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DICLOFENAC SODIUM is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults and elderly: Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute gout, (ii) and other acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder),…
Verbatim from this product's MHRA label. Tap a section to expand.
4). 75 mg to 150 mg daily in two or three divided doses. The recommended maximum daily dose of diclofenac sodium is 150mg.
Special populations Elderly:
Although the pharmacokinetics of Diclofenac sodium are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions.
In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also precautions) and the patient should be monitored for GI bleeding during NSAID therapy. Cardiovascular and significant cardiovascular risk factors Diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (see section
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, leucopoenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders Rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Very rare Angioneurotic oedema (including face oedema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders Common Rare Very rare Unknown Headache, dizziness. Somnolence, tiredness. Paraesthesia, memory impairment, convulsion, anxiety, tremo aseptic meningitis, taste disturbances, cerebrovascular acciden Confusion, hallucinations, disturbances of sensation, malaise.
Eye disorders Very rare Unknown Visual disturbance, vision blurred, diplopia. Optic neuritis. Ear and labyrinth disorders Common Very rare Vertigo. Tinnitus, hearing impaired. Cardiac disorders Uncommon* Myocardial infarction, cardiac failure, palpitations, chest pain.
Unknown Kounis syndrome Vascular disorders Very rare Hypertension, hypotension, vasculitis. Respiratory, thoracic and mediastinal disorders Rare Asthma (including dyspnoea). Very rare Pneumonitis. Gastrointestinal disorders Common Rare Very rare Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Gastritis, gastrointestinal haemorrhage, haematemesis, diarrho haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly). Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disord diaphragm-like intestinal strictures, pancreatitis.
). 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).
Paediatric Population:
For treatment of Juvenile chronic arthritis the following dosage should be given: Children (aged 1-12 years): 1 to 3-mg/kg per day in divided doses. For the short term treatment of fever related to infection of the ear, nose or throat (ENT) and post-operative pain the following dosage should be given: Children aged 9 years (min.
35 kg body weight) 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. Method of administration For oral administration To be taken preferably with or after food.
1. • Active or history of recurrent peptic ulceration / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • A history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Active, or gastric or intestinal ulcer, bleeding or perforation.
6 – Pregnancy and lactation) • Hepatic failure • Renal failure • 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, angiodema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
2, and GI and cardiovascular risks below). 5). Caution is indicated in the elderly on basic medical grounds. 2). 8). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction.
). Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Unknown Ischaemic colitis Hepatobiliary disorders Common Rare Very rare Transaminases increased. Hepatitis, jaundice, liver disorder. Fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders Common Rare Very rare Unknown Rash.
Urticaria. Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell' syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura , allergic purpura, pruritus.
Fixed drug eruption, Generalised bullous fixed drug eruption Renal and urinary disorders Very rare Acute renal failure, haematuria, proteinuria, nephrotic syndrom interstitial nephritis, renal papillary necrosis. Reproductive system and breast disorders Very rare Impotence General disorders and administration site conditions Rare Oedema *The frequency reflects data from long-term treatment with a high dose (150mg/day).
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to diclofenac. Like other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per 25 mg tablet, that is to say essentially ‘sodium-free’.
This medicine also contains Sunset Yellow (E110) which may cause allergic reactions. 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 (GI) 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). The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses including diclofenac and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.
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). Caution is recommended in patients receiving concomitant medications which could increase the risk of […]