Patient Medication Information: uses, side effects, how to take - Accel-Donepezil

ABOUT THIS MEDICATION

What the medication is used for:

This medicine is called ACCEL-DONEPEZIL (which contains donepezil hydrochloride monohydrate).

Donepezil hydrochloride is one of a group of drugs called “cholinesterase inhibitors”

ACCEL-DONEPEZIL is used for the symptomatic treatment of mild, moderate, and severe Alzheimer’s disease.

ACCEL-DONEPEZIL can only be obtained with a prescription from a doctor.

What it does:

In the brains of persons with Alzheimer’s disease, there is a decrease in the function of a neurotransmitter system which uses acetylcholine as its chemical messenger. ACCEL-DONEPEZIL acts by inhibiting an enzyme called acetylcholinesterase, leading to an increase in the level of acetylcholine in the brain, which may help relieve the symptoms of Alzheimer’s disease.

In clinical studies, patients treated with donepezil hydrochloride showed improvement, remained unchanged, or declined more slowly as compared to patients who received a placebo (sugar tablet). Benefits were seen in memory and other mental functions, as well as in the ability to perform daily activities. ACCEL-DONEPEZIL may take as long as 12 weeks to begin working, and patient response to this medicine will vary.

When it should not be used:

If you are allergic to this medicine, any of its inactive
ingredients (see the section “What the important nonmedicinal ingredients are”), or to piperidine derivatives such as Mycobutin (rifabutin), Ritalin (methylphenidate), Akineton (biperiden HCl), trihexyphenidyl, bupivacaine, and Paxil (paroxetine HCl).

What the medicinal ingredient is:

ACCEL-DONEPEZIL contain donepezil hydrochloride.

What the important nonmedicinal ingredients are: ACCEL-DONEPEZIL tablets: Corn starch, hydroxylpropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. The 10 mg tablets also contain yellow iron oxide.

What dosage forms it comes in:

ACCEL-DONEPEZIL is available as tablets. The 5 mg tablets are white and the 10 mg tablets are yellow.

WARNINGS AND PRECAUTIONS

Tell your doctor if you have any muscle pain, tenderness, soreness or weakness, especially if you also have a fever, during treatment with ACCEL-DONEPEZIL.

BEFORE you use ACCEL-DONEPEZIL talk to your doctor or pharmacist if:

You are taking other medicines, including prescription drugs or products that you can buy without a prescription, such as herbal (natural) products.
You have a condition affecting your heart, kidney, liver or your lungs, such as asthma or obstructive pulmonary disease.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist		Stop taking drug and seek immediate medical help
Symptom / effect		Only if severe	In all cases	Stop taking drug and seek immediate medical help
Rare	Rhabdomyolysis: combination of muscle pain, tenderness, or weakness, or joint pain accompanied by a fever or very dark urine that you cannot explain		X
Very Rare	Neuroleptic Malignant Syndrome: A state of high fever, muscle stiffness, irregular blood pressure, pulse and or heartbeats, altered consciousness			X

IMPORTANT PLEASE READ

You have had seizures.
You have had fainting spells.
You have a history of peptic ulcers or have an increased risk
of developing ulcers (for example, if you are taking non-steroidal anti-inflammatory drugs [NSAIDS] or high doses of acetylsalicylic acid [ASA] [Aspirin®]).
If you are pregnant or breastfeeding.
An operation with a general anesthetic is needed, inform
your doctor about the use ACCEL-DONEPEZIL.

PROPER USE OF THIS MEDICATION

This medication should only be taken after proper diagnosis of your condition has been made by your doctor.

In order to obtain the best results from ACCEL-
DONEPEZIL, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
Take ACCEL-DONEPEZIL once daily, at the same time
every day, in the morning or evening.
Take ACCEL-DONEPEZIL with or without food.
ACCEL-DONEPEZIL tablets should be swallowed whole with water.

A Reminder: This medicine has been prescribed only for you or for the person you are caring for. Never give it to anyone else.

Overdose:

If more medication has been taken than what has been prescribed, contact either your doctor, hospital emergency department or the nearest poison control center immediately, even if there are no symptoms.

Missed Dose:

If you miss taking a dose of ACCEL-DONEPEZIL do not worry, just take the next dose when it is due. Do NOT take 2 doses at once.

If you have problems remembering to take medications, it may be necessary to have someone help you.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its beneficial effect, ACCEL-DONEPEZIL may cause some undesirable reactions. The most common side effects include nausea (feeling sick) and diarrhea. In clinical studies,

these effects were often mild, and generally went away with continued treatment. If they persist you should tell your doctor.

Other possible side effects include:

insomnia (difficulty sleeping)
vomiting (being sick)
muscle cramps
fatigue
anorexia (loss of appetite)
fainting

If you feel unwell in any other way or have any symptoms that you do not understand, or find distressing, you should contact your doctor immediately. If you experience severe adverse events, stop taking the drug until you can discuss your symptoms with your doctor.

This is not a complete list of side effects. For any unexpected effects while taking ACCEL-DONEPEZIL, contact your doctor or pharmacist.

HOW TO STORE IT

Keep this medicine in a safe place, out of reach of children.

Keep ACCEL-DONEPEZIL tablets in a cool dry place (15°C to 30°C) and avoid exposure to moisture.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program Health Canada
  Postal Locator 0701E
  Ottawa, Ontario
  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.