Consumer Information for: ACH-DONEPEZIL
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
This medicine is called ACH-Donepezil (which contains
donepezil hydrochloride).
Donepezil hydrochloride is one of a group of drugs called
“cholinesterase inhibitors”
ACH-Donepezil is used for the symptomatic treatment of
mild, moderate, and severe Alzheimer’s disease.
ACH-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. ACH-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. ACH-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 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
ACH-Donepezil contains donepezil hydrochloride.
What the non-medicinal ingredients are
Lactose monohydrate, low substituted hydroxypropyl cellulose, maize starch, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide and talc. Additionally, the 10-mg tablet contains iron oxide yellow, as a colouring agent.
What dosage form it comes in
ACH-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 ACH-Donepezil.
BEFORE you use ACH-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] [Aspirin®]).
- If you are pregnant or breastfeeding.
- An operation with a general anesthetic is needed, inform your doctor about the use ACH-Donepezil.
Interactions with this medication
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 ACH-Donepezil, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
- Take ACH-Donepezil once daily, at the same time every day, in the morning or evening.
- Take ACH-Donepezil with or without food. ACH-Donepezil 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 you think you have taken too much ACH-Donepezil, contact your healthcare professional, hospital emergency department or regional poison control center immediately, even if there are no symptoms.
Missed Dose
If you miss taking a dose of ACH-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, ACH-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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get 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 |
✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACH-Donepezil, contact your doctor or pharmacist.
How to store
Keep this medicine in a safe place, out of reach of
children.
Keep ACH-Donepezil at controlled room temperature,
15°C to 30°C and away from moisture.
Reporting side effects
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting ( https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
If you want more information about ACH-Donepezil:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
This leaflet was prepared by:
Accord Healthcare Inc.
3535 Boul. St. Charles Suite 704
Kirkland, Québec
H9H 5B9
Canada
Last revised: November 27, 2020
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| SUPEUDOL 10 | 00443948 | SANDOZ CANADA INCORPORATED | OXYCODONE HYDROCHLORIDE 10 MG |
| SUPEUDOL 5 | 00789739 | SANDOZ CANADA INCORPORATED | OXYCODONE HYDROCHLORIDE 5 MG |