Ibuflex 400 tablets p/o 400mg №10×2

Name:
Ibuflex 400. Release form Tablets. INNIBuprofen. FTGNpvp.
Description:
: Film-coated tablets, white or white with a grayish tint, oval, biconvex. CompositionFor one tablet: active substance: ibuprofen – 400 mg; excipients: microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, corn starch, shell (composition of the mixture for coating Opadry II white (85F18422): polyvinyl alcohol, macrogol 3350, talc, titanium dioxide). Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Derivatives of propionic acid. Ibuprofen. Indications for use Headache, migraine, toothache, neuralgia, muscle and joint pain, menstrual pain. Ibuflex 400, as an analgesic and anti-inflammatory agent, is prescribed for the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. Ibuflex 400 is indicated for the treatment of periarticular disorders such as periarthritis of the shoulder blade, bursitis, tendinitis and tendosynovitis. Method of application and dosage Inside. 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. If the symptoms persist or worsen while using the drug, you should consult a doctor. Ibuflex 400 should be taken during or after a meal, without chewing, with a glass of water. The dosage regimen is set individually depending on the indications. For adults and children over 12 years of age, the drug is usually prescribed in an initial dose of 400 mg 1-2 times a day. To achieve a rapid therapeutic effect, the dose may be increased to 400 mg 3 times a day. Upon reaching the therapeutic effect, the daily dose is reduced to 600-800 mg. The interval between taking the tablets should be at least 4 hours. Do not take more than 3 tablets in 24 hours. The drug should not be used for more than 7 days or in higher doses without consulting a doctor. Elderly patients: Elderly people are at increased risk of serious adverse reactions. If NSAIDs are required, the lowest effective dose should be used for the shortest possible time. During NSAID therapy, the patient should be monitored regularly for gastrointestinal bleeding. Children: Contraindicated in children under 12 years of age. Patients with renal insufficiency: In patients with mild to moderate renal impairment (creatinine clearance 30-80 ml / min), dose reduction is not required. In severe renal insufficiency (creatinine clearance less than 30 ml / min), ibuprofen is contraindicated. Patients with hepatic insufficiency: In patients with mild to moderate hepatic impairment, dose reduction is not required. In severe liver failure, the appointment of ibuprofen is contraindicated. Side effect From the gastrointestinal tract: the most commonly observed adverse reactions are gastrointestinal disorders. Peptic ulcer, perforation, or gastrointestinal bleeding, sometimes fatal, may occur, especially in the elderly. After the use of ibuprofen, the following adverse reactions were noted: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, gastrointestinal bleeding and exacerbation of colitis and Crohn’s disease. Less common cases of gastritis, duodenal ulcers, gastric ulcers and perforation of the gastrointestinal tract. On the part of the immune system: hypersensitivity reactions have been observed after the use of NSAIDs, which include: non-specific allergic reaction and anaphylaxis, respiratory tract reactivity, including asthma, exacerbated asthma, bronchospasm or shortness of breath, or various skin manifestations, including various types of rash, itching, urticaria, purpura , angioedema and very rarely erythema multiforme; bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis). From the side of the cardiovascular system: edema, hypertension and heart failure have been observed in connection with the use of NSAIDs. Clinical studies show that the use of ibuprofen, especially at high doses (2400 mg/day), may lead to a slight increase in the risk of developing arterial thrombotic conditions such as myocardial infarction or stroke. Infectious and parasitic diseases: rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders such as systemic lupus erythematosus and mixed connective tissue diseases) with symptoms of neck stiffness, headache, nausea, vomiting, fever or confusion. Cases of exacerbation of inflammatory processes of infectious origin associated with the use of NSAIDs have been described. If during the use of ibuprofen signs of infection appear or increase, you should immediately consult a doctor. From the skin and subcutaneous tissue. In exceptional cases, chickenpox can cause severe skin infections and soft tissue complications. Possible adverse reactions associated with the use of ibuprofen are listed