OKITASK*OS FREE 20BUST 40MG

Pain of various origins and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone and joint pain.

Therapeutic indications

Pain of various origins and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone and joint pain.

Dosage and method of use

Adults and children over 15 years of age: 1 sachet, in a single dose, or repeated 2-3 times a day, in the most intense painful forms. 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: elderly patients in particular should adhere to the minimum doses indicated above. The duration of therapy should be limited to overcoming the painful episode.

Contraindications

The drug should not be administered in the following cases: • patients with a history of hypersensitivity reactions such as bronchospasm, asthma attacks, acute rhinitis, urticaria, 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). • patients with hypersensitivity to any of the excipients; • third trimester of pregnancy, known or suspected pregnancy, during lactation (see section 4.6 - pregnancy and 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 bleeding diathesis, during treatment with anticoagulants; • patients with severe renal or hepatic insufficiency; • patients undergoing major surgery. Furthermore, the simultaneous administration of 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 treatments with NSAIDs.

Side effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly may occur (see section 4.4 - Special warnings and precautions for use). The frequency and extent of these effects are significantly reduced by taking the drug with food. In exceptional cases, the manifestations of hypersensitivity can take on 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. Expected frequency classification: Very common (1/10), common (1/100 to ≤1/10), uncommon (1/1,000 to ≤1/100), rare (1/10,000 to ≤1/ 1,000), very rare (≤1/10,000), not known (cannot be estimated from the available data). The following adverse reactions have been observed with the use of ketoprofen in adults: Blood and lymphatic system disorders • Rare: haemorrhagic anemia • Not known: thrombocytopenia, agranulocytosis, hypoplasia, bone marrow failure Immune system disorders • Not known: anaphylactic reactions (including shock ), hypersensitivity Psychiatric disorders • Not known: mood swings Nervous system disorders • Uncommon: headache, dizziness, somnolence • Rare: paraesthesia • Not known: convulsions, dysgeusia Eye disorders • Rare: blurred vision (see section 4.4 - Special warnings and precautions for use) Ear and labyrinth disorders • Rare: tinnitus Cardiac disorders • Not known: cardiac failure Vascular disorders • Not known: hypertension, vasodilatation Respiratory, thoracic and mediastinal disorders • Rare: asthma • Not note: bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea, laryngeal edema, glottis edema. Gastrointestinal disorders • Common: dyspepsia, nausea, abdominal pain, vomiting • Uncommon: constipation, diarrhoea, flatulence, gastritis • Rare: stomatitis, peptic ulcer • Not known: exacerbation of colitis and Crohn's disease, gastrointestinal bleeding and perforation, ulcerative stomatitis , melena, haematemesis, duodenal ulcer and perforation Hepatobiliary disorders • Rare: hepatitis, increased transaminases, elevated serum bilirubin levels due to liver disorder 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, oedema, exanthema Renal and urinary disorders : • Not known: acute renal failure, tubulointerstitial nephritis, nephritic syndrome, renal function test abnormal systemic and administration site conditions • Uncommon: fatigue, edema Diagnostic investigations tics • Rare: weight increased Clinical trial and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (eg, eg. myocardial infarction or stroke) (see section 4.4 - Special warnings and precautions for use). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Warnings Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration of treatment necessary to control symptoms (see sections below on gastrointestinal and cardiovascular risks). Caution should be exercised in patients receiving concomitant medications which could 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 - Interactions with other medicinal products and other forms of interaction). Concomitant use of OKITASK 40 mg granules with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided. Gastrointestinal haemorrhage, ulceration and perforation Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section 4.3 - Contraindications), the risk of gastrointestinal haemorrhage, 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 concomitantly taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5 – Interactions with other medicines and other forms of interaction). 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 - Posology and method of administration). When gastrointestinal bleeding or ulceration occurs in patients taking OKITASK 40 mg granules 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 - Undesirable effects). 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 40 mg granules should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Clinical trial and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke). There are currently insufficient data to exclude a similar risk for ketoprofen when it is administered in the daily dose of one sachet, as a single dose, or repeated 2-3 times a day. OKITASK 40 mg granules contain aspartame as a sweetener: this substance is contraindicated in subjects suffering from phenylketonuria. OKITASK 40 mg granules does not affect low-calorie or controlled diets and can also be administered to diabetic patients. Precautions Patients with active peptic ulcer disease or a history of peptic ulcer disease. 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 - Undesirable effects). At the beginning of treatment, renal function should be closely monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, especially if the patients are elderly. In these patients, the administration of ketoprofen can cause a decrease in renal blood flow caused by prostaglandin inhibition and lead to renal decompensation. Caution is required before starting treatment in patients with a history of hypertension and/or mild to moderate congestive heart failure 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 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 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 an asthma attack or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3 - Contraindications). 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 starting long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). In case of visual disturbances, such as blurred vision, treatment should be stopped. After a few days of treatment without appreciable results, consult your doctor. Administer with caution in patients with allergic manifestations or previous allergy. Patients with current or previous gastrointestinal disease should be closely monitored for digestive disturbances, especially gastrointestinal bleeding. When the product is administered to patients with hepatic porphyria, caution is required as the drug may trigger an attack. Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity compared to other NSAIDs, especially at high doses (see also sections 4.2 - Posology and method of administration and 4.3 - Contraindications). Elderly patients are more prone to decreased renal, cardiovascular or hepatic function.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% 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 increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have 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 who is planning to conceive, 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 may expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, ketoprofen is contraindicated during the third trimester of pregnancy. Breast -feeding There is no information available on the excretion of ketoprofen in breast milk. Ketoprofen is contraindicated during breastfeeding. Fertility The use of NSAIDs can reduce female fertility and is not recommended in women who intend to start a pregnancy, as is the use of any drug that inhibits the synthesis of prostaglandins and cyclooxygenases. NSAID administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

