Diclofenac STELLA 50 mg

Rx

Indications:

Adults and elderly:

Relief of all grades of pain and inflammation in a wide range of conditions, including:

• Arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout.
• Acute musculoskeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis.
• Other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Dosage:

75-150 mg daily in two or three divided doses.

To minimize the risk for an adverse cardio vascular event in patients treated with Diclofenac STELLA 50 mg prescribe the lowest effective daily dose for the shortest duration possible.

Usage:

Diclofenac STELLA 50 mg is administered orally.

• Hypersensitivity to diclofenac, to aspirin or other NSAIDs (asthma, rhinitis, urticaria after aspirin use).
• Active peptic ulcer.
• Patients with asthma or bronchospasm, bleeding disorders, cardiovascular diseases, severe liver or renal failure.
• Patients who are receiving coumarin anticoagulants.
• Patients with congestive heart failure, diuretic-induced volume depletion or renal impairment, glomerular filtration rate < 30 ml/min (because of high risk of developing renal dysfunction).
• Patients with collagen disease (risk of developing aseptic meningitis, note that in all case of aseptic meningitis, there has been some form of auto-immune disease in the patient history as predisposing factor).
• Patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.

Common: Headache, nervousness; epigastric pain, nausea, vomiting, diarrhoea, flatulence, anorexia, dyspepsia; transaminases increased; tinnitus.

Uncommon: Edema, allergic reactions (especially bronchospasm in patients with asthma), anaphylactic reactions including hypotension, rhinitis, urticaria; abdominal pain, gastrointestinal bleeding, active ulcers, hematemesis, melena, bleeding diarrhoea; sleepy, drowsiness, depression, insomnia, anxiety, malaise, irritability; urticaria; bronchospasm; blurred vision, scotoma, eye pain, diplopia.

Use Diclofenac STELLA 50 mg with caution in:

• Patients with active GI ulceration or bleeding.
• Patients with coagulation disorders or patients receiving anticoagulants.
• Patients with preexisting asthma.
• Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders.
• Patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and edema.
• Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking)
• A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with diclofenac. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, diclofenac should be discontinued.

Diclofenac STELLA 50 mg reduces fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Patients on long-term treatment with NSAIDs, including diclofenac, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

Avoid use Diclofenac STELLA 50 mg in the third trimester and late in pregnancy. Discontinue nursing or the drug.

Patients who experience visual disturbances, dizziness, vertigo, somnolence, central nervous system disturbances, drowsiness or fatigue while taking NSAIDs should refrain from driving or operating machinery.