INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.

WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope.

Orphenadrine citrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

ADVERSE REACTIONS Adverse reactions of orphenadrine citrate are mainly due to the mild anti-cholinergic action of orphenadrine citrate and are usually associated with higher dosage.

Dryness of the mouth is usually the first adverse effect to appear.

When the daily dose is increased, possible adverse effects include tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation and rarely urticaria and other dermatoses.

Infrequently, an elderly patient may experience some degree of mental confusion.

These adverse reactions can usually be eliminated by reduction in dosage.

Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported.

No causal relationship has been established.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.

at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.