Champix

(tshamp-iks)

Varenicline tartrate
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Champix. It does not contain all the information that is known about Champix. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What CHAMPIX is used for

Champix is a medicine to help adults stop smoking. It can help to reduce craving and withdrawal symptoms that happen while you give up smoking.
People giving up smoking are often affected by nicotine withdrawal. Symptoms of nicotine withdrawal can include craving for tobacco, irritability, frustration, feeling angry, sleep problems, depressed mood, feeling anxious, difficulty in concentrating, restlessness, decreased heart rate, increased appetite or weight gain. Not everybody is affected by some or all of the symptoms of nicotine withdrawal.
Although it is not recommended that you smoke after the first one to two weeks of treatment, Champix will reduce your enjoyment of cigarettes if you do smoke while on treatment.

How Champix works

Champix works by blocking the effects of nicotine in your body. There are receptors for nicotine in the brain. When cigarette smoke is inhaled, nicotine attaches to these receptors. This sends a message to a different part of the brain to release a chemical called dopamine. Dopamine gives a feeling of pleasure which only lasts for a short time. The body wants to repeat this feeling reinforcing the need to keep smoking. Based on research, it is believed that Champix works by activating these receptors and blocking nicotine from attaching to them.
To find out how well Champix works, two groups of people who tried to stop smoking were included in a clinical study: one group took Champix and the other was given sugar pills. People who took Champix had a four times higher chance of quitting smoking after 12 weeks of treatment than those who did not. People in the Champix group had a three times higher chance of still being non-smokers one year after taking this medicine.
You will normally need to take Champix for 12 weeks. Your doctor may advise you to take Champix for a further 12 weeks after your first treatment. This may increase your chances of stopping in the long term.
Champix does not contain nicotine and it is not addictive.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Champix is only available with a doctor's prescription.

Use in children

There is not enough information to recommend the use of this medicine in children under the age of 18 years.

Deciding to stop smoking

Champix helps you give up smoking. Other things you need include:
willpower
a quit plan
support from your family and friends
counselling, advice or additional support
changes to your behaviour, so you avoid situations where you are likely to smoke.
Research has found that most people who try to quit are unable to give up without outside support. Your doctor and pharmacist can give you advice, support and sources of information to help ensure your attempt to stop smoking is successful. You can also get advice and support from Quitline by calling 13 7848 (13 QUIT) if you are in Australia and 0800 778 778 if you are in New Zealand. Quitline is a free confidential telephone smoking cessation information and advice service available throughout Australia and New Zealand.
A free internet based program that offers support and advice for people taking Champix is available in Australia at www.mytimetoquit.com.au and in New Zealand at www.liferewards.co.nz.

Before you take CHAMPIX

When you must not take it

Do not take Champix if you have an allergy to:
any medicine containing varenicline tartrate
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take Champix after the expiry date printed on the carton or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Talk to your doctor if you are not sure whether you should take this medicine.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
mental illness
This could mean having low mood, depression or anxiety that has interfered or interferes with your everyday life or that has required or requires medication.
Your doctor will discuss the risks and benefits involved in taking Champix if you suffer from mental illness. Your family or carer should be asked to monitor any changes in your behaviour, thinking or mood.
The safety and efficacy of Champix in patients with severe mental illness have not been established.
kidney problems
repeated fits or convulsions (epilepsy)
Champix has not been studied in patients with epilepsy.
heart problems such as heart attack, chest pain or stroke.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
it is not recommended that you take Champix while you are pregnant or breast-feeding.
if you plan to become pregnant, your treatment should be timed so that you have completed the course before becoming pregnant.
If you have not told your doctor about any of the above, tell him/her before you start taking Champix.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including:
all prescription medicines
all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.
This includes other medicines to help you stop smoking such as:
nicotine replacement therapy (NRT), which includes patches, gum, lozenges, sublingual tablets and inhalers (such as Nicorette, Nicabate, QuitX)
bupropion (e.g. Zyban).
The use of Champix in combination with other smoking cessation therapies is not recommended.
The safety and benefits of taking Champix in combination with other medicines to stop smoking have not been studied.
Tell your doctor or pharmacist if you are taking any of the following:
insulin
theophylline, a medicine used to treat asthma
warfarin, a medicine used to thin the blood.
The effects of changes in your body resulting from stopping smoking, with or without Champix, may alter the way these medicines work. In some cases, an adjustment of dose may be necessary.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take CHAMPIX

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.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information in this leaflet.
If you do not understand the instructions on the carton, ask your doctor or pharmacist for help.

