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RHUMALGAN CR is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis; osteoarthritis; low back pain; acute gout; relief of pain in fractures; acute musculo-skeletal disorders and trauma including periarthritis (particularly frozen shoulder), bursitis, tendinitis, tenosynovitis, dislocations, sprains and strains; ankylosing spondylitis; and the control of pain and…
Verbatim from this product's MHRA label. Tap a section to expand.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section
). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).
Gastro-intestinal bleeding or ulceration/perforation:
Haematemesis, melaena, ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac. They can occur at any time during treatment with or without warning symptoms or a previous history of serious GI events.
In the rare instances where gastro-intestinal bleeding or ulceration occurs in patients receiving diclofenac sodium the drug should be withdrawn. 3 Contraindications), and in the elderly. These patients should commence treatment on the lowest dose available.
g. 5 Interactions with other medicaments and other forms of interaction). 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.
5 Interaction with other medicaments and other forms of interaction).
Hepatic:
Close medical surveillance is also imperative in patients suffering from impairment of hepatic function. 8 Undesirable effects). In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions with NSAIDs such as exacerbation of asthma (so called intolerance to analgesics / analgesics-asthma), Quincke’s oedema (angioedema) or urticaria are more frequent than in other patients.
Therefore special precautions are recommended in such patients (readiness for emergency). This is also applicable to patients who are allergic to other substances, for example those with skin reactions, pruritis or urticaria. As with other NSAIDs, diclofenac sodium may mask the signs and symptoms of infection due to its pharmacodynamic properties.
). For oral administration.
Adults:
One 100mg tablet daily, taken whole with liquid, preferably at meal times. The recommended maximum daily dose of diclofenac sodium is 150mg.
Children:
These tablets are not recommended for children.
Elderly:
Although the pharmacokinetics of diclofenac sodium 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 Comment [TT1]: QRD template Version 7, 07/2005 Comment [TT2]: QRD template Comment [TT3]: QRD template 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. 3 Contraindications • Hypersensitivity to the active substance or any of the excipients.
• Patients who have previously shown hypersensitivity reactions (eg asthma angioedema, urticaria, or acute rhinitis) to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs. • Patients with a history of, or active, gastro-intestinal ulcers, bleeding or perforation (two or more distinct episodes of proven ulceration or bleeding).
• Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 4 Special warnings and precautions for use). • During the last trimester of pregnancy. • History of gastro-intestinal bleeding or perforation, relating to previous NSAID therapy.
2 Posology and method of administration and GI and cardiovascular risks below). The use of diclofenac with concomitant NSAIDs including cyclo-oxygenase-2- selective inhibitors should be avoided (see section
• Hypersensitivity to the active substance or any of the excipients. • Patients who have previously shown hypersensitivity reactions (eg asthma angioedema, urticaria, or acute rhinitis) to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs.
• Patients with a history of, or active, gastro-intestinal ulcers, bleeding or perforation (two or more distinct episodes of proven ulceration or bleeding). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
• Severe hepatic, renal and heart failure (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Precautions:
Renal: Patients with renal, cardiac or hepatic impairment, a history of hypertension and the elderly, should be kept under surveillance, since the use of NSAIDs including diclofenac may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored.
The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or other products that can significantly impact renal function, or those recovering from major surgery.
Effects on renal function are usually reversible on withdrawal of diclofenac sodium. g. renal function, hepatic function (elevation of liver enzymes may occur) and blood counts. This is particularly important in the elderly.
Hepatic:
If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), diclofenac sodium should be discontinued. Hepatitis may occur with diclofenac without prodromal symptoms.
Use of diclofenac sodium in patients with hepatic porphyria may trigger an attack. Use in acute porphyria is contraindicated. 5 Interaction with other medicaments and other forms of interactions). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.
Respiratory disorders:
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of, bronchial asthma.
Cardiovascular and cerebrovascular effects:
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy including diclofenac.
Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with diclofenac after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. As the cardiovascular risks of diclofenac may increase with dose and […]