FENAC EC

What it is

FENAC EC contains diclofenac sodium and is available as enteric coated tablets 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 or inflammatory pain states, 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 which 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, particularly in patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors. Treatment with FENAC EC is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders or a history of gastrointestinal ulceration, bleeding or perforation, as 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 risk increasing with higher doses, longer duration of use, and in patients with a history of ulcer or elderly patients. 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 FENAC EC use; these adverse events are idiosyncratic and independent of dose or duration of use, with patients at highest risk early in the course of therapy, most commonly within the first month of treatment. Elevations of one or more liver enzymes may occur during FENAC EC therapy; these laboratory abnormalities may progress, remain unchanged, or revert to normal despite continued therapy.

Contraindications

FENAC EC is contraindicated in patients with gastric or duodenal ulcer, gastrointestinal bleeding or perforation. It is contraindicated in patients who are hypersensitive to diclofenac or any of the excipients contained in the tablets. FENAC EC is contraindicated during the third trimester of pregnancy and in patients with severe hepatic impairment. It is contraindicated in patients with renal failure, severe cardiac failure, and in patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions.

PBS listing

FENAC EC tablets containing diclofenac sodium 25 mg and 50 mg are listed on the PBS with an unrestricted restriction type and an ex-manufacturer price of A$2.50.

Regulatory history

FENAC EC was first registered on the ARTG on 4 April 2017, with registrations for both the 25 mg and 50 mg enteric coated tablet formulations.