VOLTAREN

What it is

Voltaren Rapid is a non-steroidal anti-inflammatory drug (NSAID) and contains the potassium salt of diclofenac. Voltaren Rapid tablets contain 50 mg of diclofenac potassium. The tablets are reddish-brown, round, biconvex sugar-coated tablets. The preparation possesses analgesic, anti-inflammatory, and antipyretic properties. Voltaren Rapid tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and inflammatory conditions.

Approved indications

— Short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component. — Treatment of acute migraine attacks (with or without aura). — Symptomatic treatment of primary dysmenorrhoea.

Dosing overview

Key safety warnings

Non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events including myocardial infarction and stroke, which may increase with dose and duration of use. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk. Treatment with Voltaren Rapid is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. Physicians and patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be informed about signs and/or symptoms of serious cardiovascular toxicity and be instructed to see a physician immediately in case of such an event. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs, including diclofenac, occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. The risk of GI bleeding is higher with increasing NSAID doses, with increasing duration of use and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly. The concurrent use of aspirin and NSAIDs, including diclofenac, also increases the risk of serious gastrointestinal adverse events. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) and generalised bullous fixed drug eruption have been reported very rarely in association with the use of NSAIDs, including Voltaren Rapid. Patients appear to be at highest risk of 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. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash, mucosal legion or any other sign of hypersensitivity, and Voltaren Rapid should be discontinued.

Contraindications

Gastric or duodenal ulcer, gastrointestinal bleeding or perforation. Hypersensitivity to the active ingredient, diclofenac, or any of the excipients contained in the tablets. Third trimester of pregnancy. Severe hepatic impairment. Renal failure, severe cardiac failure, and treatment of perioperative pain in the setting of coronary artery bypass surgery (CABG). Patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions because severe, rarely fatal, anaphylactic type reactions to diclofenac have been reported in such patients.

Regulatory history

Voltaren Rapid was first approved on 27 May 1993.