Mylan-Donepezil: Uses, Side Effects and Dosage

What the medication is used for:

This medicine is called Mylan-Donepezil (which contains donepezil hydrochloride).

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

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

Mylan-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. Mylan-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 Tablets 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. Mylan-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:

Mylan-Donepezil contains donepezil hydrochloride.

What the important nonmedicinal ingredients are:

Mylan-Donepezil tablets: Lactose monohydrate. Other non-medicinal ingredients include maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, polyethylene glycol, hypromellose, titanium dioxide.and for the 10 mg only: quinoline yellow aluminium lake and yellow iron oxide.

What dosage forms it comes in:

Mylan-Donepezil is available as tablets. The 5 mg tablets are white in colour, and the 10 mg tablets are yellow in colour.

Tell your doctor if you have any muscle pain, tenderness, soreness or weakness, especially if you also have a fever, during treatment with Mylan-Donepezil.

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

BEFORE you use Mylan-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 Mylan-Donepezil.

P

ROPER 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 Mylan-Donepezil, it must be taken every day, exactly as prescribed by your doctor. Never change the dose yourself.
• Take Mylan-Donepezil once daily, at the same time every day, in the morning or evening.

• Take Mylan-Donepezil with or without food.

Mylan-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 your doctor, hospital emergency department or the nearest poison control center immediately.

Missed Dose:

If you miss taking a dose of Mylan-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, Mylan-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

PROPER USE OF THIS MEDICATION

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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 Mylan-Donepezil, contact your doctor or pharmacist.

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

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

REPORTING SUSPECTED SIDE EFFECTS

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This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor,

Mylan Pharmaceuticals ULC

Toronto, Ontario, M8Z 2S6

1-800-575-1379

Last revised: February 25, 2015

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