Okitask 40 mg Ketoprofen Lysine Salt 20 Coated Tablets

Okitask 40 mg Ketoprofen Lysine Salt 20 Coated Tablets

DOMPE

SKU
042028047
Special Price €5.57 Regular Price €11.00 Save... €5.43 -49%
Recent lowest price:   €5.62
In stock
icomoon-up
icomoon-down

Therapeutic indications

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

Dosage

Adults and children over 15 years: 1 tablet, in a single dose, or repeated 2-3 times a day, in the 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.

Overdose

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, drowsiness, headache, dizziness, confusion and loss of consciousness, as well as pain, nausea, vomiting, epigastric pain. Gastrointestinal bleeding, hypotension, respiratory depression and cyanosis can 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 should be 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 bloodstream.

Contraindications

The medicine must 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.

Side effects

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: 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 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 disorders • Not known: heart failure Vascular disorders • Not known: hypertension, vasodilation Respiratory, thoracic and mediastinal disorders • Rare: asthma • Not known: bronchospasm (mainly in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea, laryngeal edema, and dema of the glottis. 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, haematemesis, ulcer and duodenal 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, exanthema Renal and urinary disorders : • Not known: acute renal failure, interstitial tubular nephritis, nephritic syndrome, impaired renal function tests. systemic and administration site conditionsUncommon : fatigue, edema tics • 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. myocardial infarction or stroke) (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may 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 from less than 1% to approximately 1.5%. 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 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 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 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 may 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. Breastfeeding 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.

Special warnings

Warnings Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs 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 bleeding, ulceration or perforation is higher with increasing 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 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 when 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 treatment) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are currently insufficient data available to exclude a similar risk for ketoprofen when it is administered as one tablet daily, as a single dose, or repeated 2-3 times a day. 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 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 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 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. With the use of ketoprofen, rare cases of jaundice and hepatitis have been reported. 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, 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 carefully monitored for the appearance of digestive disturbances, especially gastrointestinal bleeding. Caution is required when the product is administered to patients with hepatic porphyria as the medicinal product could trigger an attack. Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of severe gastrointestinal toxicity compared to 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.

Expiry and Retention

No special storage precautions

Active principles

Each film-coated tablet contains: Active substance: ketoprofen 40 mg lysine salt (corresponding to 25 mg of ketoprofen) For the full list of excipients, see section 6.1.

Excipients

Core : 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).

Destination Cost Detail
Italy €5,90 24/48 h
Austria, Belgium, France, Germany, Netherlands, Poland, Czech Republic € 12* 3 days
Denmark,Luxembourg,Portugal,Slovakia,Spain,Hungary € 16* 4 days
Bulgary,Croatia,Estonia,Finland,Greece,Ireland,Lithuania,Romania,Slovenia,Sweden € 27* 5 days
Canada, Switzerland, United Kingdom, USA € 45 7 Days

National shipments with express courier: Bartolini, GLS
European shipments with express courier: FedEx, MBE, DHL
*For the shipment outside band B ther's an extra cost of 20€
*For the shipment outside band C ther's an extra cost of 30€
Delivery Times exclude Saturday and Holidays
For Islands and Areas of difficult Accessibility the shipments are made in 72 hours and the cost will be increased by 15€
The images of the products shown on our site are purely indicative and may differ in shape, color, text and packaging shown on them. Given the difficulty of updating all the products on our site in real time or any errors, XFarma.it, all products will be identified through SKU MINSAN (code of the Ministry of Health).