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DICLOMAX SR is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For rheumatoid arthritis; osteoarthritis; low back pain; acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures; ankylosing spondylitis; acute gout; control of pain and…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral use. 4). Adults One or two 75mg capsules daily taken whole in single or divided doses preferably with food or after food. Children Not recommended. Elderly The elderly are at an increased risk of serious consequences of adverse reactions.
Studies indicate the pharmacokinetics of diclofenac sodium are not impaired to any clinical extent in the elderly, however, as with all non-steroidal anti-inflammatory drugs, Diclomax should be used with caution in elderly patients and the lowest effective dose used for the shortest possible duration.
These patients should be monitored regularly for GI bleeding during NSAID therapy.
Adverse reactions are ranked under the 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, <1/1000); 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. Blood and lymphatic system disorders Very rare Thrombocytopenia, leucopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Not known Neutropenia. 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.
Not known Confusion, hallucinations. Nervous system disorders Common Headache, dizziness. Rare Somnolence. Very rare Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation; taste disturbances, cerebrovascular accident.
Not known Optic neuritis. Eye disorders Very rare Visual disturbance, vision blurred, diplopia. Ear and labyrinth disorders Common Vertigo. Very rare Tinnitus, hearing impaired. Cardiac disorders Very rare Palpitations, chest pain, cardiac failure, myocardial infarction.
Not known Kounis syndrome Vascular disorders Very rare Hypertension, vasculitis. Respiratory, thoracic and mediastinal disorders Rare Asthma (including dyspnoea). Very rare Pneumonitis. Not known Aggravated asthma, bronchospasm. Gastrointestinal disorders Common Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
2, and GI and cardiovascular risks below). Caution is indicated in the elderly on basic medical grounds. 2). In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.
5). As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with diclofenac without earlier exposure to the drug. 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.
As Diclomax contains lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. As Diclomax contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Diclomax contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Gastrointestinal effects:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with NSAID therapy, including diclofenac, and can occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
They generally have more serious consequences in the elderly. If GI bleeding or ulceration occurs in patients receiving Diclomax, the treatment should be withdrawn. 8). 3), and in the elderly. 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.
• Known hypersensitivity to diclofenac sodium or to any of the excipients. • Active gastric or intestinal ulcer, bleeding or perforation. • History of gastrointestinal (GI) bleeding or perforation, related to previous non-steroidal anti-inflammatory drug (NSAID) therapy.
• Active or history of recurrent peptic ulcer or haemorrhage (two or more distinct episodes of proven ulceration or bleeding). g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other NSAIDs. • Acute porphyria.
4). 6). • Established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Diclofenac in United Kingdom.
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Rare Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer (with or without bleeding or perforation) sometimes fatal particularly in the elderly. Very rare Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Not known Ischaemic colitis Hepatobiliary disorders Common Transaminases increased. Rare Hepatitis, jaundice, liver disorder. Very rare Fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders Common Rash.
Rare Urticaria. Very rare 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, pruritus.
Not known 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. General disorders and administration site conditions Rare Oedema.
Not known Fatigue, malaise. 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.
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g. 5). Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. 5). 8). NSAIDs, including diclofenac, may be associated with increased risk of GI anastomotic leak.
Close medical surveillance and caution are recommended when using diclofenac after GI surgery.
Hepatic effects:
Close medical surveillance is required when prescribing Diclomax to patients with impaired hepatic function, as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase.
During prolonged treatment with Diclomax, regular monitoring of hepatic function is indicated as a precautionary measure. g. eosinophilia, rash), Diclomax should be discontinued. Hepatitis may occur with use of diclofenac without prodromal symptoms.
3).
Renal effects:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
g. 3). Monitoring of renal function is recommended as a precautionary measure when using Diclomax in such cases. Discontinuation of therapy is usually […]