Patient Medication Information: uses, side effects, how to take - Ecl-Donepezil
ABOUT THIS MEDICATION
What the medication is used for:
This medicine is called ECL-Donepezil (which contains donepezil hydrochloride).
Donepezil hydrochloride is one of a group of drugs called “cholinesterase inhibitors”
ECL-Donepezil is used for the symptomatic treatment of mild, moderate, and severe Alzheimer’s disease.
ECL-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. ECL-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 ECL-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. ECL-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:
ECL-Donepezil contains donepezil hydrochloride.
What the important nonmedicinal ingredients are: ECL-Donepezil tablets: lactose monohydrate, maize starch, microcrystalline cellulose, hypromellose and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose and titanium dioxide. Additionally, the 10-mg tablet contains iron oxide yellow as a coloring agent.
What dosage forms it comes in:
ECL-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 ECL-Donepezil.
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
Only if severe | In all cases | |||
| 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 | ||
BEFORE you use ECL-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 ECL-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 ECL-
Donepezil, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
Take ECL-Donepezil once daily, at the same time
every day, in the morning or evening.
Take ECL-Donepezil with or without food
ECL-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.
Missed Dose:
If you miss taking a dose of ECL-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, ECL-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 ECL-Donepezil, contact your doctor or pharmacist.
HOW TO STORE IT
Keep this medicine in a safe place, out of reach of children.
Keep ECL-Donepezil tablets in a cool dry place (15 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 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
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, ECL Pharma Group Ltd.
Date of Revision: May 12, 2015