RHEUMA®-100 (Aceclofenac) Tablet: Each film coated tablet Contains Aceclofenac BP 100mg.
RHEUMA®-100: is a non-steroidal agent with anti-inflammatory and analgesic properties. Its mode of action is largely based on inhibition of prostaglandin synthesis.
RHEUMA®-100: is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. It also stimulates cartilage matrix (glycosaminoglycans) synthesis.
RHEUMA®-100 is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Adults: the maximum recommended dose is 200 mg daily, taken as two separate 100mg dose, one tablet in the morning and one in the evening.
Children: There is no clinical data on the use of aceclofenac in children.
Elderly: The pharmacokinetics of aceclofenac are not altered in elderly patients. Therefor it is not considered necessary to modify the dose and dose frequency.
Renal insufficiency: there is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment.
Hepatic insufficiency: The dose of aceclofenac should be reduced in patient with hepatic impairment. An initial daily dose of 100mg should be administered.
RHEUMA®-100 (Aceclofenac) is contraindicated in patients previously sensitive to aceclofenac or aspirin or other NSAIDs. It should not be administered to patients with active or suspected peptic ulcer or gastrointestinal bleeding and moderate to severe renal impairment.
RHEUMA®-100 (Aceclofenac) should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with history of peptic ulceration, ulcerative colitis, crohn’s disease, hepatic porphyria, and coagulation disorders. Patient suffering from severe hepatic impairment must be monitored.
Pregnancy: there is no information on the use of aceclofenac during pregnancy. RHEUMA®-100 (Aceclofenac) should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective dose should be administered.
Lactation: there is no information on the secretion of
Generally aceclofenac is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhea) and occasional occurrence of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.
Lithium and Digoxin: Aceclofenac like other NSAIDs, may increase plasma concentration of lithium and digoxin
There is no human data available on the consequences of aceclofenac over dosage, following therapeutic measures to be taken: absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications.
Keep in a cool dry place and protect from light.
Keep out of the reach of children.
RHEUMA®-100 (Aceclofenac): Each box contains 10×10’s tablets in blister strip.