Maprofen tablets p/o 100mg №15×2

Name Maprofen tab. cover p / o 100 mg in bl. in pack. No. 15×2 Main active ingredient Flurbiprofen Release form Tablets Composition 1 film-coated tablet contains: active substance: flurbiprofen 100 mg; excipients: lactose DC (Lactose monohydrate + Povidone (Kollidon 30)), microcrystalline cellulose PH 102, croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate; The composition of the film shell material No. 14 (Opadry 11 blue 85F20578): polyvinyl alcohol, PEG 3350 powder, titanium dioxide (E171), talc, FD&C Blue #2 / Indigo carmine aluminum 11% – 14%, iron oxide yellow (E172). Dosage 100mg Indications for use For the symptomatic treatment of rheumatoid arthritis and osteoarthritis. Contraindications Known hypersensitivity (eg, bronchospasm, anaphylactic reactions, serious skin reactions) to flurbiprofen or any of the excipients. In case of hypersensitivity reactions (such as bronchial asthma, rhinitis, urticaria or angioedema) after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in these patients. A history of gastrointestinal bleeding or perforation associated with NSAIDs. The use of flurbiprofen is contraindicated in patients with active or existing medical conditions such as ulcerative colitis, Crohn’s disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of confirmed ulcer or bleeding). Severe heart, liver or kidney failure. Use in patients after coronary artery bypass grafting (CABG). Children and adolescents under 18 years of age (efficacy and safety of use has not been established). 3rd trimester of pregnancy (see also section “Period of pregnancy and lactation”). Application during pregnancy and lactation Pregnancy The use of flurbiprofen during the first and second trimesters of pregnancy is possible only if absolutely necessary. Flurbiprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis can adversely affect the development of pregnancy and / or the development of the embryo / fetus. Data from epidemiological studies indicate an increased risk of miscarriages and heart defects and gastroschisis with the use of prostaglandin synthesis inhibitors in early pregnancy. It is believed that the risk increases with increasing dose and duration of treatment. In animal studies, it has been found that taking prostaglandin synthesis inhibitors increases the risk of pre- and post-implantation fetal death, as well as embryofetal mortality. In addition, there have been cases of various malformations, including malformations of the cardiovascular system. If flurbiprofen is used by a woman trying to conceive or during the first and second trimesters of pregnancy, the lowest dose and the shortest duration of treatment should be selected. Breastfeeding The limited available studies have shown that NSAIDs can be detected in breast milk at very low concentrations. As with other NSAIDs, it is not recommended to take flurbiprofen while breastfeeding. Route of administration and doses Before making a decision to take Maprofen, it is recommended to carefully weigh the potential benefits and risks, as well as consider other treatment options. The lowest effective dose of Maprofen should be taken for the shortest period of time according to individual treatment goals (see Precautions section). After observing the response to initial therapy, the dose and frequency of Maprofen should be adjusted according to the individual needs of the patient. Tablets can be divided according to risk for dose adaptation. The daily dose is usually 200 to 300 mg in two to three divided doses. The maximum single dose is 100 mg. Children and adolescents Safety and efficacy in children and adolescents have not been established. Women planning pregnancy, pregnant or breastfeeding Due to the possible negative impact on the onset of ovulation (reversible), consideration should be given to the withdrawal of non-steroidal anti-inflammatory drugs (NSAIDs), including flurbiprofen, in women who have difficulty conceiving and / or are being evaluated for cause of infertility. Flurbiprofen is contraindicated for use during the third trimester of pregnancy, use in the 1st and 2nd trimester is possible only in cases of emergency, after a thorough assessment of the risks and benefits. It is not recommended to take flurbiprofen during breastfeeding (see section “Period of pregnancy and lactation”). Elderly patients Elderly people are at greater risk of NSAID-associated serious adverse reactions from the cardiovascular system, gastrointestinal tract and / or kidneys. If the expected benefit to an elderly patient outweighs these potential risks, flurbiprofen should be started at the lowest dose under medical supervision of the patient’s condition in order to control the occurrence of adverse reactions (see sections “Precautions”, “Side Effects”). Patients with impaired renal function In this category of patients, flurbiprofen