Special warnings: Concomitant use of etodolac 200 mg with other NSAIDs, including selective cyclooxygenase 2 (cox-2) selective inhibitors, should be avoided.
The occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest treatment duration necessary to relieve symptoms.
Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis have a higher risk of allergic manifestation when taking acetylsalicylic acid and/or non-steroidal anti-inflammatory drugs than the rest of the population. Administration of etodolac may lead to an asthma attack, particularly in certain subjects allergic to acetylsalicylic acid or to an NSAID.
Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, have been reported with all NSAIDs at any time during treatment, without necessarily having any warning signs or a history of adverse effects, serious gastrointestinal illnesses.
The risk of gastrointestinal haemorrhage, ulceration or perforation increases with the dose used in patients with a history of ulcer, particularly in the event of complications such as haemorrhage or perforation as well as than in the elderly. In these patients, treatment should be started at the lowest posology possible. Mucosal protective therapy (e.g. misoprostol or proton pump inhibitor) should be considered for these patients, as for patients requiring treatment with low dose acetylsalicylic acid or treated with other drugs likely to increase gastrointestinal risk. Patients with a gastrointestinal history, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment. Particular attention should be paid to patients receiving concomitant treatments which may increase the risk of ulceration or bleeding, such as corticosteroids administered orally, oral anticoagulants such as warfarin, selective inhibitors of the reuptake of serotonin (SSRI) and antiplatelet agents such as acetylsalicylic acid.
In the event of onset of haemorrhage or ulceration occurring in a patient receiving etodolac 200 mg treatment must be stopped.
NSAIDs should be administered with caution and under close monitoring in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), due to a risk of aggravation of the pathology.
Cardiovascular and cerebrovascular effects: Adequate monitoring and recommendations are required in patients with a history of hypertension and/or mild to moderate heart failure, cases of fluid retention and edema having been reported in association with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially when used at high doses and over a long period) may be associated with a small increased risk of arterial thrombotic events (eg, heart attack myocardium or stroke). There are currently insufficient data to rule out this increased risk for etodolac.
Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or a history of stroke (including transient ischemic attack) should not be treated with etodolac only after a careful assessment of the benefit/risk ratio.
Similar attention should be paid before initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidaemia, diabetes or smoking).
Skin effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndromes and Lyell's syndromes have been reported very rarely during treatment with NSAIDs.
The incidence of these adverse effects seems to be greater at the start of treatment, the time to onset being, in the majority of cases, during the first month of treatment. Etodolac 200 mg should be discontinued as soon as a skin rash, mucosal lesions or any other sign of hypersensitivity appear.
Functional renal failure: NSAIDs, by inhibiting the vasodilating action of renal prostaglandins, are liable to cause (functional renal failure by reduction in glomerular filtration. This side effect is dose dependent.
At the start of treatment or after a dose increase, monitoring of diuresis and renal function is recommended in patients with the following risk factors: Elderly subjects; associated medications such as: ACE inhibitors, sartans, diuretics; hypovolaemia whatever the cause; heart failure; chronic renal failure; nephrotic syndrome; lupus nephropathy; decompensated hepatic cirrhosis.
Water and sodium retention: Water and sodium retention with possibility of oedema, hypertension or increase in hypertension, worsening of heart failure. Clinical monitoring is necessary from the start of treatment in the event of hypertension or heart failure. A decrease in the effect of antihypertensives is possible.
Hyperkalemia: Hyperkalaemia favored by diabetes or concomitant treatment with hyperkalaemic medicinal products.
Regular monitoring of serum potassium should be performed in these circumstances.
Cardiovascular thromboembolic risk: Systemic non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur as early as the first few weeks of treatment and may increase with duration of use. The risk of cardiovascular thromboembolic events has been observed mainly at high doses.
Physicians should periodically evaluate patients for the occurrence of cardiovascular events, even if they have no previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and should seek medical attention immediately if these symptoms occur.
To minimize the risk of adverse events, use the lowest effective daily dose for the shortest possible duration.
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium free'.
Effects on Ability to Drive and Use Machines: The drug has minor or moderate influence on the ability to drive and use machines because it can cause headaches, slight feelings of dizziness and fatigue.
Use in Pregnancy & Lactation: Precautions for use: Etodolac, like any drug that inhibits the synthesis of cyclooxygenases and prostaglandins, can impair fertility. Its use is not recommended in women who wish to conceive a child.
Use in the Elderly: Elderly are at increased risk of adverse reactions to NSAIDs, in particular gastrointestinal bleeding and perforation which may be fatal.