TIAGAM

They derive from the anti-inflammatory activity of tiaprofenic 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, in adults and children from 15 kg (i.e. approximately from 4 years), to:

· long-term symptomatic treatment:

o of chronic inflammatory rheumatism, notably rheumatoid arthritis,

o of certain painful and disabling arthroses;

· short-term symptomatic treatment:

o of acute flare-ups of arthrosis, of low back pain,

o of benign acute post-traumatic conditions of the locomotor system;

· dysmenorrhea after etiological investigation;

· symptomatic treatment of pain during inflammatory manifestations in the fields of ENT and stomatology. In this indication, the risks incurred, in particular the extension of a concomitant septic process, are those of NSAIDs. They must be evaluated against the expected analgesic benefit.

Warn patients of the possible onset of dizziness.

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.

· Very common:

o abdominal pain.

· Common:

o nausea, vomiting, dyspepsia, diarrhea, constipation, gastritis.

· Frequency unknown:

o flatulence, ulcerative stomatitis, melæna, haematemesis, exacerbation of ulcerative colitis or Crohn's disease (see section 4.4),

o these digestive disorders have been reported following the administration of NSAIDs.

Peptic ulcers, perforations or gastrointestinal haemorrhages, sometimes fatal, may occur, particularly in the elderly, (see section 4.4).

Cardiovascular disorders

· Oedema, hypertension and heart failure have been reported in association with treatment with NSAIDs.

· Rarely reported:

o elevation of blood pressure, tachycardia, chest pain, arrhythmia, palpitations, hypotension, congestive heart failure.

Immune system disorders

· Common:

o the occurrence of asthma attacks may be linked in some subjects to an allergy to aspirin or an NSAID (see section 4.3).

· Frequency unknown:

o general malaise with hypotension, Quincke's oedema, anaphylactic shock.

Skin and subcutaneous tissue disorders

· Common:

o rash, urticaria and aggravation of chronic urticaria, pruritus.

· Rare:

o erythema multiforme.

· Very rare:

o bullous reactions (including Stevens-Johnson syndrome and Lyell syndrome).

· Frequency unknown:

o purpura, cases of photosensibilisation, Quincke's oedema.

Nervous system disorders

Dizziness sensations.

Ear and labyrinth disorders:

· Frequency unknown:

o vertigo, tinnitus.

Renal and urinary disorders

· Common: cystitis.

· Acute renal failure (ARF) functional in patients presenting with risk factors (see section 4.4).

· Organic renal damage which may result in ARF: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.

· Urinary disorders of unknown frequency (cystalgia, dysuria and pollakiuria), or haematuria may occur. Serious cases have been exceptionally reported when treatment was continued. These disorders are reversible on discontinuation of treatment.

Other

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

Metabolism and nutrition disorders

· Frequency unknown:

o water and sodium retention, hyperkalaemia (see section 4.4 and section 4.5).

Investigations:

· Common:

o abnormality of liver tests.

· Frequency unknown:

o prolongation of bleeding time.

Blood and lymphatic system disorders

· Undetermined frequency:

o thrombocytopenia, anemia due to bleeding.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicinal product is important. It allows 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/ .