OKitask 40mg Dompé Granulate 20 Sachets
- Brand:DOMPE' FARMACEUTICI SpA
- Product Code: 042028023
- Availability: In Stock
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OKitask 40mg Dompé Granulate
Each sachet contains: Active ingredient: ketoprofen lysine salt 40 mg (corresponding to 25 mg ketoprofen). For the full list of excipients, see section 6.1.
Povidone, colloidal silica, hydroxypropyl methylcellulose, Eudragit EPO, sodium dodecyl sulfate, stearic acid, magnesium stearate, aspartame, mannitol, xylitol, talc, lime flavor, lemon flavor, frescofort flavor
Pain of different origin and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and osteoarticular pain.
The drug should not be administered in the following cases: • hypersensitivity to the active substance or to other similar drugs (anti-inflammatories, acetylsalicylic acid and its derivatives, etc.), hypersensitivity to any of the excipients; • manifestations with rash, rhinitis or asthma • ascertained or presumed pregnancy (see section 4.6 - Pregnancy and breastfeeding), during breastfeeding and in children under 15 years of age; • patients with gastric or duodenal ulcer, gastritis and chronic dyspepsia; • subjects with leukopenia or thrombocytopenia, with bleeding in progress or hemorrhagic diathesis, during treatment with anticoagulants; • patients with severe kidney or liver failure; • patients undergoing major surgery. It is also not recommended to administer concurrently with other anti-inflammatory drugs and acetylsalicylic acid. Active peptic ulcer, or history of gastrointestinal bleeding, ulceration or perforation related to previous active treatments or history of bleeding / recurrent peptic ulcer (two or more distinct episodes of demonstrated ulceration or hemorrhage). Severe heart failure.
Adults and children over 15 years: 1 sachet, in single dose, or repeated 2-3 times a day, in painful forms of greater intensity. The contents of the sachet can be placed directly on the tongue. It dissolves with saliva: this allows its use 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 therapy should be limited to passing the painful episode.
Warnings and Precautions
The product should only be used under medical supervision in subjects with bronchospasm or suffering from chronic obstructive pulmonary disease, allergic rhinitis (hay fever) or nasal polyposis, as well as in case of nephropathy. After a few days of treatment with no appreciable results, consult your doctor. The use of OKITASK 40 mg granules, like any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. Administration of OKITASK 40 mg granules should be discontinued in women who have fertility problems or who are undergoing fertility investigations. Concomitant use of OKITASK 40 mg granules with other NSAIDs should be avoided, including selective cyclooxygenase-2 inhibitors. Side effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see the paragraphs below on gastrointestinal and cardiovascular risks). Administer with caution in patients with allergic or past allergy. Patients with current or past gastrointestinal disease should be carefully monitored for the appearance of digestive disorders, especially gastrointestinal bleeding. Attention is required when the product is administered in patients with hepatic porphyria since the drug could trigger an attack. 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). Gastrointestinal effects 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. 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 decrease kidney, cardiovascular or hepatic function. In the elderly and in patients with a history of ulcer, especially if complicated by bleeding or perforation (see section 4.3 - Contraindications), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased 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 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, particularly the elderly, must report any abdominal symptoms (especially gastrointestinal hemorrhage) in particular in the initial stages of treatment. Caution should be exercised for patients taking concomitant medications that 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 - Interaction with other medicinal products and other forms of interaction). When bleeding or gastrointestinal ulceration occurs in patients taking OKITASK 40 mg granules, treatment should be stopped. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions can be exacerbated (see section 4.8 - Undesirable effects). Skin effects 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 stopped at the first appearance of a skin rash, mucosal lesion or any other sign of hypersensitivity. Cardiovascular and cerebrovascular effects Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension have been reported in association with NSAID treatment and edema. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-lasting treatments) may be associated with a modest increase in the 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 at 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 people with phenylketonuria. OKITASK 40 mg granules do not affect low-calorie or controlled diets and can also be administered to diabetic patients.
Since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides which should be administered simultaneously. During therapy with lithium-based drugs, the simultaneous administration of non-steroidal anti-inflammatory drugs causes an increase in plasma lithium levels. Any interactions with the following drugs should be taken into consideration: oral hypoglycaemic agents (sulfamides), ticlopidine, anti-inflammatories and methotrexate. Therefore, patients undergoing treatment with these drugs should consult their doctor before taking the product. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4 - Special warnings and precautions for use). Anticoagulants: NSAIDs can amplify the effects of anticoagulants, such as warfarin (see section 4.4 - Special warnings and precautions for use). Anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4 - Special warnings and precautions for use). Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. 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 an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, which includes possible acute renal failure, generally reversible. These changes should be considered in patients taking OKITASK 40 mg granules concomitantly with ACE angiotensin II inhibitors or antagonists. Hence, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy.
Gastrointestinal system: 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 on a full stomach. Following administration of ketoprofen, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported (see section 4.4 - Special warnings and precautions for use). Less frequently gastritis has been observed. Disorders affecting the hematopoietic system and effects affecting the central nervous system have been reported more rarely: headache, dizziness, asthenia and mood modification. Equally rare is the finding of allergic manifestations such as skin rash, itching, edema. In exceptional cases, the manifestations of hypersensitivity can assume the character of severe systemic reactions (edema of the larynx, edema of the glottis, dyspnea, palpitation) up to anaphylactic shock. In these cases immediate medical attention is required. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely. Immune system disorders: hypersensitivity, anaphylaxis. Psychiatric disorders: mood alterations. Nervous system disorders: headache, dizziness. Cardiac disorders: palpitation, heart failure. Vascular pathologies: hypertension. Respiratory, thoracic and mediastinal disorders: dyspnoea, edema of the larynx, edema of the glottis.Gastrointestinal disorders: diarrhea, nausea, vomiting, constipation, flatulence, gastritis, abdominal pain, dyspepsia, ulcerative stomatitis, melena, hematemesis, gastrointestinal bleeding, ulcer and perforation. duodenal, ulcer and gastric perforation, aggravation of colitis and Crohn's disease. Skin and subcutaneous tissue disorders: pruritus, edema, exanthema, Stevens Johnson syndrome, toxic epidermal necrolysis. Systemic diseases and administration site conditions: fatigue, edema. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-lasting treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) ( see section 4.4 - Special warnings and precautions for use).
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 abortion and 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 around 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 result in increased pre and post implantation loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular malformations, has been reported in animals that have received synthetic prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis 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 the pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delay or prolonged labor. Breastfeeding Do not administer during breastfeeding.
From 20 sachets for oral use