Patient Medication Information: uses, side effects, how to take - Act Donepezil
ABOUT THIS MEDICATION
What the medication is used for:
This medicine is called ACT DONEPEZIL (which contains donepezil hydrochloride).
Donepezil hydrochloride is one of a group of drugs called “cholinesterase inhibitors”
ACT DONEPEZIL is used for the symptomatic treatment of mild, moderate, and severe Alzheimer’s disease.
ACT 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. ACT 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. ACT 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:
ACT DONEPEZIL contain donepezil hydrochloride.
What the important nonmedicinal ingredients are:
ACT DONEPEZIL 5 mg tablets contain the following inactive ingredients: colloidal silica anhydrous, crospovidone, mannitol, sodium stearyl fumarate and sorbitol. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
ACT DONEPEZIL 10 mg tablets contain the following inactive ingredients: colloidal silica anhydrous, crospovidone, mannitol, sodium stearyl fumarate and sorbitol. In addition, the tablet film coating contains: D&C Yellow #10 aluminum lake, FD&C Blue #2/Indigo carmine aluminum lake, FD&C Red #40/allura red AC aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
What dosage forms it comes in:
ACT DONEPEZIL tablets are formulated for oral administration and are available as 5 mg and 10 mg tablets with the following descriptions:
ACT DONEPEZIL 5 mg tablet are white, round convex, film-coated tablet with ‘D5’ on one side and “ ” on the other side.
ACT DONEPEZIL 10 mg tablets are yellow, round convex, film-coated tablet with ‘D10’ on one side and “ ” on the other side.
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 ACT DONEPEZIL.
| 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 | ||||
| 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 | ||||
| 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 | ||||
| Only if severe | In all cases | |||||
| 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 ACT 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 of ACT 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 ACT
DONEPEZIL, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
Take ACT DONEPEZIL once daily, at the same time
every day, in the morning or evening.
Take ACT DONEPEZIL with or without food.
ACT 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:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you miss taking a dose of ACT 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, ACT 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 ACT DONEPEZIL, contact your doctor or pharmacist.
HOW TO STORE IT
Keep this medicine in a safe place, out of reach of children.
Keep ACT DONEPEZIL tablets in a cool dry place (stored between 15°C and 25°C), and protected from 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, Actavis Pharma Company, at
1-866-254-6111
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date revised: February 26, 2015