Aricept

DRUG DESCRIPTION

ARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as ()-2, 3-dihydro-5, 6-dimethoxy2-[[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  (donepezil hydrochloride) Structural Formula Illustration

ARICEPT (donepezil hydrochloride) 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 (donepezil hydrochloride) 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.

What are the possible side effects of donepezil (Aricept, Aricept ODT)?

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

Stop using donepezil and call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like blood or coffee grounds;
  • painful or difficult urination;
  • seizure (black-out or convulsions);

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Aricept

What are the precautions when taking donepezil hydrochloride (Aricept)?

Before taking donepezil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic obstructive pulmonary disease), fainting, heart disease (such as sick sinus syndrome, other heart conduction disorder), seizures, stomach/intestinal disease (such as ulcers, bleeding), trouble urinating (such as enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform...

Read All Potential Precautions of Aricept


Aricept Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, loss of appetite/weight loss, dizziness, drowsiness, weakness, trouble sleeping, shakiness (tremor), or muscle cramps may occur as your body adjusts to the drug. These effects usually last 1-3 weeks and then lessen. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: slow/irregular heartbeat, fainting, trouble urinating, severe stomach/abdominal pain, black stools, vomit that looks like coffee grounds, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking donepezil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic obstructive pulmonary disease), fainting, heart disease (such as sick sinus syndrome, other heart conduction disorder), seizures, stomach/intestinal disease (such as ulcers, bleeding), trouble urinating (such as enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Aricept Patient Information Including Side Effects

Brand Names: Aricept, Aricept ODT

Generic Name: donepezil (oral) (Pronunciation: doe NEP e zil)

  • What is donepezil (Aricept)?
  • What are the possible side effects of donepezil (Aricept)?
  • What is the most important information I should know about donepezil (Aricept)?
  • What should I discuss with my healthcare provider before taking donepezil (Aricept)?
  • How should I take donepezil (Aricept)?
  • What happens if I miss a dose (Aricept)?
  • What happens if I overdose (Aricept)?
  • What should I avoid while taking donepezil (Aricept)?
  • What other drugs will affect donepezil (Aricept)?
  • Where can I get more information?

What is donepezil (Aricept)?

Donepezil improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Donepezil is used to treat mild to moderate dementia caused by Alzheimer's disease.

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

What are the possible side effects of donepezil (Aricept)?

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

Stop using donepezil and call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like blood or coffee grounds;
  • painful or difficult urination;
  • seizure (black-out or convulsions);

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • loss of appetite;
  • muscle cramps;
  • tired feeling; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about donepezil (Aricept)?

Before taking donepezil, tell your doctor if you have a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats), an enlarged prostate, urination problems, asthma, obstructive pulmonary disease, or a seizure disorder such as epilepsy.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking donepezil.

Donepezil can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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