NIFLURIL

RESERVED FOR ADULTS AND CHILDREN from 12 years.

They derive from the anti-inflammatory activity of niflumic acid, the importance of the intolerance manifestations to which the medicine gives rise, and its place in the range of anti-inflammatory products currently available.

They are limited to:

· long-term symptomatic treatment

o of chronic inflammatory rheumatism, notably rheumatoid arthritis

o of certain painful and disabling arthroses

· short-term symptomatic treatment of acute flare-ups

o of arthroses,

o of abarticular rheumatism such as tendinitis, bursitis

· symptomatic treatment of pain during inflammatory manifestations in the ENT and stomatological fields.

It is an adjunct therapy for non-rheumatological conditions; the risks incurred, in particular the extension of a concomitant septic process, are those of NSAIDs. They must be evaluated in relation to the expected analgesic benefit.

Warn patients of the possible onset of dizziness and drowsiness.

Adverse effects are classified by system-organ class. Their frequencies are defined as follows:

· Very common (≥1/10)

· Common (≥1/100 to <1/10)

· Uncommon (≥1/1 000 to <1/100)

· Rare (≥1/10 000 to <1/1 000)

· Very rare (<1/10 000)

· Frequency unknown (cannot be estimated on the basis of available data)

Hematological and lymphatic system disorders

Rarely, thrombocytopenia.

Immune system disorders

· Dermatological: rash, urticaria and worsening of chronic urticaria, pruritus, purpura and erythema.

· Respiratory: the occurrence of asthma attacks may be observed in certain subjects, notably those allergic to aspirin and other non-steroidal anti-inflammatory drugs.

· General: anaphylactic shock, angioedema.

Nervous system disorders

Rare sensations of dizziness.

Cardiac and vascular disorders

Rarely reported: tachycardia, chest pain, arrhythmia, palpitations, general malaise with hypotension.

Heart failure, hypertension and oedema have also been reported in association with NSAID treatment.

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially when used at high doses and for a long duration) may be associated with a slight increase in the risk of an arterial thrombotic event (for example, myocardial infarction or stroke) (see section 4.4).

Gastrointestinal disorders

The most frequently observed adverse effects are of a gastrointestinal nature. Peptic ulcers, perforations or gastrointestinal haemorrhages, sometimes fatal, may occur, particularly in the elderly (see section 4.4).

Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melæna, haematemesis, exacerbation of ulcerative colitis or Crohn's disease (see section 4.4) have been reported following the administration of NSAIDs. Less frequently, gastritis has been observed.

Hepatobiliary disorders

Rarely, abnormal liver function tests.

Skin and subcutaneous tissue disorders

Very rarely, bullous reactions (including Stevens-Johnson syndrome and Lyell syndrome) have been observed.

Rare possibility of photosensitivity.

Exceptionally, occurrence of serious cutaneous infectious complications and soft tissue complications during varicella (see section 4.4).

Musculoskeletal and systemic disorders

A few cases of bone fluorosis have been described after several years of treatment with high doses.

Renal and urinary disorders

Interstitial nephritis, acute renal failure, rare nephrotic syndromes.

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization is important. It allows for continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr .