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

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

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

TEVA-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. TEVADONEPEZIL 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 TEVA-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. TEVA-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

TEVA-DONEPEZIL contains donepezil hydrochloride.

What the non-medicinal ingredients are

TEVA-DONEPEZIL Tablets contain the following nonmedicinal ingredients; hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinised starch, talc and titanium dioxide. The 10 mg tablets also contain iron oxide yellow as a colourant.

What dosage form it comes in

The 5 mg tablets are white and 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 TEVA-DONEPEZIL.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and seek 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     ✔

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

How to store

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

Keep TEVA-DONEPEZIL tablets in a cool dry place (15 to 25°C) and protect from moisture. Keep container tightly closed.

Reporting 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 three 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, 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, Teva Canada Limited, at:

1-800-268-4127 ext. 1255005 (English)
1-877-777-9117 (French)
or druginfo@tevacanada.com

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada

Last revised: February 3, 2016

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