CHAMPIX®

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 they expect it will have.

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 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, if you smoke while you are taking CHAMPIX it will also reduce your enjoyment of cigarettes.

CHAMPIX works by blocking the effects of nicotine in your body. There are receptors for nicotine in the brain. When 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.

CHAMPIX does not contain nicotine and it is not addictive.

Clinical trials have shown that people who took CHAMPIX were almost four times more likely to have quit smoking at the end of 12 weeks of treatment than if they took sugar pills (placebo). They were three times more likely to still be not smoking one year after they started taking the 12 week course of CHAMPIX than if they took sugar pills (placebo). Over 40% of smokers who took CHAMPIX for the 12 weeks had quit at the end of the treatment period.

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 will increase your chances of stopping in the long term.

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 on a prescription from a doctor.

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 78 48 (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

You must 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 this medicine if you are pregnant. It may affect your developing baby.

Do not take CHAMPIX after the expiry date printed on the carton.

Do not take CHAMPIX if the packaging is torn or shows signs of tampering.

Do not give CHAMPIX to people aged under 18 years. CHAMPIX has not been studied in people under 18 years.

Talk to your doctor if you are not sure whether you should take this medicine.

Before you take it

Tell your doctor if:

1. you have allergies to any other medicines, foods, preservatives or dyes.
2. you have a mental illness or a history of 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.
   CHAMPIX has not been studied in patients with severe mental illnesses.
3. you have or have had:

• kidney problems
• haemodialysis treatment.
• repeated fits or convulsions.

CHAMPIX has not been studied in patients with these problems.

4. Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
   Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you take CHAMPIX.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. This includes other medicines to help you stop smoking such as nicotine replacement therapy (NRT) and bupropion (Zyban).

NRT includes patches gum, lozenges, sublingual tablets and inhalers (such as Nicorette, Nicabate, QuitX).

The safety and benefits of taking CHAMPIX in combination with other medicines for stopping smoking have not been studied. Therefore, CHAMPIX in combination with other smoking cessation therapies is not recommended.

Some medicines and CHAMPIX may interfere with each other.

Especially tell your doctor if you use:

• insulin
• theophyline, a medicine used to treat asthma
• warfarin, a medicine used to thin the blood

When you stop smoking, there may be a change in how these and other medicines work for you.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take CHAMPIX

Follow all directions given to you by your doctor or pharmacist. 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.

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.

Before you start

Choose a date when you will stop smoking. Write this date on the carton of Pack 1

You start taking CHAMPIX 1 week to 2 weeks (7 to 14 days) before your quit date. This lets CHAMPIX build up in your body and allows it to start working. You can keep smoking during this time. Make sure that you try and stop smoking on your quit date. If you slip, try to quit again.

How much to take

CHAMPIX comes as a white tablet (0.5 mg) and a light blue tablet (1 mg). You start by taking a low dose to help your body to get use to CHAMPIX. Start with the white tablet and then increase the dose up to the light blue tablet.

The usual dosage instructions are listed below. If you have severe kidney disease your doctor may prescribe a different dose.

Day 1 - 3
One white tablet once a day.

Day 4 - 7
One white tablet in the morning and one in the evening.

Week 2 onwards
One light blue tablet in the morning and one in the evening.

Your first box of CHAMPIX will cover your first four weeks of tablets. You will need to 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 the remaining 8 weeks of treatment.

After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend another 12 weeks of treatment with CHAMPIX. This will increase your chances of stopping smoking long term. For this course take one light blue CHAMPIX 1 mg tablet twice a day.

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 at stopping 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

Take CHAMPIX with a full glass of water.

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

Most people will keep taking CHAMPIX for 12 weeks. If you have completely quit smoking by 12 weeks, ask your doctor if another 12 weeks of CHAMPIX may help you stay cigarette-free.

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.

If you forget to take it

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the tablet that you have missed.

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 take too much (overdose)

Immediately telephone your doctor or contact the Poisons Information Centre for advice by calling 13 11 26 if you are in Australia or 0800 764 766 (0800 POISON) if you are in New Zealand, 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 using CHAMPIX

Things you must do

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. CHAMPIX may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

Talk to your doctor if you plan to become pregnant. Your treatment should be timed so that you have completed the course before becoming pregnant.

