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FASTUMDOL ANTINF * 10CPR 25MG
Symptomatic treatment of painful conditions of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhea, dental pain.
Dosage Adults Depending on the nature and intensity of the pain, the recommended dose is usually 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Fastumdol Anti-inflammatory tablets are not indicated for long-term treatments and administration should be limited to the symptomatic period only. Elderly people In the elderly patient it is recommended to start therapy at the lower limit of the dosage range (50 mg total daily dose). The dosage can be increased to match that used for the general population only after good general tolerability has been established. Hepatic insufficiency Patients with mild to moderate hepatic impairment should start therapy at reduced doses (50 mg total daily dose) and undergo close medical supervision. Fastumdol Anti-inflammatory tablets should not be used in patients with severe hepatic impairment. Kidney failure In patients with mild renal impairment (creatinine clearance 60 - 89 ml / min), the starting dosage should be reduced to 50 mg total daily dose (see section 4.4). Fastumdol Anti-inflammatory tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤ 59 ml / min) (see section 4.3). Pediatric population Fastumdol Anti-inflammatory tablets have not been studied in children and adolescents. Therefore, the safety and efficacy have not been established and the product should not be used in children and adolescents.Method of administrationThe tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Concomitant administration of food delays the rate of drug absorption (see section “Pharmacokinetic Properties”), therefore in case of acute pain it is recommended that administration take place at least 30 minutes before meals.
Fastumdol Anti-inflammatory tablets should not be used in the following cases: - patients with hypersensitivity to the active substance, or to other NSAIDs, or to any of the excipients listed in section 6.1; - patients in whom active ingredients with similar action (eg acetylsalicylic acid, or other NSAIDs) trigger asthma attacks, bronchospasm, acute rhinitis, or are the cause of nasal polyps, urticaria or angioneurotic edema; - known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates; - patients with a history of gastrointestinal bleeding or perforation in relation to previous NSAID therapy; - patients with active peptic ulcer / gastrointestinal haemorrhage or a history of gastrointestinal bleeding, ulceration or perforation; - patients with chronic dyspepsia; - patients who have other active bleeding or bleeding disorders; - patients with Crohn's disease or ulcerative colitis; - patients with severe heart failure; - patients with moderate to severe renal insufficiency (creatinine clearance ≤ 59 ml / min); - patients with severe hepatic impairment (Child-Pugh score 10-15); - patients with bleeding diathesis and other coagulation disorders; - patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake); - during the third trimester of pregnancy and lactation (see section 4.6).
The table below, divided by system organ class and listed in order of frequency, lists the adverse events, probably related to dexketoprofen, which occurred during the course of clinical trials and after the marketing of Fastumdol Anti-inflammatory tablets:
|CLASSIFICATION BY SYSTEMS AND ORGANS||Common(≥1/100,||Uncommon(≥1 / 1,000,||Rare(≥1 / 10,000,||Very rare (|
|Disorders of the blood and lymphatic system||thrombocytopenia neutropenia|
|Disorders of the immune system||edema of the larynx||anaphylactic reactions, including anaphylactic shock|
|Metabolism and nutrition disorders||anorexia|
|Psychiatric disorders||insomnia; anxiety|
|Nervous system disorders||headache, dizziness, somnolence||paraesthesia, syncope|
|Eye disorders||blurred vision|
|Ear and labyrinth disorders||dizziness||tinnitus|
|Vascular pathologies||hot flashes||hypertension||hypotension|
|Respiratory, thoracic and mediastinal disorders||bradypnea||bronchospasm, dyspnoea|
|Gastrointestinal disorders||nausea and / or vomiting, abdominal pain, diarrhea, dyspepsia.||gastritis, constipation, dry mouth, flatulence||peptic ulcer, peptic ulcer haemorrhage or peptic ulcer perforation (see section 4.4)||pancreatitis|
|Hepatobiliary disorders||hepatocellular injury|
|Skin and subcutaneous tissue disorders||rash||hives, acne, increased sweating||Stevens Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, face edema, photosensitivity reaction, pruritus|