should be used with caution, after a careful assessment of the benefit-risk ratio and subject to monitoring of renal function. Monitoring of renal function is also necessary in patients with hepatic and / or heart failure, dehydration or hypovolemia. Flurbiprofen is not recommended for patients with moderate renal impairment and is contraindicated in patients with severe renal impairment. Side effects Gastrointestinal disorders: are the most common side effects. Peptic ulcers, perforations, or gastrointestinal bleeding, sometimes fatal, may occur, especially in the elderly (see Precautions). Nausea, vomiting, diarrhea, dyspepsia, flatulence, constipation, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see “Precautions”, “Contraindications”) have been reported after taking flurbiprofen. Rarely observed gastritis. Pancreatitis has been very rarely reported. Immune System Disorders: Hypersensitivity reactions have been reported with NSAID therapy. They may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity including asthma, asthma exacerbation, bronchospasm or dyspnoea, or (c) mixed skin disorders including various types of rash, pruritus, urticaria, purpura , angioedema, less often exfoliative bullous dermatosis (including toxic epidermal necrolysis and erythema multiforme). Cardiac and vascular disorders: Edema, hypertension and heart failure have been reported in patients in association with NSAID treatment. Clinical trials and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events (eg, myocardial infarction or stroke) (see “Precautions”). Respiratory, thoracic and mediastinal disorders: rhinitis. Metabolic and nutritional disorders: change in body weight. Renal and urinary disorders: urinary tract infections. Other adverse reactions that have been reported less frequently and for which a causal relationship has not been clearly established include: Blood and lymphatic system disorders: thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia, iron deficiency anemia. Mental disorders: depression, hallucinations. Nervous system disorders: cerebrovascular accident, optic neuritis, headache, paresthesia, dizziness and drowsiness, impaired sense of smell. Aseptic meningitis (especially in patients with autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms such as headache, nausea, vomiting, fever, or confusion (see Precautions). On the part of the organ of vision: clouding of the cornea, conjunctivitis. Disturbances from the organ of hearing and balance: ringing in the ears, dizziness. Liver and biliary tract disorders: Liver dysfunction, hepatitis and jaundice. Skin and subcutaneous tissue disorders: herpes simplex, alopecia, dry skin. Renal and urinary tract disorders: Toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure, hematuria. General disorders and disorders at the injection site: fatigue, malaise. Immune system disorders: photosensitivity reactions. Respiratory, thoracic and mediastinal disorders: shortness of breath, epistaxis, bronchitis, laryngitis. Metabolic and nutritional disorders: hyperpuricemia. Genital and breast disorders: vaginal bleeding. Overdose Symptoms Overdose symptoms may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea, confusion, agitation, coma, drowsiness, dizziness, tinnitus, fainting, and sometimes convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Therapeutic measures Treatment is symptomatic. Within one hour of ingestion of a potentially toxic amount, activated charcoal may be used. Alternatively, in adults, gastric lavage is possible within one hour after ingestion of a potentially life-threatening amount of the drug. Good urine excretion, careful monitoring of liver and kidney function should be ensured. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged seizures should be treated with intravenous diazepam. Interactions with other medicinal products Patients taking any of the following medicinal products should be monitored due to the possibility of interactions with flurbiprofen. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg, dehydrated patients or elderly patients with impaired renal function), the concomitant use of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit cyclooxygenase may lead to further deterioration of renal function, including the possible occurrence of acute renal failure, which is usually reversible. These interactions should be considered in patients taking flurbiprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, co-administration should be carried out with caution, especially in the elderly. