OKITASK OS FREE 20BUST 40MG

OKITASK 40 MG GRANULES

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.

Excellent

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

Therapeutic indications

Pain of various origins and natures, and in particular: headache, toothache, neuralgia, menstrual pain, muscular and osteoarticular pain.

Contraindications

Okitask 40 mg granules 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;• 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 high doses of diuretics;• third trimester of pregnancy;• children under 15 years of age.

Population

Posology. 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 people: The dosage must be carefully established taking into account a possible reduction of the dosages indicated above. Patients with hepatic or renal insufficiency: Therapy at the minimum daily dosage and careful monitoring are recommended (see section 4.4).In case of renal insufficiency, it is recommended to monitor the volume of diuresis and renal function (see section 4.4).Okitask 40 mg granules must 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 its use 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 symptoms (see section 4.4).

Conservation

This medicine does not require any special condition of conservation.

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).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 GI events.The risk of GI 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 (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (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) early in 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 people: 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 discontinued. Patients with active or previous peptic ulcer: Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of serious gastrointestinal toxicity compared to 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 must be carried out with particular caution in view of the essentially renal elimination of the drug.Renal function must 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 decompensation (see section 4.3).Caution is also required in patients subject to diuretic therapy or likely hypovolaemic 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 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.Cases of jaundice and hepatitis have been reported with the use of ketoprofen (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 required 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 are 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 pathologies: As with 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, attacks of bronchospasm and possibly shock and other allergic phenomena may occur in asthmatics and predisposed subjects allergici.Somministrare with caution in patients with allergic manifestations or previous allergy. Visual disturbances: In case of visual disturbances, such as blurred vision, treatment should be stopped.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 glucose-galactose malabsorption problems should not take this medicine.

Interactions

Associations not recommended. - Other NSAIDs (including selective inhibitors of cyclooxygenase 2) and high doses of salicylates (> 3 g/day): the concomitant administration of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding, due to a synergistic effect.- Anticoagulants (heparin and warfarin): NSAIDs may amplify the effects of anticoagulants.If co-administration cannot be avoided, the patient must be closely monitored.- Platelet aggregation inhibitors (ticlopidine and clopidogrel): the concomitant administration of an NSAID may increase the risk of bleeding by inhibition of platelet function and damage to the gastrointestinal mucosa (see section 4.4).If co-administration cannot be avoided, the patient must be closely monitored.- Lithium: the concomitant administration of several NSAIDs may increase plasma lithium levels, which may reach toxic values, due to reduced renal excretion.Plasma lithium levels should be carefully monitored and the lithium dosage should be adjusted during and after discontinuation of treatment with ketoprofen and other NSAIDs.- Methotrexate, at doses greater than 15 mg/week: concomitant administration of an NSAID may increase the risk of haematological toxicity of methotrexate, especially if administered at high doses, probably due to a displacement of binding to plasma proteins and a decrease in renal clearance.The intake of the two medicinal products should be separated by at least 12 hours.- Hydantoins and sulphonamides: the toxic effects of these substances may be increased;since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulphonamides, in case of concomitant administration. Associations requiring precaution. - Drugs or therapeutic categories that may promote hyperkalaemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), ciclosporin, tacrolimus and trimethoprim.The occurrence of hyperkalaemia may depend on the presence of cofactors.The risk is increased in case of concomitant administration of the above mentioned drugs.- Tenofovir: concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.- Diuretics: subjects treated with diuretics, especially if dehydrated, are at increased risk of developing renal failure secondary to the reduction in renal blood flow caused by prostaglandin inhibition.Hydration before initiating concomitant therapy and close monitoring of renal function after initiation of treatment are recommended (see section 4.4).NSAIDs may reduce the effect of diuretics.- ACE inhibitors and angiotensin II antagonists: co-administration with cyclooxygenase inhibitors may lead to further deterioration of renal function and possible acute renal failure, especially in dehydrated and elderly subjects.Caution, hydration and monitoring of renal function are recommended in case of concomitant therapy.- Methotrexate at doses lower than 15 mg/week: anti-inflammatory drugs cause a decrease in renal clearance of methotrexate with consequent increase in haematological toxicity.In case of impaired renal function or advanced age, monitoring must be more frequent.- Corticosteroids: concomitant administration of NSAIDs may increase the risk of gastrointestinal ulceration or bleeding (see section 4.4).- Pentoxifylline: co-administration may increase the risk of bleeding: bleeding time controls are recommended.- Zidovudine: Combination with NSAIDs increases the risk of reticulocyte toxicity, with severe anaemia occurring one week after starting NSAID treatment.Complete blood count and reticulocyte count should be checked one week after starting NSAID treatment.- Sulfonylureas: NSAIDs may increase the hypoglycaemic effect of sulfonylureas by displacing them from plasma protein binding sites.Interactions with other oral hypoglycaemic agents should also be considered.- Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate and increase cardiac glycoside levels;however, pharmacokinetic interaction between ketoprofen and active glycosides has not been demonstrated. Associations that need to be considered. - Antihypertensive agents (Beta-blockers, ACE diuretic inhibitors): treatment with an NSAID can reduce the effect of antihypertensive drugs by inhibiting the synthesis of vasodilating prostaglandins. - Mifepristone: the effectiveness of the contraceptive method can, theoretically, be reduced due to the antiprostaglandiniche properties of the NSAIDs including acetylicylic acid. There are some evidence that the simultaneous administration of FANS on the day of administration of the dose of prostaglandin does not adversely affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the medical interruption of pregnancy. - Intrauterine contraceptive devices (IUDs): the effectiveness of the device can be reduced with consequent pregnancy. - Ciclosporin and tacrolimus: contemporary treatment with NSAIDs can lead to a greater risk of nephrotoxicity especially in elderly individuals. - Trombolitics: simultaneous administration with NSAIDs can increase the risk of bleeding. - Anti-aggregating agents (ticlopidine and chlopidogrel) and selective serotonin reuptake inhibitors (SSRIs): FANS can increase the risk of gastrointestinal hemorrhage (see paragraph 4.4). - Probenecid: the concomitant administration of probenecid can clearly reduce the plasma clearance of ketoprofen for inhibition of tubular secretion and glucuronoconjugation, therefore it is necessary to adapt the dose of ketoprofen. - Chinolonic antibiotics: animal data indicate that NSAIDs can increase the risk of seizures related to the use of kinolonics. Patients in treatment with NSAIDs and Chinoloni may have an increased risk of developing seizures. - Defenilidantoin and sulfamidic: since the protein bond of ketoprofen is high, it may be necessary to reduce the dose of difenilidantoin or sulfamidic in case of co-administration. - Gemeprost: joint use with an NSA can reduce its effectiveness. Intake of alcohol during treatment is to be avoided.