|Musculoskeletal and connective tissue disorders||backache|
|Renal and urinary disorders||acute renal failure, polyuria||nephritis or nephrotic syndrome|
|Reproductive system and breast disorders||menstrual disturbances; prostatic disorders|
|General disorders and administration site conditions||fatigue, pain, asthenia, chills, feeling unwell||peripheral edema|
|Diagnostic tests||abnormal liver function tests|
The most common side effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, especially in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration (see section 4.4 “Special warnings and precautions for use). Gastritis was observed less frequently. Edema, hypertension and heart failure have been reported in association with NSAID therapy. As with other NSAIDs, the following side effects may occur: aseptic meningitis, which may occur predominantly in patients with systemic lupus erythematosus or connective tissue disorders; haematological reactions (purpura, aplastic and haemolytic anemia, and rarely agranulocytosis and bone marrow hypoplasia). Bullous reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis (very rare). 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 a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Use with caution in patients with a history of allergic conditions. The concomitant use of Fastumdol Anti-inflammatory and other NSAIDs, including selective cyclooxygenase 2 inhibitors should be avoided. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2, and the sections below on gastrointestinal and cardiovascular risks).Gastrointestinal safetyGastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at various stages of treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. In the event of gastrointestinal bleeding or ulceration in patients treated with Fastumdol Anti-inflammatory, the treatment should be discontinued. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3) and in the elderly. Elderly: The elderly have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). These patients should begin treatment with the lowest possible dose. As with all NSAIDs, prior history of esophagitis, gastritis and / or peptic ulcer must be investigated before starting treatment with dexketoprofen and be sure of their total healing. Patients with gastrointestinal symptoms or a history of gastrointestinal disturbances should be carefully monitored for the appearance of digestive disturbances, especially gastrointestinal bleeding. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see section 4.8). Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients concomitantly taking low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk (see below and paragraph 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution is advised in patients receiving concomitant treatments 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 acetylsalicylic acid (see section 4.5).Renal safetyTo be used with caution in patients with impaired renal function. In these patients, the use of NSAIDs can cause worsening of kidney function, fluid retention and edema. Caution is also required in patients on diuretic therapy or in those patients who may develop hypovolaemia due to an increased risk of nephrotoxicity. Adequate fluid intake should be ensured during treatment to prevent dehydration associated with a possible increase in renal toxicity. Like all NSAIDs, the drug can cause an increase in blood urea and creatinine levels. As with other prostaglandin synthesis inhibitors, it may be associated with adverse kidney effects that can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Elderly patients are more likely to have reduced renal function (see section 4.2).Hepatic safetyTo be used with caution in patients with impaired hepatic function. Like other NSAIDs, the medicine can cause transient mild increases in some liver parameters as well as significant increases in AST and ALT. If there is a significant increase in these parameters, the treatment should be stopped. Elderly patients are more likely to suffer from impaired liver function (see section 4.2).Cardiovascular and cerebrovascular safetyAdequate monitoring and instruction are required in patients with a history of hypertension and / or mild or moderate heart failure. Particular caution is required in patients with a history of heart disease, particularly those with previous episodes of heart failure. An increased risk of triggering heart failure has been reported in these patients, as fluid retention and edema have been reported in association with NSAID treatment. 