Cibalgina Due Fast 24 Tablets 200 mg
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WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. The use is not recommended in women who intend to become pregnant. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Ibuprofen can mask the signs and symptoms of infection due to its pharmacodynamic properties. Concomitant use should be avoided with other NSAIDs, including selective COX-2 inhibitors. Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including ibuprofen, and can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs in patients taking the medicinal product the treatment should be discontinued. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant therapy with gastroprotective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. When gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Administer with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. When ibuprofen is prescribed to patients with impaired liver function, close medical surveillance is required as their condition may be exacerbated. If signs or symptoms consistent with the development of liver disease develop or if other manifestations occur, treatment with ibuprofen should be discontinued. With the use of ibuprofen hepatitis can develop without prodromal symptoms. Ibuprofen is contraindicated in cases of severe hepatic insufficiency. Since fluid retention and edema have been reported in association with NSAID therapy, including ibuprofen, particular caution is required in patients with impaired cardiac and renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, for example before or after major surgery. Discontinuation of treatment is usually followed by a return to the pre-treatment state. Ibuprofen is contraindicated in severe renal or cardiac insufficiency. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including ibuprofen. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Discontinue at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. In patients with asthma, seasonal allergic rhinitis, edema of the nasal mucosa (e.g. nasal polyposis), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to those of allergic rhinitis), reactions to NSAIDs as exacerbation of asthma, Quincke's edema or urticaria are more frequent than in other patients. Particular caution is recommended in these patients (emergency ready). Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. There may be an increased risk of aseptic meningitis in patients with Systemic Lupus Erythematosus (SLE) and mixed connective tissue disorders. Aseptic meningitis has been observed very rarely in patients treated with ibuprofen. Although this is likely to occur more likely in patients with SLE and related connective tissue diseases, it has also been reported in individuals without an underlying chronic disease.
PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory / antirheumatic drugs.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Do not administer under 12 years of age. Hypersensitivity 'to the active substance or to any of the excipients. Subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma, and presents with bronchospasm, urticaria or acute rhinitis. Severe or active peptic ulcer. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Hematopoietic disorders of unknown origin. Cerebrovascular or other haemorrhage. Severe hepatic or renal insufficiency. Severe heart failure. Third trimester of pregnancy.
NAME
CIBALGINA DUE FAST
EXCIPIENTS
Ethylcellulose, cellulose acetate phthalate, corn starch, microcrystalline cellulose, saccharin, croscarmellose sodium, strawberry flavor, fumaric acid, silicon dioxide, magnesium stearate, anhydrous dibasic calcium phosphate.
SIDE EFFECTS
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. The undesirable effects are mostly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of the drug. Gastritis has been observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Frequencies: very common (> = 1/10), common (> = 1/100, <1/10), uncommon (> = 1 / 1,000, <1/100), rare (> = 1 / 10,000; < 1 / 1,000), very rare (<1 / 10,000), not known. Infections and infestations. Very rare: deterioration of inflammation associated with infection (eg development of necrotizing fasciitis) described in conjunction with the use of non-steroidal anti-inflammatory drugs. Disorders of the blood and lymphatic system. Very rare: thrombocytopenia, anemia, leukopenia, pancytopenia, agranulocytosis. Disorders of the immune system. Uncommon: hypersensitivity reactions', including skin rash, urticaria, pruritus and asthma attacks; very rare: anaphylactic reaction, angioedema. Psychiatric disorders. Not known: psychotic reactions, depression. Nervous system disorders. Uncommon: headache, dizziness, insomnia, agitation, irritability, fatigue; very rare: aseptic meningitis. Eye disorders. Not known: visual disturbances. Ear and labyrinth disorders. Rare: tinnitus, hearing impairment. Cardiac pathologies. Not known: palpitations, edema, heart failure, myocardial infarction. Vascular pathologies. Not known: hypertension. Gastrointestinal disorders. Common: dyspepsia, abdominal pain, nausea, vomiting; rare: peptic ulcer, gastrointestinal perforation or haemorrhage, ulcerative stomatitis, gastritis. Worsening of colitis and Crohn's disease. Esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures, flatulence, diarrhea, constipation. Hepatobiliary disorders. Very rare: abnormal liver function tests, abnormal liver function, jaundice, hepatitis. Liver damage. Skin and subcutaneous tissue disorders. Uncommon: rash; very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis bullosa. Renal pathologies. Rare: kidney failure, kidney tissue damage (papillary necrosis), increase in serum concentration of uric acid; not known: formation of edema, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal insufficiency.
PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, the medicine should not be administered except in strictly necessary cases. If used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, a possible prolongation of the bleeding time, and an antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, the drug is contraindicated during the third trimester of pregnancy. Breastfeeding: Ibuprofen passes into breast milk in small quantities. Although no undesirable effects in the infant are known to date, caution should be exercised when ibuprofen is administered to a nursing woman. Fertility: there is evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause a reduction in female fertility by effect on ovulation. However, this event is reversible upon discontinuation of treatment.
INDICATIONS
Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.
INTERACTIONS
Use caution in patients treated with any of the following medicines, as interactions have been reported in some patients. Acetylsalicylic acid: as with other NSAIDs, co-administration of ibuprofen and acetylsalicylic acid is not recommended because it may increase the risk of adverse events (unless low dose aspirin, not exceeding 75 mg / day, does was recommended by your doctor). Experimental data indicate that ibuprofen can inhibit the effects of low dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen. Other NSAIDs including selective COX-2 inhibitors: avoid concomitant use of two or more NSAIDs as this involves an increased risk of adverse effects. Lithium: ibuprofen can 'increase plasma concentrations of lithium, due to reduced elimination of the latter. Therefore, monitoring of serum lithium levels is recommended. Cardiac glycosides: Ibuprofen, like other NSAIDs, can exacerbate heart failure, reduce glomerular filtration rate (GFR) and increase plasma concentrations of glycosides. Therefore, monitoring of serum glycoside levels is recommended. Diuretics and antihypertensive agents: like other NSAIDs, the concomitant use of ibuprofen with diuretics or antihypertensive agents (eg beta-blockers, ACE inhibitors, angiotensin II antagonists) may cause a reduction in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have periodic blood pressure monitoring. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which therefore should be monitored frequently. Corticosteroids: Concomitant administration of ibuprofen and corticosteroids may increase the risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Sulfonylureas: NSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas taking ibuprofen. Methotrexate: NSAIDs may reduce the clearance of methotrexate through inhibition of tubular secretion. The administration of ibuprofen 24 hours before or after the administration of methotrexate can 'lead to an increase in the concentration of methotrexate and an increase in its toxic effect. Therefore, concomitant use of NSAIDs and high doses of methotrexate should be avoided. If concomitant administration is necessary, the patient should be carefully monitored for toxicity, especially myelosuppression and gastrointestinal toxicity. In addition, the potential risk of interactions should also be considered in low dose methotrexate treatment (<15 mg / week), particularly in patients with impaired renal function, which should be monitored during combination treatment, particularly in patients with renal impairment. first weeks. Ciclosporin and tacrolimus: the risk of a nephrotoxic effect due to cyclosporine and tacrolimus, due to the reduction of prostaglandin synthesis in the kidney, is increased by the concomitant administration of some non-steroidal anti-inflammatory drugs, including ibuprofen. Therefore, ibuprofen should be administered at lower doses than those used in patients not taking these immunosuppressive agents and renal function should be closely monitored. Fluoroquinolone antibacterials: There have been isolated cases of seizures which may have been induced by the concomitant use of fluoroquinolone and NSAIDs. Phenytoin: When phenytoin is used concomitantly with ibuprofen, blood levels of phenytoin may increase. Therefore, monitoring of phenytoin plasma concentrations is recommended. Colestipol and cholestyramine: when given concomitantly with ibuprofen, they can delay or decrease the absorption of the latter. Therefore, it is recommended to administer ibuprofen at least 1 hour before or 4-6 hours after colestipol / cholestyramine administration. Potent CYP2C9 inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitory agents (such as sulfinpyrazone, fluconazole and voriconazole) requires caution as it may lead to a significant increase in peak plasma concentrations and ibuprofen exposure due to inhibition of the metabolism of ibuprofen. Zidovudine: There is an increased risk of haematological toxicity when administered concomitantly with NSAIDs. There is evidence of an increased risk of haemarthroses and hematomas in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen.
DOSAGE
Adults, the elderly and children over 12 years: 1-2 gastro-resistant tablets 2-3 times a day. Do not exceed the dose of 6 tablets (1200 mg) within 24 hours. Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above. Method of administration: the tablets dissolve quickly in the mouth without leaving any unpleasant taste, pressing them with the tongue against the palate. Follow up, if necessary, with a glass of water. It is advisable to take the medicine during or after meals, particularly in the presence of gastric disorders. Use only for short periods of treatment.
