Fastumdol Anti-inflammatory 20 Coated Tablets 25mg,Fastumdol Antinfiammatorio 20 Compresse Rivestite 25mg,Menarini Group

“ACTIVE INGREDIENTS
Each tablet contains: dexketoprofene 12.5 mg or 25 mg as dexketoprofene trometamol.
Excipients
Corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearato, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.
CONTRAINDICATIONS/EFF.SECONDARY
DESK tablets should not be used in the following cases: – patients with hypersensitivity to the active substance or to other NSAIDs, or any of the excipients listed in paragraph 6.1; – patients in whom active actions similar (eg acetylsalicylic acid or other NSAIDs) cause asthma attacks, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioedema; – photoallergic reactions or phototoxic notes during treatment with Ketonal ofibrati; – patients with a history of bleeding or perforation of the gastrointestinal tract due to previous NSAID therapy; – patients conulcera active peptic/gastrointestinal bleeding or a history of positivaper bleeding, ulceration or perforation of the gastrointestinal tract; – patients with chronic dyspepsia; – patients who have other sanguinamentiattivi or blood clotting disorders; – patients with Crohn’s disease ulcerative colitis; – severely ill patients with heart failure; – patients with moderate to severe renal impairment (creatinine clearance DOSAGE
Adults: Depending on the nature and intensity of pain, the recommended dose is usually 12.5 mg every 4-6 hours or 25 mg every 8 hours. Ladose total daily dose should not exceed 75 mg. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment, which is necessary to controllare symptoms. Long-term treatment is not indicated and administration is limited to symptomatic periods only. The drug has not been studied in children and adolescents. Therefore, safety and effectiveness have not been established and the product should be used in children and adolescents. Elderly: In elderly patients, it is recommended to initiate therapy at the lower end of the therapeutic range (50 mg total daily dose). The dosage may be increased to reach these workers in the general population only after general well-tolerance has been established. Liver dysfunction: Patients with mild to moderate hepatic impairment should begin therapy with low doses (50 mg total daily dose) and should be closely monitored by a physician. The drug should not be used in patients with severe liver failure. Renal impairment: In patients with mild renal impairment (creatinine clearance 60 – 89 ml/min), the initial dosage should be reduced to 50 mg total daily dose. The drug should not be used in patients with moderate to severe renal impairment. Directions for use: the tablet should be swallowed with a sufficient amount of liquid (for example a glass of water). In combination with a concomitant meal, it slows down the rate of absorption of the drug, thus, in case of acute pain, it is recommended that the administration take place at least 30 minutes before meals.
STORAGE
Do not store at temperatures above 30 degrees C. Store in blisters in outdoor packaging to keep it away from light.
WARNINGS
Use with caution in patients with a history of allergic conditions. Concomitant use with other NSAIDs, including selective cyclooxygenase 2 inhibitors, should be avoided. Side effects can be minimized by using the lowest effective dose of pearl for a shorter duration of treatment and as necessary to control symptoms. Bleeding, ulceration, or perforation of the gastrointestinal tract has been cited, which can be fatal. If gastrointestinal bleeding or ulceration occurs, you should stop treatment. The risk of bleeding, ulceration and gastrointestinal perforation increases with increasing doses of NSAIDs, those with a history of peptic ulcer disease, and in the elderly. Elderly people have an increased incidence of adverse reactions to NSAIDs. These patients should begin treatment with the lowest dose possible. Before starting treatment with dexketoprofene trometamol, investigate a past history of esophagitis, gastritis and/or gastric ulcer and ensure complete healing. Patients with gastrointestinal symptoms or a history of gastrointestinal disorders should be carefully monitored for the occurrence of gastrointestinal disturbances. Prescribe with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as their conditions may be exacerbated. Therapies in combination with protective agents should be taken into account for these patients, as well as for patients who are taking concomitant low doses of”