- Diclofenac is a non-steroidal anti-inflammatory compound with pronounced
   analgesic, anti-inflammatory and antipyretic properties. Diclofenac acts by inhibiting
   prostaglandin biosynthesis, by decreasing the activity of the enzyme, 
   cyclo-oxygenase, and results in decreased formation of prostaglandin precursors, 
   which play a major role in causing inflammation, pain and fever.
- Diclof® D have a rapid onset of action, which makes them particularly suitable for 
  the treatment of acute painful and inflammatory conditions, and for those patients
  who have difficulty in swallowing conventional tablets

 Each Diclof® D dispersible tablet contains:   diclofenac 46.5 mg (equivalent to diclofenac sodium 50 mg).

- Diclof® D like other non-steroidal anti-inflammatory drugs, should not be given to
   patients with active peptic ulcer and to patients in whom attacks of asthma,
   angioedema, urticaria or acute rhinitis have been precipitated by aspirin or any other  
   drugs with prostaglandin- synthetase inhibiting activity. Diclof® D should be avoided
   in patients with a history of acute prophyria.
- Diclof® D is contraindicated for the tratment of perioperative pain in the setting of  
  coronary artery bypass graft (CABG )surgery.
- Concomitant use of anticoagulants and antiplatlets.
- Diclof® D is contraindicated for patient with prior gastrointestinal bleeding or 
  perforation, related to the use of anti-inflammatory analgesics.

- Concomitant treatment with potassium-sparing diuretics may be associated with
  increased serum potassium levels, which should therefore be monitored frequently.
- When given simultaneously with preparations contain digoxin, methotrexate,
   cyclosporin, sulfonylureas or lithium, diclofenac may raise their plasma concentrations.
- Like other NSAIDs concomitant administration with beta-blockers may antagonize the 
  hypotensive effect of the beta-blockers.
- Concomitant administration of other systemic NSAIDs or corticosteroids may increase 
  the occurrence of side effects.
- Patients taking diclofenac and oral anticoagulants should undergo routine blood tests.
- Colestipol and Cholestyramine induced decrease in absorpion of diclofenac.

- Absorption of diclofenac from Diclof® D dispersible tablets sets in immediately 
  after administration. The time to achieve maximum plasma concentration is attained
  on average 1 hour after ingestion of one tablet  Diclof® D  dose on an empty stomach.
- The bioavalability of diclofenac from DDiclof® D is 82% of the bioavailability of 
  diclofenac enteric-Coated tablets. 
- Administration of diclofenac together with or immediately after a meal does not delay 
  the onset of absorption but reduces the amount absorbed by an average of about 16% 
  and the maximum concentrations by about 50%.
- Diclofenac appears to be widely distributed in the body, with significant amounts in
  synovial fluid (present in the joints) the concentrations attained in the synovial fluid 
  are higher than those in plasma and remain higher for up to 12 hours.
- Diclofenac is metabolized in the liver and the metabolites  are excreted in the urine 
  and the bile. 
- The elimination half-life is about 1-2 hours following oral administration.

- Diclof® D should not be used during pregnancy particularly the last three months owing 
  to the possibility of uterine inertia and/or premature closure of the ductus arteriosus.
- Diclof® D is excreted in breast milk, but in quantities so small that no undesirable
   effects on the infant are to be expected.

- Diclof® D is generally well tolerated. The reported adverse effects include 
  gastrointestinal disturbances, such as epigastric pain, heartburn, nausea, vomiting,
  diarrhea, and indigestion. Rarely gastrointestinal bleeding, gastric or intestinal ulcer 
  with or without bleeding or perforation may occur. Fluid retention, liver function 
  disorders, rash and prurtitis have been reported.

- Management of acute poisoning with NSAIDs consists essentially of supportive and 
  symptomatic measures. There is no typical clinical picture associated with overdosage 
  of diclofenac.
  The following therapeutic measures should be taken in cases of overdosage:
- Absorption should be prevented as soon as possible after the overdosage by means of 
  gastric lavage and treatment with activated charcoal.
- Supportive and symptomatic treatment should be given for complications such as 
   hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory
- Specific therapy such as forced diuresis, dialysis or haemoperfusion is unlikely to be 
   helpful in accelerating the elimination of NSAIDs because of their high  protein binding 
   rate and extensive metabolism.

- Use of  Diclof® D particulary higher doses of 150 mg/ day and in prolong treatment
  may be associated with a slightly increased risk of arterial thromobotic events.
- Patients with uncontrolled hyprtension, congestive heart failure, established ischaemic
  heart disease, peripheral arterial disease, and/ or cerebrovascular disease should only 
  be treated with Diclof® D after careful consideration.
  similar consideration should also be made before initiating longer term treatment of 
  patients with risk factors for cardiovascular events.
- As with all types of analgesics, long term use for relief of headache can develop or 
  worsen. Headache caused by over usage of analgesic should not be treated with
  increased dose of analgesic.  In such cases the treatment should be withdrawn.
- Diclof® D should be used cautiously with the elderly patients. In patients with
  congestive heart failure, hyprtension, decreased renal or hepatic function, history of 
  gastrointestinal disease or those receiving anticoagulants.
- Diclof® D is recommended for short-term treatment only.

Warning :-
- Diclof® D may cause elevation of one or more liver enzyme ;  close medical
   surveillance is required when prescribing Diclof® D to patients with impaired hepatic 
- If abnormal liver function tests persist or worsen, if signs or  symptoms consistent with
  liver disease develop, Diclofenac should be discontinued.
- Physicians should measure transaminases periodically in patients receiving long-term
   therapy with Diclof® D. Transaminases should be monitored during 4 to 8 weeks after
   initiating treatment with Diclof® D.
- Cardiovascular risk:  NSAIDs may cause an increased risk of serious cardiovascular
   thrombotic events, myocardial infraction and stroke, which can be fatal. This risk may
   increase with duration of use. Patients with cardiovascular disease or risk factors for
   cardiovascular disease may be at greater risk.
- Gastrointestinal  Risk: NSAIDs may cause an increased risk of serious gastrointestinal 
  adverse events including bleeding ulceration and perforation of the stomach or 

intestines, which can be fatal. These events can occur at any time during use and 
  without warming symptoms. Elderly patients are at greater risk for serious 
  gastrointestinal events.

- Diclof® D dispersible tablets: pack of 2 blisters, blister of  10 tablets.

- Store at a temperature below 25 Cº in a dry place, and protect from light.