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ETOPAN XL is a brand name for Etodolac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Etopan XL is indicated for acute or long-term use in rheumatoid arthritis and osteoarthritis.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Adults One tablet daily, if a lower dose is sufficient, conventional Etodolac capsules or tablets may be used. Etopan XL must be swallowed whole. The safety of doses in excess of 600 mg per day has not been established. No occurrence of tolerance or tachyphylaxis has been reported.
Elderly No change in initial dosage is generally required in the elderly (see precautions). 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. Paediatric population Not recommended. Method of administration For oral administration. To be taken preferably with or after food. Swallow the tablet whole with a tumblerful of water.
1. Etopan XL should not be used in patients with severe heart failure. Etopan XL should not be used in patients with active or history of recurrent peptic ulceration or a history of peptic ulcer disease (with two or more distinct episodes of proven ulceration or bleeding).
g. asthma, rhinitis angioedema or urticaria) during therapy with ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. 4). 6). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment. 4). 4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular and cerebrovascular Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). Renal Nephrotoxicity in various forms including interstitial nephritis, nephrotic syndrome and renal failure.
Hepatic Abnormal liver function, hepatitis and jaundice. 4), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness. Haematological Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological Bullous reactions including Stevens-Johnson syndrome, and Toxic Epidermal Necrolysis (very rare). Photosensitivity. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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2, and GI and cardiovascular risks below). 5). 2).
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 some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for Etopan XL. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Etopan XL after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Respiratory disorders:
Caution is required if Etopan XL is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. 3). Caution is required since the use of NSAIDs may result in a dose dependent reduction in prostaglandin formation and precipitate renal failure.
The dose should be kept as low as possible. However, impairment of renal or hepatic functions due to other causes may alter drug metabolism; patients receiving concomitant long term therapy, especially the elderly, should be observed for potential side effects and their drug doses adjusted as needed, or the drug discontinued.
Gastrointestinal bleeding, ulceration and perforation:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Etodolac in United Kingdom.
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Serious gastrointestinal adverse effects such as bleeding, ulceration and perforation, which can be fatal, has been reported and can occur at any time with or without warning symptoms in patients treated with NSAIDs or a previous history of serious GI events.
If any sign of gastrointestinal bleeding occurs, Etopan XL should be stopped immediately.
Platelets:
Although non-steroidal anti-inflammatory drugs do not have the same direct effects on platelets as does aspirin, all drugs which inhibit the biosynthesis of prostaglandins may interfere, to some extent, with platelet function. Patients receiving Etopan XL who may be adversely affected by such actions should be carefully observed.
g. for changes in, renal function, haematological parameters, or hepatic function. 3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particularly when 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 Etodolac, the treatment should be withdrawn. 8). 8). 8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Etopan XL should be discontinued at the first appearance of the skin rash, mucosal lesions, or any other sign of hypersensitivity.
Lactose:
Etopan XL contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.