OKITASK * 10CPR RIV 40MG
Pain of different origins and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone pain.
Dosage and method of use
Adults and children over 15 years: 1 tablet, in single dose, or repeated 2-3 times a day, in painful forms of greater intensity. 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.
The medicinal product should not be used in the following cases: • hypersensitivity to the active substance or to any of the excipients listed in section 6.1; • history of hypersensitivity reactions such as bronchospasm, asthma attacks, acute rhinitis, hives, skin rashes or other allergic-type reactions to ketoprofen, or to substances with a similar mechanism of action (for example acetylsalicylic acid or other NSAIDs). Serious, rarely fatal, anaphylactic reactions have been observed in these patients (see section 4.8). • third trimester of pregnancy, known or suspected pregnancy, during lactation (see section 4.6) and in children under 15 years; • severe heart failure • gastric or duodenal ulcer, gastritis and chronic dyspepsia; • subjects with leukopenia or thrombocytopenia, with ongoing bleeding or haemorrhagic diathesis, undergoing treatment with anticoagulants; • severe renal or hepatic insufficiency; • patients undergoing major surgery; • active peptic ulcer / haemorrhage or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or haemorrhage). • a history of gastrointestinal bleeding, ulceration or perforation related to previous NSAID treatment. Furthermore, simultaneous administration with other anti-inflammatory drugs and acetylsalicylic acid is not recommended.
Gastrointestinal system: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4 - Special warnings and precautions for use). The frequency and extent of these effects are significantly reduced by taking the medicine 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 (cannot be estimated from the available data). 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 (see section 4.4) 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, larynx edema, glottal edema. Gastrointestinal disorders • 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 , hematemesis, ulcer and duodenal perforation Hepatobiliary disorders • Rare: hepatitis, increased 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 (eg heart attack). myocardium or stroke) (see section 4.4). Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system http://www.agenziafarmaco.gov.it/it/responsabili
Warnings Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks). Caution should be exercised 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 (see section 4.5). The concomitant use of okitask with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest possible dose. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5 ). 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: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). When gastrointestinal bleeding or ulceration occurs in patients taking okitask the treatment should be discontinued. 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 (see section 4.8). 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. okitask should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs 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 (e.g. myocardial infarction or stroke). There are currently insufficient data to exclude a similar risk for ketoprofen when it is administered as a single tablet or repeated 2-3 times a day daily. okitask does not affect low-calorie or controlled diets and can also be administered to diabetic patients. Precautions 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 (see section 4.8). 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, particularly if the patients are elderly. In these patients, administration of ketoprofen may 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 congestive heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. 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. For fertility, pregnancy and lactation, see section 4.6. 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. Administration of this medicinal product may cause asthma attack or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Therefore in these subjects, as well as in 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 (eg hypertension, hyperlipidemia, diabetes mellitus, smoking). In case of visual disturbances, such as blurred vision, treatment should be stopped. After a few days of treatment without noticeable results, consult your doctor. 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. Caution is required when the product is administered to patients with hepatic porphyria as the medicinal product may 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 (see also sections 4.2 and 4.3). Elderly patients are more prone to decreased renal, cardiovascular or hepatic function.
Pregnancy and breastfeeding
Pregnancy Inhibition of prostaglandin synthesis can adversely 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 by less than 1%, up to about 1.5%. The risk was considered 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 malformations, has been reported in animals given 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 treatment duration. 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 can 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. Feeding time There is no information available on the excretion of ketoprofen in human milk. Ketoprofen is contraindicated during breastfeeding. Fertility The use of NSAIDs can reduce female fertility and is not recommended in women intending to become pregnant as well as the use of any drug that inhibits prostaglandin synthesis and cyclooxygenase. Administration of NSAIDs should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
Expiration and retention
No special storage precautions
Interactions with other drugs
Combinations not recommended Others NSAIDs, (including selective cyclooxygenase 2 inhibitors) and high doses of salicylates: increased risk of gastrointestinal ulceration and bleeding. Anticoagulants (heparin and warfarin) e platelet aggregation inhibitors (ticlopidine, clopidogrel): increased risk of bleeding (see - section 4.4 - special warnings and precautions for use). If co-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 above 15 mg / week: increased risk of methotrexate blood toxicity, especially when administered at high doses (> 15 mg / week), possibly related to 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 insufficiency secondary to reduced renal blood flow caused by prostaglandin inhibition. These patients should be rehydrated prior to initiating co-administration and closely monitored renal function (see Section 4.4) 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 angiotensin II antagonist and agents capable of inhibiting cyclo-oxygenase may lead to further deterioration of the renal function, which includes 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 deterioration in renal function, as well as in the elderly. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Pentoxifylline: increased risk of bleeding. More frequent clinical checks and monitoring of bleeding time. Any interactions with the following drugs should be considered: oral hypoglycemic agents. Associations that need to be considered: Antihypertensive drugs (Beta-blockers, ACE inhibitors and angiotensin II antagonists, diuretics): treatment with an NSAID may 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 (see section 4.4 - Special warnings and precautions for use). 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 dosage of diphenylhydantoin or sulfonamides that should be administered simultaneously.
Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases, the symptoms observed were benign and limited to lethargy, somnolence, headache, dizziness, confusion and loss of consciousness, as well as pain, nausea, vomiting, epigastric pain. Gastrointestinal bleeding, hypotension, respiratory depression and cyanosis may also occur. There is no specific antidote to ketoprofen overdose. In the event of suspected massive overdose, gastric lavage is recommended and symptomatic and supportive treatment instituted to compensate for dehydration, monitor urinary excretion and correct acidosis, if present. In cases of kidney failure, hemodialysis can be helpful in removing the drug from the circulation.
Each film-coated tablet contains: Active substance: ketoprofen 40 mg lysine salt (corresponding to 25 mg ketoprofen) For the full list of excipients, see section 6.1.
Nucleus: crospovidone, anhydrous colloidal silica, sodium dodecyl sulfate, mannitol (E421), sodium stearyl fumarate Coating: (Opadry II 85 F blue 320 U) polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, brilliant blue aluminum lake (E133), quinoline yellow aluminum lake (E104).