DICLOFENAC-WGR

What it is

Diclofenac-WGR is an enteric coated tablet containing either 25 mg or 50 mg of diclofenac sodium.

Approved indications

— 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.

Dosing overview

For adults with inflammatory and degenerative rheumatism and inflammatory pain states, the initial dosage is 75 to 150 mg daily, with 75 to 100 mg daily usually sufficient for long-term therapy. 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 that may be raised in the course of several menstrual cycles up to a maximum of 200 mg per day. Treatment should be started upon appearance of the first symptoms and, depending on the symptomatology, continued for a few days. Tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.

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 or duration of use, and patients with cardiovascular disease or cardiovascular risk factors may be at greater risk. Treatment with Diclofenac-WGR is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. Physicians and patients should remain alert for signs and symptoms of serious arteriothrombotic events such as chest pain, shortness of breath, weakness and slurring of speech, which can occur without warnings. Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders or with a history of gastrointestinal ulceration, bleeding or perforation; upper GI 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 risk higher with increasing doses, duration of use, and in patients with a history of ulcer or in the elderly. Gastric or duodenal ulceration, perforation or gastrointestinal bleeding, which can be fatal, have been reported in patients receiving Diclofenac-WGR. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely with NSAIDs; these reactions are idiosyncratic and independent of dose or duration of use, with patients at highest risk early in the course of therapy, the majority of cases occurring within the first month of treatment. Diclofenac-WGR tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Contraindications

Gastric or duodenal ulcer, gastrointestinal bleeding or perforation. Hypersensitivity to diclofenac sodium or any of the excipients contained in the tablets. Third trimester of pregnancy, severe hepatic impairment. Renal failure, severe cardiac failure, treatment of perioperative pain in coronary artery bypass surgery, or patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions.

Regulatory history

Diclofenac-WGR was first listed on the ARTG on 4 April 2017 as a modified release tablet in two strengths: 25 mg (ARTG 272873) and 50 mg (ARTG 272877).