OKItask 40 mg ketoprofen lysine salt coated tablets - 20 tablets

Indicated for the treatment of pains of different origins and natures, and in particular: headache, toothache, neuralgia, menstrual pain, muscular and osteoarticular pain.

Active Ingredients

Each sachet contains: Active ingredient: ketoprofen lysine salt 40 mg (corresponding to 25 mg of ketoprofen). Excipients with known effect: aspartame, sodium dodecyl sulphate. For the full list of excipients, see section 6.1.

Excipients

Povidone, colloidal silica, hydroxypropyl methylcellulose, eudragit EPO, sodium dodecyl sulfate, stearic acid, magnesium stearate, aspartame, mannitol, xylitol, talc, lime flavouring, lemon flavouring, frescofort flavouring.

Dosage

Dosage. Adults and over 15 years: the recommended dose is 40 mg (corresponding to 1 sachet), in a single dose, or repeated 2-3 times a day, in the most intense painful forms. Do not exceed the recommended doses. Special populations. Elderly: The dosage should be carefully established taking into consideration a possible reduction of the dosages indicated above. Patients with hepatic or renal insufficiency: Therapy at the minimum daily dose and careful monitoring are recommended (see section 4.4). In case of renal insufficiency, it is recommended to check the volume of diuresis and renal function (see section 4.4). Okitask 40 mg granules should not be used in patients with severe hepatic or renal dysfunction (see section 4.3). Paediatric population: The safety and efficacy of Okitask 40 mg granules in children have not yet been established. 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 product on a full stomach. Duration of treatment: The duration of therapy should be limited to overcoming the painful episode. The lowest effective dose should be used for the shortest period necessary to relieve the symptoms (see section 4.4).

Warnings

Warnings: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and sections below on gastrointestinal and cardiovascular risks). The concomitant use of Okitask 40 mg granules with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided. Gastrointestinal reactions: Gastrointestinal bleeding, ulceration and perforation: gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest possible dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients receiving concomitant low dose acetylsalicylic acid or other drugs likely to increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, especially the elderly, should report any abdominal symptoms and/or signs (including gastrointestinal bleeding) also at the beginning of treatment. Caution should be advised 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 anti-platelet agents such as acetylsalicylic acid (see section 4.5). Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Patients with active or previous gastrointestinal disease should be carefully observed for digestive disturbances, especially gastrointestinal bleeding. When gastrointestinal bleeding or ulceration occurs in patients receiving Okitask 40 mg granules, the treatment should be withdrawn. Patients with active or previous peptic ulcer: Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of serious gastrointestinal toxicity than other NSAIDs, particularly at high doses (see sections 4.2 and 4.3). Skin reactions: 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). Patients appear to be at higher risk at the beginning of treatment. Okitask 40 mg granules should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Precautions. Cardiovascular, renal and hepatic dysfunction: In patients with impaired renal function, the administration of ketoprofen should be carried out with particular caution in view of the essentially renal elimination of the drug. 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, the administration of ketoprofen may cause a decrease in renal blood flow caused by prostaglandin inhibition and lead to renal failure (see section 4.3). Caution is also required in patients subject to diuretic therapy or likely to be hypovolemic because the risk of nephrotoxicity is increased. As with all NSAIDs, Okitask 40 mg granules may increase plasma urea nitrogen and creatinine. As with other prostaglandin synthesis inhibitors, Okitas 40 mg granules may be associated with adverse events on the renal system that may lead to glomerular nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure (see section 4.8). In patients with abnormal liver function values ​​or with a history of liver disease, transaminase levels should be periodically evaluated. As with other NSAIDs, Okitask 40 mg granules may cause increases in some liver parameters and also significant increases in SGOT and SGPT (see section 4.8). In case of significant increases in these parameters, therapy should be discontinued. With the use of ketoprofen, cases of jaundice and hepatitis have been reported (see section 4.8). Elderly patients are more predisposed to reduction of renal, cardiovascular or hepatic function. Cardiovascular and cerebrovascular effects: As with other NSAIDs, patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar consideration should be made before initiating treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Caution is advised before initiating treatment in patients with a history of hypertension and/or mild to moderate congestive heart failure since fluid retention and oedema have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that the use of some NSAIDs may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude such a risk for Okitask 40 mg granules. An increased risk of atrial fibrillation associated with the use of NSAIDs has been reported. Hyperkalaemia may occur, especially in patients with underlying diabetes, renal insufficiency, and/or concomitant treatment with agents promoting hyperkalaemia (see section 4.5). In these circumstances, potassium levels should be periodically assessed. Infections. Masking of symptoms of underlying infections: Okitask 40 mg granules may mask the symptoms of infection, which may delay initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of varicella. When Okitask 40 mg granules is administered for the relief of infection-related fever or pain, monitoring for infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Respiratory disorders: Like all non-steroidal drugs, the use of ketoprofen in patients with bronchial asthma or allergic diathesis may cause an asthma attack. Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are more exposed to the risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this drug may cause asthma attacks or bronchospasm, shock and other allergic phenomena, especially in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Due to the action on the metabolism of arachidonic acid, bronchospasm attacks and possibly shock and other allergic phenomena may occur in asthmatics and predisposed subjects. Administer with caution in patients with allergic manifestations or a history of allergy. Visual disturbances: In case of visual disturbances, such as blurred vision, it is necessary to discontinue treatment. Okitask 40 mg granules should be administered with caution to patients with haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue diseases. When Okitask 40 mg granules are administered to patients with hepatic porphyria, caution is required as it may trigger an attack. Important information about some of the excipients: Okitask 40 mg granules contain less than 1 mmol (23 mg) sodium per sachet, i.e. essentially 'sodium-free'. Okitask 40 mg granules contain lemon flavour and lime flavour. Lemon flavour contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Lime flavour contains glucose. Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine.

