MEFSAL15 MG

· Short-term symptomatic treatment of acute osteoarthritis flares;

· Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis;

· MELOXICAM BIOGARAN is indicated in adults and children aged 16 years and older.

No specific study on the ability to drive and use machines has been carried out.

However, given its pharmacodynamic profile and the reported adverse effects, it is unlikely that meloxicam affects the ability to drive or use machines. However, in the event of vision disturbances, notably blurred vision, dizziness, drowsiness, vertigo or other central nervous system disorders, it is recommended to refrain from driving or using machines.

a) General description

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

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

The most frequently observed adverse effects are gastrointestinal in nature. Peptic ulcers, perforations or gastrointestinal hemorrhages, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, 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.

Severe cutaneous adverse reactions: Stevens-Johnson syndrome and Lyell's syndrome, have been reported (see section 4.4).

The frequencies of the events reported below are based on the occurrence rates of adverse effects observed during 27 clinical trials, with a treatment duration of at least 14 days. The data are derived from clinical trials conducted on 15 197 patients treated with daily oral doses of 7,5 or 15 mg of meloxicam in the form of tablets or capsules over periods of up to 1 year.

Adverse effects identified during spontaneous post-marketing notifications are also mentioned.

Adverse effects have been classified according to their incidence using the following classification:

Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

b) Table of adverse effects

Blood and lymphatic system disorders

Uncommon: anemia.

Rare: blood count abnormalities (including differential white blood cell count), leukopenia, thrombocytopenia.

Very rare cases of agranulocytosis have been reported (see section c).

Immune system disorders

Uncommon: allergic reactions other than anaphylactic/anaphylactoid reactions.

Not known: anaphylactic/anaphylactoid reactions.

Psychiatric disorders

Rare: altered mood, nightmares.

Not known: confusional state, disorientation.

Nervous system disorders

Common: headache.

Uncommon: dizziness, somnolence.

Eye disorders

Rare: visual disturbances, including blurred vision, conjunctivitis.

Ear and labyrinth disorders

Uncommon: vertigo.

Rare: tinnitus.

Cardiac disorders

Rare: palpitations.

Heart failure has been reported in association with NSAID treatment.

Vascular disorders

Uncommon: increased blood pressure (see section 4.4), flush.

Respiratory, thoracic and mediastinal disorders

Rare: asthma in subjects allergic to aspirin or other NSAIDs.

Gastrointestinal disorders

Very common: gastrointestinal disorders such as dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea.

Uncommon: occult or macroscopic gastrointestinal hemorrhage, stomatitis, gastritis, eructation.

Rare: colitis, gastroduodenal ulcers, esophagitis.

Very rare: gastrointestinal perforation.

Not known: pancreatitis.

Gastrointestinal hemorrhage, ulceration or perforation may sometimes be severe and potentially fatal, especially in the elderly (see section 4.4).

Hepatobiliary disorders

Uncommon: liver function abnormalities (e.g., increased transaminases or bilirubin).

Very rare: hepatitis.

Skin and subcutaneous tissue disorders

Uncommon: angioedema, pruritus, rash.

Rare: Stevens-Johnson syndrome, Lyell's syndrome, urticaria.

Very rare: bullous dermatitis, erythema multiforme.

Not known: photosensitivity reaction, fixed drug eruption (see section 4.4).

Renal and urinary disorders

Uncommon: sodium and water retention, hyperkalemia (see sections 4.4 and 4.5), renal function test abnormalities (increased serum creatinine and/or serum urea).

Very rare: acute renal failure especially in patients at risk (see section 4.4).

Reproductive system and breast disorders

Not known: female infertility, delayed ovulation.

General disorders and administration site conditions

Uncommon: edema, including edema of the lower limbs.

c) Information concerning individual serious cases or particularly frequent reactions

Very rare cases of agranulocytosis have been reported in patients treated with MELOXICAM and other potentially myelotoxic drugs (see section 4.5).

d) Adverse effects not observed to date with the medicinal product, but generally known to be related to the administration of other products of the same class

Organic renal lesions resulting in acute renal failure: very rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and renal papillary necrosis have been reported (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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/.