Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aricept Rdt (Donepezil). If you are concerned about side effects, discuss the risks and benefits of Aricept Rdt (Donepezil) with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• loss of appetite
• muscle cramps
• nausea
• trouble sleeping
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fainting
• mood or mental changes, including abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness
• signs of muscle damage (e.g., muscle pain, tenderness or weakness, or brown or discoloured urine), especially if you also have a Fever or a general feeling of being unwell

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
• symptoms of neuroleptic malignant syndrome (e.g., muscle pain, tenderness or weakness, or joint pain accompanied by a fever or very dark urine)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aricept Rdt (Donepezil).

Tablet

5 mg
Each white, film-coated tablet, marked "ARICEPT" on one side and "5" on the other, contains Aricept Rdt (Donepezil) 5 mg. Nonmedicinal ingredients: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: hydroxypropyl methylcellulose, polyethylene glycol, talc, and titanium dioxide.

10 mg
Each yellow, film-coated tablet, marked "ARICEPT" on one side and "10" on the other, contains Aricept Rdt (Donepezil) 10 mg. Nonmedicinal ingredients: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: hydroxypropyl methylcellulose, iron oxide, polyethylene glycol, talc, and titanium dioxide.

Rapidly Disintegrating Tablet (RDT)

5 mg
Each white, film-coated tablet contains 5.0 mg of Aricept Rdt (Donepezil) hydrochloride, equivalent to 4.56 mg of Aricept Rdt (Donepezil) free base. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate; film coating: talc, polyethylene glycol, hypromellose, and titanium dioxide.

10 mg
Each yellow, film-coated tablet contains 10 mg of Aricept Rdt (Donepezil) hydrochloride, equivalent to 9.12 of Aricept Rdt (Donepezil) free base. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate; film coating: talc, polyethylene glycol, hypromellose, and titanium dioxide. This tablet also contains iron oxide as a coloring agent.

Do not take Aricept Rdt (Donepezil) if you:

• are allergic to Aricept Rdt (Donepezil) or any ingredients of the medication
• are allergic to piperidine-type medications (e.g., rifabutin, Methylphenidate, bupivacaine, Paroxetine)

There may be an interaction between Aricept Rdt (Donepezil) and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

Asthma and lung conditions: If you have lung conditions such as asthma or COPD (Chronic Obstructive Pulmonary Disease), discuss with your doctor how this medication may affect your medical condition, and whether any special monitoring is needed. Aricept Rdt (Donepezil) could cause symptoms of these conditions to worsen.

Chronic illness: In general, people with chronic medical conditions should be cautious when taking Aricept Rdt (Donepezil) because of the increased risk of side effects. The benefits of taking the medication must be carefully weighed against the risks.

Epilepsy: There is a possibility that Aricept Rdt (Donepezil) may increase the risk of seizures for susceptible people. If you have a history of seizure disorder, speak to your doctor about the risks and benefits of taking Aricept Rdt (Donepezil).

Heart disease: If you have heart disease such as active Coronary Artery Disease or Congestive Heart Failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aricept Rdt (Donepezil), and whether any special monitoring is needed. Aricept Rdt (Donepezil) has the potential to slow the heart rate. People with cardiac conduction abnormalities (e.g., heart rhythm problems such as sick sinus syndrome) should not take Aricept Rdt (Donepezil).

Liver function: Liver disease or reduced liver function may cause Aricept Rdt (Donepezil) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Aricept Rdt (Donepezil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aricept Rdt (Donepezil), and whether any special monitoring is needed.

Muscle effects: In rare cases, serious muscle damage has been associated with the use of Aricept Rdt (Donepezil). Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Neuroleptic malignant syndrome (NMS): Aricept Rdt (Donepezil), can rarely cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS, get immediate medical attention. Symptoms include high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, and fainting.

Stomach problems: Aricept Rdt (Donepezil) has the potential to cause an increase in the amount of acid that the stomach produces. If you have a history of ulcers or are at increased risk of developing stomach ulcers, discuss with your doctor how Aricept Rdt (Donepezil) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aricept Rdt (Donepezil), and whether any special monitoring is needed.

Pregnancy: The safety of Aricept Rdt (Donepezil) for use during pregnancy has not been established. Aricept Rdt (Donepezil) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Aricept Rdt (Donepezil), contact your doctor immediately.

Breast-feeding: It is not known if Aricept Rdt (Donepezil) passes into breast milk. If you are a breast-feeding mother and are taking Aricept Rdt (Donepezil), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aricept Rdt (Donepezil) have not been established for children.