Conservation

This medicinal product does not require any special storage conditions.

Contraindications

Okitask 40 mg granules must not be administered in the following cases: • hypersensitivity to the active substance, to other nonsteroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1; • asthma, bronchospasm, acute rhinitis, urticaria, skin rashes, nasal polyps, angioneurotic oedema or other allergic-type reactions caused by ketoprofen, or by medicinal products with a similar mechanism of action (for example acetylsalicylic acid, other NSAIDs and selective cyclooxygenase 2 inhibitors), see section 4.8; • previous bronchial asthma; • severe heart failure; • gastritis; • 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 or chronic dyspepsia; • history of gastrointestinal bleeding or perforation following previous therapy with NSAIDs; • Crohn's disease or ulcerative colitis; • severe hepatic insufficiency (liver cirrhosis, severe hepatitis); • severe renal insufficiency; • leukopenia and thrombocytopenia; • haemorrhagic diathesis and other coagulation disorders, haemostatic disorders; • use of a high dose of diuretics; • third trimester of pregnancy; • children under 15 years of age.

Side effects

The most commonly observed adverse events are gastrointestinal in nature. Classification of expected frequencies: very common (1/10), common (from 1/100 to ≤1/10), uncommon (from 1/1000 to ≤1/100), rare (from 1/10000 to ≤1/1000), very rare (≤1/10000), not known (frequency cannot be estimated from the available data). The following adverse reactions have been observed with the use of ketoprofen in adults:

Overdose

Overdosage with doses of up to 2.5 g of ketoprofen has been reported. In most cases, symptoms observed were limited to lethargy, confusion, loss of consciousness, drowsiness, headache, vertigo, dizziness, nausea, vomiting, epigastric pain, abdominal pain and diarrhoea. In case of severe overdose, gastrointestinal bleeding, hypotension, respiratory depression and cyanosis may also occur, in which case the patient should be immediately transferred to a specialized hospital centre for symptomatic treatment. There is no specific antidote for ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended and symptomatic and supportive treatment is recommended to compensate for dehydration, monitor urinary excretion and correct acidosis, if present. In cases of renal insufficiency, haemodialysis may be useful to remove the drug from circulation.

Pregnancy

Pregnancy: The use of ketoprofen during the first and second trimester of pregnancy should be avoided, the administration of ketoprofen should be considered only if the expected benefit for the mother outweighs the risk to the embryo or fetus. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of 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%, up 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 clearly necessary. If ketoprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dosage should be kept as low as possible for the shortest duration possible. 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 may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Use of the medicinal product close to delivery may cause alterations in the haemodynamics of the small circulation of the newborn with serious consequences for respiration. Consequently, ketoprofen is contraindicated during the third trimester of pregnancy. Breastfeeding: There is no information available on the excretion of ketoprofen in breast milk. Ketoprofen is not recommended during breastfeeding. Fertility: The use of NSAIDs may reduce female fertility and is therefore not recommended in women intending to become pregnant. The administration of NSAIDs, as well as Okitask 40 mg granules, must be suspended in women who have fertility problems or who are undergoing investigations of fertility.