Medicinal Products

ENANTYUM 125 mg

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

Coated tablet
box of 20
All forms

Indication

Symptomatic treatment of mild to moderate pain, such as musculoskeletal pain, dysmenorrhea, dental pain.

Dosage ENANTYUM 125 mg film-coated tablet box of 20

Symptomatic treatment of mild to moderate pain, such as musculoskeletal pain, dysmenorrhea, dental pain.

Against indications

ENANTYUM 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,

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

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

· Patients with gastrointestinal bleeding or any other type,

· Crohn's disease or ulcerative colitis,

· History of bronchial asthma,

· Severe heart failure,

· Moderate to severe renal impairment (creatine clearance <50 ml / min),

· Severe hepatic impairment (Child-Pugh score: 10-15),

· Patients with hemorrhagic diatheses and other bleeding disorders,

· From the third trimester of pregnancy or lactation (see section Pregnancy and lactation ).

Adverse effects Enantyum

Adverse events reported as possibly related to dexketoprofen trometamol reported in clinical trials and post-marketing of ENANTYUM are summarized below, by organ type and order of frequency:

Type of organs

frequent

Uncommon

few

Very rare / Isolated cases

(1 - 10%)

(0.1 - 1%)

(0.01 - 0.1%)

(<0.01%)

Blood and lymphatic system disorders

neutropenia

thrombocytopenia

Immune system disorders

Laryngeal edema

Anaphylactic reaction, including anaphylactic shock

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

Hepatitis

Hepatocellular impairment

Skin and subcutaneous tissue disorders

Eruption

Urticaria, acne, increased sweating

Stevens Johnson syndrome, epidermal necrolysis (Lyell's syndrome), angioedema, facial edema, photosensitivity reactions, pruritus

Musculoskeletal and connective tissue disorders

Lumbar pains

Renal and urinary disorders

Acute renal failure, polyuria

Nephritis or nephrotic syndrome

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

Gastrointestinal disorders: The most commonly observed adverse 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, ulcerative stomatitis, abdominal pain, melaena, haematemesis, 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.

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).

Very rarely can occur bullous reactions including Stevens-Johnson syndrome and Lyell syndrome.

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 ).

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