Medicinal Products

ENANTYUM 25 mg

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

Coated tablet
box of 1 plate of 20
All forms

Indication

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

Dosage ENANTYUM 25 mg film-coated tablet box of 1 pack of 20

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

Against indications

ENANTYUM should not be administered in the following cases:

· Patients with hypersensitivity to the active substance, other NSAIDs or to any of the excipients listed under Composition ;

· Patients in whom substances with a similar mode of action (eg acetylsalicylic acid or other NSAIDs) cause asthma attacks, bronchospasm, acute rhinitis or nasal polyps, urticaria or angioneurotic edema;

· Photoallergic or phototoxic reactions known 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 or active gastrointestinal hemorrhage or any history of gastrointestinal bleeding, ulceration or perforation;

· Patients with chronic dyspepsia;

· Patients with other active hemorrhages or bleeding disorders;

· Patients with Crohn's disease or ulcerative colitis (ulcerative colitis);

· Patients with severe heart failure;

· Patients with moderate to severe renal impairment (creatinine clearance ≤ 59 ml / min);

· Patients with severe hepatic impairment (Child-Pugh: 10-15);

· Patients with haemorrhagic bleeding and other bleeding disorders;

· Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);

· During the third trimester of pregnancy and during lactation (see section Pregnancy and lactation ).

Adverse effects Enantyum

Adverse reactions reported to be probably related to dexketoprofen trometamol reported during clinical trials and after the marketing of ENANTYUM are presented below, classified by organ-class system and by order of frequency:

Type of organs

frequent
(1/100 to <1/10)

Uncommon
(³ 1 / 1, 000 to <1/100)

few
(³ 1 / 10, 000 to <1 / 1, 000)

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

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

Eye disorders

Blurred vision

Affections of the ear and eardrum

Dizziness

tinnitus

Heart conditions

palpitations

tachycardia

Vascular disorders

Congestive flushes

Hypertension

hypotension

Respiratory, thoracic and mediastinal disorders

bradypnea

Bronchospasm, dyspnea

Gastrointestinal disorders

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

Gastritis, constipation, dry mouth, flatulence

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

pancreatitis

Hepatobiliary disorders

Hepatitis

Hepatocellular lesion

Skin and subcutaneous tissue disorders

rash

Urticaria, acne, increased sweating

Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, edema of the face, photosensitivity reactions, pruritus

Musculoskeletal and systemic disorders

Back pain

Renal and urinary disorders

Acute renal failure, polyuria

Nephritis or nephrotic syndrome

Disorders of reproductive organs and breast

Menstrual disorder, prostatic disorder

General disorders and administration site conditions

Fatigue, pain, asthenia, stiffness, discomfort

Peripheral edema

investigations

Abnormal liver function test

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, abdominal pain, melaena, hematemesis, ulcerative stomatitis, exacerbation of hemorrhagic colitis or Crohn's disease (see Warnings and precautions for use ) have been reported. reported. Less frequently, gastritis has been observed. Edema, hypertension and heart failure have been reported in association with NSAIDs.

As with other NSAIDs, the following side effects may occur: Aseptic meningitis, which occurs mainly in patients with systemic lupus erythematosus or mixed connective tissue disease; haematological reactions (purpura, aplastic and haemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia).

Bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis can very rarely occur.

Clinical and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in the long term) may be associated with a small increase in the risk of arterial thrombotic events (eg myocardial infarction or stroke) ( see section Warnings and precautions for use ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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