origins in: colds; acute respiratory viral infections; flu angina (pharyngitis); childhood infections accompanied by fever; post-vaccination reactions. Pain syndrome of various origins of weak and moderate intensity with: ear pain with inflammation of the middle ear; toothache, painful teething; headache, migraine; pain in muscles, joints; injuries of the musculoskeletal system. Method of administration and doses For oral administration. 5 ml suspension contains 100 mg or 200 mg ibuprofen. Shake before use until a homogeneous suspension is obtained. The drug is taken after a meal with a liquid. The measuring cup attached to the package with a scale allows you to accurately dose the drug. The dose is set depending on the age and body weight of the child. A single dose of ibuprofen is 5 to 10 mg/kg of the child’s body weight, 3-4 times a day. The maximum daily dose should not exceed 30 mg/kg of body weight. IBUPROFEN D is released as completely as possible from the measuring cup. The remnants of the drug on the walls of the cup are washed off and used with liquid. Infants from 3 to 6 months with post-vaccination reactions: 2.5 ml of the drug IBUPROFEN D 100 mg / 5 ml, if necessary, repeat the dose of 2.5 ml after 6 hours. The drug can be taken every 6-8 hours, with an interval of at least 4 hours between successive doses. Do not double the dose if a dose is missed! The use of the drug in children under 6 months is possible only after consulting a doctor in accordance with his instructions. If in children aged 3-6 months, symptoms persist for 24 hours or if the condition worsens, it is necessary to consult a doctor again. Do not exceed the recommended dose. Do not use the drug for more than 3 days without consulting a doctor. IBUPROFEN D is intended for short-term use. IBUPROFEN D is used for no more than 3 days as an antipyretic and no more than 5 days as an anesthetic. If symptoms persist or the condition worsens, a doctor should be consulted. In order to minimize the risk of developing adverse reactions, ibuprofen should be taken at the lowest effective dose and for the shortest period necessary to achieve a clinical effect. Use during pregnancy and lactation The use of ibuprofen should be avoided during the first 6 months of pregnancy. During the third trimester of pregnancy, the use of ibuprofen is contraindicated due to the risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labor may be delayed, the duration of labor may be prolonged, and the risk of bleeding may be increased for both the mother and the baby. In small amounts, ibuprofen can be excreted in breast milk, so it is recommended to stop breastfeeding for the period of treatment. Precautions The severity of undesirable effects can be reduced by taking the minimum effective dose required to control symptoms for the shortest period of time. In the elderly, the incidence of adverse reactions caused by NSAIDs increases. Especially gastrointestinal bleeding and perforation, which can be fatal. In patients with bronchial asthma, or allergic diseases, or with a history of such conditions, bronchospasm may develop when taking ibuprofen. In the presence of systemic lupus erythematosus (SLE) and mixed connective tissue diseases while taking ibuprofen, the risk of aseptic meningitis is increased. When taking ibuprofen, further deterioration of the initially impaired renal function is possible. In case of impaired liver function, IBUPROFEN D is used with caution. In the treatment of ibuprofen in patients with a history of hypertension and / or heart failure, caution should be exercised due to the risk of fluid retention, increased blood pressure and edema in connection with the treatment of NSAIDs. There is a possibility that drugs that inhibit cyclooxygenase and prostaglandin synthesis may interfere with female reproductive function by affecting ovulation, which is reversible after treatment is discontinued. In patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), NSAIDs should be used with caution, since exacerbation of these conditions is possible. In the treatment of all NSAIDs, bleeding from the gastrointestinal tract, the formation of ulcers or their perforation, up to death (regardless of the duration of treatment), are possible. However, there may be no warning symptoms or a history of serious gastrointestinal events. With an increase in the dose of NSAIDs, the risk of bleeding from the gastrointestinal tract, ulceration or perforation increases in patients with a history of ulcers, especially if the ulcer is complicated by bleeding or perforation, and in the elderly. These patients should start treatment at the lowest dose. If the patient has a history of toxic effects of NSAIDs on the gastrointestinal tract, it is necessary to inform the attending physician about all unusual symptoms in the abdomen (especially bleeding from the gastrointestinal tract), to a greater extent it is worth paying attention to this in the early stages of treatment and the elderly. Caution must be exercised in patients concomitantly taking agents that may increase the risk of ulceration and bleeding, such