CHAMPIX®

(tshamp-iks)

Varenicline tartrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Champix. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Champix

against the benefits it is expected to

have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

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

CHAMPIX® 1

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.

CHAMPIX® 2

- Write this date on the carton of

Pack 1 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.

- Write this date on the carton of

Pack 1 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 cigarettefree.

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.

CHAMPIX® 3

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 sugarfree

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

- dry mouth

- vomiting

- stomach discomfort

• headache

• dizziness

• sleep problems

- difficulty sleeping

- sleepiness

- abnormal dreams

• feeling tired, fatigue

• increased appetite

• changes in taste.

CHAMPIX® 4

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:

• a combination pack to start

treatment, containing:

- 11 x Champix 0.5 mg tablets and

14 x Champix 1 mg tablets as

Pack 1, and

- 28 x Champix 1 mg tablets as

Pack 2

• a 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

CHAMPIX® 5

• 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 June

2013.

® Registered Trademark

© Pfizer Australia Pty Ltd 2013.

CHAMPIX® 6