Things you must not do

You should 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 even if you have stopped smoking.

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 have the same condition as you.

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. Make sure you know how you react to CHAMPIX before you drive a car or operate machinery.

Side effects

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 most 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.

Tell your doctor or pharmacist if...

It is important to tell your doctor if you have any mental illness or have a history of mental illness before you start taking CHAMPIX. 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 Some people have reported changes in behaviour, thinking or mood when they start taking CHAMPIX. These may include depression, anxiety, agitation, feelings of aggression, thoughts of self-harm, self-harm or seeing, hearing or sensing things that are not there. 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. If you experience any mood changes or changes in behaviour, stop taking CHAMPIX and tell your doctor immediately.

Tell your doctor or pharmacist if you have nausea while taking CHAMPIX and it worries you.

In clinical trials with CHAMPIX, up to 3 in 10 people had nausea. It usually started in the first week. In these trials 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:

1. stomach or bowel problems

• nausea
• constipation
• feeling bloated
• indigestion
• flatulence
• dry mouth
• vomiting
• stomach discomfort

2. headache
3. dizziness
4. sleep problems

• difficulty sleeping
• sleepiness
• abnormal dreams

5. feeling tired, fatigue
6. increased appetite
7. changes in taste

These side effects are usually mild and short-lived.

Tell your doctor soon if...

Tell your doctor as soon as possible if you notice:

• trembling
• abnormal co-ordination
• difficulty in speaking
• abnormal or fast heartbeat
• problems with your vision or pain in your eyes
• blood in vomit
• red blood in stools
• abdominal pain
• skin problems such as rash, itching or reddening of the skin
• abnormal thinking

This list includes serious side effects which may require medical attention. Serious side effects are rare and may affect up to 1 person in 1,000.

Go to hospital if...

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

1. sudden severe itchy swellings on the skin
2. severe painful red blisters on the skin with chills, fever, aching muscles and generally feeling unwell
3. breathing problems

• wheezing
• difficulty breathing
• shortness of breath

4. 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.
5. chest pain

These are very serious side effects. If you have them, you may have had a serious allergic reaction to CHAMPIX. You may need urgent medical attention or hospitalisation.

All of these side effects are very rare. They may affect up to 1 person in 10,000.

After using CHAMPIX

Storage

Keep your tablets in the pack until it is time to take them.

Store CHAMPIX in a cool dry place where the temperature stays below 30 degrees.

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 0.5mg tablets are white, film-coated, modified capsular shaped tablets marked "Pfizer" on one side and "CHX 0.5" on the other.

CHAMPIX 1.0mg tablets are light blue, film-coated, modified capsular shaped tablets, marked "Pfizer" on one side and "CHX 1.0" on the other.

A combination pack containing 11 x CHAMPIX 0.5 mg tablets and 14 x CHAMPIX 1mg tablets as Pack 1 and 28 x CHAMPIX 1 mg tablets as Pack 2, is available to assist with the initial dose schedule required when commencing CHAMPIX. This pack has a green and blue stripe on the spine, back and front of the pack.

For continuing treatment, CHAMPIX 1 mg tablets are available in a pack of 56 tablets. This pack has a green stripe on the spine of the pack.

Ingredients

Active Ingredients

CHAMPIX 0.5mg tablets contain the equivalent of 0.5mg of varenicline.

CHAMPIX 1.0mg tablets contain the equivalent of 1.0mg of varenicline.

Inactive Ingredients

Each tablet of CHAMPIX contains the following inactive ingredients:

• Cellulose - microcrystalline
• Calcium hydrogen phosphate
• Croscarmellose sodium
• Silica-colloidal
• Magnesium stearate
• Opadry Blue, Opadry Clear and Opadry Clear as a coating

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 0.5mg and 1.0mg Tablet Blisters: AUST R No. 124940
• CHAMPIX 1.0mg Tablet Blister Pack: AUST R No. 124941

This leaflet was prepared in July 2009

© Pfizer Australia Pty Ltd.
All rights reserved.
® Registered Trademark

Published by MIMS/myDr November 2009

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