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter. Cardiac glycosides: NSAIDs may exacerbate heart failure, decrease GFR, and increase plasma levels of cardiac glycosides.4 Anticoagulants: NSAIDs may increase the effects of anticoagulants such as warfarin (see Precautions). Aspirin: As with other NSAIDs, the concomitant use of flurbiprofen and aspirin is not recommended due to the potential for increased risk of side effects. Antiplatelet agents: increased risk of gastrointestinal bleeding with NSAIDs (see “Precautions”). Serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding with NSAIDs (see “Precautions”). Lithium salts: decreased excretion of lithium. Methotrexate: Use concomitant therapy with flurbiprofen and methotrexate with caution, as NSAIDs may increase methotrexate levels. Cyclosporine: increased risk of nephrotoxicity. Corticosteroids: increased risk of gastrointestinal bleeding or ulcers when taken with NSAIDs (see Precautions). Other analgesics and selective cyclooxygenase-2 inhibitors: avoid the use of two or more NSAIDs, including COX-2 inhibitors, as this may increase the risk of side effects (see “Precautions”), Quinolone antibiotics: data from clinical trials in animals show that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may be at an increased risk of developing seizures. Mifepristone: NSAIDs should not be used within 8-12 days after taking mifepristone, as NSAIDs may reduce the effect of mifepristone. Tacrolimus: There may be an increased risk of NSAID nephrotoxicity when taken with tacrolimus. Zidovudine: increased risk of haematological toxicity when taken with NSAIDs. There is evidence of an increased risk of hemarthrosis and hematomas in HIV (+) patients with hemophilia receiving concomitant treatment with zidovudine and other NSAIDs. Antacids: Administration of flurbiprofen to volunteers on an empty stomach or with an antacid suspension showed similar serum profiles of flurbiprofen over time in both groups in young adult patients (n = 12). In the geriatric group (n=7), a decrease in the rate, but not extent, of flurbiprofen absorption was seen. Studies have not shown any interaction between flurbiprofen and tolbutamide. There is no evidence that flurbiprofen interferes with standard laboratory tests. Precautions Undesirable effects can be minimized by reducing the effective dose, shortening the duration of administration and controlling symptoms. The patient should be regularly monitored for gastrointestinal bleeding during NSAID therapy (see “Method of application and dosage”). Patients with rare hereditary problems of galactose intolerance, fructose intolerance, lactase deficiency, sucrase-isomaltase deficiency or glucose-galactose malabsorption should not take this medicinal product. Maprofen should be avoided in conjunction with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the possibility of additional side effects (see “Interactions with other drugs, other forms of interaction”). Elderly The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see Dosage and Administration). Gastrointestinal bleeding, ulceration and perforation Gastrointestinal bleeding, ulceration or perforation may occur with all NSAIDs at any time during therapy. These side effects can be fatal and may occur with or without warning symptoms or a history of gastrointestinal bleeding. The risk of gastrointestinal bleeding, ulcers or perforation increases with increasing dose of NSAIDs in patients with a history of ulcers, especially complicated by bleeding or perforation (see “Contraindications”), and in the elderly. In these patients, treatment should be initiated at the lowest effective dose. Combination therapy with protective agents (eg, misoprostol or proton pump inhibitors) should be considered for these patients, as well as for patients requiring concomitant low doses of aspirin or other drugs that may increase the risk of gastrointestinal bleeding. Patients with a history of gastrointestinal disease, in particular the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of therapy. Particular attention should be paid to this in patients receiving concomitant medications that could increase the risk of ulcers or bleeding, such as corticosteroids, oral anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin (see “Interactions with other drugs, other forms of interaction”). If gastrointestinal bleeding or ulcers are found in patients receiving Maprofen, treatment should be discontinued. Respiratory disorders Caution is necessary when using Maprofen in patients with current or history of bronchial asthma, since NSAIDs provoke bronchospasm in such patients. Cardiovascular, renal and hepatic insufficiency Taking NSAIDs can lead to a dose-dependent decrease in prostaglandin and the formation of renal failure. Patients with impaired renal function, heart failure, liver dysfunction, diuretics, and the elderly are most at risk for this side effect. Renal function should be monitored in these patients (see “Contraindications”). Maprofen should be used with caution in patients with a history of heart failure or hypertension, as edema has been reported in this category of patients while