How to start

There are 2 ways to use Champix to help you quit smoking:

1. Choose a quit date when you will stop smoking.

Make a note of this date. You can write this date on the carton of the Initiation Pack as a reminder.
Start taking Champix 1 to 2 weeks (7 to 14 days) before your quit date.
You can keep smoking during this time.
Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again.

2. Start taking Champix.

Choose a quit date when you will stop smoking between days 8 and 35 of starting Champix.
Make a note of this date. You can write this date on the carton of the Initiation Pack as a reminder.
Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again.

How much to take

Start with the white 0.5 mg tablet and then increase the dose up to the light blue 1 mg tablet.
Starting with a low dose helps your body get used to Champix.
If you have severe kidney disease your doctor may prescribe a different dose.
The usual dosage instructions are listed below.
Days 1 - 3
Take one white 0.5 mg tablet once a day.
Days 4 - 7
Take one white 0.5 mg tablet in the morning and one in the evening.
Weeks 2 - 4
Take one light blue 1 mg tablet in the morning and one in the evening.
Your first box of Champix will cover your first four weeks of treatment.
Visit your doctor before the end of the fourth week that you take Champix for a check-up and for a new prescription.
At this appointment, your doctor will check your progress and give you a new prescription for the tablets you need to complete your treatment.
Weeks 5 - 12
Take one light blue 1 mg tablet in the morning and one in the evening.
After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend another 12 weeks of treatment with Champix.
This may increase your chances of stopping smoking long term. For this course, continue to take one light blue 1 mg tablet in the morning and one in the evening.
If you do not stop smoking during the first 12 weeks of treatment or if you start smoking again after treatment, you can make another attempt to stop smoking.
However, before you make another attempt, you should try to understand the reasons why your attempt to stop smoking failed, so that your next attempt has a better chance of success.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

Take your medicine at about the same time each day.
This will have the best effect and help you remember when to take it.
It does not matter if you take Champix before or after food.
Some people find it helpful to take Champix with food.

How long to take it

Take Champix for 12 weeks or longer as advised by your doctor.
Completing the full treatment with Champix will help you stay cigarette-free.

If you forget to take it

If it is less than 6 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or contact the Poisons Information Centre for advice (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766), or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much Champix. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Take your tablets with you to hospital.

While you are taking CHAMPIX

Things you must do

Make sure you try to stop smoking on your quit date.
If you slip up and smoke, try again.
If you have existing heart or blood vessel problems, tell your doctor as soon as possible if you notice any changes in symptoms while taking Champix.
Your doctor may check your blood pressure and blood glucose levels from time to time to make sure you have not developed any unwanted side effects.
It is important to keep all of your doctor's appointments so that your progress can be checked.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Champix.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

Do not stop taking Champix until you have completed all 12 weeks, even if you have stopped smoking.
It is important to keep taking Champix for the full 12 weeks.
Do not stop taking Champix or change the dosage without checking with your doctor.
Do not take Champix to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they are also trying to stop smoking.

Things to be careful of

Be careful driving or operating machinery until you know how Champix affects you.
Champix may cause dizziness and sleepiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Things that could help while you are giving up smoking

Examples of strategies to help you quit include the following:
Reduce your consumption of caffeine
Drinking coffee may be a smoking trigger for you.
Reduce your consumption of alcohol
Drinking alcohol may be a smoking trigger for you and it can also weaken your resolve to quit.
Socialise with non-smoking friends in smoke-free venues
Do something else to take your mind off smoking; for example, drink water slowly, chew sugar-free gum, eat a healthy snack or exercise.

Side effects

Giving up smoking with or without treatment can cause various symptoms. These could include changes of mood, sleeplessness, difficulty concentrating, decreased heart rate, increased appetite or weight gain.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are you are taking Champix.
This medicine helps many people give up smoking, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.

Pay special attention to...

