Fastumdol Anti-inflammatory 25mg Granules for Oral Solution 20 Sachets

Granules for oral solution in sachets with 25 mg of dexketoprofen.

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 Posology

• Adults : Depending on the nature and intensity of the pain, the recommended dose is 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 time strictly necessary to eliminate symptoms.
• Elderly : 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, the elderly should be monitored with particular care.
• Hepatic dysfunction : Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) under close medical supervision. Fastumdol Anti-inflammatory should not be used in patients with severe liver dysfunction.
• Renal dysfunction : In patients with mild renal insufficiency (creatinine clearance 60 - 89 ml / min) the starting dosage should be reduced to 50 mg total daily dose. Fastumdol Anti-inflammatory should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤ 59 ml / min).
• Children: Fastumdol Antinflammatory 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.

How to use

Dissolve 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, therefore, in case of acute pain, it is recommended to administer the drug at least 15 minutes before meals.

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.

Contraindications

Fastumdol Anti-inflammatory Granules for oral solution should 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;
• 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 fibrates;
• 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 impairment (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 breastfeeding.

Side effects

The table below, grouped by system and listed in order of frequency, shows the adverse events, probably related to dexketoprofen trometamol, which occurred during clinical trials and after the marketing of Fastumdol Anti-inflammatory. Plasma C _max levels of 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. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Gastritis was reported 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). 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 reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.

Pregnancy and breastfeeding

Fastumdol Anti-inflammatory is contraindicated in the third trimester of pregnancy and during breastfeeding.

• Pregnancy

Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or the development of the embryo or fetus. Results of 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 trometamol have not shown reproductive toxicity. During the first and second trimester of pregnancy, dexketoprofen trometamol should only be administered in strictly necessary cases. If dexketoprofen trometamol 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 dysfunction, 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 time

Fastumdol Anti-inflammatory is contraindicated during breastfeeding.

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 safety

Gastrointestinal bleeding, ulceration or perforation Life-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 previous ulcer, particularly if complicated with haemorrhage or perforation 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. 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 can be exacerbated. 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 aspirin or other drugs that may increase gastrointestinal risk. 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 aspirin.

Renal safety

Use 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 is needed, due to an increased risk of nephrotoxicity, even in patients on diuretic therapy or who are at risk of developing hypovolemia. 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.

Hepatic safety

Caution 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.

Cardiovascular and cerebrovascular safety

Appropriate 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 trometamol. 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 trometamol 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 trometamol is therefore not recommended in patients receiving another therapy that interferes with haemostasis, such as warfarin or other coumarins or heparins. Elderly patients are more likely to develop changes in cardiovascular function.

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. 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, therapy with Anti-inflammatory Fastumdol should be discontinued.

Other information

Particular caution is required in patients with: - congenital abnormalities of porphyrin metabolism (e.g. acute intermittent porphyria) - dehydration - immediately after major surgery If the physician considers long-term therapy with dexketoprofen 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 greater 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. 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 Fastumdol Anti-inflammatory in patients with chickenpox. Fastumdol Anti-inflammatory should be administered with caution to patients suffering from haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases. 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 population The safety of use in children and adolescents has not been established.

Expiry and Retention

This medicinal product does not require any special storage conditions.

Composition

Each sachet of Fastumdol Anti-inflammatory granules for oral solution contains:

Active principles

12.5 mg or 25 mg of dexketoprofen as dexketoprofen trometamol.

Excipients

Excipients with known effects: sucrose with colloidal silica: respectively 1.20 - 1.22 g or 2.40 - 2.44 g. Ammonium glycyrrhizinate Neoesperidina – dihydrocalcone Quinoline yellow (E104) Lemon flavor Sucrose Hydrated colloidal silica.