Medicinal Products

ADENURIC 80 mg

Generic drug of the therapeutic class: Rheumatology
active ingredients: Febuxostat
laboratory: Menarini France

Coated tablet
box of 2 blister packs of 14
All forms

Indication

Treatment of chronic hyperuricemia in cases where urate deposition has already occurred (including history or presence of tophi and / or gouty arthritis).


ADENURIC is indicated in adults.

Dosage ADENURIC 80 mg film-coated tablet box of 2 blister packs of 14

Treatment of chronic hyperuricemia in cases where urate deposition has already occurred (including history or presence of tophi and / or gouty arthritis).


ADENURIC is indicated in adults.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition (see also section 4.8 ).

Adenuric side effects

Summary of the security profile

The most commonly reported adverse reactions in clinical studies (4, 072 patients treated with at least one dose of 10 mg to 300 mg) and post-marketing experience include gout, abnormal liver function, diarrhea, nausea, headaches, rashes and edema. These adverse effects were generally of mild or moderate severity. Few serious hypersensitivity reactions to febuxostat, some of which were associated with systemic symptoms, were observed after marketing.


Tabulated list of adverse effects

Common side effects (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1/100), and rare (≥ 1/10 000 to <1/1000), occurring in patients treated by febuxostat are mentioned below.


In each frequency group, the adverse effects are presented in order of decreasing severity.

Table 1: Adverse Events in Phase III Studies, Long-Term and Post-marketing Extension Studies

Blood and lymphatic system disorders

Rare

Pancytopenia , thrombocytopenia

Immune system disorders

Rare

Anaphylactic reaction *, drug hypersensitivity *

Endocrine disorders

Rare

Increased blood serum

Eye disorders

Rare

Blurry vision

Metabolism and nutrition disorders

Frequent ***

Crisis of gout

Rare

Diabetes mellitus, hyperlipidemia, decreased appetite,

weight

Rare

Weight loss, increased appetite, anorexia

Psychiatric disorders

Rare

Decreased libido, insomnia

Rare

Nervousness

Nervous system disorders

Frequent

Headache

Rare

Dizziness, paresthesia, hemiparesis, somnolence, taste alteration, hypoesthesia, hyposmia

Hearing and labyrinth disorders

Rare

tinnitus

Heart conditions

Rare

Atrial fibrillation, palpitations, ECG abnormalities

Vascular disorders

Rare

Hypertension, flushing, hot flushes

Respiratory disorders

Rare

Dyspnoea, bronchitis, upper respiratory infections, cough

Gastrointestinal disorders

Frequent

Diarrhea **, nausea

Rare

Abdominal pain, abdominal distension, gastrooeophageal reflux, vomiting, dry mouth, dyspepsia, constipation, frequent bowel movements, flatulence, gastrointestinal discomfort Rare

Pancreatitis, ulceration of the mouth

Hepatobiliary disorders

Frequent

Abnormal liver function **

Rare

Chole lithiasis

Rare

Hepatitis, jaundice *, liver injury *

Skin and tissue disorders

subcutaneous

Frequent

Eruptions (including various types of eruptions reported with a lower frequency, see below)

Rare

Dermatitis, urticaria, pruritus, discolouration of the skin, skin lesions, petechia, macular rash, maculopapular rash, papular rash

Rare

Toxic epidermal necrolysis (Lyell syndrome) *, Stevens-Johnson syndrome *, angioedema *, hypersensitivity syndrome

medications with eosinophilia and systemic symptoms

(DRESS syndrome) *, generalized rash (severe) *, erythema, exfoliative eruption, follicular rash, vesicular rash, pustular rash, itchy rash *, erythematous rash, morbilliform rash, alopecia, hyperhydrosis.

Musculoskeletal and systemic disorders

Rare

Arthralgia, arthritis, myalgia, musculoskeletal pain,

muscle weakness, muscle spasms, contracture

Muscular bursitis

Rare

Rhabdomyoly se *, joint stiffness, musculoskeletal stiffness

Kidney disorders and pathways

urinary

Rare

Renal insufficiency, renal lithiasis, hematuria, pollakiuria,

proteinuria

Rare

Tubulointerstitial nephritis *, urgent urination

Disorders of the reproductive system and breasts

Rare

Erectile dysfunction

General disorders and abnormalities

at the administration site

Frequent

Edema

Rare

Fatigue, chest pain, discomfort in the chest

Rare

Thirst

Changes in biological parameters

Rare

Increase in amylase, decreased platelet count, decreased white blood cell count, decreased lymphocyte count, increased serum creatinine, reduced hemoglobin, increased uremia, increased triglyceride levels, increased cholesterolemia, decreased hematocrit, increased

lactate dehydrogenase in the blood, increased serum potassium

Rare

Increased blood glucose, increased activated partial thromboplastin time, reduced red blood cells, increased alkaline phosphatase in the blood

* treatment-related adverse effects from post-market data

** The combined results of phase 3 studies have shown non-infectious diarrhea and liver function abnormalities more frequent in patients treated concomitantly with colchicine.

*** See Pharmacodynamic properties for the incidence of gout attacks in randomized, controlled phase III studies.


Description of specific adverse events

Rare severe hypersensitivity reactions to febuxostat, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), and anaphylactic reaction / shock have been observed post-marketing. Stevens-Johnson syndrome and toxic epidermal necrolysis are characterized by a progressive skin rash, accompanied by bubbles or mucosal lesions and eye irritation. Hypersensitivity reactions to febuxostat may be associated with the following symptoms: skin reactions characterized by an infiltrated maculopapular rash, generalized or exfoliative rash, but also cutaneous lesions, facial edema, fever, abnormalities of the skin. blood tests such as thrombocytopenia and eosinophilia, and involvement of a single organ or multiple organ (liver and kidneys including tubulointerstitial nephritis) (see Warnings and Precautions for Use section ).


The gout attacks were frequently observed shortly after the start of treatment and during the first few months. Subsequently, the frequency of gout attacks decreases over time. Prophylaxis of gout flares is recommended (see sections Posology and method of administration and 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 report any suspected adverse reactions via the national reporting system - see Annex V.

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