Medicinal Products

ENANTYUM 25 mg granules for oral solution in sachets sachets box of 20

Generic drug of the therapeutic class: Analgesics
active ingredients: Dexketoprofen, Dexketoprofen
laboratory: Menarini France

Granulate for oral solution
All forms

Indication

Short-term symptomatic treatment of mild to moderate acute pain, such as acute musculoskeletal pain, dysmenorrhea and dental pain.

Dosage ENANTYUM 25 mg granules for oral solution in sachet sachets box of 20

Short-term symptomatic treatment of mild to moderate acute pain, such as acute musculoskeletal pain, dysmenorrhea and dental pain.

Against indications

ENANTYUM 25 mg granules for oral solution in sachets should not be administered in the following cases:

· Patients with hypersensitivity to dexketoprofen, other NSAIDs or any of the excipients

· Patients in whom substances with a similar action (eg acetylsalicylic acid or other NSAIDs) have caused asthma attack, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioedema,

· Photoallergic or phototoxic reactions known during treatment with ketoprofen or fibrates,

· Patients with a history of bleeding or digestive perforation during previous NSAID treatment,

· Patients with active peptic ulcer, history of peptic ulcer or recurrent hemorrhage (two or more distinct episodes of objectified haemorrhage or ulceration),

· Patients with suspected chronic dyspepsia or peptic ulcer or haemorrhage,

· Patients with other types of active bleeding or bleeding disorders,

· Crohn's disease or ulcerative colitis,

· Severe heart failure,

· Moderate to severe renal impairment,

· Severe liver failure,

· Patients with hemorrhagic diatheses and other bleeding disorders,

· Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake),

· During the third trimester of pregnancy and lactation.

Adverse effects Enantyum

The undesirable effects reported as probably related to dexketoprofen trometamol reported in clinical trials (for the tablet form) and after the marketing of ENANTYUM 25 mg Pellets for oral solution in sachets are summarized below, classified by type. of organs and in order of frequency:

Because the plasma C max values ​​of dexketoprofen for the granular form are higher than those reported for the tablet form, a potentially increased risk of adverse (gastrointestinal) effects can not be ruled out.

Types of organs

Frequent (≥ 1/100 to <1/10)

Uncommon (≥ 1/1000 to <1/100)

Rare (≥ 1/10 000 to <1/1000)

Very rare / Isolated cases (<1 / 10, 000)

Undetermined (can not be estimated from the available data)

Blood and lymphatic system disorders

Neutropenia Thrombocytopenia

Immune system disorders

Anaphylactic reaction, including anaphylactic shock

Laryngeal edema

Metabolism and nutrition disorders

Anorexia

Psychiatric disorders

Insomnia, anxiety

Nervous system disorders

Headache, dizziness, drowsiness

Paresthesia, syncope

Visual disorders

Blurred vision

Hearing disorders

Dizziness

tinnitus

Cardiac disorders

palpitations

tachycardia

Vascular disorders

Flushing

Hypertension

hypotension

Respiratory, thoracic and mediastinal disorders

bradypnea

Bronchospasm, dyspnea

Gastrointestinal disorders

Nausea and / or vomiting, abdominal pain, diarrhea, dyspepsia

Gastritis, constipation, xerostomia, flatulence

Peptic ulcer, gastrointestinal haemorrhage or gastrointestinal perforation (see Warnings and precautions for use )

pancreatitis

Hepatobiliary disorders

Hepatic injury

Hepatocellular impairment

Hepatitis

Skin and subcutaneous tissue disorders

Eruption

Urticaria, acne, increased sweating

Stevens Johnson syndrome, epidermal necrolysis (Lyell's syndrome), angioneurotic edema (Quincke's edema), facial edema, photo-sensitivity reactions, pruritus

Musculoskeletal and connective tissue disorders

Lumbar pains

Renal and urinary disorders

polyuria

Nephritis or nephrotic syndrome

Acute renal failure

Reproductive and breastfeeding disorders

Menstrual disorders, prostate disorders

General Disorders and Administration Site

Fatigue, pain, asthenia, chills or discomfort

Peripheral edema

Analyzes

Abnormal liver parameters

The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, can occur, especially in the elderly (see section Warnings and precautions for use ). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, hematemesis, ulcerative stomatitis, exacerbation of ulcerative colitis or Crohn's disease (see Warnings and precautions for use ) have been reported following the administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension, and heart failure have been reported in association with NSAID therapy.

Clinical studies and epidemiological data suggest that the use of NSAIDs (especially when used at high doses and over a long period of time) may be associated with a small increase in the risk of thrombotic arterial event (eg, coronary artery infarction). heart attack or stroke) (see Warnings and Precautions for Use section ).

The following undesirable effects may occur because they have been observed with other NSAIDs: aseptic meningitis that occurs mainly in patients with systemic lupus erythematosus or other connective tissue disease and hematologic reactions (purpura, aplastic and haemolytic anemia, rarely agranulocytosis, and spinal hypoplasia).

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