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Analgesics & Antipyretics

Diclofenac STADA® 50 mg


Pack size:

Box of 5 blisters x 10 tablets.

 

Composition:

Each enteric-coated tablet contains diclofenac sodium 50 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Protect from moisture.

Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

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.
     
  • To minimize the risk for an adverse cardiovascular event in patients treated with Diclofenac STADA® 50 mg prescribe the lowest effective daily dose for the shortest duration possible (see section PRECAUTIONS).
  • 75-150 mg daily in two or three divided doses.


Or as prescribed by physicians.

 

  • 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.

     

  • The adverse effects on the gastrointestinal tract were reported in 5-15% of patients receiving diclofenac.
  • Cardiovascular thrombosis risk: Clinical trial and epidemiological data suggest that the use of diclofenac, particularly at high doses (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section PRECAUTIONS).

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.

Rare

  • Edema, rash, Stevens-Johnson syndrome, alopecia.
  • Aseptic meningitis.
  • Leucopenia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, anaemia.
  • Dyskinesia of gallbladder, abnormal liver function test, hepatotoxicity (jaundice, hepatitis).
  • Cystitis, hematuria, acute renal failure, interstitial nephritis, nephrotic syndrome.

     

  • Use with caution in patients with active GI ulceration or bleeding.
  • Diclofenac cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.
  • The pharmacological activity of diclofenac in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
  • 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 (e.g., eosinophilia, rash, etc.), diclofenac should be discontinued.
  • 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.
  • Patients receiving diclofenac who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
  • Patients with preexisting asthma.
  • Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties.
  • In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders  there may be an increased risk of aseptic meningitis.
  • Appropriate monitoring and advice are required for patients with a history of hypertension and/or  mild to  moderate congestive heart failure as fluid retention and edema have been reported in  association with  NSAIDs therapy including diclofenac.
  • Risk of cardiovascular thrombotic events: Systemic non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. This risk may occur as early as the first weeks of treatment and may increase with duration of use. The cardiovascular thrombotic risk has been observed most consistently at higher doses.
    Physicians should assess periodically appearance of cardiovascular adverse events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and seek physicians immediately if these symptoms occur.
    To minimize the risk for an adverse cardiovascular event in patients treated with Diclofenac STADA® 50 mg, prescribe the lowest effective daily dose for the shortest duration possible.
    Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
  • Pregnancy: Avoid use diclofenac in the third trimester because of possible premature closure of the ductus arteriosus; avoid use late in pregnancy because of possible delay in labor or parturition.
  • Lactation: Discontinue nursing or the drug because of potential risk in nursing infants.
  • Effects on ability to drive and use machines: 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.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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