DICLOFENAC SODIUM

4). Posology Adults 75 - 150 mg daily in 2 -3 divided doses. The recommended maximum daily dose of diclofenac sodium is 150 mg. Paediatric population Children (1 year or over) 1 - 3 mg/kg per day in divided doses. For the short term treatment of fever related to infections of the ear, nose or throat (ENT) and post-operative pain the following dosage should be given: Children aged 9 years (min.

35 kg BW) or over and adolescents should be given up to 2 mg/kg body weight per day in 3 divided doses, depending on the severity of the disorder. Elderly The elderly are at increased risk of the serious consequences of adverse reactions.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. 3). No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made.

4). 3). No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. 4). Method of administration For oral administration Swallow tablets whole with some water.

Do not crush or chew. To be taken preferably with or after food.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.

The following undesirable effects include those reported with either short-term or long-term use. Table 1 Blood and lymphatic system disorders Very rare Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), Agranulocytosis.

Immune system disorders Rare Very rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Angioneurotic oedema (including face oedema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders Common Rare Very rare Not known Headache, dizziness. Somnolence, tiredness. Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident, Confusion, hallucinations, disturbances of sensation, malaise.

Eye disorders Very rare Visual disturbance, vision blurred, diplopia. Not known Optic neuritis. Ear and labyrinth disorders Common Very rare Vertigo. Tinnitus, hearing impaired. Cardiac disorders Very rare Palpitations, chest pain, cardiac failure, myocardial infarction.

Not known Kounis syndrome Vascular disorders Very rare Hypertension, hypotension, vasculitis. Respiratory, thoracic and mediastinal disorders Rare Very rare Asthma (including dyspnoea). Pneumonitis. Gastrointestinal disorders Common Rare Very rare Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

4)). Colitis (including haemorrhagic colitis and Not known exacerbation of ulcerative colitis or Crohn's disease), constipation, Stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

2 and GI and cardiovascular risks below). 5). Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

8). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to diclofenac.

Like other NSAIDs, diclofenac sodium may mask the signs and symptoms of infection due to its pharmacodynamic properties. Gastrointestinal effects Gastrointestinal bleeding (haematemesis, melaena), ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be withdrawn. 8). 3) and in the elderly. 2). To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.

g. 5). Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms, (especially GI bleeding). 5). 8). When GI bleeding or ulceration occurs in patients receiving diclofenac, the treatment should be withdrawn.

NSAIDs, including diclofenac, may be associated with increased risk of gastro- intestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery. Hepatic effects Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

1. • Active gastric or intestinal ulcer, bleeding or perforation • History of gastrointestinal bleeding or perforation, related to previous non- steroidal anti-inflammatory drugs NSAIDs therapy. 6). 4). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease • Like other non-steroidal anti-inflammatory drugs-NSAIDs, diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, angioedema or acute rhinitis are precipitated by acetylsalicylic acid (aspirin), ibuprofen or other NSAIDs.