Bristaflam

Description

Indications

For the treatment of inflammation and pain in

• rheumatoid arthritis
• osteoarthritis
• ankylosing spondylitis
• acute treatment of the signs and symptoms of
• scapulohumeral periarthritis
• pain of various etiologies such as musculoskeletal pain le glow back in), dental pain

Dosage and Administration

• Bristaflam tablets should be swallowed whole with a sufficient quantity of liquid Bristaflam should be.
• ulceration or taken preferably with or after food,
  Undesirable effects may be minimize BY using the lowest effective case for the shortest duration necessary to control symptomo (see Section Warnings and Precautions).
• The usual dose is 100 mg every 12 hours. The dosage regimen should be individualized according to the indication and other clinical variables.
• mere are no clinical data on the use of aceclofenac in children and therefore it is not recommended

for use in children

• The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of the serious consequences of adverse reactions.
• If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.
• The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency

Renal insufficiency

• There is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see Section Warnings and Precautions).
• Aceclofenac is contraindicated in patients with severe renal impairment.

Hepatic insufficiency

• There is some evidence that the dose of bristaflam should be reduced in patients with hepatic impairment
  and it is suggested that an initial daily dose of 100 mg be used, Contraindications

Aceclofenac is contraindicated in:

• patients with known hypersensitivity to aceclofenac or to any of the excipients, active, or history of recurrent peptic ulcer haemorrhage (two or more distinct episodes of proven or bleeding)
  patients with histories of gastrointestinal bleeding or perforation, related to previous NSAIDS
• therapy (see Section Warnings and Precautions),
  patients who have previously shown hypersensitivity reactions (0.9. asthma, rhinitis, angioedema response to Ibuprofen, aspirin, or other non-steroidal anti-

 Dosage and Administration)..

• Respiratory disordersCardiovascular, renal and hepatic impairment precipitate renal falute
  Caution is required if administered to patients suffering from or with a previous history of bronchial asuima since NSAIDs have been reported to precipitate bronchospasm in such patients,
• The administration of an NSAID may cause a dose dependent reduction in prostagland information and
  yatuncion, those taking diuretics of recovering from major surgery and the elderly.
• The importance ofPatiente a greatest risk of this reaction are those with impaired renal function, cardiac impairment

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