COMPOSITION
Fleco Tablet: Each film-coated tablet contains Aceclofenac BP 100 mg.
PHARMACOLOGY
Fleco (Aceclofenac) is a non-steroidal agent with marked anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme Cyclooxygenase, which is involved in the production of prostaglandin.
INDICATION
For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Dosage & Administration
Adult: The recommended dose is 100 mg, twice daily.
Children: There is no clinical data on the use of Aceclofenac in children.
Elderly: The pharmacokinetics of Aceclofenac is not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
CONTRAINDICATION & PRECAUTION
Aceclofenac should not be administered to patients with active or suspected peptic ulcer or gastro-intestinal bleeding. It should not be given to patients with moderate to severe renal impairment. Aceclofenac should not be administered in patients previously sensitive to aceclofenac or aspirin or other NSAIDs.
SIDE EFFECTS
The majority of side-effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological complaints including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.
DRUG INTERACTION
Lithium and Digoxin: Aceclofenac, like many NSAIDs may increase plasma concentrations of lithium and digoxin.
Diuretics: Aceclofenac, like other NSAIDs, may interact the activity of diuretics.
Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulant. Methotrexate: Caution should be exercised if NSAIDs and Methotrexate are administered within 24 hours of each other, since NSAIDs may increase Methotrexate plasma level, resulting in increased toxicity.
USE IN PREGNANCY AND LACTATION
There is no information on the use of aceclofenac during pregnancy. There is no information of the secretion of aceclofenac in breast milk. 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 children.
STORAGE
Keep at a cool and dry place, protected from light and moisture.
PACKING
Fleco tablet: Box containing 10 x 10 tablets in Alu-Alu blister pack.
