Champix Consumer Medicine Information
|Class:||Smoking cessation agents|
|Ingredients:||varenicline tartrate, microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate|
(varenicline tartrate tablets)
About This Medication
What the Medication is Used For
CHAMPIX is a prescription medicine which is used in combination with supportive counselling to help motivated adults stop smoking. In many cases, nicotine replacement therapy (patches, gum, lozenges, etc.) should be tried before trying CHAMPIX.
What it Does
CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking.
CHAMPIX does not contain nicotine, but it has been shown to affect the nicotine receptor in the brain that is thought to be most related to smoking addiction. CHAMPIX can affect this receptor in two opposite ways: it acts like a weaker version of nicotine, and also blocks nicotine from getting to the receptor because it binds more tightly. Although it is thought that this may be, in part, how CHAMPIX works, it is not known exactly how the drug works in people. When it should not be used:
Do not take CHAMPIX
- If you are allergic (hypersensitive) to varenicline tartrate or any of the other ingredients of CHAMPIX (see list below of non-medicinal ingredients).
- If you are using nicotine replacement therapy, such as patches, gum or inhaler. The combination of CHAMPIX and nicotine replacement therapy is not expected to improve your chances of quitting, and may result in more side effects than with CHAMPIX alone.
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
The nonmedicinal ingredients are microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. The film-coating contains hypromellose, titanium dioxide, polyethylene glycol and triacetin. The 1 mg tablet also contains FD&C Blue #2/Indigo Carmine Aluminum Lake as a colouring agent.
What Dosage Forms it Comes In
CHAMPIX is available as film-coated tablets. The 0.5 mg tablets are white and the 1 mg tablets are light blue.
Warnings and Precautions
Serious Warnings and Precautions
- Some people have had changes in behavior, hostility, agitation, aggression, depressed mood, and suicidal thoughts or actions while taking CHAMPIX to help them quit smoking. Some people developed them within days or weeks of starting CHAMPIX, or after stopping taking the drug.
- These psychiatric symptoms have occurred in people with previous mental health issues, as well as in those with no previous history.
- For more information on this, go to the section at the front of this leaflet "What is the most important information I should know about CHAMPIX".
- Be sure to have a discussion with your doctor about the risks and benefits of all options, including CHAMPIX, before deciding whether to start CHAMPIX.
- If you experience emotional, behavioral or psychiatric changes that are unusual for you while on CHAMPIX, stop taking the drug right away, and talk to your doctor.
- Drinking alcohol may increase the risk of experiencing psychiatric events during your treatment with CHAMPIX.
- You are encouraged to inform friends and family members of your quit attempt which includes treatment with CHAMPIX and ask for their support and help in monitoring for potential psychiatric symptoms.
BEFORE you use CHAMPIX talk to your doctor or pharmacist if:
- You have experienced depression or any other mental health problems. There is limited information about the use of CHAMPIX in people with mental health problems and therefore your doctor will monitor you closely for new or worsened emotional or behavioral problems during treatment with CHAMPIX.
- You have any problems with your kidneys, as you may need a lower dose of CHAMPIX.
- You have heart or blood vessel (cardiovascular) problems.
- You have a history of seizures
- You have any other medical conditions.
- You are pregnant, are breastfeeding or plan to become pregnant (see "Pregnancy" and "Breastfeeding" below).
- You have diabetes. CHAMPIX can potentially affect your blood sugar regulation, and you may need to monitor your blood sugar more often. If you notice changes, discuss this with your doctor.
The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other drugs work. Tell your doctor about all your other medicines, including prescription and nonprescription medicines, vitamins and herbal supplements. Especially, tell your doctor if you take:
- Asthma medicines (theophylline)
- Blood thinner (warfarin) as an adjustment of the dose of these medicines may be necessary once you are smoke-free.
Quitting smoking can be associated with changes in mood and behavior, with or without taking medication to help quit. Some patients taking CHAMPIX may experience unusual feelings of agitation, depressed mood, hostility, aggression, changes in behavior or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others.
Stop taking CHAMPIX right away and tell your doctor if you experience these symptoms in a way that is not typical for you, or if you have thoughts of self-harm or harm to others. In a few cases, these symptoms have occurred after stopping CHAMPIX (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
It is not known if these symptoms occur more often in people treated with CHAMPIX compared to those attempting to quit without any medication, or with other smoking cessation medications.
Talk to your doctor if you are pregnant or planning to become pregnant.
