Donepezil is used to help improve mental function in people with Alzheimer's disease.

Donepezil does not work the same in all people. Some people taking donepezil have improved mental function, while others may have unchanged or even worsening mental function.

Donepezil is not a cure for Alzheimer's disease. This condition will progress over time, even in people who take donepezil.

Donepezil may also be used for other purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take donepezil with or without food.

Swallow the regular tablet whole and do not crush, chew, or break it.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves. After the tablet dissolves completely, drink a glass of water.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using donepezil. You may need to stop using the medicine for a short time.

You should not stop using donepezil without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Alzheimer's Disease:

Initial dose: 5 mg orally once a day, in the evening prior to retiring

Mild to moderate Alzheimer's disease:
-Maintenance dose: 10 mg orally once a day, after the patient has been on an initial dose of 5 mg once a day for 4 to 6 weeks

Moderate to severe Alzheimer's disease:
-Maintenance dose: 23 mg orally once a day, after the patient has been on a dose of 10 mg once a day for at least 3 months

Comments: A higher dose of 10 mg may or may not provide a statistically significantly greater clinical benefit than a 5 mg dose. Prescriber and patient's preference should be considered.

Uses: For mild, moderate, and severe Alzheimer's type dementia

You should not use donepezil if you are allergic to donepezil or certain other drugs. Tell your doctor if you are allergic to any medicines.

Tell your doctor if you have ever had:

• a heart rhythm disorder;

• a stomach ulcer;

• urination problems;

• asthma or other breathing disorder;

• liver or kidney disease;

• a seizure; or

• trouble swallowing tablets.

Tell your doctor if you are pregnant or breast-feeding.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

If you miss your doses for more than 7 days in a row, call your doctor before taking the medicine again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe nausea, vomiting, drooling, sweating, blurred vision, feeling light-headed, slow heartbeat, shallow breathing, muscle weakness, fainting, or seizure (convulsions).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how donepezil will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Donepezil may cause serious side effects. Call your doctor at once if you have:

• slow heartbeats;

• a light-headed feeling, like you might pass out;

• new or worsening stomach pain, heartburn, nausea, or vomiting;

• a seizure;

• painful or difficult urination;

• new or worsening breathing problems; or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of donepezil may include:

• nausea, vomiting, diarrhea;

• loss of appetite;

• muscle pain;

• sleep problems (insomnia); or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with donepezil may increase your risk of stomach ulcer.

Other drugs may affect donepezil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.