Enantyum single-dose oral solution 10ml 20 bst 033656378
Medical information Enantyum single-dose oral solution:
Enantyum single-dose oral solution in sachets sachets is the new practical version to use, ready in 10 ml sachets with lemon flavor. Single-dose Enantyum acts rapidly by carrying out an anti-inflammatory and analgesic action. Please read the package insert before use or the card below.
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Enantyum 25 mg oral solution 20 single-dose sachets 10 ml
What is it for
Enantyum is a drug based on the active ingredient Dexketoprofen Trometamol, belonging to the category of NSAID analgesics and specifically Derivatives of propionic acid. It is marketed in Italy by the company A. Menarini Industrie Farmaceutiche Riunite Srl.
Enantyum can be prescribed with OTC recipe - non-prescription medicines over the counter.
Enantyum it is used for the therapy and treatment of various diseases and pathologies such as Rheumatoid arthritis, Arthrosis, Gout, Herpes zoster, Systemic lupus erythematosus, Fibrocystic mastopathy, Paget's disease, Mumps, Pleurisy, Polyposis, Scleroderma, Temporo-mandibular syndrome, Tendinitis, Thyroiditis, Varicella.
Commercial Prescribing Information
Holder:Laboratorios Menarini SA
Dealer:A. Menarini Industrie Farmaceutiche Riunite Srl
Recipe:OTC - non-prescription medicines over the counter
Class:C.
Active principle:Dexketoprofen Trometamol
Therapeutic group:NSAID analgesics
Pharmaceutical form:solution
Indications
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
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 (vsee paragraph 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.
Contraindications
Enantyum oral solution in sachet should 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 (eg 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 haemorrhage 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
patients with severe hepatic insufficiency (Child-Pugh score 10-15);
patients with hemorrhagic diathesis and other coagulation disorders;
patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
during the third trimester of pregnancy and lactation (see section 4.6).
Special warnings and precautions for use
Use with caution in patients with a history of allergic conditions.
The 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 Enantyum, 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 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 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 (e.g. 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
The 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.
Pregnancy and lactation
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 from 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 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. 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 bleeding time, an antiplatelet effect that can occur even at very low doses;
inhibition of uterine contractions, resulting in delayed or prolonged 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.
Effects on ability to drive and use machines
Enantyum oral solution in sachet may cause side effects such as dizziness, visual disturbances or sleepiness. In such cases, the ability to react, drive cars or operate machinery may be impaired.
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 system and listed in order of frequency:
Given that the plasma levels Cmax of dexketoprofen for oral solution formulations 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 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
|
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
|
Urticaria, acne,
increased sweating
|
Stevens Johnson syndrome, toxic epidermal necrolysis (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 reactions
Overdose
Valerian root at a dose of about 20 g caused benign symptoms (fatigue, abdominal cramps, chest tightness, lightheadedness, hand tremor and mydriasis), ...
List of excipients
Ammonium glycyrrhizinate
Neohexperidin-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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