You should not take CHAMPIX while you are pregnant. It is unknown if CHAMPIX will harm your unborn baby.
It is best to stop smoking before you get pregnant.
You should ask your doctor or pharmacist for advice before taking any medication, including CHAMPIX, if you are breastfeeding, as the medecine may pass into breast milk.
CHAMPIX is not recommended for use in children under 18 years of age.
Accidental Injury Including While Driving Operating Machinery
Do not engage in potentially hazardous tasks, such as driving a car or operating dangerous machines, until you know how CHAMPIX may affect you. In some cases, people have reported sleepiness, dizziness, blackouts, seizures or difficulty concentrating while driving.
Tell your doctor if you have experienced seizures or have epilepsy before you start CHAMPIX treatment. Some people have reported seizures while taking CHAMPIX, both with and without a history of seizures.
Heart or Stroke Events
New or worse heart or blood vessel (cardiovascular) problems have been reported in people taking CHAMPIX, primarily in those who already have cardiovascular problems. From the information available to date, it is not possible to determine whether CHAMPIX increases the risk of heart or stroke events.
Tell your doctor if you have any changes in cardiovascular symptoms during treatment with CHAMPIX. Get emergency medical help right away if you have symptoms of a heart attack, including any of the following:
- Chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back
- Pain or discomfort in one or both arms, back, neck, jaw or stomach
- Shortness of breath, sweating, nausea, vomiting, or feeling lightheaded associated with chest discomfort
Get emergency medical help right away if you have symptoms of a stroke, including any of the following:
- Weakness - Sudden loss of strength or sudden numbness in the face, arm or leg even if temporary.
- Trouble speaking - Sudden difficulty speaking or understanding or sudden confusion, even if temporary.
- Vision problems - Sudden trouble with vision, even if temporary.
- Headache - Sudden severe and unusual headache.
- Dizziness - Sudden loss of balance, especially with any of the above signs.
Interactions With This Medication
Drinking alcohol during treatment with CHAMPIX may increase the risk of psychiatric symptoms.
Use of CHAMPIX with other therapies for smoking-cessation:
The safety and benefits of taking CHAMPIX in combination with other medicines for stopping smoking have not been studied. Taking CHAMPIX in combination with other smoking-cessation therapies (eg, nicotine replacement therapy) is therefore not recommended. Using CHAMPIX in combination with nicotine replacement therapies (eg, patch gum or inhaler) is not likely to increase your chances of quitting smoking, and it may result in more side effects than with CHAMPIX alone.
Proper Use of This Medication
You are more likely to stop smoking if you are motivated to stop. Your doctor and pharmacist can provide advice, support and sources of further information to help ensure your attempt to stop smoking is successful.
To increase the chances of success, CHAMPIX should be used in combination with supportive counselling as recommended by your doctor. CHAMPIX was used in combination with supportive counselling in the clinical trials. At any time, you can also call government-funded toll-free provincial Quit Lines, to speak to a knowledgeable and supportive specialist; these phone numbers are available on the Health Canada website, or by calling 1-800-CHAMPIX.
Always take CHAMPIX exactly as your doctor or healthcare professional has told you. You should check with your doctor or pharmacist if you are not sure.
REMEMBER: This medication has been prescribed specifically for you. Do not give it to anyone else.
Setting Your Quit Date
Starting treatment before your quit date lets CHAMPIX build up in your body. You can keep smoking until your quit date.
There are two ways to set your quit date when using CHAMPIX. Talk to your doctor or healthcare professional about which way is best for you:
- Set a quit date when you will stop smoking. Start taking CHAMPIX 8 -14 days (1 to 2 weeks) before your quit date.
- Start taking CHAMPIX, then quit smoking between Day 8 and Day 35 after the start of your treatment (ie between Weeks 2 and 5).
Either way, you take CHAMPIX for 12 weeks.
Write down, and keep in a visible or convenient place (for example on the fridge or on the CHAMPIX pack), the date that you started CHAMPIX, your quit date, and the date to stop taking CHAMPIX.
Make sure that you try to stop smoking on your quit date. If you slip-up and smoke after that target date, keep trying. Some people need a few weeks on CHAMPIX for it to work best.
After the Week 1 Dosing Schedule (see below), there are two dosing options: the dose can remain at 0.5 mg twice a day or go up to 1.0 mg twice a day.
Based on the limited data available, the two doses do not appear different in terms of either quit rates, or rates of serious psychiatric side effects (your doctor can provide more information).
Discussion with your doctor is important in order to choose the dose that is best for you.
