Diclofenac tablets bp 100mg

Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

However, severe hepatic reactions can occur at any time during treatment with diclofenac. Inform patients of the warning signs and symptoms of hepatotoxicity e. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. To minimize the potential risk for an adverse liver related event in patients treated with VOLTAREN, use the lowest effective dose for the shortest duration possible. Patients taking angiotensin converting enzyme ACE inhibitors, thiazides diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions e. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.

In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia , heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly.

Hyperkalemia Increases in serum potassium concentration, including hyperkalemia , have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. When VOLTAREN is used in patients with preexisting asthma without known aspirin sensitivity , monitor patients for changes in the signs and symptoms of asthma. These serious events may occur without warning.

Inform patients about the signs and symptoms of serious skin reactions and to discontinue the use of VOLTAREN at the first appearance of skin rash or any other sign of hypersensitivity. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

Co-morbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents e. Abrupt discontinuation of corticosteroids may lead to disease exacerbation.

Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

The pharmacological activity of VOLTAREN in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Inform patients, families, or their caregivers of the following information before initiating therapy with VOLTAREN and periodically during the course of ongoing therapy. Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately see WARNINGS; Cardiovascular Thrombotic Events.

Gastrointestinal Bleeding, Ulceration, And Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia , melena , and hematemesis to their health care provider. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity e.

If you have high blood pressure. If you have any blood clotting problems. If you have a connective tissue disorder, such as a condition called systemic lupus erythematosus SLE. If you have problems with the way your liver works, or problems with the way your kidneys work. If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines. If you have ever had an allergic reaction to any other NSAID such as aspirin, naproxen, indometacin, and ibuprofen , or to any other medicine.

How to take diclofenac Before you start taking diclofenac, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about diclofenac and will provide you with a full list of the side-effects which you may experience from taking it. Take diclofenac exactly as your doctor tells you to. Your doctor or pharmacist will tell you how much to take and how often to take it. You may be asked to take just one dose a day, or several doses each day.

This information will also be printed on the label of the pack to remind you. As a general rule, taking diclofenac with a glass of milk or after eating some food can help to reduce side-effects such as indigestion.

On the label of your pack there will be instructions to tell you how to take the type you have been given. Read and follow the directions on the label carefully. If you forget to take a dose, take it as soon as you remember. If when you remember, it is nearly time for your next dose then take your next dose when it is due but leave out the missed dose. This is applicable as well for patients who are allergic to other substances, e.

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. Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose 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.

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. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically. Dermatological Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs see section 4.

Patients appear to be at highest risk for these reactions early in the course of therapy: Diclofenac potassium should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertility The use of Diclofenac Potassium tablets may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Diclofenac Potassium tablets should be considered see section 4.

Co-administration of diclofenac with other systemic NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Diuretics and antihypertensive agents: Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored.

Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.

If used concomitantly, diclofenac may increase plasma concentrations of lithium Monitoring of the serum lithium level is recommended. Diclofenac can inhibit the tubular renal clearance of methotrexate hereby increasing methotrexate levels.

Caution is recommended when NSAIDs, including diclofenac, are administered less than 24 hours before treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increase.

Cases of serious toxicity have been reported when methotrexate and NSAIDs including diclofenac are given within 24 hours of each other. This interaction is mediated through accumulation of methotrexate resulting from impairment of renal excretion in the presence of the NSAID. Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins.

Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin. Anti-coagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding see section 4.

Although clinical investigations do not appear to indicate that diclofenac has an influence on the effect of anticoagulants, there are reports of an increased risk of haemorrhage in patients receiving diclofenac and anticoagulant concomitantly see section 4. Therefore, to be certain that no change in anticoagulant dosage is required, close monitoring of such patients is required.

Caution in patients with fluid retention or heart failure Can lead to onset of new hypertension or worsening of pre-existing hypertension Side effects[ edit ] Diclofenac consumption has been associated with significantly increased vascular and coronary risk in a study including coxib, diclofenac, ibuprofen and naproxen. Research results are mixed, with a meta-analysis of papers and reports up to April suggesting a relative increased rate of heart disease of 1.

Only aspirin was found not to increase the risk of heart disease; however, this is known to have a higher rate of gastric ulceration than diclofenac. A subsequent large study of 74, users of NSAIDs or coxibs found no additional cardiovascular risk from diclofenac use. Hepatic[ edit ] Liver damage occurs infrequently, and is usually reversible. Hepatitis may occur rarely without any warning symptoms and may be fatal.

Patients with osteoarthritis more often develop symptomatic liver disease than patients with rheumatoid arthritis. Liver function should be monitored regularly during long-term treatment. If used for the short-term treatment of pain or fever, diclofenac has not been found more hepatotoxic than other NSAIDs.

As of December , Endo, Novartis, and the US FDA notified healthcare professionals to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.

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