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DICLOFENAC is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis, acute gout, (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis,…
Verbatim from this product's MHRA label. Tap a section to expand.
4). For oral administration. To be taken preferably with or after food. Adults: 75-150 mg daily in two or three divided doses. The recommended maximum daily dose is 150 mg. Special populations Elderly Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in elderly patients, non steroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions.
4) and the patient should be monitored regularly 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
If serious side-effects occur, Diclofenac should be withdrawn. 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, neutropenia, leucopenia, 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, nightmares, 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.
Disturbances of sensation, confusion, hallucinations, malaise Eye disorders Very rare Not known Visual disturbance, vision blurred diplopia. Optic neuritis. Ear and labyrinth disorders Common Very rare Vertigo. Tinnitus, hearing impaired.
Cardiac disorders Uncommon* Palpitations, chest pain, cardiac failure, myocardial infarction. Not known Kounis syndrome Vascular disorders Very rare Hypertension, vasculitis, hypotension. Respiratory, thoracic and mediastinal disorders Rare Very rare Not known Asthma (including dyspnoea).
Pneumonitis. Bronchospasm Gastrointestinal disorders Common Rare Very rare Not known Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain flatulence, anorexia. Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation, (sometimes fatal, particularly in the elderly).
). 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 children over 14 years of age, the recommended daily dose is 75-100 mg in two or three divided doses. Diclofenac tablets are not recommended for children under 14 years of age. 3 Contraindications Known hypersensitivity to the active substance or to any of the excipients.
Active gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration, perforation or bleeding).
4). Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, acute rhinitis or angioedema are precipitated by ibuprofen, acetylsalicylic acid or other NSAIDs.
Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 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. 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, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose.
). 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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Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, oesophageal lesions, diaphragm-like intestinal strictures, pancreatitis, colonic damage.
Ischaemic colitis Hepatobiliary disorders Common Rare Very rare Not known Transaminases increased. Hepatitis, jaundice, liver disorder. Fulminant hepatitis, hepatic necrosis, hepatic failure Abnormal liver function. Skin and subcutaneous tissue disorders Common Rare Very rare Not known Rash Urticaria Bullous eruptions, eczema, erythema, erythema multiforme, Stevens Johnson Syndrome, toxic epidermal necrolysis (Lyell’s syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritis.
Fixed drug eruption, Generalised bullous fixed drug eruption Renal and urinary disorders Very rare Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. Acute renal insufficiency.
General disorders and administration site conditions Rare Oedema Reproductive system and breast disorders Very rare Impotence * The frequency reflects data from long-term treatment with a high dose (150 mg/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.
The tablets contain methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium free'. Gastrointestinal effects Gastrointestinal bleeding, 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). 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). 5). 8). NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal anastomotic leak.
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