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DICLO-SR 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, osteoarthritis, ankylosing spondylitis, acute gout. (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis,…
Verbatim from this product's MHRA label. Tap a section to expand.
4).
Adults:
One tablet once or twice daily The recommended maximum daily dose of diclofenac sodium is 150mg.
Special populations Elderly:
Although the pharmacokinetics of Diclo-SR 75 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-SR 75 is considered necessary the lowest effective dosage should be used in frail elderly patients or those with a low body weight (see section
Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known: cannot be estimated from the available data.
The following undesirable effects include those reported with other short-term or long-term use. Blood and lymphatic system disorders Very rare Thrombocytopenia, leucopoenia, anemia (including hemolytic and aplastic anemia), 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 Headache, dizziness. Rare Somnolence, tiredness.
Very rare Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident. Unknown Confusion, hallucinations, disturbances of sensation, malaise. Eye disorders Very rare Visual disturbance, vision blurred, diplopia.
Unknown Optic neuritis. Ear and labyrinth disorders Common Vertigo. Very rare Tinnitus, hearing impaired. Cardiac disorders Uncommon* Palpitations, chest pain, cardiac failure, myocardial infarction. Not known Kounis syndrome Vascular disorders Very rare Hypertension, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders Rare Asthma (including dyspnoea). Very rare Pneumonitis. Gastrointestinal disorders Common Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia. Rare Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly).
) for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. 3 Contraindications). Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration.
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:
Diclofenac sodium is not recommended for use in children as dosage recommendations and indications for use in this group of patients have not been established. Method of administration For oral use only. To be taken whole with liquid, preferably with or after food.
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.
g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti- inflammatory drugs. 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).
Elderly:
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.
). 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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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.
Unknown 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, hematuria, proteinuria, nephrotic syndrome, 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 (150 mg/day). Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment.
4 for Contraindications and Special warnings and special precautions for use). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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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 rhinitislike 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 of therapy is usually followed by […]