Voltaren-XR (Diclofenac Sodium Extended Release) - Indications and Dosage

INDICATIONS AND USAGE

Voltaren^® -XR (diclofenac sodium extended-release tablets) is indicated:

• For relief of signs and symptoms of osteoarthritis
• For relief of signs and symptoms of rheumatoid arthritis

DOSAGE AND ADMINISTRATION

For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.

For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where Voltaren^® -XR (diclofenac sodium extended-release tablets) 100 mg/day is unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.

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.

HOW SUPPLIED

Voltaren-XR Extended-Release Tablets

100 mg

Light pink, film-coated, round, biconvex with beveled edges (imprinted Voltaren XR on one side and 100 on the other side in black ink)

   Bottles of 100...........................................................................NDC 0028-0205-01

Do not store above 30°C (86°F). Protect from moisture.

Dispense in tight container (USP).

REV: OCTOBER 2002                                                        T2002-42

89008903

NOVARTIS

Manufactured by:

Novartis Pharma Stein AG

Stein, Switzerland For

Novartis Pharmaceuticals Corporation

East Hanover, NJ 07936