Consumer Information for: SANDOZ 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 Sandoz Donepezil/Sandoz Donepezil ODT (which contains donepezil hydrochloride).

Sandoz Donepezil/Sandoz Donepezil ODT is used for the symptomatic treatment of mild, moderate, and severe Alzheimer’s disease.

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

Sandoz Donepezil/Sandoz Donepezil ODT 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. Sandoz Donepezil/Sandoz Donepezil ODT 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 tablets). Benefits were seen in memory and other mental functions, as well as in ability to perform daily activities. Donepezil hydrochloride may take as long as 12 weeks to begin working, and patients response to this medicine will vary.

When it should not be used

If you are allergic to donepezil hydrochloride, to any of its inactive ingredients in Sandoz Donepezil/Sandoz Donepezil ODT (see section “What the nonmedicinal ingredients are”, or to piperidine derivatives such as rifabutin, methylphenidate, biperiden hydrochloride, trihexyphenidyl, bupivacaine, and paroxetine hydrochloride .

Patients suffering phenylketonuria: Sandoz Donepezil ODT contains Aspartame, a non medicinal ingredient which contains phenylalanine.

What the medicinal ingredient is

Sandoz Donepezil/Sandoz Donepezil ODT contain donepezil hydrochloride

What the non-medicinal ingredients are

Each Sandoz Donepezil tablet contains lactose monohydrate. Other non-medicinal ingredients include corn starch, microcrystalline cellulose, and magnesium stearate. The film coating contains polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol and lecithin. Additionally, the 10-mg tablet contains iron oxide yellow as a coloring agent.

Each Sandoz Donepezil ODT contains: aspartame, colloidal silicon dioxide, croscarmellose sodium, mannitol, magnesium stearate, microcrystalline cellulose, peppermint flavour and zinc sulfate monohydrate. Additionally, the 10-mg tablet contains iron oxide yellow as a coloring agent.

What dosage form it comes in

Sandoz Donepezil is supplied as film-coated tablets. The 5 mg tablets are white with embossment “135” on one side. The 10 mg tablets are yellow with embossment “136” on one side.

Sandoz Donepezil ODT is supplied as 5 mg (white tablets) or 10 mg (yellow tablets) of donepezil hydrochloride with embossment “SZ 265” on one side for the 5 mg and with embossment “SZ 266” on one side for the 10 mg.

Sandoz Donepezil 5 mg and 10 mg are available in bottles of 100 tablets.

Sandoz Donepezil ODT 5 mg and 10 mg are available in blister strips of 30 tablets (combination of 3 strips of 10 tablets)

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 Sandoz Donepezil/Sandoz Donepezil ODT.

BEFORE you use Sandoz Donepezil/Sandoz Donepezil ODT 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 if you are using Sandoz Donepezil/Sandoz Donepezil ODT.
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 Sandoz Donepezil/Sandoz Donepezil ODT, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
  • Take Sandoz Donepezil/Sandoz Donepezil ODT once daily, at the same time every day, in the morning or evening.
  • Take Sandoz Donepezil/Sandoz Donepezil ODT with or without food.

Sandoz Donepezil tablets should be swallowed whole with water.

Sandoz Donepezil ODT should be placed on the tongue and allowed to disintegrate before swallowing with water.

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 Sandoz Donepezil/Sandoz Donepezil ODT 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, Sandoz Donepezil/Sandoz Donepezil ODT 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 Sandoz Donepezil/Sandoz Donepezil ODT, contact your doctor or pharmacist.
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, 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     ✔
How to store

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

Keep Sandoz Donepezil and Sandoz Donepezil ODT in a cool dry place (15 to 25°C). Protect from moisture.

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 obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062

or by written request at: 145, Jules-Léger Boucherville, (QC), Canada J4B 7K8 www.sandoz.ca

or by e-mail at : medinfo@sandoz.com

This leaflet was prepared by Sandoz Canada Inc.

Last revised: February 25, 2015

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