Carefully consider the potential benefits and risks of Voltaren® (diclofenac sodium enteric-coated tablets) and other treatment options before deciding to use Voltaren. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Voltaren is indicated:

• For relief of the signs and symptoms of osteoarthritis
• For relief of the signs and symptoms of rheumatoid arthritis
• For acute or long-term use in the relief of the signs and symptoms of ankylosing spondylitis

Carefully consider the potential benefits and risks of Voltaren® (diclofenac sodium enteric-coated tablets) and other treatment options before deciding to use Voltaren. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with Voltaren, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).

For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).

For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.

Different formulations of diclofenac [Voltaren® (diclofenac sodium enteric-coated tablets); Voltaren®-XR (diclofenac sodium extended-release tablets); Cataflam® (diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.

Voltaren® (diclofenac sodium enteric-coated tablets)

25 mg – yellow, biconvex, triangular-shaped, enteric-coated tablets (imprinted VOLTAREN 25 on one side in black ink)

Bottles of 100 .................... NDC 0028-0258-01

50 mg – light brown, biconvex, triangular-shaped, enteric-coated tablets (imprinted VOLTAREN 50 on one side in black ink)

Bottles of 100 .................... NDC 0028-0262-01

75 mg – light pink, biconvex, triangular-shaped, enteric-coated tablets (imprinted VOLTAREN 75 on one side in black ink)

Bottles of 100 .................... NDC 0028-0264-01

Do not store above 30°C (86°F). Protect from moisture. Dispense in tight container (USP).

REV: JANUARY 2006 Manufactured by: Mova Pharmaceuticals Corporation Caguas, Puerto Rico 00726 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936
FDA rev date: 7/9/2007

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