Aricept (Page 5 of 6)


16.1 ARICEPT Tablets

Supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 mg of donepezil hydrochloride.

The 5 mg tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side.

  • Bottles of 30 (NDC# 62856-245-30)
  • Bottles of 90 (NDC# 62856-245-90)
  • Unit Dose Blister Package 100 (10×10) (NDC# 62856-245-41)

The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

  • Bottles of 30 (NDC# 62856-246-30)
  • Bottles of 90 (NDC# 62856-246-90)
  • Unit Dose Blister Package 100 (10×10) (NDC# 62856-246-41)

The 23 mg tablets are reddish in color. The strength, in mg (23), is debossed on one side and ARICEPT is debossed on the other side.

  • Bottles of 30 (NDC# 62856-247-30)


Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride.

The 5 mg orally disintegrating tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side.

  • 5 mg (White) Unit Dose Blister Package 30 (10×3) (NDC# 62856-831-30)

The 10 mg orally disintegrating tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

  • 10 mg (Yellow) Unit Dose Blister Package 30 (10×3) (NDC# 62856-832-30)

Store at controlled room temperature, 15ºC to 30ºC (59ºF to 86ºF).


Advise the patient to read the FDA-approved patient labeling (Patient Information).

Instruct patients and caregivers to take ARICEPT only once per day, as prescribed.

Instruct patients and caregivers that ARICEPT can be taken with or without food. ARICEPT 23 mg tablets should be swallowed whole without the tablets being split, crushed or chewed. ARICEPT ODT should not be swallowed whole, but be allowed to dissolve on the tongue and followed with water.

Advise patients and caregivers that ARICEPT may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite.

Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.


ARICEPT® (Air-eh-sept)

(donepezil hydrochloride) tablets

  • Tablets: 5 mg, 10 mg, and 23 mg

ARICEPT ® ODT (Air-eh-sept oh-dee-tee)

(donepezil hydrochloride) orally disintegrating tablets

  • ODT Tablets: 5 mg and 10 mg

Read this Patient Information that comes with ARICEPT before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about Alzheimer’s disease or treatment for it. If you have questions, ask the doctor or pharmacist.

What is ARICEPT?

ARICEPT comes as ARICEPT film-coated tablets in dosage strengths of 5 mg, 10 mg, and 23 mg, and as ARICEPT Orally Disintegrating Tablets (ODT; 5 mg and 10 mg). Except where indicated, all the information about ARICEPT in this leaflet also applies to ARICEPT ODT.

ARICEPT is a prescription medicine to treat mild, moderate, and severe Alzheimer’s disease. ARICEPT can help with mental function and with doing daily tasks. ARICEPT does not work the same in all people. Some people may:

  • Seem much better
  • Get better in small ways or stay the same
  • Get worse over time but slower than expected
  • Not change and then get worse as expected

ARICEPT does not cure Alzheimer’s disease. All patients with Alzheimer’s disease get worse over time, even if they take ARICEPT.

ARICEPT has not been approved as a treatment for any medical condition in children.

Who should not take ARICEPT?

Do not take ARICEPT if you are allergic to any of the ingredients in ARICEPT or to medicines that contain piperidines. Ask your doctor if you are not sure. See the end of this leaflet for a list of ingredients in ARICEPT.

What should I tell my doctor before tak ing ARICEPT?

Tell the doctor about all of your present or past health problems and conditions . Include:

  • Any heart problems including problems with irregular, slow, or fast heartbeats
  • Asthma or lung problems
  • A seizure
  • Stomach ulcers
  • Difficulty passing urine
  • Liver or kidney problems
  • Trouble swallowing tablets
  • Present pregnancy or plans to become pregnant. It is not known if ARICEPT can harm an unborn baby.
  • Present breast-feeding. It is not known if ARICEPT passes into breast milk. Talk to your doctor about the best way to feed your baby if you take ARICEPT.

