Details for: DONEPEZIL
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02416417 | DONEPEZIL | DONEPEZIL HYDROCHLORIDE | 5 MG | TABLET | ORAL |
| 02416425 | DONEPEZIL | DONEPEZIL HYDROCHLORIDE | 10 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
This medicine is called DONEPEZIL (which contains donepezil hydrochloride).
Donepezil hydrochloride is one of a group of drugs called “cholinesterase inhibitors”.
DONEPEZIL is used for the symptomatic treatment of mild, moderate, and severe Alzheimer’s disease.
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. 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 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. 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 rifabutin, methylphenidate, biperiden HCl, trihexyphenidyl, bupivacaine, and paroxetine HCl.
What the medicinal ingredient is
Donepezil hydrochloride.
What the non-medicinal ingredients are
Hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The film coating contains: hypromellose, polyethylene glycol and titanium dioxide. Additionally, the 10-mg tablet contains iron oxide yellow as a coloring agent.
What dosage form it comes in
Tablets: 5 mg and 10 mg
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 DONEPEZIL.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist 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 | ✔ | ||
| Very Rare | |||
| Neuroleptic Malignant Syndrome: A state of high fever, muscle stiffness, irregular blood pressure, pulse and or heartbeats, altered consciousness | ✔ | ||
BEFORE you use 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.
- 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]).
- If you are pregnant or breastfeeding.
- An operation with a general anesthetic is needed, inform your doctor about the use 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 DONEPEZIL, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
- Take DONEPEZIL once daily, at the same time every day, in the morning or evening.
- Take DONEPEZIL with or without food.
- 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
Missed Dose
If you miss taking a dose of 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, 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 DONEPEZIL, contact your doctor or pharmacist.
How to store
Store between 15°C and 30°C. Protect from moisture.
Keep this medicine in a safe place, out of reach of children
Reporting 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 three ways:
- Online at MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect
Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal
Locator 0701E
Ottawa, ON
K1A 0K9
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be obtained by Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée
Laval, Québec
H7L 3W9
Last revised: August 30, 2018