Okitask 40 mg Ketoprofen Lysine Salt 20 Sachets

WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Use caution in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. Concomitant use of the medicinal product with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported. 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 possible dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, especially if elderly, should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. When gastrointestinal bleeding or ulceration occurs in patients taking the medicinal product, discontinue treatment. 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. 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. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with an increased risk of arterial thrombotic events. There are currently insufficient data to exclude a similar risk for ketoprofen when it is administered at the daily dose of one sachet, single dose, or repeated 2-3 times a day. The product contains aspartame as a sweetener. The drug does not affect low-calorie or controlled diets and can also be administered to diabetic patients. Patients with active peptic ulcer or with a history of peptic ulcer. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. At the start of treatment, renal function should be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, in particular six patients are elderly. In these patients, the administration of ketoprofen can 'cause a decrease in renal blood flow caused by the inhibition of prostaglandins and lead to renal failure. Caution is required before starting treatment in patients with a history of mild to moderate hypertension and / or cardiac congestive insufficiency as fluid retention, hypertension and edema have been reported in association with NSAID treatment. As with other NSAIDs, in the presence of an infection, it must be taken into account that the anti-inflammatory, analgesic and antipyretic properties of ketoprofen can mask the common symptoms of the progression of the infection such as fever. In patients with abnormal liver function values or with a history of liver disease, transaminase levels should be evaluated periodically, especially during long-term therapy. Rare cases of jaundice and hepatitis have been reported with the use of ketoprofen. Patients with asthma associated with chronic and allergic rhinitis, chronic sinusitis and / or nasal polyposis are at greater risk of allergies to acetylsalicylic acid and / or NSAIDs than the rest of the population. The administration of this drug can cause asthma attack or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs. Therefore in these subjects, as well as in the case of chronic obstructive pulmonary disease or nephropathy, the product should only be used under medical supervision. As with other NSAIDs, patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease. In case of visual disturbances, such as blurred vision, treatment should be discontinued. Administer with caution in patients with allergic manifestations or previous allergy. Patients with current or previous gastrointestinal disease should be carefully monitored for the appearance of digestive disorders, especially gastrointestinal bleeding. When the product is administered to patients with hepatic porphyria, caution is required as the drug could trigger an attack. Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of severe gastrointestinal toxicity than other NSAIDs, especially at high doses. Elderly patients are more prone to impaired renal, cardiovascular or hepatic function.
PHARMACOTHERAPEUTIC CATEGORY
Anti-inflammatory / antirheumatic drugs.
STORAGE
Store at a temperature not exceeding 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Patients with a history of hypersensitivity reactions' such as bronchospasm, asthma attacks, acute rhinitis, urticaria, rash or other allergic-type reactions to ketoprofen, or substances with a similar mechanism of action (e.g. acetylsalicylic acid or other NSAIDs) severe, rarely fatal, anaphylactic reactions have been observed in these patients; patients with hypersensitivity to any of the excipients; third trimester of pregnancy, known or suspected pregnancy, during lactation and in children under 15 years; severe heart failure; patients with gastric or duodenal ulcer, gastritis and chronic dyspepsia; subjects with leukopenia or thrombocytopenia, with ongoing bleeding or haemorrhagic diathesis, undergoing treatment with anticoagulants; patients with severe renal or hepatic insufficiency; patients undergoing major surgery. Furthermore, simultaneous administration with other anti-inflammatory drugs and acetylsalicylic acid is not recommended. Active peptic ulcer / haemorrhage or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or haemorrhage). Previous history of gastrointestinal bleeding, ulceration or perforation related to previous NSAID treatment.
