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DICLO-XL is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of: • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. • Symptomatic, short-term treatment of post-traumatic and post-operative pain (POP), inflammation,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
The usual dosage is 100mg (one tablet) daily, taken whole with liquid, preferably with or after food.
Elderly:
Although the pharmacokinetics of Diclo-XL 100 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.
If Diclo-XL 100 is considered necessary the lowest effective dose should be used in frail elderly patients or those with a low body weight (see section
). 4). 6). • 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).
Elderl y:
Caution is indicated in the elderly on basic medical grounds. 2). 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 the infection due to its pharmacodynamic properties. e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis like symptoms), reactions on NSAIDs like asthma exacerbations (so called intolerance to analgesics/analgesics asthma), Quincke's oedema or urticaria are more frequent than in other patients.
Therefore, special precaution is recommended in such patients (readiness for emergency). g. with skin reactions, pruritus or urticaria. 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.
g. 3). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.
Hepatic effects:
Close medical surveillance is required when prescribing diclofenac to patients with impairment of hepatic function as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase.
) for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. 4 Special warnings and precautions for use). 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:
Diclo-XL 100 tablets are not recommended for use in Children and adolescents. 4 Special warnings and precautions for use). Method of administration For oral use only. 1. • Active, or gastric or intestinal ulcer, bleeding or perforation.
• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. 8 Undesirable effects).
4). 6). • 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).
Elderl y:
Caution is indicated in the elderly on basic medical grounds. 2). 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 the infection due to its pharmacodynamic properties. e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis like symptoms), reactions on NSAIDs like asthma exacerbations (so called intolerance to analgesics/analgesics asthma), Quincke's oedema or urticaria are more frequent than in other patients.
1. • Active, or gastric or intestinal ulcer, bleeding or perforation. • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • History of gastrointestinal bleeding or perforation, related to previous NSAID therapy.
e NSAID-induced cross reactivity reactions) (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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During prolonged treatment with Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. 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 should be discontinued.
Hepatitis may occur with diclofenac without prodromal symptoms. Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.
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 (NHYA-1) as fluid retention and oedema have been reported in association with NSAID therapy including diclofenac.
Clinical trial and epidemiological data consistently point towards increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (l50mg daily) and in long term treatment.
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 and only at doses ≤100mg daily when treatment continues for more than 4 weeks.. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically especially when treatment continues for more than 4 weeks. g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings.
Patients should be instructed to see a physician immediately in case of such an event.
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 […]
Therefore, special precaution is recommended in such patients (readiness for emergency). g. with skin reactions, pruritus or urticaria. 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.
g. 3). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.
Hepatic effects:
Close medical surveillance is required when prescribing diclofenac to patients with impairment of 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 Diclofenac, […]