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 (e.g. myocardial infarction or stroke). There are insufficient data to exclude such a risk for dexketoprofen. Consequently, patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with dexketoprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). All non-selective NSAIDs are able to inhibit platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. Therefore, the use of dexketoprofen in patients receiving other treatments that interfere with haemostasis, such as warfarin or other coumarins or heparins is not recommended (see section 4.5). Elderly patients are more likely to have reduced cardiovascular function (see section 4.2).Skin reactionsSerious 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. Patients appear to be at increased risk of such reactions at the start of therapy, as the onset of reactions occurs in most cases within the first month of treatment. Treatment with Anti-inflammatory Fastumdol should be stopped at the first appearance of skin rashes, mucosal lesions or any other signs of hypersensitivity.Masking of symptoms of underlying infectionsDexketoprofen can mask the symptoms of infection, which could delay the 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 chickenpox. When this medicine is given for the relief of infection-related pain, monitoring of infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. In exceptional cases, chickenpox can be associated with severe infectious skin and soft tissue complications. To date, a role of NSAIDs in the aggravation of these infections cannot be excluded, so it is advisable to avoid the use of Ketesse in patients with chickenpox.Other informationParticular caution is required in patients: - with congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria) - with dehydration - immediately after major surgery If the physician considers long-term dexketoprofen therapy necessary, liver function and kidney and complete blood counts (blood counts) should be checked regularly. Severe acute hypersensitivity reactions (anaphylactic shock, for example) have been observed very rarely. Treatment should be stopped at the first signs of severe hypersensitivity following the intake of Fastumdol Anti-inflammatory. Any necessary medical procedures should be initiated by healthcare professionals based on symptoms. Patients with asthma associated with chronic rhinitis, chronic sinusitis, and / or nasal polyposis have a greater risk of allergy to acetylsalicylic acid and / or NSAIDs than the rest of the population. Administration of this medicinal product may cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Fastumdol Anti-inflammatory should be administered with caution in patients suffering from haematopoietic disorders, systemic lupus erythematosus or in the presence of connective tissue disorders. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, ie essentially 'sodium-free'.Pediatric populationThe safety of use in children and adolescents has not been established.
Fastumdol Anti-inflammatory tablets are contraindicated during the third trimester of pregnancy and during breastfeeding. (see section 4.3).PregnancyInhibition of prostaglandin synthesis can 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 is increased from less than 1% to approximately 1.5%. The risk has been 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-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. However, animal studies with dexketoprofen did not indicate reproductive toxicity (see section 5.3). During the first and second trimester of pregnancy, dexketoprofen should not be administered except in strictly necessary cases. If dexketoprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. 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 failure, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, an anti-aggregating effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor.Feeding timeIt has not been established whether dexketoprofen is secreted in human milk. Fastumdol Anti-inflammatory is contraindicated during lactation (see section 4.3).FertilityAs with other NSAIDs, the use of Anti-inflammatory Fastumdol may reduce female fertility and is not recommended in women planning to conceive. Discontinuation of dexketoprofen should be considered in women who have difficulty conceiving or are undergoing investigation of infertility.
PVC-aluminum blisters: Do not store above 30 ° C. Store the blister in the outer carton in order to protect it from light. Aclar-aluminum blisters: This medicinal product does not require any special storage conditions.
