ACIGAM

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 20 kg (i.e. approximately from 6 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 osteoarthritis flare-ups, 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 (particularly when used at high doses and for long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see section 4.4).

Gastrointestinal disorders:

The most commonly observed adverse effects are gastrointestinal in nature.

· Very common:

o abdominal pain

· Common:

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

· Frequency not known:

o flatulence, ulcerative stomatitis, melaena, 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 haemorrhage, 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 NSAID treatment.

· Rarely reported:

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

Immune system disorders:

· Common:

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

· Frequency not known:

o general malaise with hypotension, angioedema, anaphylactic shock.

Skin and subcutaneous tissue disorders:

· Common:

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

· Rare:

o erythema multiforme.

· Very rare:

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

· Frequency not known:

o purpura, cases of photosensitivity, angioedema.

Nervous system disorders:

· Dizziness.

Ear and labyrinth disorders:

· Frequency not known:

o vertigo, tinnitus.

Renal and urinary disorders:

· Common:

o cystitis.

· Functional acute renal failure in patients with risk factors (see section 4.4).

· Organic renal damage which may result in acute renal failure; 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 upon discontinuation of treatment.

Other:

· Exceptionally, occurrence of serious infectious complications of the skin and soft tissues during chickenpox (see section 4.4).

Metabolism and nutrition disorders:

· Frequency not known:

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

Investigations:

· Common:

o abnormal liver function tests,

· Frequency not known:

o prolonged bleeding time.

Blood and lymphatic system disorders:

· Frequency not known:

o thrombocytopenia, anaemia due to bleeding.

Reporting of suspected adverse reactions

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