according to the classification of undesirable side effects in accordance with the damage to organs and organ systems and the frequency of their development: very frequent (≥1/10), frequent (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000) and frequency unknown (cannot be estimated from available data). System organ class Frequency Side effects Infectious and parasitic diseases Uncommon Rhinitis Rare Aseptic meningitis Blood and lymphatic system disorders Rare Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia Immune system disorders Rare Anaphylaxis Psychiatric disorders Rare Insomnia, anxiety Uncommon Depression, confusion Nervous system disorders Common Headache, dizziness Uncommon Paresthesia, drowsiness Rare Optic neuritis Eye disorders Uncommon Decreased visual acuity Rare Toxic optic neuropathy Hearing and balance disorders Uncommon Hearing impairment, ringing in the ears , vestibular vertigo Respiratory, thoracic and mediastinal disorders Uncommon Asthma, bronchospasm, dyspnea Gastrointestinal disorders Common Dyspepsia, diarrhea, nausea, vomiting, abdominal pain, met Bleeding, constipation, tarry stools, bloody vomiting, gastrointestinal bleeding Uncommon Hepatitis, jaundice, abnormal liver function Very rare Liver failure Skin and subcutaneous tissue disorders Common Rash Uncommon Urticaria, pruritus, purpura, angioedema, photosensitivity reaction Very rare Stevens-Johnson syndrome and toxic epidermal necrolysis) Frequency unknown at the start of treatment). Stop taking Ibuflex 400 and contact your doctor immediately if the symptoms described occur Renal and urinary tract disorders Uncommon Various forms of nephrotoxicity such as tubulointerstitial nephritis, nephrotic syndrome and renal failure General disorders and administration site disorders Common Fatigue Rare Edema side of the heart Very rare Heart failure, myocardial infarction Vascular disorders Very rare Hypertension In the event of the listed or any other adverse reactions not listed in this leaflet, you should consult a doctor! Contraindications Hypersensitivity to any of the ingredients that make up the drug. Hypersensitivity to acetylsalicylic acid or other NSAIDs in history (for example, asthma, rhinitis, angioedema, urticaria). Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, Crohn's disease, ulcerative colitis). History of bleeding or perforation of a gastrointestinal ulcer associated with previous NSAID therapy. Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis. Patients with impaired renal function with a decrease in glomerular filtration rate less than 30 ml / min. Severe liver failure. Severe heart failure (NYHA class IV). III trimester of pregnancy. Children's age up to 12 years. OverdoseSymptoms Nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache, gastrointestinal bleeding. In severe poisoning, toxic damage to the central nervous system is observed, which manifests itself as drowsiness, sometimes an excited state and disorientation or coma. Occasionally, patients develop seizures. In more severe poisoning, metabolic acidosis, increased prothrombin time, acute renal failure, or liver damage may occur. Patients with asthma may experience an exacerbation of their symptoms. Treatment Treatment should be symptomatic and supportive and should include airway management, monitoring of cardiac function and vital signs until the patient is well. Within 1 hour after taking a potentially toxic dose of ibuprofen, oral activated charcoal or gastric lavage is recommended. If asthma worsens, bronchodilators should be used. Other treatments may be prescribed based on the patient's clinical symptoms. Precautions Undesirable effects can be minimized by selecting the minimum effective dose for the short time necessary for the disappearance of symptoms. Elderly The elderly have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration, and perforation Fatal bleeding, ulceration, or perforation of the gastrointestinal tract has been reported with any NSAID, at any stage of treatment, with or without prior symptoms. The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with increasing doses of NSAIDs in patients with a history of peptic ulcer disease, especially if they were complicated by bleeding or perforation, and in the elderly. These patients are advised to take the drug at the lowest effective dose required to relieve symptoms. Combination therapy with protective agents (eg, proton pump inhibitors, misoprostol) should be considered in these patients and in patients requiring acetylsalicylic acid or other agents that may increase the risk of gastrointestinal bleeding. Patients with a history of