as oral corticosteroids, anticoagulants (warfarin, etc.), selective serotonin reuptake inhibitors, and antiplatelet agents (aspirin, etc.). taking ibuprofen, bleeding from the gastrointestinal tract or the formation of peptic ulcers should stop treatment. Skin reactions. During the treatment of NSAIDs, in very rare cases, serious skin reactions are possible, in some cases with a fatal outcome: exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The risk of developing such reactions is more typical for the beginning of the course of treatment, in particular, during the first month of therapy. In the event of a skin rash, focal mucosal lesions and other signs of hypersensitivity, ibuprofen should be discontinued. The results of clinical trials suggest a possible relationship between taking ibuprofen, especially at high doses (? 2400 mg per day), with a slight increased risk of developing arterial thrombotic events (for example, myocardial infarction and stroke). Epidemiological studies do not suggest a relationship between low-dose ibuprofen (≥1200 mg/day) and an increased risk of arterial thrombotic events. In patients with uncontrolled hypertension, NYHA class II-III congestive heart failure, established coronary artery disease, peripheral arterial disease, and/or cerebrovascular disease, ibuprofen should only be used after a careful benefit-risk assessment, and high doses of ibuprofen should be avoided. (?2400 mg/day). Before initiating long-term ibuprofen therapy, especially at high doses (≥2400 mg per day), in patients with risk factors for cardiovascular complications (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking), a careful assessment of the benefit-risk ratio is necessary. Due to the fact that the drug contains maltitol syrup, patients with fructose intolerance are not recommended to take this drug. Interaction with other drugs Ibuprofen (as well as other drugs of the group of non-steroidal anti-inflammatory drugs) should not be used simultaneously with the following drugs. Acetylsalicylic acid The simultaneous use of ibuprofen and acetylsalicylic acid is not recommended due to a possible increase in the development of adverse events. Based on the results of laboratory studies, it is assumed that ibuprofen, when used simultaneously with low doses of acetylsalicylic acid, can competitively inhibit platelet aggregation. Although the admissibility of extrapolating these data to clinical practice remains uncertain, the possible effect of regular long-term ibuprofen use on reducing the cardioprotective effect of low doses of acetylsalicylic acid cannot be ruled out. The effect of episodic use of ibuprofen on the cardioprotective properties of acetylsalicylic acid seems unlikely. Other NSAIDs, including selective cyclooxygenase-2 inhibitors: The simultaneous use of two or more NSAIDs should be avoided, as this may increase the risk of adverse drug effects. Diuretics, ACE inhibitors, beta-blockers and angiotensin II receptor antagonists. Ibuprofen may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function, the co-administration of ACE inhibitors, beta-blockers or angiotensin II receptor antagonists and ibuprofen may lead to further deterioration of renal function. Therefore, the combination of these drugs should be administered with caution, especially in the elderly. The simultaneous use of ibuprofen and potassium-sparing diuretics can lead to hyperkalemia. Digoxin. phenytoin, lithium, methotrexate. Simultaneous use of ibuprofen with digoxin, phenytoin, methotrexate or lithium preparations may increase the concentration of these drugs in the blood. Cyclosporine. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects, and also increases the risk of developing nephrotoxicity. Tacrolimus. With simultaneous administration, the risk of nephrotoxicity increases. Corticosteroids. Ibuprofen increases the risk of gastrointestinal bleeding. Antidiabetic agents. When used together, ibuprofen increases the hypoglycemic effect of oral antidiabetic agents (sulfonylurea derivatives) and insulin. Zidovudine. There is a possibility of an increased risk of hemarthrosis and hematomas in HIV-positive people with hemophilia who take zidovudine and ibuprofen at the same time. Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants). Increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions. Antacids and cholestyramine. Reduce the absorption of ibuprofen. With the simultaneous appointment of drugs should be administered at intervals of several hours. Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin. Increase the incidence of hypoprothrombinemia. Quinolone antibiotics. Simultaneous use with ibuprofen may increase the risk of seizures. Captopril. Ibuprofen inhibits sodium excretion (captopril effect). Probenecid and sulfinpyrazone. Medicines containing probenecid and sulfinpyrazone may delay the release of ibuprofen. Ritonavir. May increase plasma concentrations of ibuprofen. Aminoglycosides. Ibuprofen may reduce the excretion of aminoglycosides. myelotoxic agents. Strengthen the manifestations of hematotoxicity of the drug. Caffeine. Enhances the analgesic effect of ibuprofen. Contraindications hypersensitivity to ibuprofen or other components of the drug; hypersensitivity reactions to aspirin or other NSAIDs in history (for example, bronchial asthma, allergic rhinitis, angioedema, urticaria); recurrent peptic ulcer or ulcer bleeding, including history (two or more separate episodes of confirmed ulcer or bleeding); a history of gastrointestinal bleeding from the upper gastrointestinal tract or perforations associated with previous NSAID therapy; severe liver, kidney or heart failure (NYHA IV); last trimester of pregnancy; blood clotting disorders (including hemophilia, prolonged bleeding time, bleeding tendency, hemorrhagic diathesis); children’s age up to 3 months. Active ingredient: ibuprofen Excipients: macroglycerol hydroxystearate, xanthan gum, glycerin, sodium benzoate, sodium dihydrogen phosphate dihydrate, sodium hydroxide, diluted phosphoric acid, citric acid monohydrate, sodium saccharin, liquid maltitol, Orange PX1488 flavor (or Cola AN2066 flavor), water purified. Overdose In children, symptoms may occur when oral doses exceed 400 mg/kg. In adults, the dependence of symptoms on the dose is less pronounced. The half-life of ibuprofen in overdose is 1.5-3 hours. Symptoms: nausea, vomiting, epigastric pain, lethargy, tinnitus, headache, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, hypotension, convulsions, abnormal liver function, acute renal failure, bradycardia, tachycardia. In patients with bronchial asthma, an exacerbation of the disease is possible. Treatment: in case of an overdose, symptomatic therapy is carried out, aimed at maintaining the patency of the respiratory tract, monitoring cardiac activity and vital activity until the indicators normalize. Within one hour after taking a toxic dose of the drug, it is possible to wash the stomach and take activated charcoal. In the case of an asthmatic attack, the use of bronchodilators is indicated. Side effects The frequency of side effects is estimated according to the following scheme: very often (? 1/10); often (?1/100 to <1/10); infrequently (?1/1000 to <1/100); rarely (?1/10000 to <1/1000); very rarely (<1/10000). From the gastrointestinal tract: infrequently: dyspepsia, abdominal pain, nausea; Rare: diarrhea, vomiting, flatulence, constipation, gastritis; Very rarely: melena, blood vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, esophagitis, pancreatitis, intestinal strictures; ulceration of the mucous membrane of the stomach and / or duodenum, in some cases complicated by perforation and bleeding, sometimes fatal, especially in the elderly. From the nervous system: Infrequently: headache. Rare: dizziness, agitation, insomnia, irritability, fatigue, aseptic meningitis (more often in patients with autoimmune diseases). In patients with existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever, and disorientation have been observed during ibuprofen treatment. In isolated cases, tinnitus, depression and psychotic reactions are described. From the urinary system: Very rarely: acute renal failure, nephritic syndrome, interstitial nephritis, papillary necrosis, especially with prolonged use, associated with edema and increased serum urea levels. On the part of the liver: Very rarely: abnormal liver function, liver damage (especially with prolonged use), acute hepatitis. On the part of the blood system: Very rarely: hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis), the first signs of which are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising. On the part of the skin: infrequently: various skin rashes; Very rare: severe forms of skin reactions, in particular bullous disorders, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis. From the immune system: Rarely: hypersensitivity reactions, accompanied by urticaria and pruritus. Very rare: serious hypersensitivity reactions. Symptoms may include swelling of the face, tongue and throat, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). From the side of the cardiovascular system: Very rarely: the development of edema, arterial hypertension and heart failure in connection with the treatment of NSAIDs; palpitations, myocardial infarction. When using ibuprofen, especially for a long time and in high doses (2400 mg / day), there may be a slight increase in the risk of episodes of arterial thrombosis. From the sensory organs: Infrequently: visual disturbances (blurred vision or diplopia), dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis). Rare: hearing loss, ringing or tinnitus. Infections and invasions: Very rare: exacerbation of the inflammatory process caused by infection (for example, the development of necrotizing fasciitis), the appearance of symptoms of aseptic meningitis with the manifestation of neck muscle tension, headache, vomiting, fever. If any of the listed side effects occur, or if any side effects are not mentioned in the package leaflet, you should consult a doctor. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. on application for Ibuprofen D susp.d / ext.prim. 200mg / 5ml in vial 100g in pack No. 1