Donepezil (oral route)

Brand Name

US Brand Name

Aricept

Description

Donepezil is used to treat dementia (memory loss and mental changes) associated with mild, moderate, or severe Alzheimer's disease. Donepezil will not cure Alzheimer'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.

This product is available in the following dosage forms:

Tablet
Tablet, Disintegrating

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of donepezil in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of donepezil in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Levoketoconazole
Mesoridazine
Pimozide
Piperaquine
Posaconazole
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate
Abiraterone Acetate, Micronized
Acetophenazine
Aclidinium
Acrivastine
Adagrasib
Alcaftadine
Alfentanil
Alfuzosin
Amantadine
Ambenonium
Amdinocillin
Amifampridine
Amineptine
Aminophylline
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Amphetamine
Ampicillin
Anagrelide
Anisotropine
Antazoline
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Atomoxetine
Atropine
Azatadine
Azelastine
Azithromycin
Azlocillin
Bacampicillin
Baclofen

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ramelteon

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Bitter Orange
Grapefruit Juice

Proper Use

Take this medicine exactly as directed by your doctor in order to improve your 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 your doctor. It may be taken with or without food, on a full or empty stomach.

Swallow the tablet whole. Do not crush, break, or chew it.

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.
Do not swallow the tablet whole. The tablet will dissolve in seconds, and you may swallow it with your saliva. You should drink a glass of water after the tablet has dissolved.

For patients taking the oral solution form of this medicine:

Shake the bottle well before measuring the dose.
Use a specially marked measuring spoon, a plastic syringe, or a small marked measuring cup to measure each dose accurately. The average household teaspoon 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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (oral disintegrating tablets, oral solution, and tablets):
- For mild to moderate Alzheimer's disease:
  - Adults—5 milligrams (mg) taken at bedtime. Your doctor may increase your dose as needed. However, the dose usually is not more than 10 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For moderate to severe Alzheimer's disease:
  - Adults—10 milligrams (mg) taken at bedtime. Your doctor may increase your dose as needed. However, the dose usually is not more than 23 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to reduce any unwanted effects.

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

This medicine may cause some people to become dizzy or drowsy, to have blurred vision, or to have problems with clumsiness or unsteadiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see clearly.

Some people who have used this medicine developed problems such as nausea, severe vomiting, loss of appetite, diarrhea, and weight loss. Talk with your doctor before using this medicine if you have any concerns.

Tell you doctor right away if you have bloody or black tarry stools, constipation, severe stomach pain, or vomiting of blood or material that looks like coffee grounds. These may be symptoms of stomach or bowel bleeding.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause 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 possible if any of the following side effects occur:

More common

Diarrhea
loss of appetite
muscle cramps
nausea
trouble in sleeping
unusual tiredness or weakness
vomiting

Less common

Abnormal dreams
constipation
dizziness
drowsiness
fainting
frequent urination
headache
joint pain, stiffness, or swelling
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
dryness of mouth
eye irritation
fever
flushing of skin
frequent urge to urinate
high or low blood pressure
hives
hot flashes
increase in sexual desire or performance
increased heart rate and breathing
increased sweating
increased urge to urinate during the night
irregular heartbeat
itching
loss of bladder control
loss of bowel control
mood or mental changes, including abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness
nasal congestion
pain in chest, upper stomach, or throat
problems with 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
bleeding gums
chest pain or discomfort
coma
convulsions
dark urine
difficulty breathing
fast or irregular heartbeat
fatigue
general body swelling
general tiredness and 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 the back
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 or stomach pain
yellow eyes and 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 effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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