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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

GALZIN® (zinc acetate) is a prescription medicine used as a maintenance treatment of Wilson’s disease in patients that were initially treated with a medication used to remove metallic deposits in the body.

IMPORTANT SAFETY INFORMATION

Always take GALZIN exactly as your doctor has directed.

Do not take GALZIN if you are allergic to zinc acetate or any of its other ingredients.

You should take GALZIN on an empty stomach, at least one hour before or two to three hours after meals.

Capsules should be swallowed whole, not opened or chewed.

Copper Deficiency: Zinc acetate taken over long periods of time (i.e., months to years) may result in a loss of your body’s ability to absorb copper and therefore very low levels of copper. Your doctor will monitor you for signs and/or symptoms of low levels of copper during treatment with GALZIN. Your treatment may be interrupted so your doctor can test for zinc levels.

Gastric Ulcer: Gastric (stomach) ulcers may develop with long-term use of zinc acetate. If you develop signs and/or symptoms of stomach ulcers during treatment with zinc acetate, your doctor will have you discontinue GALZIN treatment.

The most common adverse reactions are inflammation of the stomach lining, and increased levels of serum alkaline phosphatase (an enzyme that breaks down proteins), amylase (an enzyme that breaks starch into sugars), and lipase (an enzyme that helps the body digest fat) lasting from weeks to months suggesting pancreatitis (inflammation of the pancreas).

You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.