Flexi SR 200mg 10pcs

INDICATION
For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis.

DOSAGE AND ADMINISTRATION
Flexi® Tablet :
Adults :The recommended dose is 100 mg,twice daily.
Children :There are 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.
Flexi® SRTablet : The recommended dose is 200 mg, once daily.
CONTRAINDICATION AND 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. Close medical surveillance is also imperative in patients suffering from severe
impairment of hepatic function. It should not be prescribed during pregnancy, unless there are
compelling reasons for doing so. The lowest effective dosage should be used. Aceclofenac should
not be administered to patients previously sensitive to Aceclofenac or in whom aspirin or NSAIDs
precipitate attacks of asthma, acute rhinitis or urticaria or who are hypersensitive to these drugs.

SIDE EFFECT
The majority of side-effects observed have been reversible and of a minor nature and include
gastro-intestinal disorders (dyspepsia, abdominal pain, nausea and diarrhea) and occasional
occurrence of dizziness. Dermatological complaints including pruritus and rash and abnormal
hepatic enzyme levels and raised serum creatinine have occasionally been reported.
OVER DOSAGE
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.
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.

USE IN PREGNANCY AND LACTATION
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits
to the mother outweigh the possible risks to the fetus.