PAINO 100 mg tablet: Each film-coated tablet contains Aceclofenac BP 100 mg.
PAIN® is the preparation of Aceclofenac. Aceclofenac, a phenylacetic acid derivative, is peripherally acting, non-steroidal anti-inflammatory analgesic with anti-inflammatory, antiarthritic and antipyretic activities. It is converted to active metabolites intracellularly that inhibit the production of prostaglandins. Aceclofenac demonstrates better gastric tolerance and consequently offers greater potential security than other NSAIDs such as indomethacin and diclofenac.
Adult: The recommended dose is 200 mg daily in two divided doses, one tablet in the morning and one in the evening. The initial dose should be reduced to 100 mg daily in patients with hepatic impairment.
Children: It is not recommended.
Aceclofenac is highly protein-bound. Concomitant use of other proteinbinding drugs, e.g. anticoagulants, sulphonamides, hydantoins might necessitate modification of dosage in order to avoid increased levels of such drugs resulting from competition for plasma protein-binding sites. Similar acting drugs such as aspirin, or other non-steroidal antiinflammatory agents should not be administered concomitantly with aceclofenac as the potential for adverse reactions is increased. Serious interactions have been recorded after the use of high dose methotrexate with non-steroidal anti-inflammatory agents including aceclofenac.
Overdose:
Like other propionic acid derivatives, aceclofenac is of low toxicity in ovee are avo aec a aee aecgs aoei limited to drowsiness, abdominal pain and vomiting, but adverse effects seen after over dosage with propionic acid derivatives such as hypotension, bronchospasm and gastrointestinal haemorrhage should be anticipated. Treatment should be symptomatic and may include gastric washout and the use of activated charcoal.
There is no information in the use of aceclofenac during pregnancy. The use of aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the mother outweigh the possible risk to the fetus.
Cautions must be taken in renal, cardiac, hepatic impairment, and elderly patients. The dose should be kept as low as possible and renal function should be monitored.
Warnings:
Gastro-intestinal disorders, with a history suggestive of gastro-intestinal ulceration, with ulcerative colitis or with Crohn's disease, bleeding diathesis or haematological abnormalities, severe impairment of hepatic function. Gastro-intestinal bleeding or ulcerative perforation, haematemesis and melaena may occur at any time during the treatment. As with other NSAIDs allergic reactions, including anaphylactic reactions can also occur without earlier exposure to the drug.
Do not store above 30°C. Keep away from light and wet place. Keep out of reach of children.