- Articolar pains.
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Short-term symptomatic treatment of acute painful conditions of mild to moderate intensity, such as acute musculoskeletal pain, dysmenorrhea and dental pain. Enantyum is indicated in adult patients.
Dosage Adults: Based on the nature and intensity of the pain, the recommended dose is generally 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 control symptoms (see section 4.4). Enantyum oral solution in sachet is indicated only for short-term treatments and administration should be limited to the symptomatic period only. Senior citizens: 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 established. Due to the risk profile (see section 4.4), the elderly should be monitored with particular care. Hepatic dysfunction Patients with mild to moderate hepatic dysfunction should initiate therapy at reduced doses (50 mg total daily dose) under close medical supervision. Enantyum oral solution in sachet should not be used in patients with severe hepatic dysfunction. Renal dysfunction: In 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). Enantyum oral solution in sachet must not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml / min) (see section 4.3). Pediatric population: Enantyum has not been studied in children and adolescents. Therefore, the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescents. Method of administration Oral use. The oral solution should be taken directly from the sachet or after mixing the entire contents in a glass of water. Once the sachet is opened, the entire contents must be consumed. Concomitant administration of food delays the rate of drug absorption (see "Pharmacokinetic properties"), so in case of acute pain it is recommended to administer the drug at least 15 minutes before meals.
Enantyum oral solution in sachet must not be administered in the following cases: - patients with known 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 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 coagulation disorders; - patients with Crohn's disease or ulcerative colitis; - patients with severe heart failure; - patients with moderate to severe renal insufficiency (creatinine clearance
Adverse events reported as possibly related to dexketoprofen in clinical trials (tablet formulation), as well as post-marketing adverse reactions of Enantyum oral solution in sachet are included in the table below, grouped by device and listed in order of frequency: Data that plasma levels Cmax of dexketoprofen for the oral solution formulations are higher than those reported for the tablet formulation, a potential increased risk of adverse (gastrointestinal) events cannot be excluded .
|CLASS / APPARATUS / ORGAN||Common ( ≥ 1/100 a||Uncommon ( ≥ 1 / 1,000 a||Rare ( ≥ 1 / 10,000 a||Very rare / Isolated cases (|
|Disorders of the blood and lymphatic system||---||---||---||Neutropenia, thrombocytopenia|
|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, sleepiness||Paresthesia , syncope||---|
|Eye disorders||---||---||---||Blurred vision|
|Ear and labyrinth disorders||---||Dizziness||---||Tinnitus|
|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, haemorrhage or peptic ulcer perforation (see section 4.4)||Pancreatitis|
|Hepatobiliary disorders||---||---||Hepatocellular damage|
|Skin and subcutaneous tissue disorders||---||Rash||Urticaria, acne, increased sweating||Stevens Johnson syndrome, toxic epidermal neccrolysis (Lyell's syndrome), angioedema, face edema, photosensitivity reaction, pruritus|
|Musculoskeletal and connective tissue disorders||---||---||Back pain||---|
|Renal and urinary disorders||---||---||Acute renal failure, Polyuria||Nephritis or nephrotic syndrome|
|Reproductive system and breast disorders||---||---||Menstrual disorder, prostate pathology||---|
|General disorders and administration site disorders||---||Fatigue, pain, asthenia, chills, feeling unwell||Peripheral edema||---|
|Diagnostic tests||---||---||Abnormalities in liver function tests||---|
Use with caution in patients with a history of allergic conditions. Concomitant use of ENANTYUM 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 control symptoms (see section 4.2 and gastrointestinal and cardiovascular risks below). Gastrointestinal safety 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 Enatyum, 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. Use in the elderly: The elderly have an increased 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 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 aspirin or other drugs that may increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly if 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 (see section 4.5). 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 required, 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 at risk of renal failure (see section 4.2). Hepatic safety Caution should be exercised in patients with impaired hepatic function. Like other NSAIDs, it can cause small transient increases in some parameters of liver function, as well as significant increases in GOT and GPT. In the event of a significant increase in these parameters, the therapy must be stopped. Elderly patients are the most at risk of impaired liver function (see section 4.2). Cardiovascular and cerebrovascular safety For patients with a history of hypertension and / or mild to moderate heart failure, appropriate monitoring is required. 