- Menstrual pains.
- Articolar pains.
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Symptomatic treatment of acute mild and moderate pain.
Dosage Adults and adolescents over 15 years: 1 sachet, in single dose, or repeated 2-3 times a day, in painful forms of greater intensity. The duration of therapy should be limited to overcoming the painful episode (see section 4.4). Special populations Senior citizens: elderly patients should follow the minimum dosages indicated above. Patients with mild or moderate renal impairment: monitoring of urine output and renal function is advised (see section 4.4). Patients with mild or moderate hepatic insufficiency: must be followed closely and treated with the lowest effective daily dose (see section 4.4). KETOORO must not be used in patients with severe hepatic and renal dysfunction (see section 4.3). Pediatric population KETOORO is contraindicated in children and adolescents under the age of 15. Method of administration 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 medicine on a full stomach.
KETOORO must not be administered in the following cases: • hypersensitivity to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1. • patients with a history of hypersensitivity reactions, such as bronchospasm, asthma attacks, acute rhinitis, nasal polyps, urticaria, angioneurotic edema or other allergic-type reactions to ketoprofen or substances with a similar mechanism of action [for example acetylsalicylic acid ( ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs)]. Serious, rarely fatal, anaphylactic reactions have been reported in these patients (see section 4.8). • active peptic ulcer / haemorrhage, or a history of gastrointestinal haemorrhage, ulceration or perforation (two or more distinct, proven episodes of bleeding or ulceration) or chronic dyspepsia. • gastrointestinal bleeding or gastrointestinal perforation following previous NSAID therapy or other active bleeding or bleeding disorders. • severe heart failure. • severe hepatic insufficiency. • severe renal insufficiency. • bleeding diathesis and other coagulation disorders, or patients subject to anticoagulant therapy. • patients undergoing major surgery. • third trimester of pregnancy and lactation (see section 4.6) • children and adolescents under the age of 15 years.
Patients should be advised of the potential for somnolence, dizziness or seizures and should avoid driving or engaging in activities requiring special alertness if such symptoms occur (see section 4.8).4.8 Undesirable effects 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). The frequency and extent of these effects are reduced by taking the medicine on a full stomach. 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. The following adverse reactions have been observed following administration of ketoprofen lysine salt in adults. The frequency of adverse events is classified as follows: very common (≥1 / 10); common (≥1 / 100, Infections and infestations Not known: aseptic meningitis, lymphangitis. Disorders of the blood and lymphatic system: Rare: haemorrhagic anemia. Not known: agranulocytosis, thrombocytopenia, bone marrow aplasia, haemolytic anemia, leukopenia, neutropenia, aplastic anemia, leukocytosis, thrombocytopenic purpura. Disorders of the immune system: Not known: anaphylactic reactions (including shock), hypersensitivity. Psychiatric disorders: Not known: depression, hallucinations, mood swings, excitability, insomnia. Nervous system disorders: Uncommon: headache, dizziness, somnolence. Rare: paraesthesia. Not known: syncope, convulsions, dysgeusia, tremor, hyperkinesia, dyskinesia, dizziness. Eye disorders: Rare: blurred vision (see section 4.4). Not known: periorbital edema. Ear and labyrinth disorders: Rare: tinnitus. Cardiac pathologies: Not known: heart failure, palpitations, tachycardia. Vascular pathologies: Not known: hypotension, hypertension, vasodilation, vasculitis.Respiratory, thoracic and mediastinal disorders: Rare: asthma. Not known: edema of the larynx, bronchospasm (mainly in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea, laryngospasm, acute respiratory failure. Gastrointestinal disorders: Common: nausea, vomiting, dyspepsia, abdominal pain. Uncommon: constipation, diarrhea, flatulence, gastritis. Rare: ulcerative stomatitis, peptic ulcer. Not known: exacerbation of colitis and Crohn's disease, gastrointestinal haemorrhage and perforation (see section 4.4), gastric ulcer, duodenal ulcer, pancreatitis, melaena, haematemesis, gastric pain, erosive gastritis, tongue edema. Hepatobiliary disorders: Rare: hepatitis, increased serum transaminase levels, elevated serum bilirubin levels due to liver disorders, jaundice. Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus. Not known: photosensitivity, alopecia, urticaria, angioedema, bullous eruptions, including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis, erythema, rash, maculo-papular rash, purpura, dermatitis. Renal and urinary disorders: Not known: fluid retention, haematuria, acute renal failure, tubulointerstitial nephritis, nephritic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, nephrotic syndrome, oliguria, renal function test abnormality, dysuria. General disorders and administration site conditions: Uncommon: edema, fatigue. Not known: chills, asthenia, face edema, peripheral edema. Diagnostic tests: Rare: weight gain. 