Each film coated tablet contains:
Aceclofenac BP 100 mg
Excipients q.s.
Approved colours used
Each film coated sustained
release tablet contains:
Aceclofenac BP 200 mg
Excipients
Approved colours used
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has bran reposed very rarely.
Hypersensitivity:
Hypersensitivity reaction have been reported following treatment with NSAIDs. These may consist of:
(a) Non-specific allergic reactions and anaphylaxis
(b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnea,
(c) Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpose, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Other adverse reactions reported less commonly include:
Renal:
Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.
Hepatic:
Abnormal liver function, hepatitis and jaundice.
