VOLTAREN

What it is

Voltaren contains diclofenac sodium and is available in enteric coated tablets of 25 mg or 50 mg , or suppositories containing 12.5 mg, 25 mg, 50 mg or 100 mg diclofenac sodium .

Approved indications

**Tablets:** — Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis . — Relief of acute or chronic pain states in which there is an inflammatory component . — Symptomatic treatment of primary dysmenorrhoea .

**Suppositories:** — Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis . — Short term (up to three days) treatment of post-operative pain in children .

Dosing overview

**Adults (tablets):** Initial dosage is 75 to 150 mg daily, and for long-term therapy, 75 to 100 mg daily is usually sufficient . The daily dosage should generally be prescribed in 2 or 3 fractional doses . In primary dysmenorrhoea the daily dosage is generally 50 to 150 mg, with an initial dose of 50 to 100 mg raised if necessary to a maximum of 200 mg per day .

**Post-operative pain in children (suppositories):** A first dose of 1–2 mg per kilogram followed by 1 mg per kilogram three times daily for a maximum of three days total therapy, with a maximum daily dose of 3 mg per kilogram .

Key safety warnings

**Cardiovascular events:** Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events including myocardial infarction and stroke, which may increase with dose or duration of use, and patients with cardiovascular disease or cardiovascular risk factors may be at greater risk . Treatment with Voltaren is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension .

**Gastrointestinal effects:** Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months and in about 2–4% of patients treated for one year, with the risk higher with increasing NSAID doses, increasing duration of use and in patients with a history of ulcer . Gastric or duodenal ulceration, perforation or gastrointestinal bleeding, which can be fatal, have been reported in patients receiving Voltaren .

**Serious skin reactions:** Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and Drug Reaction with Eosinophilia with Systemic Symptoms have been reported very rarely in association with the use of Voltaren . Patients appear to be at highest risk of these reactions early in the course of therapy, with the onset occurring in the majority of cases within the first month of treatment .

**Hepatic effects:** Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, have been reported . Severe hepatotoxicity may develop without prodromal symptoms, so transaminases should be measured periodically in patients receiving long-term therapy with Voltaren .

**Pregnancy:** When given during the latter part of pregnancy, NSAIDs may cause closure of the foetal ductus arteriosus, foetal renal impairment, inhibition of platelet aggregation, and delay labour and birth .

Contraindications

— Gastric or duodenal ulcer, gastrointestinal bleeding or perforation . — Hypersensitivity to the active ingredient, diclofenac, or any of the excipients contained in the tablets or suppositories . — Third trimester of pregnancy . — Severe hepatic impairment . — Renal failure, severe cardiac failure, or treatment of perioperative pain in the setting of coronary artery bypass surgery . — Patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions . — Proctitis (suppositories only) .

Regulatory history

Voltaren diclofenac sodium 100 mg suppository was first listed on the ARTG on 30 October 1992 . Voltaren 25 mg tablet was first registered on 17 December 2009 .