FLAMARYX Tablet Ref.[51178] Active ingredients: Meloxicam

• Children under the age of 18 years – Safety and efficacy have not been established.
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal.
• The risk of gastrointestinal bleeding or perforation (PUBs) is higher with increasing doses of FLAMARYX, in patients with a history of ulcers, and the elderly.
• When gastrointestinal bleeding or ulceration occurs in patients receiving FLAMARYX, treatment with FLAMARYX should be stopped.
• FLAMARYX should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, StevensJohnson syndrome, and toxic epidermal necrolysis have been reported. FLAMARYX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with FLAMARYX therapy.
• Congestive heart failure increases the risk of renal decompensation (see “CONTRAINDICATIONS”).
• FLAMARYX should be used with caution in patients with:-
  • Hepatic impairment: Increases risk of renal decompensation.
  • Renal impairment: Increases risk of renal decompensation.

Patients with a history of gastrointestinal disease should be monitored very carefully while on FLAMARYX and therapy should be discontinued if any ulceration or bleeding occurs. Patients who are dehydrated, have hepatic or renal dysfunction, taking diuretics or have undergone surgery leading to hypovolaemia, are at particular renal decompensation and renal function should be carefully monitored.

Patients who have heart failure are at particular renal decompensation (see “CONTRAINDICATIONS”).

In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Acetylsalicylic acid / Aspirin and other NSAIDS

Use of two or more NSAIDs concomitantly could result in an increase in side-effects. May result in an increase in gastric ulceration and/or bleeding.

Anticoagulants

FLAMARYX may enhance the effects of anti-coagulants such as warfarin, and increase the risk of bleeding complications.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs)

Increased risk of gastrointestinal bleeding.

Corticosteroids

Increased risk of gastrointestinal ulceration or bleeding (PUBs).

Lithium

May result in an increase in plasma lithium concentrations. Monitor lithium plasma concentrations carefully when therapy with FLAMARYX is initiated or withdrawn.

Methotrexate

May result in increased haematological toxicity due to methotrexate toxicity.

Angiotensin-converting enzyme (ACE) inhibitors, ARBs and other anti-hypertensive agents

May result in a decrease in antihypertensive effects and an increased risk of renal failure.

Cardiac glycosides

May result in an increase in plasma cardiac glycosides (e.g. digoxin) concentrations.

Cholestyramine

May result in a reduced therapeutic effect of FLAMARYX.

Ciclosporin

Increases the risk of nephrotoxicity.

Alcohol

Simultaneous intake may increase the risk of bleeding.

Diuretics

May result in renal impairment if the patient is dehydrated (see “WARNINGS AND SPECIAL PRECAUTIONS”).

Intrauterine device

NSAIDS may decrease the efficacy of intrauterine devices.

Safety and efficacy in pregnancy and lactation has not been established.

The use of FLAMARYX during the third trimester is not recommended because of possible adverse effects on the foetus, such as premature closure of the ductus arteriosus, which may lead to persistent pulmonary hypertension in the newborn. The onset of labour may be delayed and its duration increased (see “CONTRA-INDICATIONS”).

Patients should not operate machinery or drive a vehicle if they experience drowsiness, blurred vision or any other central nervous system effect.

Blood and the lymphatic system disorders

Less frequent: Anaemia, thrombocytopenia, agranulocytosis, leucopoenia.

The following side effects have been reported and frequencies are unknown: Neutropenia, eosinophilia.

Nervous system disorders

Less frequent: Headache, dizziness, light-headedness, vertigo, drowsiness, confusion.

The following side effects have been reported and frequencies are unknown: Insomnia, nightmares.

Eye disorders

Less frequent: Visual disturbances (such as blurred vision), conjunctivitis.

Cardiac disorders

Less frequent: Oedema, palpitations, elevated blood pressure (hypertension), cardiac failure.

Respiratory, thoracic and mediastinal disorders

Less frequent: Bronchospasm.

Gastrointestinal disorders

The most commonly observed adverse events are gastrointestinal in nature.

Frequent: Dyspepsia, diarrhoea, flatulence.

Less frequent: Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal. Perforation or ulceration is generally more serious in the elderly. Nausea and vomiting, constipation and abdominal pain, melaena, haematemesis, ulcerative stomatitis, induction or exacerbation of colitis, gastritis.

The following side effects have been reported and frequencies are unknown: exacerbation of Crohn’s disease.

Hepato-biliary disorders

Less frequent: Hepatitis.

Skin and subcutaneous tissue disorders

Less frequent: Pruritus, rash, flushing, urticaria, stomatitis, photosensitivity, bullous reactions, including erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary disorders

Less frequent: Nephrotic syndrome, glomerulonephritis, interstitial nephritis and papillary necrosis, renal failure.

Other

Less frequent: Tinnitus, hypersensitivity reactions including anaphylaxis, angioedema and bronchospasm (especially if patient is aspirin-sensitive and has asthma and/or nasal polyps FLAMARYX should be withdrawn immediately).