Product Name & Strength: Acycor Tablets (Aceclofenac 100 mg), 10 x 1 x 10's.
Indications (Approved Uses): Officially approved for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults.
Contraindications (Safety Warnings): Absolutely contraindicated in patients with hypersensitivity to aceclofenac or any of its excipients, and in those who have previously shown hypersensitivity reactions (such as asthma, rhinitis, angioedema, or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). It must not be used in patients with an active or history of recurrent peptic ulcer or haemorrhage, active bleeding or bleeding diathesis, a history of gastrointestinal bleeding or perforation related to previous NSAID therapy, severe hepatic failure, or severe renal failure. It is also contraindicated in patients with established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. It must not be used during pregnancy (especially the third trimester), during lactation, or by women attempting to conceive. Major drug interactions include other NSAIDs, COX-2 selective inhibitors, anti-hypertensives, diuretics, cardiac glycosides (digoxin), lithium, methotrexate, mifepristone, corticosteroids, anti-coagulants (such as warfarin), quinolone antibiotics, anti-platelet agents, selective serotonin reuptake inhibitors (SSRIs), ciclosporin, tacrolimus, zidovudine, and antidiabetic agents.
Side Effects (Adverse Reactions): Known adverse reactions include dyspepsia, abdominal pain, nausea, diarrhoea, dizziness, and increased hepatic enzymes. Less commonly, patients may experience flatulence, gastritis, constipation, vomiting, mouth ulceration, pruritus, rash, dermatitis, urticaria, and elevated blood urea or creatinine. Rare but serious risks include gastrointestinal haemorrhage or perforation, peptic ulcers, exacerbation of Crohn's disease and colitis, anaphylaxis, severe cardiac failure, hypertension, bronchospasm, severe hepatotoxicity (including hepatitis and jaundice), renal failure, bone marrow depression (including neutropenia and thrombocytopenia), and severe mucocutaneous skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Nutritional Information (per tablet): Aceclofenac BP 100 mg.
Instructions for Use / Dosage: For oral administration. Tablets should be swallowed whole with a sufficient quantity of liquid, preferably with or after food. Adults: The recommended dose is 200 mg daily, taken as two separate 100 mg doses (one tablet in the morning and one in the evening). Elderly patients and those with hepatic impairment should use the lowest effective dose; for patients with liver impairment, an initial daily dose of 100 mg is suggested. It is not recommended for use in children.
Regulatory Information: NAFDAC Registration Number: A4-4595. Manufactured by: Globela Pharma Pvt Ltd.
