Consumer Information for: BIO-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 BIO-DONEPEZIL (which contains donepezil hydrochloride)

Donepezil hydrochloride is one of a group of drugs called “cholinesterase inhibitors”

BIO-DONEPEZIL is used for the symptomatic treatment of mild, moderate, and severe Alzheimer’s disease.

BIO-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. BIO-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 BIO- 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. BIO-DONEPEZIL may take as long as 12 weeks to begin working, and patient response to this medicine will vary.

In clinical studies, patients treated with BIO-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. BIO-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

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

BIO-DONEPEZIL contains donepezil hydrochloride.

What the non-medicinal ingredients are

BIO-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 form it comes in

BIO-DONEPEZIL is available as tablets. The 5 mg tablets are white and the 10 mg tablets are yellow.

Warnings and precautions

Serious 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 BIO- DONEPEZIL.

BEFORE you use BIO-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 BIO- DONEPEZIL.
Interactions with this medication

Proper use of this medication

Usual Dose

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 BIO- DONEPEZIL, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
  • Take BIO-DONEPEZIL once daily, at the same time every day, in the morning or evening.
  • Take BIO-DONEPEZIL with or without food

BIO-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.

If you miss taking a dose of BIO-DONEPEZIL do not worry, just take the next dose when it is due. Do NOT take 2 doses at once.

Overdose

If you think you have taken too much BIO-DONEPEZIL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss taking a dose of BIO-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, BIO-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 BIO-DONEPEZIL, contact your doctor or pharmacist.

Serious side effects and what to do about them
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     ✔
How to store

Keep BIO-DONEPEZIL tablets in a cool dry place (15 to 30°C) and avoid exposure to moisture.

Keep this medicine in a safe place, out of reach and sight of children.

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 for information on how to report online, by mail or by fax; or
  • Call toll-free at 1-866-234-2345

NOTE: Contact your healthcare 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 BIO-DONEPEZIL:

  • Talk to your doctor or pharmacist.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; by contacting Biomed Pharma at 1-888-731-6703 or info@biomed-pharma.ca.

This leaflet was prepared by

Biomed Pharma
1B-9450 Boulevard Langelier,
Montreal, Quebec
H1P 3H8

Date of revision: August 12, 2020

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