FASTUMDOL ANTINF * 20BUST 25MG

FASTUMDOL ANTINF * 20BUST 25MG

Therapeutic indications

Short-term symptomatic treatment of painful conditions of mild to moderate intensity, such as acute musculoskeletal pain, dysmenorrhea and dental pain.

Dosage and method of use

Dosage Adults Based on the nature and intensity of the pain, the recommended dose is 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 time strictly necessary to eliminate symptoms (see section 4.4). Fastumdol Anti-inflammatory is indicated only for short-term treatments and administration should be limited to the symptomatic period only. Elderly people In elderly patients it is recommended to start therapy with the lowest therapeutic dose (50 mg total daily dose). The dosage can be increased to that recommended for adults only after good tolerability has been ascertained. Due to the risk profile (see section 4.4), the elderly should be monitored with particular care. Hepatic insufficiency Patients with mild to moderate hepatic impairment should initiate therapy at reduced doses (50 mg total daily dose) under close medical supervision. Fastumdol Anti-inflammatory should not be used in patients with severe hepatic impairment. InsufficiencyrenalIn patients with mild renal impairment (creatinine clearance 60 - 89 ml / min) the initial dosage should be reduced to 50 mg total daily dose (see section 4.4). Fastumdol Anti-inflammatory 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 granules for oral solution has not been studied in children and adolescents. Therefore, as safety and efficacy data are not available, the product should not be used in children and adolescents.Method of administrationDissolve the entire contents of each sachet in a glass of water: mix well to dissolve completely. The solution thus obtained must be swallowed immediately after reconstitution. Concomitant administration of food delays the rate of drug absorption (see “Pharmacokinetic properties”), therefore, in case of acute pain, it is recommended to administer the drug at least 15 minutes before meals.

Contraindications

Fastumdol Anti-inflammatory granules for oral solution must not be administered in the following cases: - patients with hypersensitivity to the active substance, or to any other NSAID, or to any of the excipients listed in section 6.1; - patients who have developed asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioedema after exposure to substances with a similar mechanism of action (e.g. acetylsalicylic acid, or other NSAIDs) - patients with known photoallergic or phototoxic reactions during treatment with ketoprofen or bundles; - patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy; - patients with active peptic ulcer / gastrointestinal bleeding or any previous history of gastrointestinal bleeding, ulceration or perforation; - patients with chronic dyspepsia; - patients who have other ongoing 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 insufficiency (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).

Side effects

The table below, grouped by system and listed in order of frequency, shows the adverse events, probably related to dexketoprofen, which occurred during clinical trials and after the marketing of Fastumdol Anti-inflammatory granules. Plasma levels C_maxof dexketoprofen in the granule formulation are higher than those reported for the tablet formulation, therefore a potential increased risk of adverse (gastrointestinal) events cannot be excluded.

The most commonly observed undesirable effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, especially in the elderly, may occur (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). Gastritis was found less frequently. Edema, hypertension and heart failure have been reported in association with NSAID therapy. The results of clinical trials and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long periods) may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). As with other NSAIDs, the following undesirable effects may occur: aseptic meningitis, which may occur predominantly in patients with systemic lupus erythematosus or mixed connective tissue disease; haematological reactions (purpura, aplastic and haemolytic anemia, and rarely agranulocytosis and bone marrow hypoplasia).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

Special warnings

Use with caution in patients with a history of allergic conditions. The concomitant use of Anti-inflammatory Fastumdol with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Undesirable effects can be minimized by using the lowest effective dose for the time strictly necessary to eliminate symptoms (see section 4.2 and gastrointestinal and cardiovascular risks below).Gastrointestinal safetyLife-threatening gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs in patients receiving Fastumdol Anti-inflammatory, therapy should be stopped immediately. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dosage in patients with a history of ulceration, 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 start treatment with the lowest available dose. As with all NSAIDs, prior esophagitis, gastritis and / or peptic ulcers must be investigated before starting treatment with dexketoprofen trometamol and ensure their total healing. Patients with gastrointestinal symptoms or a history of gastrointestinal disease 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 these conditions may be exacerbated (see section 4.8). Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients receiving concomitant 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 early stages of treatment. Caution is advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors and antiplatelet agents such as acetylsalicylic acid (see section 4.5).Renal safetyUse with caution in patients with impaired renal function. In these patients the use of NSAIDs can cause deterioration of renal function, fluid retention and edema. Caution should be exercised, due to an increased risk of nephrotoxicity, even in patients on diuretic therapy or who are at risk of developing hypovolaemia. Adequate fluid intake should be ensured during treatment to prevent dehydration and the risk of renal toxicity. Like all NSAIDs, the product can cause an increase in blood urea and creatinine levels. As with other prostaglandin synthesis inhibitors, adverse kidney effects may occur which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Elderly patients are the most exposed to the risk of renal failure (see section 4.2).Hepatic safetyCaution should be exercised in patients with impaired hepatic function. Like other NSAIDs, it can cause small transient increases in some liver function parameters, as well as significant increases in GOT and GPT. In the event of a significant increase in these parameters, the therapy must be interrupted. Elderly patients are the most at risk of impaired liver function (see section 4.2).Cardiovascular and cerebrovascular safetyAppropriate monitoring is required for patients with a history of hypertension and / or mild to moderate heart failure. Particular caution should be exercised in cardiac patients, especially if with a history of heart failure as there is an increased risk of heart failure, as fluid retention and edema have been reported in association with the use of NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high doses and protracted therapies) may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude this risk for dexketoprofen. Therefore, 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 evaluation. Similar attention should be paid 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 capable of inhibiting platelet aggregation and prolonging bleeding time by inhibiting prostaglandin synthesis. The use of dexketoprofen is therefore not recommended in patients receiving other therapy that interferes with haemostasis, such as warfarin or other coumarins or heparins (see section 4.5). Elderly patients are more likely to develop changes in 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. In the early stages of therapy, patients appear to be at higher risk: the onset of reactions occurs, in most cases, within the first month of treatment. At the first appearance of skin rash, mucosal lesions or any other symptoms of hypersensitivity, Fastumdol Anti-inflammatory therapy should be discontinued.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 complications of the skin and soft tissues. To date, a role of NSAIDs in the aggravation of these infections cannot be excluded, so it is advisable to avoid the use of Fastumdol Anti-inflammatory in patients with chickenpox.Other informationParticular caution is required in patients with: - congenital abnormalities of porphyrin metabolism (e.g. acute intermittent porphyria) - dehydration - immediately after major surgery If the doctor considers that long-term therapy with dexketoprofen is necessary, hepatic function should be checked regularly, kidney and blood count. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed in very rare cases. At the first manifestation of severe hypersensitivity reactions after taking Fastumdol Anti-inflammatory, stop the treatment immediately. Depending on the symptoms, initiate the necessary medical procedures immediately, with qualified medical personnel. Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis have a higher risk of allergy to acetylsalicylic acid and / or NSAIDs than the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm especially in allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Fastumdol Anti-inflammatory should be administered with caution to patients suffering from haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. This medicinal product contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicinal product. To be taken into consideration in people with diabetes mellitus.Pediatric populationSafe use in children and adolescents has not been established.

