ANTARENE

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen.

It is indicated, in adults and children weighing more than 20 kg (approximately 6 years), for the short-term treatment of fever and/or pains such as headaches, flu-like states, dental pains, body aches, and painful periods.

Warn patients of the possible onset of dizziness and visual disturbances.

A single dose or short-term use generally does not require taking special precautions.

SPEDIFEN 200 mg, comprimé therefore has only a minor influence on the ability to drive vehicles and use machines.

Adverse effects are mainly related to the pharmacological effects of ibuprofen on prostaglandin synthesis.

Clinical studies suggest that the use of ibuprofen, particularly at a high dose (2400 mg daily) is likely to be associated with a slightly increased risk of arterial thrombotic events (myocardial infarction or stroke, for example) (see section 4.4).

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

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

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

The table below lists the adverse effects by system organ class and by frequency (very common [≥ 1/10], common [≥ 1/100, < 1/10], uncommon [≥ 1/1 000, < 1/100], rare [≥ 1/10 000, < 1/1 000], very rare [< 1/10 000] and frequency not known [cannot be estimated from the available data]).

Pediatric population

Based on accumulated clinical experience, no clinically significant difference in the safety profile has been observed between adults and the approved pediatric population (≥ 12 years) in terms of the nature, frequency, severity, and reversibility of adverse effects.

Reporting of suspected adverse effects

Reporting suspected adverse effects after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance 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 Centers - Website: https://signalement.social-sante.gouv.fr .