Effects

The most commonly observed adverse events are gastrointestinal. Classification of expected frequencies: very common (1/10), common (from 1/100 to ≤1/10), not common (from 1/1000 to ≤1/100), rare (from 1/10000 to ≤1/1000), very rare (≤1/10000), unknown (frequency cannot be defined on the basis of available data). The following adverse reactions were observed with the use of ketoprofen in adults:

Classification for systems and organs MedDRA	Very common (≥1/10)	Common (≥1/100,	Not common (≥1/1.000,	Rare (≥1/10.000,	Very rare (	Frequency not known
Emolinfopoietic system pathologies				hemorrhagic anemia		thrombocytopenia, agranulocytosis, medullary insufficiency, hemolytic anemia, leukopenia, neutropenia, aplastic anemia, leukocytosis, thrombocytopenic purple.
Immune system disorders						anaphylactic reaction (including shock), hypersensitivity
Gastrointestinal disorders		dyspepsia, nausea, abdominal pain, vomiting	stipsi, diarrhea, flatulence, gastritis	stomatitis, peptic ulcer		exacerbation of colitis and Crohn's disease, gastrointestinal hemorrhage, gastrointestinal perforation (sometimes fatal, especially in the elderly - see paragraph 4.4), gastric ulceration, mouth ulceration, duodenal ulcer, duodenal perforation, melena, abdominal discomfort, colitis, gastric pyrosis, mouth edema, pancreatite
Pathologies of skin and subcutaneous tissue			rash, itching		erythema	photosensitivity reaction, alopecia, hives, angioedema, bollous dermatitis including Stevens-Johnson syndrome and toxic epidermal necrolysis, edema, hexantema, Lyell syndrome, maculo-papula esantema, porpora, hexantematic acute generalized acute, dermatitis
Systemic pathologies and conditions for administration			fatigue,		face edema	peripheral edema, bruises, astenia
Diseases of the nervous system			headache, dizziness, drowsiness	the week		seizures, dysgeusia, capogiro, discinesia, sincope, tremor, hypercinesia
Eye pathologies				blurred vision (see paragraph 4.4)		periorbital edema
Ear and labyrinth pathologies				tinnitus
Hepatobiliary pathologies				hepatitis, increased transaminasis, increased blood bilirubin		itterosexual
Respiratory, chest and mediastinic pathologies				asbestos		bronchospasm (especially in patients with hypersensitivity ascertained to acetylsalicylic acid and other NSAIDs), rhinitis, dispnea, larynx edema, laryngospasm, acute respiratory failure (a fatal case has been reported in an asthmatic patient and sensitive to acetylsalicylic acid).
Kidney and urinary pathologies:						acute kidney failure, piping-interstitial nephritis, nephritic syndrome, abnormal kidney function test, hematuria, nephritis, nephrosic syndrome, glomerulonephritis, water/sodium retention with possible edema, acute tubular necrosis, kidney papillar necrosis, oliguria
Psychiatric disorders						altered mood, depression, hallucination, confusion, agitation, insomnia
Heart disease						heart failure, atrial fibrillation, palpitations, tachycardia
Vascular diseases						hypertension, vasodilation, hypotension, vasculitis (including leukocytoclastic vasculitis)
Metabolism and nutrition disorders						hyperpotassiemia, iponatremia
Infections and infestations						aseptic meningitis, lymphangitis
Diagnostic examinations				Increased weight

Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high doses and long-term treatments) may be associated with an increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

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 specialised hospital centre for symptomatic treatment.There are no specific antidotes 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 failure, haemodialysis may be useful to remove the drug from circulation.

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 drug 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.

Nursing:

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 attempting to conceive.The administration of NSAIDs, as well as Okitask 40 mg granules, must be suspended in women who have fertility problems or who are undergoing investigation of fertility.

Source: Farmadati