Regardless of which dose is prescribed, the first week on CHAMPIX is the same, and is described in the following table:
Week 1 Dosing Schedule:
|Day 1 – 3||Take one white CHAMPIX|
0.5 mg tablet once a day.
|Day 4 - 7||Take one white CHAMPIX|
0.5 mg tablet twice a day, once
in the morning and once in the
evening, at about the same time
Week 2 (day 8) to the end of treatment: There are two dosing options
Continue on 0.5 mg twice a day
|Day 8- end of|
|0.5 mg twice a day:|
Continue to take one white
CHAMPIX 0.5 mg pill in the
morning, and one in the evening,
at about the same time each day
Start taking 1.0 mg twice a day
|Day 8- end of|
|1.0 mg twice a day:|
Take one light blue CHAMPIX
1.0 mg pill in the morning, and
one in the evening, at about the
same time each day
The maximum dose of CHAMPIX is 1.0 mg twice a day.
If needed, the dose can be changed depending on how well you tolerate CHAMPIX and how effective your doctor and you consider it is in helping you quit smoking. Your doctor will help decide what dose is right for you.
CHAMPIX should be taken after eating and with a full glass of water
You should take CHAMPIX for 12 weeks.
If you have stopped smoking after 12 weeks of treatment, your doctor may recommend additional weeks of CHAMPIX treatment.
Your doctor or pharmacist may recommend to gradually lower the dose at the end of the treatment period rather than stopping abruptly.
Can I Smoke While Taking Champix
You can keep smoking prior to your quit date.
Smoking after your quit date will reduce your chance of breaking your smoking addiction.
Some people have reported a change in the taste of cigarettes after starting CHAMPIX.
If you accidentally take more CHAMPIX than your doctor prescribed, you must seek medical advice or go to the nearest hospital emergency department immediately. Take your medication with you.
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.
Do not take a double dose to make up for a forgotten tablet. It is important that you take CHAMPIX regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, as long as it is within a few hours of the missed dose. If it is longer than that since the missed dose, or if you do not remember whether you took a dose or not, then skip that dose, and wait to take the next dose at the correct time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side Effects and What to Do About Them
Whether you are taking medication to stop smoking or not, the following are symptoms you may feel: depressed, short-tempered, frustrated or angry, nervous, impatient; have difficulty concentrating. Your appetite may increase, and you may gain some weight.
Like all medicines, CHAMPIX can cause side effects, although not everybody gets them.
The common side effects are mostly mild to moderate and these usually occur in the first weeks of treatment.
Some of the most common side effects you should be aware of include:
- Nausea, vomiting
- Trouble sleeping,
- Abnormal dreams (vivid, unusual, or increased dreaming; rarely may include nightmares)
- Sleepiness, tiredness, dizziness
- Constipation, diarrhea, gas
Tell your doctor immediately if you experience unusual feelings of agitation, aggression, depressed mood, hostility, hallucinations, changes in behavior or suicidal thoughts. Stop taking CHAMPIX if you experience these symptoms in a way that is not typical for you, or if you have thoughts of self-harm or harm to others. These symptoms have been reported in patients trying to stop smoking with or without CHAMPIX. When symptoms were reported, most were during CHAMPIX treatment, but some were following discontinuation of CHAMPIX therapy. It is not known if these symptoms are related to CHAMPIX (see WARNINGS AND PRECAUTIONS).
Some people have allergic reactions to CHAMPIX. Some of these allergic reactions can be lifethreatening and include: swelling of the face, mouth (lips, gums, tongue), and throat can cause trouble breathing. If you have these symptoms, stop taking CHAMPIX and seek immediate emergency medical attention.
Some people can have serious skin reactions while taking CHAMPIX. These can include rash, swelling, redness, and peeling of the skin. Some of these reactions can become life-threatening. If you have a rash with peeling skin, or blistering of the mouth, around the eyes or genitals, stop taking CHAMPIX and seek immediate emergency medical attention.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom / effect||Talk with|
swelling of the
neck area, or
peeling of the
skin, or rash
|Х||X (if severe,|
or if involves
harm to self
and/or loss of
limbs or face,
This is not a complete list of side effects. For any unexpected effects while taking CHAMPIX, contact your doctor or pharmacist.
How to Store It
Store CHAMPIX at room temperature (15°C – 30°C).
Keep out of the reach of children.
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
Postal Locator 0701E
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.
This document plus the full product monograph, prepared for health professionals can be found at:http://www.Pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001