You and your family or carer need to pay special attention to your mood, behaviour and thinking while you are taking Champix.
Some people have reported changes in behaviour, thinking or mood when they start taking Champix. These may include depression, anxiety, agitation, feelings of aggression, mood swings, seeing, hearing or sensing things that are not there, thoughts of self-harm or self-harm. Worsening of these symptoms has also been reported in people who already had mental health problems.
It is not known whether these are related to Champix. It is known that mood changes can be due to the effects of stopping smoking, with or without treatment.
Stop taking Champix and tell your doctor immediately if you or your family/carer notice any changes in your behaviour or thinking, if you become agitated or depressed, or have thoughts of self-harm.

Tell your doctor if...

Tell your doctor or pharmacist if you have nausea (feel sick) while taking Champix and it worries you.
In clinical studies with Champix, up to 3 in 10 people had nausea. It usually started in the first week. Most people who had nausea still felt able to keep on taking the medicine. Some people find it helpful to take Champix with food.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
stomach or bowel problems
constipation
diarrhoea
feeling bloated
indigestion
wind
vomiting
stomach discomfort
dry mouth, toothache
headache
dizziness
sleep problems
difficulty sleeping
sleepiness
abnormal dreams
feeling tired, fatigue
increased appetite
changes in taste
muscle or joint pain.
These are the more common side effects of Champix. They are usually mild.

Tell your doctor as soon as possible if...

Tell your doctor as soon as possible if you notice any of the following:
trembling, fits or convulsions
problems with your vision or pain in your eyes
red blood in stools
stomach pain
excessive thirst, having a dry mouth and skin, passing large amounts of urine.
This list includes serious side effects which may require medical attention.

Go to hospital if...

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital and stop taking Champix if you experience any of the following:
rash or sudden severe itchy swellings on the skin
severe painful red blisters on the skin with chills, fever, aching muscles and generally feeling unwell
breathing problems
wheezing
difficulty breathing
shortness of breath
swelling of the face, lips, mouth, tongue, throat, hands or feet
Some people have reported swelling of parts of their face and body after taking Champix.
chest pain, which may spread to the neck and shoulders
collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech or loss of speech
abnormal or fast heartbeat
blood in vomit.
This list includes very serious side effects. If you have some of them, you may have had a serious allergic reaction to Champix. You may need urgent medical attention or hospitalisation.
Very serious side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects (for example, changes in blood pressure or blood sugar levels) can only be found when your doctor does tests to check your progress.

After taking CHAMPIX

Storage

Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store Champix or any other medicine in the bathroom or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Champix is available in 2 strengths:
Champix 0.5 mg tablets are white, film-coated, modified capsular shaped tablets marked "Pfizer" on one side and "CHX 0.5" on the other.
Champix 1 mg tablets are light blue, film-coated, modified capsular shaped tablets, marked "Pfizer" on one side and "CHX 1.0" on the other.

Packs Available

To assist with the dosing schedule the following packs are available.
In Australia:
Initiation pack to start treatment, containing 11 x Champix 0.5 mg tablets and 42 x Champix 1 mg tablets
Continuation pack containing 56 x Champix 1 mg tablets to continue treatment.
In New Zealand:
a starter pack containing 11 x Champix 0.5 mg tablets and 14 x Champix 1 mg tablets
a pack containing 28 x Champix 1 mg tablets
a pack containing 56 x Champix 1 mg tablets.

Ingredients

Active Ingredients
Champix 0.5 mg tablets contain the equivalent of 0.5 mg of varenicline.
Champix 1 mg tablets contain the equivalent of 1 mg of varenicline.
Inactive Ingredients
Each tablet of Champix contains the following inactive ingredients:
Cellulose - microcrystalline
Calcium hydrogen phosphate anhydrous
Croscarmellose sodium
Silica-colloidal anhydrous
Magnesium stearate
Opadry Blue, Opadry White and Opadry Clear.
Champix is gluten free.

Supplier

Champix is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia.
Toll Free Number: 1800 675 229.
Champix is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland, New Zealand.
Toll Free Number: 0800 736 363.

Australian Registration Numbers

Combination Pack containing Champix 0.5 mg and 1 mg Tablet Blisters: AUST R No. 124940.
Champix 1 mg Tablet Blister Pack: AUST R No. 124941.
This leaflet was prepared in January 2014.
® Registered Trademark
© Pfizer Australia Pty Ltd 2014.