Patient Medication Information: uses, side effects, how to take - Donepezil (Ranbaxy Pharmaceuticals Canada)
ABOUT THIS MEDICATION
What the medication is used for:
This medicine is called DONEPEZIL (which contains donepezil hydrochloride USP).
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 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. 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:
DONEPEZIL contains donepezil hydrochloride USP. What the important nonmedicinal ingredients are: DONEPEZIL tablets:
5 mg: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.
10 mg: corn starch, hydroxypropyl cellulose, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.
What dosage forms it comes in:
DONEPEZIL is available as tablets. 5 mg tablets are white to off-white and the 10 mg tablets are yellow coloured.
WARNINGS AND PRECAUTIONS
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] [Aspirin®]).
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 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.
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.
IMPORTANT: PLEASE READ
DONEPEZIL (Donepezil Hydrochloride Tablets USP) Product Monograph Page 47 of 47
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 IT
Keep this medicine in a safe place, out of reach of children. Keep DONEPEZIL tablets in a cool dry place at controlled room temperature, 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:
- 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, ON K1A 0K9
Postage Paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at:
www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, please contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1-866-840-1340
RANBAXY
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200 Mississauga, Ontario
L4W 0A5