This is a summary of the most important information about Galantamine HBr. For details, talk to your healthcare professional.

FDA ALERT [3/2005]: FDA and other international health authorities are reviewing the safety of Galantamine HBr after data from two clinical studies indicated that people taking the drug had a higher death rate than those taking a placebo (sugar pill). Based on this information, FDA has asked the manufacturer to revise the labeling. Please ask your healthcare provider if Galantamine HBr is right for you.

This information reflects FDA�s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

What Is Galantamine HBr?

Galantamine HBr is a medicine used to treat mild to moderate Alzheimer�s disease.

Who Should Not Take Galantamine HBr?

You should NOT take Galantamine HBr if you:

• Have severe liver or kidney disease

What Are The Risks?

The most frequent side effects experienced in patients taking Galantamine HBr were:

• Nausea

• Vomiting

• Diarrhea

• Loss of appetite

• Weight loss

What Should I Tell My Healthcare Professional Before Taking Galantamine HBr?
Tell your healthcare professional if you:

• Have or have ever had asthma; an enlarged prostate; stomach ulcers; or heart, kidney, liver, or lung disease

• Have seizures or a history of seizures

• Are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Galantamine HBr, call your healthcare professional.

• Are having surgery, including dental surgery that will require anesthesia.

Are There Any Interactions With Drugs or Foods?

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter drugs, and supplements. Your healthcare professional may have to adjust your dose or watch you more closely if you take any of the following medications:

• Amitriptyline

• Fluoxetine

• Fluvoxamine

• Quinidine

• Cimetidine

• Ketoconazole

• Erythromycin

• Paroxetine

How Do I Take Galantamine HBr?

Galantamine HBr comes as a tablet to take by mouth. It is usually taken twice a day, preferably with the morning and evening meals. Your healthcare professional will start you on a low dose of Galantamine HBr and gradually increase your dose over time, with a minimum of 4 weeks between each increase in dose. This helps to minimize the amount of side effects.

Is There Anything Else I Need To Know?

Galantamine HBr may make you drowsy. Do not drive a car or operate machinery until you know how Galantamine HBr affects you.