DONEPEZIL (Systemic)

Some commonly used brand names are:

In the U.S.?

• Aricept
• Aricept ODT

Another commonly used name is E2020.

Category

• Dementia symptoms treatment adjunct

Description

Donepezil (doe-NEP-ah-zil) is used to treat thesymptoms of mild to moderate Alzheimer's disease. Donepezil will not cureAlzheimer's disease, and it will not stop the disease from getting worse.However, it can improve thinking ability in some patients.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Oral disintegrating tablets (U.S.)
• Oral solution (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For donepezil, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to donepezil, or to biperiden (e.g., Akineton), bupivacaine(e.g., Marcaine), methylphenidate (e.g., Ritalin), paroxetine (e.g., Paxil),rifabutin (e.g., Mycobutin), or trihexyphenidyl (e.g., Artane). Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in pregnant women. However,studies in pregnant animals have shown that donepezil may cause unwanted effectson the offspring when the mother is given doses many times higher than thehuman dose. Before taking this medicine, make sure your doctor knows if youare pregnant or if you may become pregnant.

Breast-feeding?It is not known whether donepezil passes into breastmilk. Because of the possibility of serious unwanted effects in the nursinginfant, it is important that you discuss the use of this medicine with yourdoctor if you wish to breast-feed.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of donepezilin children with use in other age groups.

Older adults?In studies done to date that have included olderadults, some side effects of donepezil have been shown to occur more frequentlyin older people than in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingdonepezil, it is especially important that your health care professional knowif you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicines.

Other medical problems?The presence of other medicalproblems may affect the use of donepezil. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Asthma or
• Lung disease or
• Peptic ulcers, or history of or
• Seizures, or history of or
• Urinary tract blockage?Donepezil may make these conditionsworse

• Heart problems?Donepezil may have unwanted effects on heartrate

• Liver problems?Higher blood levels of donepezil may resultand increase the chance of side effects

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor in order to improveyour condition as much as possible. Do not take more of it or less of it,and do not take it more or less often than your doctor ordered.

Donepezil should be taken at bedtime unless otherwise directed by yourdoctor. It may be taken with or without food, on a full or empty stomach.

For patients using the oral disintegrating tablet form of this medicine:

• Make sure your hands are dry.
• Do not push the tablet through the foil backing of the package. Instead,gently peel back the foil backing and remove the tablet.
• Immediately place the tablet on top of the tongue.
• The tablet will dissolve in seconds, and you may swallow it withyour saliva. You should drink a glass of water after the tablet has dissolved.

For patients taking the oral solution formof this medicine:

• Shake the bottle well before measuring the dose.
• Use a specially marked measuring spoon, a plastic syringe, or a smallmarked measuring cup to measure each dose accurately. The average householdteaspoon may not hold the right amount of liquid.
• If your dose is 5 mg, you should take 5 mL of this medicine.
• If your dose is 10 mg, you should take 10 mL of this medicine.

Dosing?The dose of donepezil will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of donepezil. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage forms (oral disintegratingtablets, oral solution, and tablets):
  • For Alzheimer's disease:
    • Adults?5 milligrams (mg) taken at bedtime. Your doctor mayincrease your dose as needed. However, the dose usually is not more than 10mg a day.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, skip the misseddose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regularvisits. This is necessary to allow dose adjustments and to reduce anyunwanted effects.

Before you have any kind of surgery, dental treatment,or emergency treatment, tell the medical doctor or dentist in charge thatyou are using this medicine. Taking donepezil together with certainmedicines that are used during surgery or dental or emergency treatments mayincrease the effects of those medicines and cause unwanted effects.

This medicine may cause some people to become dizzy or drowsy, to haveblurred vision, or to have problems with clumsiness or unsteadiness. Make sure you know how you react to this medicine before youdrive, use machines, or do anything else that could be dangerous if you arenot alert, well-coordinated, and able to see clearly.

If you think that you or someone else may have takenan overdose of this medicine, get emergency help at once. Taking anoverdose of this medicine may cause convulsions (seizures) or serious effectson your heart and your breathing. Signs of overdose include increased wateringof mouth, increased sweating, low blood pressure, muscle weakness, severenausea, severe vomiting, slow heartbeat, and troubled breathing.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.

Check with your doctor as soon as possibleif any of the following side effects occur:

More common

Diarrhea; loss of appetite; muscle cramps; nausea; trouble in sleeping; unusual tirednessor weakness; vomiting

Less common

Abnormal dreams; constipation; dizziness; drowsiness; fainting; frequent urination; headache; joint pain, stiffness, orswelling; mental depression; pain; unusual bleeding or bruising; weight loss

Rare

Black, tarry stools; bloating; bloody or cloudy urine; blurred vision; burning, prickling, or tingling sensations; cataract; chills; clumsiness or unsteadiness; confusion; cough; decreased urination; difficult or painful urination; drynessof mouth; eye irritation; fever; flushing of skin; frequent urge to urinate; high or low blood pressure; hives; hot flashes; increased heart rate and breathing; increase in sexual desire or performance; increasedsweating; increased urge to urinate during the night; irregular heartbeat; itching; loss of bladder control; loss of bowel control; mood or mental changes, includingabnormal crying, aggression, agitation, delusions, irritability, nervousness,or restlessness; nasal congestion; pain in chest, upper stomach, or throat; problemswith speech; runny nose; severe thirst; shortness of breath; sneezing; sore throat; sunken eyes; tightness in chest; tremor; troubled breathing; wheezing; wrinkled skin

Incidence not known

Back, leg, or stomach pains; bleedinggums; chest pain or discomfort; coma; convulsions; darkurine; difficulty breathing; fast or irregular heartbeat; fatigue; general body swelling; general tirednessand weakness; high fever; increased thirst; indigestion; light-colored stools; muscle pain or cramps; nausea and vomiting; nosebleeds; pains in stomach, side, or abdomen, possibly radiating to theback; pale skin; rash; seeing, hearing, or feeling things that are not there; seizures; severe muscle stiffness; severe nausea; slow or irregular heartbeat; stomach pain; sweating; swelling of face, ankles, or hands; tiredness; unusually pale skin; upper right abdominal pain; yellow eyesand skin

Symptoms of overdose

Convulsions (seizures); increased sweating; increased watering of mouth; increasing muscle weakness; low blood pressure; severe nausea; severe vomiting; slow heartbeat; troubled breathing

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.