Composition
Each film coated tablet contains Aceclofenac BP 100 mg.
Pharmacology
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
Indication
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Dosage & Administration
The recommended dose in adults is 100 mg, twice daily.
Contraindication
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
Warning And Precaution
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
Side Effects
Most of the side effects are minor in nature and transient. These are indigestion, abdominal pain, nausea, vomiting and urticaria.
Use in Pregnancy and Lactation
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Use in Children and Adolescent
There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age.
Drug Interaction
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
Diuretics: may interact the activity of diuretics.
Anticoagulants: may enhance the activity of anticoagulant.
Methotrexate: may increase the plasma level of methotrexate.
Overdose
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.
Storage
Keep at cool and dry place below 300 C, protected from light and moisture. Keep out of the reach of children.
Packing
Fleco Tablet: Box containing 10 x 10 tablets in Alu-PVC blister pack.