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 at 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 Enantyum 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 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). In the early stages of therapy, patients appear to be at a higher risk of developing reactions, 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 Enantyum should be discontinued. Other information Particular caution is required in patients with: - congenital abnormalities of porphyrin metabolism (eg acute intermittent porphyria); - dehydration; - immediately after major surgery. If the physician considers that long-term therapy with dexketoprofen is necessary, hepatic, renal and blood counts should be checked regularly. Severe acute hypersensitivity reactions (eg anaphylactic shock) have been observed in very rare cases. Treatment should be stopped when the first manifestation of severe hypersensitivity reactions occurs after taking Enantyum. Depending on the symptoms, start 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 medicinal product may cause asthma attacks or bronchospasm especially in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). In exceptional cases, chickenpox can be associated with infectious complications of the skin and soft tissues. To date, a role of NSAIDs in the aggravation of these infections cannot be excluded, therefore it is advisable to avoid the use of Enantyum in patients with chickenpox. Enantyum oral solution in sachet 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. Pediatric population Safe use in children and adolescents has not been established. This drug can cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate. This pharmaceutical product contains 2 g of sucrose per dose and this should be taken into consideration in the treatment of patients with severe hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency and in patients with diabetes mellitus.
Enantyum oral solution in sachet is contraindicated during the third trimester of pregnancy and during lactation (see section 4.3). Pregnancy Inhibition of prostaglandin synthesis can have adverse effects on 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 the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased by less than 1% up to about 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 increased 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. During the first and second trimester of pregnancy, dexketoprofen should not be administered except when strictly necessary. 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 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 It is not known whether dexketoprofen is excreted in human milk. Enantyum oral solution in sachet is contraindicated during breastfeeding (see section 4.3). Fertility As with other NSAIDs, the use of dexketoprofen can damage female fertility and is not recommended for use in women wishing to become pregnant. In the case of women with difficulty in conceiving or who are undergoing tests for infertility, consider interrupting the administration of dexketoprofen.
This medicinal product does not require any special storage conditions.
The following interactions are characteristic of non-steroidal 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): administration Simultaneously with multiple NSAIDs may increase the risk of gastrointestinal ulceration and bleeding due to a synergistic effect. Anti-coagulants: 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 combination cannot be avoided, rigorous clinical observation and monitoring of laboratory parameters are required. -Heparin: increased risk of haemorrhage (due to inhibition of platelet function and damage to the gastrointestinal mucosa). If the combination 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. -Idantoins and sulfonamides: the toxic effects of these substances can be enhanced. Combinations requiring caution: - Diuretics, ACE inhibitors, aminoglycoside antibiotics and angiotensin II receptor antagonists: dexketoprofen may reduce the effect of diuretics and antihypertensive drugs. In some patients with impaired renal function (for example, 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 a 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 Enantyum and potassium-sparing diuretics can cause hyperkalaemia. Blood potassium concentrations should be monitored (see section 4.4). - Methotrexate when used in low doses (
The symptoms resulting from overdose are unknown. Similar medicinal products have caused 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 patients. 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.
Each sachet of oral solution contains: dexketoprofen 25 mg as dexketoprofen trometamol. Excipients with known effects: 2 g of sucrose and 20 mg of methyl parahydroxybenzoate. For the full list of excipients, see section 6.1.
Ammonium glycyrrhizinate Neohesperidin-dihydrocalcone Methyl parahydroxybenzoate Sodium saccharin Sucrose Macrogol 400 Lemon flavor Povidone K-90 Disodium phosphate anhydrous Sodium dihydrogen phosphate dihydrate Purified water
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