gastrointestinal disease, especially the elderly, should report any unusual abdominal symptoms (primarily gastrointestinal bleeding), especially during the initial stages of treatment. Particular attention should be paid to patients who are simultaneously taking drugs that can increase the risk of ulceration or bleeding: oral corticosteroids, anticoagulants, warfarin, selective serotonin reuptake inhibitors, antiplatelet agents such as acetylsalicylic acid. In case of bleeding or ulceration of the gastrointestinal tract, patients taking ibuprofen should immediately stop taking the drug. NSAIDs are prescribed with caution in patients with ulcerative colitis, Crohn's disease, due to the risk of exacerbation of these conditions. Ibuflex 400 should be used with caution in patients with or with a history of bronchial asthma, as NSAIDs may cause bronchospasm in such patients. Cardiovascular and cerebrovascular effects Appropriate monitoring and consultation is necessary in patients with hypertension and / or moderate heart failure, as fluid retention and edema are possible with the use of NSAIDs. The results of clinical trials suggest a possible relationship between ibuprofen, especially at high doses (≥2400 mg per day), with a slight increased risk of arterial thrombotic events (eg, myocardial infarction and stroke). Epidemiological studies do not suggest a relationship between low-dose ibuprofen (≤1200 mg daily) 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). Impaired renal function Like other NSAIDs, long-term use of ibuprofen leads to renal capillary necrosis and other renal pathological changes. There is an increased risk of kidney complications in patients for whom prostaglandin synthesis plays a compensatory role in maintaining renal blood flow (dehydration, impaired renal and hepatic function, heart failure, severe atherosclerosis, taking diuretics, ACE inhibitors, old age). The following precautions are recommended for patients at risk: - ensuring monitoring of renal function when administered to elderly patients, patients with arterial hypertension and diabetes mellitus during the first week of administration if administered for more than one week; - ensuring monitoring of serum creatinine after 48-72 hours from the start of administration in patients with chronic heart failure class III according to the NYHA classification, and chronic renal failure with a glomerular filtration rate of less than 60 ml / min; SLE and mixed connective tissue diseases Patients with systemic lupus erythematosus (SLE) and mixed collagenosis may be at increased risk of aseptic meningitis. Skin reactions Serious skin reactions have been reported with the use of ibuprofen. You should immediately stop taking Ibuflex 400 and consult a doctor if you develop skin rashes, lesions of the mucous membranes, blisters or other signs of allergy, as the described symptoms may be the first signs of a serious skin reaction. Hematological Effects Ibuprofen, like other NSAIDs, may interfere with platelet aggregation and increase bleeding time in healthy individuals. Aseptic meningitis Aseptic meningitis has rarely been observed in patients treated with ibuprofen. Patients with systemic lupus erythematosus and mixed collagenosis are most susceptible to it; however, cases have also been reported in patients without chronic disease. Violation of female fertility Ibuprofen, by inhibiting the synthesis of cyclooxygenase and prostaglandins, can affect ovulation and disrupt female reproductive function. Reversible after discontinuation of treatment. Use during pregnancy or lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or development of the embryo / fetus. Data from epidemiological studies indicate an increased risk of miscarriage, congenital heart and gastrointestinal tract defects after the use of prostaglandin synthesis inhibitors in early pregnancy. It is believed that the risk increases with increasing dose and duration of therapy. In animals, taking a prostaglandin synthesis inhibitor led to an increase in pre- and post-implantation mortality of the embryo and fetus. In addition, an increase in the incidence of various malformations, including cardiovascular, was observed in animals after receiving a prostaglandin synthesis inhibitor during the period of organogenesis. Ibuprofen should not be used in the 1st and 2nd trimesters of pregnancy unless absolutely necessary. If ibuprofen is used by a woman who is trying to conceive, or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest period of time. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can have the following effects: on the fetus: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and the development of pulmonary hypertension), - impaired renal function, which can progress to renal failure, with the development of oligohydramnios; on the mother at the end of pregnancy and the newborn: - an increase in bleeding time, an antiplatelet effect that can develop even at very low doses, - inhibition of uterine contractions, which leads to a delay or increase in the duration of labor. In connection with the above actions, ibuprofen is contraindicated in the third trimester of pregnancy. Lactation In limited studies, ibuprofen has been found in human milk at very low concentrations. There are no known cases of its negative effect on the infant, but breastfeeding, if possible, should be stopped during the period of taking ibuprofen. Influence on the ability to drive vehicles and other potentially dangerous mechanisms After taking NSAIDs, side effects such as dizziness, drowsiness, fatigue and visual impairment may occur. When these symptoms appear, patients should refrain from driving vehicles and other potentially dangerous mechanisms. Interaction with other drugs Ibuprofen, like other NSAIDs, should not be used in combination with: - acetylsalicylic acid (aspirin), 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, especially selective cyclooxygenase-2 inhibitors. This may increase the risk of side effects. Ibuprofen should be used with caution in combination with the following drugs: - anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin; - diuretics, ACE inhibitors, beta-blockers and angiotensin II antagonists: NSAIDs may reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with limited renal function), the co-administration of ACE inhibitors, beta-blockers or angiotensin II antagonists, and substances that suppress the cyclooxygenase system, may cause a further decrease in kidney function (up to acute renal failure), which is usually reversible. Therefore, the combination should be used with caution, especially in the elderly. Patients should receive sufficient fluids. Both after the start of joint therapy, and subsequently, renal function should be carefully monitored periodically. - corticosteroids: increased risk of gastrointestinal ulceration and bleeding; - antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding; - cardiac glycosides: NSAIDs can increase heart failure, reduce glomerular filtration rate and increase the level of glycosides in blood plasma; - lithium: there is evidence that NSAIDs can cause an increase in the concentration of lithium in the blood plasma; - methotrexate: there is evidence that NSAIDs can cause an increase in the concentration of methotrexate in blood plasma; - cyclosporine: increased risk of nephrotoxicity; - Mifepristone: The decrease in drug efficacy could theoretically be due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely affect cervical dilation of mifepristone or prostaglandins and does not reduce the clinical efficacy of medical termination of pregnancy; - tacrolimus: there may be an increased risk of nephrotoxicity with the simultaneous use of NSAIDs with tacrolimus; - zidovudine: increased risk of haematological toxicity with the combined use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia in the case of concomitant treatment with zidovudine and ibuprofen; - quinolone antibiotics: in patients taking ibuprofen and quinolone antibiotics at the same time, there may be an increased risk of seizures; Sulfonylureas: NSAIDs may increase the effect of sulfonylureas. There have been rare reports of hypoglycemia in patients taking both sulfonylureas and ibuprofen; - aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides; - plant extracts: ginkgo biloba may increase the risk of bleeding when used with NSAIDs; - CYP2C9 inhibitors: concomitant use of ibuprofen with CYP2C9 inhibitors may increase the time of exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S (+)-ibuprofen by approximately 80-100% was noted. The dosage of ibuprofen should be reduced when co-administered with CYP2C9 inhibitors, especially when high doses of ibuprofen are co-administered with voriconazole or fluconazole. Storage conditions Store at a temperature not exceeding 25 ° C, protected from light. Keep out of the reach of children. Shelf life Shelf life is 2 years. Do not use after the expiration date! Conditions of leave By doctor's prescription. Packing: 10 tablets in a blister pack made of PVC polymer film and aluminum foil. One, two, three or five blister packs, together with instructions for use, are placed in a cardboard pack. Buy Ibuflex 400 tablets p / o 400 mg No. 10x2 about 400mg №10x2