Aricept

Donepezil, which is sold under the brand name Aricept, is a cholinesterase inhibitor (an enzyme blocker) used to treat mild, moderate, or severe dementia in people who have Alzheimer's disease.

It improves mental functions (including attention, memory, and the ability to interact and speak with others) by preventing the naturally occurring neurotransmitters in the brain from breaking down.

It will not cure Alzheimer's or prevent the loss of mental abilities in the future.

Donepezil was approved by the Food and Drug Administration (FDA) in 1996 to treat mild to moderate Alzheimer's. Currently, donepezil is the world's best-selling Alzheimer's drug.

In 2006, Aricept was approved to treat severe dementia in people with Alzheimer's. The first generic formulation became available in 2010.

Donepezil has also been tested in patients with schizophrenia, attention deficit disorder, and mild cognitive impairment. A 2001 study shows donepezil improves the speech of autistic children.

Donepezil Warnings

Donepezil must be taken as prescribed, even if you feel good, to be effective. If you experience sleep problems, your doctor may switch you to a morning dose.

Before taking donepezil, consult with your doctor if you are pregnant or breastfeeding, or if you are planning to have surgery, including dental surgery.

Donepezil should be used with caution by patients who also experience cardiac disease, asthma, severe cardiac arrhythmias, and chronic obstructive pulmonary disease (COPD), so consult with your doctor before using.

Always tell your doctor if your symptoms worsen.

Donepezil is generally taken once daily at night prior to retiring. Its absorption is not affected by food so that it may be taken with or without food. Mild to moderate disease is treated with 5 or 10 mg once daily. Moderate to severe Alzheimer's disease is treated with 10 or 23 mg daily.

Tablets: 5, 10 and 23 mg. Tablets (orally disintegrating tablets): 5 and 10 mg.

Tablets should be stored at room temperature, 15-30 C (59-86 F).

>10%

Nausea (3-19%)

Diarrhea (5-15%)

Insomnia (2-14%)

Accident (7-13%)

Infection (11%)

1-10%

Headache (3-10%)

Vomiting (3-8%)

Cramping (3-8%)

Fatigue (3-8%)

Anorexia (2-8%)

Hypertension (3% )

Abnormal dreams (3%)

Hallucinations (3%)

Confusion (2%)

Syncope (2%)

Postmarketing reports

Abdominal pain, agitation, aggression, cholecystitis, convulsions, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, rhabdomyolysis, QTc prolongation, Stevens Johnson syndrome toxic epidermal necrolysis and torsade de pointes

Alzheimer’s Disease

Palliative treatment of mild to moderate dementia of the Alzheimer’s type (Alzheimer’s disease, presenile or senile dementia).1 2 3 4 6 15

Comparative studies have not been performed to date, but donepezil does not share the hepatotoxic potential of tacrine and may be preferable to tacrine as a first-line treatment because it can be administered once daily and does not require regular monitoring of liver function.5 6

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 6

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Aricept is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.

2.1 Dosing in Mild to Moderate Alzheimer’s Disease

The recommended starting dosage of Aricept is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of Aricept in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

2.2 Dosing in Moderate to Severe Alzheimer’s Disease

The recommended starting dosage of Aricept is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of Aricept in patients with moderate to severe Alzheimer’s disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months. 

2.3 Administration Information

Aricept should be taken in the evening, just prior to retiring. Aricept can be taken with or without food. 

The Aricept 23 mg tablet should not be split, crushed, or chewed.

Allow Aricept ODT to dissolve on the tongue and follow with water.

Aricept (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane.

Aricept is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride.

Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, 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.

Inactive ingredients in 23 mg tablets include ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The film coating includes ferric oxide, hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide.

Aricept ODT tablets are available for oral administration. Each Aricept ODT tablet contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent.

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 (10x10) (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 (10x10) (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)
  

16.2  Aricept ODT

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 (10x3) (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 (10x3) (NDC# 62856-832-30)

Storage
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.

Aricept PATIENT PACKAGE INSERT

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 the Patient Information that comes with Aricept before the patient starts taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the 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?

The patient should not take Aricept if allergic to any of the ingredients in Aricept or to medicines that contain piperidines. Ask the patient’s doctor if you are not sure. See the end of this leaflet for a list of ingredients in Aricept.

What should I tell the doctor before the patient takes Aricept?

Tell the doctor about all the patient’s present or past health problems. 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. Aricept is not for women who are breast-feeding.

Tell the doctor about all the medicines the patient takes, 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 the patient takes 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 the patient’s medicines are NSAIDs. Taking NSAIDs and Aricept together may make the patient 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 the patient takes Aricept before the patient has:

• surgery
  
• medical procedures
  
• dental surgery or procedures.

Know the medicines that the patient takes. Keep a list of all the patient’s medicines. Show it to the doctor or pharmacist before the patient starts a new medicine.

How should the patient take Aricept?

• Give Aricept exactly as prescribed by the doctor. Do not stop Aricept or change the dose yourself. Talk with the doctor first.
  
• Give Aricept one time each day. 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 melts on the tongue. The patient should drink some water after the tablet melts.
  
• If you miss giving the patient a dose of Aricept, just wait. Give only the next dose at the usual time. Do not give 2 doses at the same time.
  
• If Aricept is missed for 7 days or more, talk with the doctor before starting again.
  
• If the patient takes too much Aricept at one time, call the 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 the doctor right away if the patient faints 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 patients who 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 the doctor right away if the patient has:

• 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 the patient takes Aricept for a while. This is not a complete list of side effects with Aricept. For more information, ask the 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 people other than the patient, even if they have the same symptoms as the patient, as it may harm them. 

This leaflet summarizes the most important information about Aricept. If you would like more information talk with the patient’s doctor. You can ask your pharmacist or doctor for information about Aricept that is written for health professionals. For more information, go to www.Aricept.com, 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., Woodcliff Lake, NJ 07677

Rx Only

© 2016 Eisai Inc.

PRINCIPAL DISPLAY PANEL - Aricept 5 MG TABLETS

NDC 62856-245-30

Aricept® 5
(donepezil HCl tablets)

5 mg
30 Tablets

PRINCIPAL DISPLAY PANEL - Aricept 10 MG TABLETS

NDC 62856-246-30

Aricept® 10
(donepezil HCl tablets)

10 mg
30 Tablets

PRINCIPAL DISPLAY PANEL - Aricept 23 MG TABLETS

NDC 62856-247-30

Aricept®
donepezil HCl

23 mg
30 tablets

PRINCIPAL DISPLAY PANEL - Aricept ODT 5 MG TABLETS

NDC 62856-831-30

Aricept® ODT™
(donepezil HCl) 5 MG
orally disintegrating tablets

PRINCIPAL DISPLAY PANEL - Aricept ODT 10 MG TABLETS

NDC 62856-832-30

Aricept® ODT™
(donepezil HCl) 10 MG
orally disintegrating tablets

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

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

Stop using Aricept and call your doctor at once if you have:

• severe or ongoing vomiting;

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

• slow heartbeats;

• seizure (convulsions);

• painful or difficult urination;

• new or worsening breathing problems; or

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

Common Aricept side effects 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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Aricept, especially:

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

This list is not complete. Other drugs may interact with donepezil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. (AU, US) This drug should be used only if clearly needed. (UK) AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have not revealed evidence of teratogenicity; however, toxicity was observed in the peri and post natal period, slight increase in the incidence of stillborn births and a slight reduction in postpartum survival. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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