CARTREX

ACECLOFENAC VIATRIS 100 mg, film-coated tablet is indicated in adults for the symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

In case of lightheadedness, dizziness or other central nervous system adverse effects during NSAID intake, one should refrain from driving a vehicle or using a machine.

Class effects reported with NSAIDs

The most frequently reported adverse effects are gastrointestinal in 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, melaena, haematemesis, exacerbation of ulcerative haemorrhagic colitis or Crohn's disease (see section 4.4) have been reported following administration of NSAIDs. Less frequently, gastritis has been observed. Oedema, hypertension and heart failure have been reported in association with NSAID treatment.

Other very rare (< 1/10 000) class effects reported with NSAIDs

· Renal and urinary disorders, interstitial nephritis.

· Bullous reactions including Stevens-Johnson syndrome and Lyell syndrome.

Exceptionally, the occurrence of serious cutaneous or soft tissue infectious complications during varicella has been reported in association with NSAID treatment.

Effects with aceclofenac

Adverse effects reported during clinical trials and/or notified during the marketing of the product are presented by organ-system and in order of frequency. Very frequent (≥ 1/10); frequent (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000); very rare (< 1/10 000).

Aceclofenac, which is structurally related to diclofenac, is metabolized into diclofenac, for which a significant amount of clinical and epidemiological data indicate a constant increase in the risk of arterial thrombotic events (myocardial infarction or stroke, particularly at high doses and long-term use). Epidemiological studies have shown an increase in the risk of acute coronary syndrome and myocardial infarction associated with aceclofenac treatment (see sections 4.3 and 4.4 for contraindications and special warnings and precautions for use).

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/