NAME
OKITASK 40 MG GRANULES
EXCIPIENTS
Povidone, colloidal silica, hydroxypropylmethylcellulose, eudragit EPO, sodium dodecyl sulfate, stearic acid, magnesium stearate, aspartame, mannitol, xylitol, talc, lime flavor, lemon flavor, fresh flavor
SIDE EFFECTS
Gastrointestinal system: 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 frequency and extent of these effects are significantly reduced by taking the drug on a full stomach. In exceptional cases, the manifestations of hypersensitivity 'can take the character of severe systemic reactions (edema of the larynx, edema of the glottis, dyspnoea, palpitation) up to anaphylactic shock. In these cases, immediate medical assistance is required. Classification of expected frequencies: very common (1/10), common (1/100 to <= 1/10), uncommon (1/1000 to <= 1/100), rare (1/10000 to <= 1/1000), very rare (<= 1/10000), not known. The following adverse reactions have been observed with the use of ketoprofen in adults. Disorders of the blood and lymphatic system. Rare: haemorrhagic anemia; not known: thrombocytopenia, agranulocytosis, hypoplasia, bone marrow failure. Disorders of the immune system. Not known: anaphylactic reactions (including shock), hypersensitivity '. Psychiatric disorders. Not known: mood changes. Nervous system disorders. Uncommon: headache, dizziness, somnolence; rare: paraesthesia; not known: convulsions, dysgeusia. Eye disorders. Rare: blurred vision. Ear and labyrinth disorders. Rare: tinnitus. Cardiac pathologies. Not known: heart failure. Vascular pathologies. Not known: hypertension, vasodilation. Respiratory, thoracic and mediastinal disorders. Rare: asthma; not known: bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea, edema of the larynx, edema of the glottis. Gastrointestinal pathology. Common: dyspepsia, nausea, abdominal pain, vomiting; uncommon: constipation, diarrhea, flatulence, gastritis; rare: stomatitis, peptic ulcer; not known: exacerbation of colitis and Crohn's disease, gastrointestinal haemorrhage and perforation, ulcerative stomatitis, melaena, haematemesis, duodenal ulcer and perforation. Hepatobiliary disorders: Rare: hepatitis, elevated transaminases, elevated serum bilirubin levels due to liver disorders. Skin and subcutaneous tissue disorders. Uncommon: rash, pruritus; not known: photosensitivity reactions', alopecia, urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, edema, rash. Renal and urinary disorders. Not known: acute renal failure, interstitial tubular nephritis, nephritic syndrome, renal function test abnormal. General disorders and administration site conditions. Uncommon: fatigue, edema. Diagnostic tests. Rare: weight increased. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). . The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
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 risk was believed 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. Therefore ketoprofen should not be administered during the first and second trimester of pregnancy unless strictly necessary. If ketoprofen is used by a woman conceiving, or during the first and second trimester of pregnancy, the dosage should be kept as low as possible for the shortest possible duration of treatment. 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); renal dysfunction, which may progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ketoprofen is contraindicated during the third trimester of pregnancy. Breast-feeding There is no information available on the excretion of ketoprofen in human milk. Ketoprofen is contraindicated during breastfeeding. The use of NSAIDs can reduce female fertility and is not recommended for women intending to become pregnant as well as the use of any drug that inhibits prostaglandin synthesis and cyclooxygenase. The administration of NSAIDs should be discontinued in women who have fertility problems 'or who are undergoing investigation of fertility'.
INDICATIONS
Pain of different origins and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone pain.
INTERACTIONS
>> Combinations not recommended. Other NSAIDs, (including selective cyclooxygenase 2 inhibitors) and high doses of salicylates: increased risk of gastrointestinal ulceration and bleeding. Anticoagulants (heparin and warfarin) and platelet aggregation inhibitors (ticlopidine, clopidogrel): increased risk of bleeding. If administration is unavoidable, patients should be closely monitored. Lithium: risk of increased plasma lithium levels, which may reach toxic levels due to decreased renal excretion of lithium. If necessary, plasma lithium levels should be closely monitored and the lithium dosage adjusted during and after NSAID therapy. Methotrexate, at doses higher than 15 mg / week: increased risk of methotrexate blood toxicity, especially when administered at high doses (> 15 mg / week), possibly related to the shift from methotrexate-binding proteins and decreased renal clearance. Therefore, patients undergoing treatment with such drugs should consult their doctor before taking the product. >> Associations requiring precaution. Diuretics: patients who are taking diuretics and among them, those who are particularly dehydrated are most at risk of developing renal failure secondary to the reduction in renal blood flow caused by the inhibition of prostaglandins. These patients must be rehydrated prior to commencing co-administration and closely monitoring renal function after initiation of treatment. NSAIDs can reduce the effect of diuretics. ACE inhibitors and angiotensin II antagonists: in patients with impaired renal function (e.g. dehydrated patients and elderly patients) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents capable of inhibiting the cyclo-oxygenase can lead to further deterioration of renal function, including possible acute renal failure. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. Methotrexate at doses below 15 mg / week: perform weekly monitoring of the complete blood count during the first weeks of the combination. Increase the frequency of monitoring in the presence of even a slight worsening of renal function, as well as in the elderly. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Pentoxifylline: increased risk of bleeding. More frequent clinical checks and monitoring of bleeding time. Any interactions with the following drugs should be taken into account: oral hypoglycemic agents. >> Associations that need to be taken into consideration. Antihypertensive drugs (Beta-blockers, ACE inhibitors and angiotensin II antagonists, diuretics): treatment with an NSAID can reduce the effect of antihypertensive drugs by inhibiting the synthesis of vasodilating prostaglandins. Thrombolytics and anti-aggregating agents: increased risk of bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen Diphenylhydantoin and sulfonamides: As the protein binding of ketoprofen is high, it may be necessary to reduce the dose of diphenylhydantoin or sulfonamides that are administered concomitantly.
DOSAGE
Adults and children over 15 years: 1 sachet, in a single dose, or repeated 2-3 times a day, in the painful forms of greater intensity. The contents of the sachet can be placed directly on the tongue. It dissolves with saliva: this allows it to be used without water. It is preferable to take the product on a full stomach. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. The duration of the therapy must be limited to the overcoming of the painful episode.
ACTIVE PRINCIPLES
Ketoprofen lysine salt.