Not recommended combinations 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 (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 higher than 15 mg/week: Increased risk of blood toxicity of methotrexate, especially when given in high doses (>15 mg/week), possibly related to shifts from methotrexate binding proteins and decreased renal clearance. Therefore, patients undergoing treatment with these drugs should consult their doctor before taking the product. Associations requiring precaution Diuretics : patients taking diuretics and among these, those particularly dehydrated are more at risk of developing renal failure secondary to the reduction in renal blood flow caused by prostaglandin inhibition. These patients should be rehydrated before initiating co-administration and renal function should be monitored closely (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 an angiotensin II antagonist and agents capable of inhibiting -oxygenase may 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 lower than 15 mg/week : Perform weekly monitoring of the complete blood count during the first weeks of the association. Increase the frequency of monitoring in the presence of even slight deterioration of renal function, as well as in the elderly. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4 - Special warnings and precautions for use). Pentoxifylline: increased risk of bleeding. More frequent clinical check-ups and bleeding time monitoring. Potential interactions with the following drugs should be taken into account: Oral hypoglycaemic drugs Combinations 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 inhibition of vasodilator prostaglandin synthesis. Thrombolytics and antiplatelet 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 can markedly reduce the plasma clearance of ketoprofen. Diphenylhydantoin and sulfonamides: since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides that may be administered simultaneously.

Overdose

Cases of overdose with doses of up to 2.5 g of ketoprofen have been reported. In most cases, the symptoms observed were benign and limited to lethargy, drowsiness, headache, dizziness, confusion and loss of consciousness, as well as pain, nausea, vomiting, epigastric pain. GI bleeding, hypotension, respiratory depression, and cyanosis may also occur. There are no specific antidotes for ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended and symptomatic and supportive treatment is advised to compensate for dehydration, monitor urinary output and correct acidosis, if present. In cases of renal insufficiency, hemodialysis may be useful to remove the drug from the circulation.

Active principles

Each sachet contains: Active ingredient: 40 mg ketoprofen lysine salt (corresponding to 25 mg of ketoprofen) For the complete list of excipients, see section 6.1.

Excipients

Povidone, colloidal silica, hydroxypropyl methylcellulose, eudragit EPO, sodium dodecyl sulphate, stearic acid, magnesium stearate, aspartame, mannitol, xylitol, talc, lime flavour, lemon flavour, frescofort flavor