Aricept ODT

Name: Aricept ODT

What special precautions should I follow?

Before taking donepezil,

  • tell your doctor and pharmacist if you are allergic to donepezil, any piperidine medications, any other medications, any of the ingredients in donepezil tablets or orally disintegrating tablets. Ask your doctor or pharmacist if you do not know if a medication that you are allergic to is a piperidine medication. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); bethanechol (Duvoid, Urecholine); carbamazepine (Tegretol); dexamethasone (Decadron, Dexone); ipratropium (Atrovent); ketoconazole (Nizoral); medications for glaucoma, irritable bowel disease, motion sickness, myasthenia gravis, Parkinson's disease, ulcers, or urinary problems; phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); quinidine (Quinidex); and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you weigh less than 120 lb (55 kg) and if you have or have ever had bleeding in your stomach or intestines; an ulcer; irregular, slow, or fast heartbeat, seizures; difficulty urinating; asthma;chronic obstructive pulmonary disease (a group of lung disease including chronic bronchitis or emphysema); or kidney, liver, or heart disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking donepezil, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking donepezil.

What side effects can this medication cause?

Donepezil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • weight loss
  • frequent urination
  • difficulty controlling urination
  • muscle cramps
  • joint pain, swelling, or stiffness
  • pain
  • excessive tiredness
  • difficulty falling asleep or staying asleep
  • headache
  • dizziness
  • nervousness
  • depression
  • confusion
  • changes in behavior or mood
  • hallucinations (seeing things or hearing voices that do not exist)
  • abnormal dreams
  • red, scaling, itchy skin

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • fainting
  • slow heartbeat
  • chest pain
  • new or worsening breathing problems
  • new or worsening stomach pain or heartburn
  • black or tarry stools
  • red blood in stools
  • bloody vomit
  • vomit that looks like coffee grounds
  • difficulty urinating or pain when urinating
  • lower back pain
  • fever
  • seizures
  • discoloration or bruising of the skin

Donepezil may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • nausea
  • vomiting
  • drooling
  • sweating
  • slow heartbeat
  • difficulty breathing
  • muscle weakness
  • fainting
  • seizures

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Is donepezil safe to take if I'm pregnant or breastfeeding?

It is not known whether donepezil is harmful to the fetus. Safe use during pregnancy has not been established.

It is not known whether the donepezil is secreted into breast milk or if breastfeeding while taking donepezil is safe for the nursing infant.

Manufacturer

  • Eisai, Inc

Aricept ODT Precautions

Aricept ODT 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 ODT.
  • more stomach acid. This raises the chance of ulcers and bleeding. 
  • 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.

Do not take Aricept ODT if you are allergic to any of the ingredients in Aricept ODT or to medicines that contain piperidines. 

Aricept ODT can cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Aricept ODT affects you.

 

 

Patient Handout

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Dosage forms and strengths

ARICEPT is 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.
  • The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.
  • The 23 mg tablets are reddish. The strength, in mg (23), is debossed on one side, and ARICEPT is debossed on the other side.

Aricept ODT is 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.
  • 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.

Description

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.

Before taking this medicine

You should not use this medicine if you are allergic to donepezil or certain other drugs. Tell your doctor if you are allergic to any medicines.

To make sure donepezil is safe for you, tell your doctor if you have:

  • a heart rhythm disorder;

  • a history of stomach ulcers;

  • an enlarged prostate or urination problems;

  • liver or kidney disease;

  • epilepsy or other seizure disorder;

  • trouble swallowing; or

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder.

It is not known whether donepezil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether donepezil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe nausea, vomiting, drooling, sweating, blurred vision, feeling light-headed, slow heartbeat, shallow breathing, muscle weakness, fainting, or seizure (convulsions).

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