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 at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Administer with caution in patients with allergic manifestations or previous allergy. Treatment with ketoprofen lysine salt should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks). The concomitant use of KETOORO with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided (see section 4.5). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. 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. Cardiovascular and cerebrovascular effects Adequate monitoring and instruction are required 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 NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude a similar risk for ketoprofen lysine salt when it is administered as a daily dose of one sachet, as a single dose, or repeated 2-3 times a day. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ketoprofen lysine salt, as well as with all NSAIDs, 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). Gastrointestinal effects 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. Some epidemiological evidence suggests that ketoprofen lysine salt may be associated with a higher risk of severe gastrointestinal toxicity, compared to other NSAIDs, especially at high doses. 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 available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking 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, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking ketoprofen lysine salt the treatment should be discontinued. 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). Effects on the skin 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. Ketoprofen lysine salt should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Renal and hepatic effects As with all NSAIDs, the medicine can increase plasma urea nitrogen and creatinine. As with other prostaglandin synthesis inhibitors, ketoprofen lysine salt may be associated with adverse events on the renal system which can lead to glomerular nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Renal function should be carefully monitored at the initiation of treatment in patients with heart failure, with cirrhosis and nephrosis, in patients on diuretic therapy, with chronic renal failure particularly when elderly. In such patients the administration of ketoprofen lysine salt can cause a reduction in renal blood flow, caused by the inhibition of prostaglandins and lead to renal changes. As with other NSAIDs, the medicinal product may cause transient small increases in some liver parameters and also significant increases in SGOT and SGPT (see section 4.8). In the event of a significant increase in these parameters, therapy must be discontinued. In patients with impaired hepatic function or with previous liver disease, transaminases should be evaluated regularly, particularly during long-term therapy. Cases of jaundice and hepatitis have been reported with ketoprofen lysine salt. Caution is required when administering ketoprofen lysine salt to patients with hepatic porphyria as it may trigger an attack. Ketoprofen lysine salt should be administered with caution in patients with haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disorders. The use of NSAIDs may impair fertility and is not recommended in women planning to become pregnant (see section 4.6). The administration of ketoprofen should be discontinued in women who have difficulty conceiving or who are undergoing investigation of fertility. Treatment should be stopped if visual disturbances such as blurred vision occur. Patients presenting with asthma associated with chronic rhinitis and allergy, chronic sinusitis and / or nasal polyposis have a higher risk of allergy to aspirin and / or NSAIDs than the rest of the population. Administration of this medicinal product may cause asthma attacks or bronchospasm, especially in subjects allergic to acetylsalicylic acid (aspirin) or NSAIDs (see sections 4.3 and 4.8). Therefore in these subjects, as well as in the case of chronic obstructive pulmonary disease or nephropathy, the medicine should only be used under medical supervision. To avoid any hypersensitivity or photosensitization phenomena it is advisable not to expose yourself to the sun during use. Important information about some of the excipients KETOORO contains 10.56 mg of aspartame per dose (1 sachet) equivalent to 31.78 mg per maximum recommended daily dose (3 sachets). Aspartame is a source of phenylalanine. It can be harmful in patients with phenylketonuria.
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 the 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 result in increased pre- and post-implantation loss, embryo-fetal mortality and an increased incidence of various malformations, including cardiovascular (see section 5.3). Therefore ketoprofen should not be administered during the first and second trimester of pregnancy unless strictly necessary. If ketoprofen is used in women who wish to become pregnant 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); • 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. KETOORO is therefore contraindicated during the third trimester of pregnancy. Feeding time Since no data are available on the secretion of ketoprofen lysine salt in breast milk, ketoprofen should not be administered during breastfeeding. Fertility The use of ketoprofen lysine salt, as with any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant. Administration of ketoprofen lysine salt should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
This medicinal product does not require any special storage conditions.
