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ECONAC 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 musculoskeletal disorders such as periarthritis (for example frozen shoulder), tendinitis,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adult population The recommended dose is one tablet once or twice daily (maximum daily dose is 150mg). Elderly The pharmacokinetics of Econac SR 75 mg Tablets is not impaired in elderly patients, and the standard adult dose may be used.
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 for GI bleeding for 4 weeks following initiation of NSAID therapy.
Paediatric population Econac SR 75 mg Tablets are 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 The tablets should be swallowed whole with liquid, to be taken preferably with or after food.
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 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, <1/1,000); 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. System Organ Class Frequency Adverse effects Blood and lymphatic system disorders Very rare Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), Agranulocytosis.
Rare Anaphylactic and anaphylactoid reactions (including hypotension and shock) and hypersensitivity. Immune system disorders Very rare Angioneurotic oedema (face oedema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Anxiety Common Headache, dizziness. Rare Somnolence. Nervous system disorders Very rare Cerebrovascular accident, meningitis aseptic *, convulsion, memory impairment, tremor Paraesthesia, dysgeusia. Eye disorders Very rare Visual impairment, vision blurred, diplopia.
Ear and labyrinth disorders Very rare Tinnitus, hearing impaired. Very rare cardiac failure, myocardial infarction, chest pain and palpitations. Cardiac disorders Not known Kounis syndrome Vascular disorders Very rare Hypertension, hypotension vasculitis Rare Asthma (including dyspnoea) Respiratory, thoracic and mediastinal disorders Very rare Pneumonitis.
Common Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Rare gastrointestinal ulcer **, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena and gastritis Gastrointestinal disorders Very rare Colitis *** constipation, stomatitis (including ulcerative stomatitis) mouth ulceration, glossitis, oesophageal disorder, crohn's disease, large intestinal stricture, pancreatitis.
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). 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, Econac may mask the signs and symptoms of infection due to its pharmacodynamic properties.
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 a high dose (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). 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.
1. •Active gastric or intestinal ulcer, bleeding or perforation. • History of gastrointestinal bleeding or perforation, relating to previous NSAID 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.
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Not known Ischaemic colitis Common Transaminases increased. Rare Hepatitis, jaundice, liver disorder. Hepatobiliary disorders Very rare hepatic failure, hepatitis fulminant, hepatic necrosis. Skin and subcutaneous Common Rash. tissue disorders Very rare Not known Stevens-Johnson syndrome, toxic epidermal necrolysis ****), dermatitis bullous, eczema, erythema multiforme, dermatitis exfoliative alopecia, photosensitivity reaction, purpura, henoch-Schonlein purpura, pruritus Fixed drug eruption, Generalised bullous fixed drug eruption Renal and urinary disorders Very rare Renal failure acute, haematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis.
Reproductive system and breast disorders Not known Erectile dysfunction Rare Generalised oedemaGeneral disorders and administration site conditions 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), ****Toxic epidermal necrolysis includes Lyell’s syndrome 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.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Gastro-intestinal effects:
Gastrointestinal bleeding, ulceration/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 gastro- intestinal 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 patient 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. 5). When GI bleeding or ulceration occurs in patients receiving Diclofenac, the treatment should be withdrawn.
8). Patients with a history of haematemesis, or melaena, should be carefully observed 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.
Hepatic effects:
Close medical surveillance is required when prescribing Diclofenac 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 Diclofenac, regular monitoring of hepatic function is indicated as a […]