Pregnancy and breastfeeding

Fastumdol Anti-inflammatory is contraindicated in the third trimester of pregnancy and during lactation (see section 4.3).PregnancyInhibition of prostaglandin synthesis can have adverse effects on pregnancy and / or the development of the embryo or fetus. Results from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%. The risk is 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. In addition, an increased incidence of various malformations, including cardiovascular ones, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. However, animal studies with dexketoprofen have not shown reproductive toxicity (see section 5.3). During the first and second trimester of pregnancy, dexketoprofen should only be administered 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 antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions, with consequent delay or prolongation of labor.Feeding timeIt is not known whether dexketoprofen is excreted in human milk. Fastumdol Anti-inflammatory is contraindicated during lactation (see section 4.3).FertilityThe use of Fastumdol Anti-inflammatory can damage female fertility and is not recommended for use in women wishing to become pregnant. In the case of women with conception difficulties or who are undergoing tests for infertility, consider interrupting the administration of dexketoprofen.

Expiration and retention

This medicinal product does not require any special storage conditions.

Interactions with other drugs

The following interactions are characteristic of nonsteroidal anti-inflammatory drugs (NSAIDs) in general:Combinations not recommended- Other NSAIDs (including selective cyclo-oxygenase-2 inhibitors) and high doses of salicylates (≥3 g / day): co-administration of multiple NSAIDs may increase the risk of gastrointestinal ulceration 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, inhibition of platelet function and damage to the gastro-duodenal mucosa. If the association cannot be avoided, rigorous clinical observation and monitoring of laboratory parameters are required. - Heparin: increased risk of bleeding (due to inhibition of platelet function and damage to the gastrointestinal mucosa). If the association cannot be avoided, rigorous clinical observation and monitoring of laboratory parameters are required. - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). - Lithium (described with many NSAIDs): NSAIDs increase blood levels of lithium with the risk of reaching toxic values (decreased renal excretion of lithium); therefore, this parameter requires careful monitoring at the beginning, during the adjustment and at the end of treatment with dexketoprofen. - Methotrexate when used at high doses (≥ 15 mg / week): increased haematological toxicity of methotrexate due to a decrease in its renal clearance, in general with NSAIDs. - 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 can reduce the effect of diuretics and antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), concomitant administration of cyclooxygenase inhibiting agents and ACE inhibitors, angiotensin II receptor antagonists or aminoglycoside antibiotics may cause further deterioration of renal function, usually reversible. In case of concomitant prescription of dexketoprofen and a diuretic, it is essential to ensure adequate hydration of the patient and to monitor renal function both at the beginning of treatment and periodically thereafter. Concomitant administration of Anti-inflammatory Fastumdol and potassium-sparing diuretics may cause hyperkalemia. Blood potassium concentrations should be monitored (see section 4.4). - Methotrexate when used at low doses (Combinations to be carefully considered - Beta-blockers: treatment with NSAIDs can decrease their antihypertensive effect due to inhibition of prostaglandin synthesis. - Cyclosporine and tacrolimus: NSAIDs can potentiate their nephrotoxicity due to renal prostaglandin mediated effects Monitor renal function during therapy - Thrombolytics: increased risk of haemorrhage - Anti-platelet agents and SSRIs (selective serotonin reuptake inhibitors): 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 an adjustment of the dexketoprofen dose. - Cardioactive glycosides: NSAIDs may increase plasma concentrations of glycosides cardioactives. - 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. - Quinolones: Animal studies indicate that high doses of quinolone antibiotics in combination with NSAIDs may increase the risk of seizures. - 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 when 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.

Overdose

The symptoms resulting from overdose are unknown. Similar medicinal products have caused gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, dizziness, disorientation, headache) disturbances. In case of accidental or excessive intake, immediately adopt adequate symptomatic therapy based on the clinical condition of the patient. Activated charcoal should be given within one hour if more than 5 mg / kg has been ingested by an adult or child. Dexketoprofen trometamol can be eliminated by dialysis.

Active principles

Each sachet of granules for oral solution contains 25 mg of dexketoprofen as dexketoprofen trometamolExcipients with known effects: sucrose: 2.418 g For a full list of excipients, see section 6.1.

Excipients

Ammonium glycyrrhizinate Neoesperidina-dihydrocalcone Quinoline yellow (E104) Lemon flavor Sucrose