• Save €1.00
search

ENANTYUM * 10BS SOLUZ 25MG 10ML

  • A.MENARINI IND.FARM.RIUN.Srl
  • 033656416
Enantyum single-dose, ready-to-use oral solution with lemon flavor. Indicated in case of:



  • Articolar pains.

  • Toothache.

  • Headache.




























info_outline View product sheet
Final Price €6.90
Regular Price €7.90
Save €1.00
Quantity
check_circle Available (5 Items)
48h

redeem loyalty points

By buying this product you can collect up to 6 loyalty points that can be converted into a voucher. More info

  Convenient and safe payments

Even with a credit card

  Shipping in 48h-72h all over the world

FREE in Italy over € 39.90

  Fast returns

14 days to reconsider

  Pharmaceutical experience

Always at your service

Other products Others products at unbeatable price

A.MENARINI IND.FARM.RIUN.Srl

Discover all products

ENANTYUM * 10BS SOLUZ 25MG 10ML

Therapeutic indications

Short-term symptomatic treatment of acute painful conditions of mild to moderate intensity, such as acute musculoskeletal pain, dysmenorrhea and dental pain. This medicine is indicated in adult patients.

Dosage and method of use

DosageThe lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).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. This medicinal product is indicated for short-term treatments only 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 insufficiencyPatients with mild to moderate hepatic dysfunction should initiate therapy at reduced doses (50 mg total daily dose) under close medical supervision. Dexketoprofen should not be used in patients with severe hepatic dysfunction.Kidney failureIn 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). Dexketoprofen should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml / min) (see section 4.3).Pediatric population:Dexketoprofen 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 administrationOral 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.

Contraindications

- 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 bleeding disorders; - patients with Crohn's disease or ulcerative colitis; - patients with severe heart failure; - patients with moderate to severe renal insufficiency (creatinine clearance

Side effects

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 Cmaxof dexketoprofen for oral solution formulation are higher than those reported for tablet formulation, a potential increased risk of adverse (gastrointestinal) events cannot be excluded .

CLASS / APPARATUS / ORGAN Common (≥1 / 100 y Uncommon (≥1 / 1,000 y Rare (≥1 / 10,000 y Very rare (
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
Cardiac pathologies --- Palpitations --- Tachycardia
Vascular pathologies --- Redness Hypertension Hypotension
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 Hives, 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 ---

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 Warnings and precautions for use). 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. As with other NSAIDs, the following side effects may occur: aseptic meningitis, which may occur more in patients with systemic lupus erythematosus or mixed connective tissue disease; haematological reactions (purpura, aplastic and haemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia). Bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis (very rare). 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).Reporting of suspected adverse reactionsIt is important to report suspected adverse reactions after drug authorization. Allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals are asked to report any suspected adverse reactions through 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. Concomitant use of dexketoprofen 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 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 dexketoprofen, therapy should be discontinued 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 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 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 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 (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 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 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 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 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 (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.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.Other informationParticular caution is required in patients with: - congenital abnormalities of porphyrin metabolism (eg acute intermittent porphyria); - dehydration; - immediately after major surgery. If the doctor considers that long-term therapy with dexketoprofen is necessary, hepatic and renal function and blood counts should be checked regularly. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed in very rare cases. Treatment should be discontinued at the onset of the first manifestation of severe hypersensitivity reactions after taking dexketoprofen. 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 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 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 dexketoprofen in patients with chickenpox. Dexketoprofen should be administered with caution to patients suffering from haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. With concomitant alcohol intake, undesirable effects related to the active substance, particularly those affecting the gastrointestinal tract or the central nervous system, may increase with the use of NSAIDs. This medicine can cause allergic reactions (including delayed) as it contains methyl parahydroxybenzoate (E 218). This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. To be taken into consideration in people with diabetes mellitus. This medicinal product contains less than 1 mmol sodium (23 mg) per sachet, ie essentially "sodium-free".

Pregnancy and breastfeeding

Dexketoprofen is contraindicated during 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 (see section 5.3). 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 timeIt is not known whether dexketoprofen is excreted in human milk. Its use is contraindicated during lactation (see section 4.3).FertilityAs 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 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 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. - 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 combination 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. 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 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 may cause hyperkalaemia. Blood potassium concentrations should be monitored (see section 4.4). - Methotrexate when used in low doses (

Overdose

Symptoms resulting from overdose are unknown. Similar medicinal products have caused gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (drowsiness, dizziness, disorientation, headache) disturbances. 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.

Active principles

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 (E 218). For the full list of excipients, see section 6.1.

Excipients

Ammonium glycyrrhizinate Neohexperidin-dihydrocalcone Methyl parahydroxybenzoate (E 218) Sodium saccharin Sucrose Macrogol 400 Lemon flavor Povidone K-90 Disodium phosphate anhydrous Sodium dihydrogen phosphate dihydrate Purified water

033656416
5 Items

Data sheet

Packaging
25 mg oral solution 10 single-dose sachets 10 ml
Product Type
HUMAN DRUG
ATC code
M01AE17
ATC description
Dexketoprofen
Therapeutic Group
NSAID analgesics
Active principle
dexketoprofen trometamol
Class
C.
Pharmaceutical form
solution
Type of Administration
oral
Container
sachet in box
Quantity
10 sachet
Capacity
10 milliliters
Quantity of the Active Ingredient
25MG
Recipe required
OTC - self-medication medicine