The following interactions are characteristic of non-steroidal anti-inflammatory drugs (NSAIDs) in general:Associations not advisable: - Other NSAIDs, (including selective cyclooxygenase-2 inhibitors) and high doses of salicylates (≥ 3 g / day): co-administration of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect; Anticoagulants: NSAIDs may potentiate the effects of anticoagulants such as warfarin (see section 4.4) due to the high plasma protein binding of dexketoprofen and the inhibition of platelet function and damage to the gastroduodenal mucosa. If the association cannot be avoided, careful clinical observation and monitoring of laboratory parameters should be performed; - Heparin: increased risk of bleeding (due to inhibition of platelet function and damage to the gastroduodenal mucosa). If the association cannot be avoided, careful clinical observation and monitoring of laboratory parameters should be performed; - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4); - Lithium (described with several NSAIDs): NSAIDs increase blood levels of lithium which can reach toxic values (decreased renal excretion of lithium). This parameter therefore requires careful monitoring during the institution, adjustment and discontinuation of dexketoprofen treatment; - Methotrexate, used at high doses such as 15 mg / week or more: increased haematological toxicity of methotrexate due to a decrease in its renal clearance, caused by anti-inflammatory drugs in general; - Hydantoins and sulfonamides: the toxic effects of these substances can be enhanced.Associations requiring caution: - Diuretics, ACE inhibitors, aminoglycoside antibiotics and angiotensin II receptor antagonists: dexketoprofen may 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 concomitant administration of agents that inhibit cyclooxygenase and ACE inhibitors, angiotensin II receptor antagonists or aminoglycoside antibiotics may cause an further deterioration of kidney function, which is usually reversible. In case of combined prescribing of dexketoprofen with a diuretic, it is essential to ensure that the patient is adequately hydrated and to monitor renal function at the start of treatment (see section 4.4 Special warnings and precautions for use). - Methotrexate, used at doses below 15 mg / week: increased haematological toxicity of methotrexate due to a decrease in its renal clearance caused by anti-inflammatory drugs in general. Weekly blood count in the first weeks of the association. Increased surveillance, as well as for the elderly patient, in case of even mild renal insufficiency. - Pentoxifylline: increased risk of bleeding. Increase clinical monitoring and check bleeding time more frequently. - Zidovudine: risk of increased toxicity to the erythrocyte line due to the action on reticulocytes, with onset of severe anemia one week after the start of treatment with NSAIDs. Check complete blood counts and reticulocytes every one to two weeks during NSAID treatment. - Sulfonylureas: NSAIDs may increase the hypoglycemic effect of sulfonylureas by displacement from plasma protein binding sites.Combinations to consider: - Beta-blockers: treatment with NSAIDs may decrease their antihypertensive effect due to inhibition of prostaglandin synthesis. - Ciclosporine and tacrolimus: NSAIDs can potentiate nephrotoxicity due to the mediated effects of renal prostaglandins. Renal function should be monitored during combination therapy. - Thrombolytics: increased risk of bleeding. - Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). - Probenecid: may increase plasma concentrations of dexketoprofen; this interaction may be due to an inhibitory mechanism at the level of renal tubule secretion and glucuronide conjugation and requires adjustment of the dexketoprofen dose. - Cardiac glycosides: NSAIDs can increase plasma concentrations of glycosides. - Mifepristone: There is a theoretical risk that prostaglandin synthetase inhibitors may alter the efficacy of mifepristone. Limited evidence suggests that concomitant administration of NSAIDs on the same day as prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandins on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy. - Quinolone antibiotics: Animal studies indicate that high doses of quinolones in combination with NSAIDs may increase the risk of developing convulsions. - Tenofovir: concomitant use with NSAIDs may increase blood urea and creatinine, consequently renal function should be monitored to control a possible synergistic influence on renal function. - Deferasirox: concomitant use with NSAIDs may increase the risk of gastrointestinal toxicity. Strict clinical monitoring is required when administering deferasirox with these substances. - Pemetrexed: concomitant use with NSAIDs may reduce the elimination of pemetrexed, therefore caution should be exercised in administering higher doses of NSAIDs; in patients with mild to moderate renal impairment (creatinine clearance between 45 and 79 ml / min), concomitant administration of pemetrexed with NSAIDs should be avoided for 2 days before and 2 days after administration of pemetrexed.
The symptoms following overdose are unknown. Similar drugs have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological disorders (drowsiness, dizziness, disorientation, headache). In case of accidental or excessive intake, immediately adopt adequate symptomatic therapy based on the clinical condition of the patient. Activated charcoal should be administered within one hour if more than 5 mg / kg have been ingested by an adult or child. Dexketoprofen can be eliminated by dialysis.
Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol. For the full list of excipients, see section 6.1.
Tablet core: - corn starch - microcrystalline cellulose - sodium starch glycolate - glycerol distearate Film coating: - dry lacquer composed of: - hypromellose - titanium dioxide - macrogol 6000 - propylene glycol