Composition
Flexidol tablet: Each film coated tablet contains Aceclofenac BP 100 mg.
Pharmacology
Flexidol is a non-steroidal anti-inflammatory agent. This drug exhibits anti-inflammatory, analgesic and activity. Flexidol is an inhibitor of prostaglandin synthesis.
Indication
For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Dosage & administration
Adults: The recommended dose is 100 mg, twice daily.
Children: There are no clinical data on the use of Aceclofenac in children.
Contra-indication
This preparation is contraindicated in patients with known hypersensitivity to Aceclofenac or any other components of this preparation. This preparation should not be given to patients who have experienced asthma, urticaria.
Warning & precaution
Use of Aceclofenac should be avoided in patients with gastro-intestinal disorders and gastro-duodenal ulcer. In case of severe hepatic or renal damage or disturbance of cardiac function, a close medical surveillance is indicated. Blood counts including platelet counts, as well as monitoring of hepatic and renal functions are recommended, particularly in patients under long-term therapy.
Side effects
Aceclofenac is generally well tolerated, but occasionally patient may complain gastric discomfort, nausea & dizziness. In exceptional cases, very sensitive patients may suffer from gastro-intestinal bleeding, skin rashes and thrombocytopenia.
Use in pregnancy & lactation
Pregnancy: This drug should be avoided in pregnancy.
Lactation: Aceclofenac should be avoided during lactation period.
Use in children & adolescents
There are no clinical data on the use of Aceclofenac in children.
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. Close monitoring of patients on combined anticoagulants and Aceclofenac therapy should be undertaken.
Methotrexate: Caution should be exercised if NSAIDs and Methotrexate are administered within 24 hours of each other, since NSAIDs may increase Methotrexate plasma levels, resulting in increased toxicity.
Overdose
There are no human data available on the consequences of Aceclofenac over dosage. If over dosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Flexidol tablet: Each box contains 10x10's tablet in blister pack.
