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Analgesics & Antipyretics

Diclofenac STADA® 100 mg

 

Pack size:

Box of 10 blisters x 10 tablets.  

 

Composition:

Each retard film-coated tablet contains diclofenac sodium 100 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

  • Used mainly for the relief of pain and inflammation in musculoskeletal and joint disorders such as rheumatoid arthritis, chronic osteoarthritis.
     
  • Orally taken with food; The drugs should be swallowed whole, do not break, crush or chew before swallowing.
    Carefully consider the potential benefits and risks of diclofenac sodium retard tablets and other treatment options before deciding to use.
    After observing the response to initial therapy with diclofenac, the dose and frequency should be adjusted to suit an individual patient's needs.
    To minimize the risk for an adverse cardiovascular event in patients treated with Diclofenac STADA® 100 mg, prescribe the lowest effective daily dose for the shortest duration possible (see section PRECAUTIONS).
     
  • For the relief of chronic osteoarthritis: The recommended dosage is 100 mg once daily.
  • For the relief of rheumatoid arthritis: The recommended dosage is 100 mg once daily. In the rare patient where 100 mg dose once daily is unsatisfactory, the dose may be increased to 100 mg twice daily if the benefits out weigh the clinical risks of increased side effects.


Or as prescribed by physicians.

 

  • Known hypersensitivity to diclofenac or to any ingredient of the drug.
  • Patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
  • Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • Patients in the last 3 months of pregnancy.
  • 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, nausea.
  • Epigastric pain, nausea, vomiting, diarrhoea, flatulence, anorexia, dyspepsia.
  • Transaminases increased.
  • Tinnitus.

Uncommon

  • Edema, allergic reactions (especially bronchospasm in patients with asthma), anaphylactoid systemic reactions including hypotension, rhinitis, urticaria.
  • Abdominal pain, gastrointestinal bleeding, active ulcers, hematemesis, melena, bloody diarrhoea.
  • Sleepy, drowsiness, depression, insomnia, anxiety, malaise, irritability.
  • Urticaria.
  • Bronchospasm.
  • Blurred vision, blind spot, eyes aches and pains, diplopia.

Rare

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

     

  • Use with caution in patients with active gastrointestinal 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.
  • Diclofenac should be used with caution in patients with preexisting asthma.
  • 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 troke, 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® 100 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.
  • Patients who experience dizziness, drowsiness, fatigue or visual disturbances, 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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