ACTIVE PRINCIPLES
Ibuprofen 200 mg.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. The use is not recommended in women who intend to become pregnant. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Ibuprofen can mask the signs and symptoms of infection due to its pharmacodynamic properties. Concomitant use should be avoided with other NSAIDs, including selective COX-2 inhibitors. Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including ibuprofen, and can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs in patients taking the medicinal product the treatment should be discontinued. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant therapy with gastroprotective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. When gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. Administer with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. When ibuprofen is prescribed to patients with impaired liver function, close medical surveillance is required as their condition may be exacerbated. If signs or symptoms consistent with the development of liver disease develop or if other manifestations occur, treatment with ibuprofen should be discontinued. With the use of ibuprofen hepatitis can develop without prodromal symptoms. Ibuprofen is contraindicated in cases of severe hepatic insufficiency. Since fluid retention and edema have been reported in association with NSAID therapy, including ibuprofen, particular caution is required in patients with impaired cardiac and renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, for example before or after major surgery. Discontinuation of treatment is usually followed by a return to the pre-treatment state. Ibuprofen is contraindicated in severe renal or cardiac insufficiency. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including ibuprofen. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Discontinue at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. In patients with asthma, seasonal allergic rhinitis, edema of the nasal mucosa (e.g. nasal polyposis), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to those of allergic rhinitis), reactions to NSAIDs as exacerbation of asthma, Quincke's edema or urticaria are more frequent than in other patients. Particular caution is recommended in these patients (emergency ready). Ibuprofen is contraindicated in subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. There may be an increased risk of aseptic meningitis in patients with Systemic Lupus Erythematosus (SLE) and mixed connective tissue disorders. Aseptic meningitis has been observed very rarely in patients treated with ibuprofen. Although this is likely to occur more likely in patients with SLE and related connective tissue diseases, it has also been reported in individuals without an underlying chronic disease.
PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory / antirheumatic drugs.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Do not administer under 12 years of age. Hypersensitivity 'to the active substance or to any of the excipients. Subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyposis and asthma, and presents with bronchospasm, urticaria or acute rhinitis. Severe or active peptic ulcer. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Hematopoietic disorders of unknown origin. Cerebrovascular or other haemorrhage. Severe hepatic or renal insufficiency. Severe heart failure. Third trimester of pregnancy.
NAME
CIBALGINA DUE FAST
EXCIPIENTS
Ethylcellulose, cellulose acetate phthalate, corn starch, microcrystalline cellulose, saccharin, croscarmellose sodium, strawberry flavor, fumaric acid, silicon dioxide, magnesium stearate, anhydrous dibasic calcium phosphate.
SIDE EFFECTS
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. The undesirable effects are mostly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of the drug. Gastritis has been observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Frequencies: very common (> = 1/10), common (> = 1/100, <1/10), uncommon (> = 1 / 1,000, <1/100), rare (> = 1 / 10,000; < 1 / 1,000), very rare (<1 / 10,000), not known. Infections and infestations. Very rare: deterioration of inflammation associated with infection (eg development of necrotizing fasciitis) described in conjunction with the use of non-steroidal anti-inflammatory drugs. Disorders of the blood and lymphatic system. Very rare: thrombocytopenia, anemia, leukopenia, pancytopenia, agranulocytosis. Disorders of the immune system. Uncommon: hypersensitivity reactions', including skin rash, urticaria, pruritus and asthma attacks; very rare: anaphylactic reaction, angioedema. Psychiatric disorders. Not known: psychotic reactions, depression. Nervous system disorders. Uncommon: headache, dizziness, insomnia, agitation, irritability, fatigue; very rare: aseptic meningitis. Eye disorders. Not known: visual disturbances. Ear and labyrinth disorders. Rare: tinnitus, hearing impairment. Cardiac pathologies. Not known: palpitations, edema, heart failure, myocardial infarction. Vascular pathologies. Not known: hypertension. Gastrointestinal disorders. Common: dyspepsia, abdominal pain, nausea, vomiting; rare: peptic ulcer, gastrointestinal perforation or haemorrhage, ulcerative stomatitis, gastritis. Worsening of colitis and Crohn's disease. Esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures, flatulence, diarrhea, constipation. Hepatobiliary disorders. Very rare: abnormal liver function tests, abnormal liver function, jaundice, hepatitis. Liver damage. Skin and subcutaneous tissue disorders. Uncommon: rash; very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis bullosa. Renal pathologies. Rare: kidney failure, kidney tissue damage (papillary necrosis), increase in serum concentration of uric acid; not known: formation of edema, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal insufficiency.
PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, the medicine should not be administered except in strictly necessary cases. If used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, a possible prolongation of the bleeding time, and an antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, the drug is contraindicated during the third trimester of pregnancy. Breastfeeding: Ibuprofen passes into breast milk in small quantities. Although no undesirable effects in the infant are known to date, caution should be exercised when ibuprofen is administered to a nursing woman. Fertility: there is evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause a reduction in female fertility by effect on ovulation. However, this event is reversible upon discontinuation of treatment.
INDICATIONS
Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.
INTERACTIONS
Use caution in patients treated with any of the following medicines, as interactions have been reported in some patients. Acetylsalicylic acid: as with other NSAIDs, co-administration of ibuprofen and acetylsalicylic acid is not recommended because it may increase the risk of adverse events (unless low dose aspirin, not exceeding 75 mg / day, does was recommended by your doctor). Experimental data indicate that ibuprofen can inhibit the effects of low dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen. Other NSAIDs including selective COX-2 inhibitors: avoid concomitant use of two or more NSAIDs as this involves an increased risk of adverse effects. Lithium: ibuprofen can 'increase plasma concentrations of lithium, due to reduced elimination of the latter. Therefore, monitoring of serum lithium levels is recommended. Cardiac glycosides: Ibuprofen, like other NSAIDs, can exacerbate heart failure, reduce glomerular filtration rate (GFR) and increase plasma concentrations of glycosides. Therefore, monitoring of serum glycoside levels is recommended. Diuretics and antihypertensive agents: like other NSAIDs, the concomitant use of ibuprofen with diuretics or antihypertensive agents (eg beta-blockers, ACE inhibitors, angiotensin II antagonists) may cause a reduction in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have periodic blood pressure monitoring. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which therefore should be monitored frequently. Corticosteroids: Concomitant administration of ibuprofen and corticosteroids may increase the risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Sulfonylureas: NSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas taking ibuprofen. Methotrexate: NSAIDs may reduce the clearance of methotrexate through inhibition of tubular secretion. The administration of ibuprofen 24 hours before or after the administration of methotrexate can 'lead to an increase in the concentration of methotrexate and an increase in its toxic effect. Therefore, concomitant use of NSAIDs and high doses of methotrexate should be avoided. If concomitant administration is necessary, the patient should be carefully monitored for toxicity, especially myelosuppression and gastrointestinal toxicity. In addition, the potential risk of interactions should also be considered in low dose methotrexate treatment (<15 mg / week), particularly in patients with impaired renal function, which should be monitored during combination treatment, particularly in patients with renal impairment. first weeks. Ciclosporin and tacrolimus: the risk of a nephrotoxic effect due to cyclosporine and tacrolimus, due to the reduction of prostaglandin synthesis in the kidney, is increased by the concomitant administration of some non-steroidal anti-inflammatory drugs, including ibuprofen. Therefore, ibuprofen should be administered at lower doses than those used in patients not taking these immunosuppressive agents and renal function should be closely monitored. Fluoroquinolone antibacterials: There have been isolated cases of seizures which may have been induced by the concomitant use of fluoroquinolone and NSAIDs. Phenytoin: When phenytoin is used concomitantly with ibuprofen, blood levels of phenytoin may increase. Therefore, monitoring of phenytoin plasma concentrations is recommended. Colestipol and cholestyramine: when given concomitantly with ibuprofen, they can delay or decrease the absorption of the latter. Therefore, it is recommended to administer ibuprofen at least 1 hour before or 4-6 hours after colestipol / cholestyramine administration. Potent CYP2C9 inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitory agents (such as sulfinpyrazone, fluconazole and voriconazole) requires caution as it may lead to a significant increase in peak plasma concentrations and ibuprofen exposure due to inhibition of the metabolism of ibuprofen. Zidovudine: There is an increased risk of haematological toxicity when administered concomitantly with NSAIDs. There is evidence of an increased risk of haemarthroses and hematomas in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen.
DOSAGE
Adults, the elderly and children over 12 years: 1-2 gastro-resistant tablets 2-3 times a day. Do not exceed the dose of 6 tablets (1200 mg) within 24 hours. Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above. Method of administration: the tablets dissolve quickly in the mouth without leaving any unpleasant taste, pressing them with the tongue against the palate. Follow up, if necessary, with a glass of water. It is advisable to take the medicine during or after meals, particularly in the presence of gastric disorders. Use only for short periods of treatment.
ACTIVE PRINCIPLES
Ibuprofen 200 mg.
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