Enantyum 25mg 20 Coated Tablets

Product details

Therapeutic indications
Enantyum Tablets is used in the symptomatic treatment of painful conditions of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhea, dental pain.

Dosage and method of use
Based on the nature and intensity of pain, the recommended dose of Enantyum Tablets is generally 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. It is not indicated for long-term treatments and administration should be limited to the symptomatic period only. The concomitant administration of food delays the rate of absorption of the drug, therefore in case of acute pain it is recommended that the administration take place at least 30 minutes before meals.

In the elderly patient it is recommended to start therapy at the lower limit of the therapeutic range (50 mg total daily dose). The dosage may be increased to match that used for the general population only after good general tolerability has been ascertained. Patients with mild to moderate hepatic impairment should be initiated at reduced doses (50 mg total daily dose) and monitored closely. Do not use in patients with severe hepatic insufficiency. The starting dosage should be reduced to 50 mg total daily dose in patients with mild renal impairment. Do not use in patients with moderate to severe renal insufficiency. It has not been studied in children and adolescents; therefore, as safety and efficacy have not been established, the product cannot be used.

Contraindications

Hypersensitivity 'to dexketoprofen, or other NSAIDs, or to any of the excipients of the drug.
Patients in whom active substances with similar action (eg aspirin, or other NSAIDs) trigger asthma attacks, bronchospasm, acute rhinitis, or are the cause of nasal polyps, urticaria or angioneurotic edema.
Patients with active or suspected peptic ulcer / haemorrhage or a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of ascertained ulceration or bleeding) or chronic dyspepsia.
Patients with a history of gastrointestinal bleeding or perforation in connection with previous NSAID therapy.
Patients who have gastrointestinal or other active bleeding or bleeding disorders.
Patients with: Crohn's disease or ulcerative colitis; history of bronchial asthma; severe heart failure; moderate to severe renal insufficiency; severe hepatic insufficiency; hemorrhagic diathesis and other coagulation disorders.
Pregnancy and breastfeeding.

Special warnings
Safe use in children and adolescents has not been established. Use with caution in patients with a history of allergic conditions. Concomitant use with 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.

Gastrointestinal 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, treatment should be discontinued. The risk increases with increasing NSAID doses, in patients with a history of ulcer, especially if complicated with haemorrhage or perforation, and in elderly patients. These have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal; start treatment with the lowest possible dose.

Before starting treatment with dexketoprofen trometamol, previous history of esophagitis, gastritis and / or peptic ulcer must be investigated and made 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. Administer with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking 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 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 aspirin. All non-selective NSAIDs are able to inhibit platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. Therefore, the use of dexketoprofen trometamol in patients receiving other treatments that interfere with haemostasis, such as warfarin or other coumarins or heparins is not recommended. The drug can 'cause an increase in blood urea and creatinine. It may be associated with adverse kidney effects which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. It can cause transient slight increases in some liver parameters and also significant increases in AST and ALT. If there is a significant increase in these parameters, the treatment must be stopped. Administer with caution in patients with haematopoiesis disorders, systemic lupus erythematosus or connective tissue disorders. Dexketoprofen can mask the symptoms of an infectious disease.

Use with caution in patients with impaired hepatic and / or renal function and in patients with a history of hypertension and / or heart failure. In these patients, the use of NSAIDs can 'cause worsening of renal 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. Use with particular caution in patients with a history of heart disease, particularly those with previous episodes of heart failure, due to the greater risk of triggering heart failure. Elderly patients are more likely to have renal, cardiovascular or hepatic insufficiency. 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. 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 should be stopped at the first appearance of skin rashes, mucosal lesions or any other sign of hypersensitivity '. It can reduce female fertility and is not recommended for women intending to conceive.

Discontinuation of dexketoprofen trometamol should be considered in women who have difficulty conceiving or are undergoing investigation of infertility. Adequate monitoring and appropriate instructions are required in patients with a history of mild to moderate hypertension and / or congestive heart failure 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 a similar risk for dexketoprofen trometamol. 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 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).

Pregnancy and breastfeeding
It is contraindicated in pregnancy and lactation.

Pregnancy

Inhibition 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 trometamol did not indicate reproductive toxicity. During the first and second trimester of pregnancy, it should not be administered except in strictly necessary cases. If dexketoprofen trometamol is used by a woman awaiting conception, or during the first and second trimester, the dose and duration of treatment should be kept as low as possible. During the third trimester, all prostaglandin synthesis inhibitors can expose: the fetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and / or renal dysfunction, which can progress to renal failure with oligohydroamnios; the mother and the newborn, at the end of pregnancy, a possible prolongation of the bleeding time, an antiplatelet effect that can occur even at low doses and / or inhibition of uterine contractions resulting in delay or prolongation of labor.

Feeding time

It has not been established whether dexketoprofen is secreted in human milk.

Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 30 ° C. Keep the blister in the outer carton in order to protect it from light.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition
Efferalgan Suppositories contains:
Active ingredient: dexketoprofen 25 mg
Excipients: Corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Enantyum 25 mg in packs of 20 Coated Tablets