Tell the doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal products. ARICEPT and other medicines may affect each other.

Be particularly sure to tell the doctor if you take aspirin or medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). There are many NSAID medicines, both prescription and non-prescription. Ask the doctor or pharmacist if you are not sure if any of your medicines are NSAIDs. Taking NSAIDs and ARICEPT together may make you more likely to get stomach ulcers.

ARICEPT taken with certain medicines used for anesthesia may cause side effects. Tell the responsible doctor or dentist that you take ARICEPT before you have:

  • surgery
  • medical procedures
  • dental surgery or procedures.

Know the medicines that you take. Keep a list of all your medicines. Show it to your doctor or pharmacist before you start a new medicine.

How should you take ARICEPT?

  • Take ARICEPT exactly as prescribed by the doctor. Do not stop ARICEPT or change the dose yourself. Talk with your doctor first.
  • Take ARICEPT one time each day. ARICEPT can be taken with or without food.
  • ARICEPT 23 mg tablets should be swallowed whole. Do not split, crush, or chew the tablets.
  • ARICEPT ODT melts on the tongue. You should drink some water after the tablet melts.
  • If you miss a dose of ARICEPT, just wait. Take only the next dose at the usual time. Do not take 2 doses at the same time.
  • If ARICEPT is missed for 7 days or more, talk with your doctor before starting again.
  • If you take too much ARICEPT at one time, call your doctor or poison control center, or go to the emergency room right away.

What are the possible side effects of ARICEPT?

ARICEPT may cause the following serious side effects:

  • slow heartbeat and fainting. This happens more often in people with heart problems. Call your doctor right away if you feel faint or lightheaded while taking ARICEPT.
  • more stomach acid. This raises the chance of ulcers and bleeding, especially when taking ARICEPT 23 mg. The risk is higher for people who have had ulcers, or take aspirin or other NSAIDs.
  • worsening of lung problems in people with asthma or other lung disease.
  • seizures.
  • difficulty passing urine.

Call your doctor right away if you ha ve :

  • fainting.
  • heartburn or stomach pain that is new or won’t go away.
  • nausea or vomiting, blood in the vomit, dark vomit that looks like coffee grounds.
  • bowel movements or stools that look like black tar.
  • new or worse asthma or breathing problems.
  • seizures.
  • difficulty passing urine.

The most common side effects of ARICEPT are:

  • nausea
  • diarrhea
  • not sleeping well
  • vomiting
  • muscle cramps
  • feeling tired
  • not wanting to eat

These side effects may get better after you take ARICEPT for a while . This is not a complete list of side effects with ARICEPT . For more information, ask your doctor or pharmacist.

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

How should ARICEPT be stored?

Store ARICEPT at room temperature between 59º to 86ºF (15º to 30ºC).

Keep ARICEPT and all medicines out of the reach of children.

General information about ARICEPT
Medicines are sometimes prescribed for conditions that are not mentioned in this Patient Information Leaflet. Do not use ARICEPT for a condition for which it was not prescribed. Do not give ARICEPT to other people, even if they have the same symptoms or condition. It may harm them.

This leaflet summarizes the most important information about ARICEPT. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ARICEPT that is written for health professionals. For more information, go to, or call 1-800-760-6029.

What are the ingredients in ARICEPT?

Active ingredient: donepezil hydrochloride

Inactive ingredients:

  • ARICEPT 5 mg and 10 mg film-coated tablets: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent.
  • ARICEPT 23 mg film-coated tablets: ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The reddish color film coating includes ferric oxide, hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide.
  • ARICEPT ODT 5 mg and 10 mg tablets : carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. The 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent.

ARICEPT® is a registered trademark used by Eisai Inc. under license from
Eisai R&D Management Co., Ltd.

Distributed by Eisai Inc., Nutley, NJ 07110

Rx Only

© 1996-2021 Eisai Inc.

Revised: 12/2021

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