• Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis (tab, SR tab, inj.-i.m.).
• Exacerbation of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis (inj.- i.m.).
• Inflammatory and degenerative forms of rheumatism: juvenile rheumatoid arthritis (tab) in adolescents over 14 years of age.
• Inflammatory and degenerative forms of rheumatism: painful syndromes of the vertebral column, non-articular rheumatism (Tab, SR tab, D tab, inj-i.m.).
• Post-traumatic and post-operative pain, inflammation and swelling e.g., following dental or orthopaedic surgery (Tab, SR tab, D tab; inj.-i.m.).
• Acute attacks of gout (Tab, inj.-i.m., D tab.).
• Painful and/or inflammatory conditions in gynaecology, e.g, primary dysmenorrhoea or adnexitis (Tab., SR tab., D tab.).
• Renal colic (inj.-i.m.).
• Treatment or prevention of post-operative pain in a hospital setting (inj- i.v. only). 
• Painful post-traumatic inflammatory states, e.g. due to sprains.

Dose to be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary.

Dosage: Dose to be individually adjusted, lowest effective dose to be given for the shortest duration.

(For Tab., SR tab., D tab.):

Adults - 50 to 150 mg/day in divided doses (dysmenorrhoea: up to 200 mg/day for Tab., D tab.). Adolescents over 14 years of age: 0.5 to 2 mg/kg/day (juvenile rheumatoid arthritis up to 3mg/kg/day for Tab.), with a maximum daily dose of 150 mg.

(For Inj):

Adults- 1 or at the most 2 ampoules (i.m. or i.v.) daily as initial therapy for not more than 2 days. Ampoules must not be given as an i.v. bolus injection. For 75mg/3ml inj. before i.v. infusion dilute contents of 1 ampoule with 100 to 500 mL of saline 0.9% or glucose 5% buffered with 0.5 mL sodium bicarbonate 8.4% or 1 mL of 4.2%. For 75mg/1ml inj. before i.v. infusion dilute contents of 1 ampoule with 100 to 500 mL of saline 0.9% or glucose 5% and buffering with sodium bicarbonate should not be done. I. V administration should be done as slow infusion over 30min to 2hrs. Total maximum daily dose is 150 mg. The directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site.(For D tab): Adults- Short-term treatment only.

Special patient populations: Patients with established heart disease or cardiovascular risk factors should only receive doses up to max. 100 mg daily if treated for more than 4 weeks.

Known hypersensitivity to diclofenac, to sodium metabisulphite (INJ only) or other excipients.

• Active gastric or intestinal ulcer, bleeding or perforation.
• Last trimester of pregnancy.
•  Hepatic failure.
•  Renal failure (GFR <15 mL/min/1.73m2).
• Severe cardiac failure.

Known hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

Warnings and precautions:

• Caution recommended in patients with symptoms/history of gastrointestinal (GI) disease and in elderly because of the risks of GI bleeding or perforation. To be discontinued if these conditions occur.
• Combined use with protective agents to be considered in patients with history of ulcer, elderly and those requiring low dose acetylsalicylic acid.
• Caution when used concomitantly with corticosteroids, anticoagulants, anti-platelet agents or SSRIs.
• Caution recommended in patients with ulcerative colitis or Crohn’s disease.
• Treatment generally not recommended in patients with established heart disease or uncontrolled hypertension. If needed in patients with established heart disease, uncontrolled hypertension or significant cardiovascular risk factors, treat only after careful consideration and with dose adjustment and periodic re-evaluation, especially when treatment continues for more than 4 weeks.
• Monitoring of blood counts recommended during prolonged treatment.
• Monitoring recommended in patients with defects of haemostasis.
• Caution recommended in patients with asthma, seasonal allergic rhinitis or chronic pulmonary diseases.
• Special caution recommended for parenteral use in patients with bronchial asthma (INJ only). Risks of serious allergic reactions.

To be discontinued if these conditions occur:

• Caution recommended in patients with impaired hepatic function (including porphyria).
• Monitoring of liver function during prolonged treatment.
• Beware of severe fluid retention and edema.
• Monitoring of renal function recommended in patients with history of hypertension, impaired cardiac or renal function, extracellular volume depletion, the elderly, patients treated with diuretics or drugs that impact renal function.
• Caution is indicated in the elderly.
• Avoid use with other systemic NSAIDs including COX-2 inhibitors.
• May mask signs and symptoms of infection. Pregnancy and breast-feeding: • Must not be used during the third trimester of pregnancy.
• Should not be used in the first and second trimester of pregnancy and by breast-feeding mothers.

Fertility:

• Not recommended to use in women attempting to conceive as it may impair female fertility.

Excipients:

• Possibility of hypersensitivity reactions to sodium metabisulphite (INJ only).