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ENSTAR XL is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: In the management of chronic conditions, such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration.
Adults:
One tablet once daily, taken whole with liquid, preferably at meal times.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Children:
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. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section
Adverse reactions associated with diclofenac obtained from clinical studies and post marketing surveillance are tabulated below according to the system organ classes in MedDRA and 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 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, leucopoenia, anaemia (including haemolytic and aplastic anaemia), 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, anxiety.
Not known Confusional state Nervous system disorders Common Headache, dizziness. Rare Somnolence, tiredness. Very rare Paraesthesia, memory impairment, convulsion, tremor, meningitis aseptic*, dysgeusia, cerebrovascular accident. Not known Hallucinations, sensory disturbance Eye disorders Very rare Visual impairment, vision blurred, diplopia.
Not known Optic neuritis. 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, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders Rare Asthma (including dyspnoea). Very rare Pneumonitis. Gastrointestinal disorders Common Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Rare Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer** sometimes fatal particularly in the elderly).
). 1. • Active, gastric or intestinal ulcer, bleeding or perforation. • History of upper gastrointestinal bleeding or perforation, related to previous NSAID’s therapy. 6). 4). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, angioedema or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other NSAIDs.
2, and GI and cardiovascular risks below). Monitoring of renal function, hepatic function (elevation of liver enzymes may occur) and blood counts should be performed on long-term NSAID patients, as a precautionary measure. 5).
Elderly:
Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight. 2).
General:
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 the 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.
1. • Active, gastric or intestinal ulcer, bleeding or perforation. • History of upper gastrointestinal bleeding or perforation, related to previous NSAID’s therapy. 6). 4). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, angioedema or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other NSAIDs.
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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Very rare Colitis***, constipation, stomatitis (including ulcerative stomatitis), mouth ulceration, glossitis, oesophageal disorder, Crohn’s disease, large 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, alopecia, photosensitivity reaction, purpura, Henoch-Schönlein 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. Reproductive system and breast disorders Very rare Erectile dysfunction General disorders and administration site conditions Rare Generalised oedema.
Not known Malaise. * Meningitis aseptic (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation ** Gastrointestinal ulcer could be with or without bleeding or perforation *** Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis) 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). 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.
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. Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150 mg 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). As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically.
Gastro-intestinal 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). 3), and in the elderly. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
These patients should commence treatment on the lowest dose available. g. 5). 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.
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. Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such […]