Associations not recommended • Other NSAIDs, (including selective cyclooxygenase-2 inhibitors), including high doses of salicylates (≥ 3g / day): the simultaneous administration of several NSAIDs can increase the risk of gastrointestinal ulcers and bleeding, due to a synergistic effect. • Anticoagulants (e.g. heparin and warfarin) and antiplatelet agents (e.g. ticlopidine and clopidogrel): increased risk of bleeding due to inhibition of platelet function and damage to the gastrointestinal mucosa (see section 4.4). If concomitant administration cannot be avoided, patients should be carefully monitored. • Lithium: risk of increased plasma levels of lithium, which can sometimes reach toxic levels due to reduced renal excretion of lithium. Where necessary, plasma lithium levels should be carefully monitored with possible dosage adjustment during and after NSAID therapy. • Methotrexate, used in high doses, (greater than 15 mg / week): Increased risk of methotrexate blood toxicity, particularly when administered at high doses (> 15 mg / week), possibly due to displacement of methotrexate from protein binding and reduction in its renal clearance. • Hydantoins and sulfonamides: the toxic effects of these substances can be increased. Associations requiring precaution • Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). • Diuretics: Patients taking diuretics, particularly if dehydrated, are at high risk of developing renal failure secondary to decreased renal blood flow caused by inhibition of prostaglandins. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy (see section 4.4). NSAIDs can reduce the effect of diuretics. Concomitant use of NSAIDs and potassium-sparing diuretics, in addition to a reduction of the diuretic effect and potential for nephrotoxicity, may also lead to hyperkalaemia. • ACE inhibitors and angiotensin II antagonists: In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to an further deterioration of renal function, with possible onset of acute renal failure. The combination should therefore 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 used in low doses, less than 15 mg / week: a complete blood count should be performed every week during the first few weeks of combination therapy. In the presence of even mild worsening of renal function or in elderly patients, monitoring should be more frequent. • Pentoxifylline: increased risk of bleeding. Clinical monitoring should be increased and bleeding time monitored more frequently. • Zidovudine: risk of increased toxicity on the red cell line by action on reticulocytes, with severe anemia occurring one week after starting treatment with the NSAID. Check the complete blood count and reticulocyte count one to two weeks after starting NSAID treatment. • Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure. • Sulfonylureas: NSAIDs can increase the hypoglycemic effect of sulfonylureas by displacing them from plasma protein binding sites. Associations that need to be considered: • Antihypertensives (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): NSAIDs can reduce the effect of antihypertensive drugs by inhibiting prostaglandin synthesis. • Thrombolytics: increased risk of bleeding. • Probenecid: concomitant administration of probenecid can significantly reduce the plasma clearance of ketoprofen and consequently the plasma concentrations of ketoprofen may be increased; this interaction may be due to an inhibitory mechanism at the site of renal tubular secretion and glucuronide conjugation and requires a dose adjustment of ketoprofen. • Selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants: increased risk of gastrointestinal and intracranial haemorrhage (see section 4.4). • Ciclosporin, tacrolimus: risk of additive nephrotoxic effects, particularly in the elderly. Renal function should be measured during associated therapy. • Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.
Cases of overdose have been reported with doses exceeding 2.5 g of ketoprofen lysine salt. In most cases, symptoms observed include: lethargy, drowsiness, nausea, vomiting and epigastric pain. Symptoms of overdose may also include: central nervous system disorders such as headache, dizziness, confusion and loss of consciousness. Hypotension, respiratory depression and cyanosis may occur. Renal failure, convulsions and coma have also been described. A single case of anxiety, visual hallucinations, hyperexcitability and behavioral alteration was reported in a pediatric patient who took twice the recommended dose. Symptoms disappeared spontaneously within 1-2 days. There is no specific antidote for an overdose of ketoprofen lysine salt. If severe overdose is suspected, gastric lavage and the institution of supportive and symptomatic therapies are recommended to compensate for dehydration, to monitor renal function and to correct acidosis if present. In case of renal insufficiency, hemodialysis may be useful for removing the drug from the circulation.
One sachet contains: Active principle : ketoprofen 40 mg lysine salt (corresponding to 25 mg ketoprofen) Excipient with known effects: aspartame. For the full list of excipients, see section 6.1.
Mannitol, xylitol, lime aroma, lemon aroma, fresh aroma, aspartame, talc, basic butylated methacrylate copolymer, magnesium stearate, hydrated colloidal silica, hypromellose, stearic acid, povidone, sodium lauryl sulfate.
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