taking flurbiprofen. Cardiovascular and cerebrovascular effects Appropriate monitoring and consultation is necessary in patients with hypertension and/or mild to moderate heart failure due to the possible occurrence of fluid retention and edema, as reported in connection with flurbiprofen and other NSAIDs. Clinical trials and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term therapy) may be associated with a small increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. The exclusion of such a risk when taking flurbiprofen is not possible due to insufficient data. Patients with uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only use flurbiprofen after careful consideration. Similar consideration should be made before initiating long-term treatment in patients with cardiovascular risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). Nephrotoxicity Prolonged use of NSAIDs can lead to renal papillary necrosis and other kidney damage. Renal toxicity has also been observed in patients whose renal prostaglandins have a compensatory effect in maintaining renal perfusion. In these patients, the administration of NSAIDs can cause, first of all, a dose-dependent decrease in the formation of prostaglandin and, secondly, in renal blood flow, which may accelerate the onset of renal decompensation. Patients with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly are most at risk for this reaction. Discontinuation of NSAID therapy is usually followed by recovery to pre-treatment status. In clinical studies, the half-life of flurbiprofen did not change in patients with renal insufficiency. Flurbiprofen metabolites are excreted primarily by the kidneys. Excretion of 4-hydroxyflurbiprofen was reduced in patients with moderate to severe renal insufficiency. Therefore, treatment with flurbiprofen is not recommended in patients with kidney disease. If flurbiprofen therapy is necessary, careful monitoring of patients’ renal function is recommended. The degree of dehydration in dehydrated or hypovolemic patients should be corrected prior to initiating flurbiprofen therapy. It is necessary to monitor renal function in patients with renal or hepatic insufficiency, heart failure, dehydration, or hypovolemia when using flurbiprofen (see section “Interactions with other medicinal products, other forms of interaction”). The use of flurbiprofen should be avoided in patients with kidney disease unless the expected benefit outweighs the risk of worsening kidney function. If flurbiprofen is used in patients with kidney disease, patients should be monitored for signs of deterioration in renal function. Hyperkalemia An increase in serum potassium concentration, including hyperkalemia, has been reported with the use of NSAIDs in some patients, even in the absence of renal insufficiency. In patients with normal renal function, these effects have been attributed to the condition hyporeninic hypoaldosteronism. Systemic lupus erythematosus and mixed connective tissue disease Patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases may have an increased risk of aseptic meningitis (see “Side Effects”). Dermatological effects Very rarely, serious skin reactions have been reported in connection with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which were fatal (see “Side Effects”). The highest risk of these reactions is at the beginning of the course of therapy, in most cases – during the first month of treatment. Hematological effects Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and increase bleeding time. Maprofen should be used with caution in patients with the potential for abnormal bleeding. Impaired fertility The use of Maprofen may impair female fertility and is not recommended for women planning a pregnancy. In women who have difficulty conceiving or who are being tested for infertility, withdrawal of Maprofen should be considered. Premature closure of the fetal ductus arteriosus Flurbiprofen may cause premature closure of the fetal ductus arteriosus. Masking inflammation and fever The pharmacological activity of flurbiprofen in reducing inflammation, and possibly fever, may reduce the usefulness of diagnostic features in detecting infection. Laboratory monitoring Because serious gastrointestinal bleeding, hepatotoxicity, and kidney damage can occur without warning symptoms or signs, monitoring of patients with periodic CBC and biochemical blood tests is recommended during long-term treatment with NSAIDs. Blurred vision There have been reports of blurred and/or decreased visual acuity with the use of flurbiprofen and other non-steroidal anti-inflammatory drugs. Patients reporting visual disturbances should undergo ophthalmological examinations. Storage conditions Store below 25°C in the original packaging to protect from light. Keep out of the reach of children. Buy Maprofen tablets p/o 100mg No. 15×2