1. What varenicline is

The active ingredient is the chemical in the medicine that makes the medicine work.

Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines are available under several different brand names.

The active ingredient of this medicine is varenicline (pronounced VA-ren-i-kleen). It is also known by the brand name Champix.

Varenicline is a tablet to help you quit smoking. It does this by blocking the effects of nicotine.

2. What varenicline is for

Varenicline helps smokers quit. It’s used together with a counselling program, like the one offered by Quitline (137 848).

If you smoke, you are at higher risk of lung disease (like emphysema and lung cancer), heart attack and stroke. Smoking is bad for you — and for the people around you.

3. Who can take varenicline

Most medicines prescribed by your doctor are covered by the PBS. This means that the Australian government pays part of the cost of your medicine.

Varenicline is available through the Pharmaceutical Benefits Scheme (PBS) if:

• you follow a counselling program for quitting smoking over the full course of treatment
• you are not taking other PBS-subsidised quit-smoking treatments at the same time
• more than 6 months have passed since you started a course of bupropion (Prexaton, Zyban SR), another quit-smoking treatment.

Only one course of varenicline is available through the PBS per person per year.

Varenicline may not be suitable for everyone.

There are other quit-smoking options that may be more appropriate if you:

• have depression, schizophrenia or bipolar disorder (see section 6: Important side effects to consider)
• have a serious medical condition (for example, epilepsy, cardiovascular disease or a serious lung problem called chronic obstructive pulmonary disease).

We don’t have information about the safety of varenicline in people who drink more than the recommended limit of alcohol or who use illegal drugs like marijuana.

Tell your doctor if you have kidney disease. You may still be able to take varenicline, but your doctor will need to adjust the dose.

4. How to take varenicline

To help make sure you take the right dose of varenicline, remember that:

white tablets contain 0.5 milligrams of varenicline and are taken for the first week of treatment only, and

light blue tablets contain 1 milligram of varenicline and are taken for the rest of your course.

You start taking varenicline 1–2 weeks before you intend to stop smoking (your quit date). The dose starts low and then increases slowly over the first week:

• Days 1–3, take one white tablet once a day.
• Days 4–7, take one white tablet twice daily (one in the morning and one in the evening).
• From day 8 until the end of treatment, take one light blue tablet twice daily (one in the morning and one in the evening).

The first prescription of varenicline is for 4 weeks of treatment, but you will need to visit your doctor 2–3 weeks after starting treatment for a second prescription for the next 8 weeks. This is also an opportunity to get further support and advice.

A full course of varenicline can be 12 weeks or 24 weeks

Some people will successfully quit after a 12 week course, but your doctor may recommend a further 12 weeks of treatment (that’s 24 weeks in total) to increase your chance of quitting in the long term.

Take the tablets with food and a glass of water

This can help to reduce nausea. Nausea affects about one in three people taking varenicline, but it usually settles with time (see section 6: Important side effects to consider).

Tell your doctor if nausea is troubling you, or if it is stopping you from taking your medication — you may be able to adjust the dose.

5. What does varenicline do?

Varenicline works by blocking the effects of nicotine.

This reduces the enjoyment of smoking when you start taking varenicline during the 1–2 week period before your quit date.

It also reduces cravings and withdrawal symptoms after you have quit.

6. Important side effects to consider

For a list of possible side effects, see the consumer medicine information (CMI) leaflet for Champix (varenicline).

Ask your doctor about the possible side effects of varenicline before you take it.

Always tell your doctor about any changes to your condition if you are taking a new medicine.
You can also discuss side effects with a pharmacist, by calling the Adverse Medicines Event (AME) Line on 1300 134 237 (Mon–Fri, 9am–5pm).

Nausea, difficulty sleeping, strange dreams, headache, and stomach or bowel problems are common side effects of varenicline.

Watch out for changes in mood or behaviour

Some people have become depressed, anxious, agitated or even aggressive when taking varenicline. Others developed mood swings or had hallucinations (seeing or hearing things that are not there), as well as thinking of self-harm or suicide. Some people did harm themselves.

Talk to your doctor as soon as possible if you — or people around you like family and friends — notice a change in your mood or behaviour.

Can other factors affect your mood? 

Some people who experienced mood or behavioural changes when taking varenicline had a previous mental health problem. But others didn’t.

It’s also difficult to tell the difference between varenicline’s side effects and withdrawal symptoms from smoking. These symptoms include irritability, depression and problems with sleeping — and they can also happen when you stop taking varenicline at the end of your treatment.

Nonetheless, if you have a mental health problem, such as depression, bipolar disorder or schizophrenia, you should discuss this with your doctor when thinking about varenicline.

Small possible increase in cardiovascular risk

In some studies, more people who took varenicline experienced a cardiovascular event — such as a heart attack — than those who took a placebo (dummy pill). It’s difficult to tell if varenicline caused these events or if they would have occurred anyway.

While the chance that varenicline may cause a heart attack appears to be small, if you experience chest pain, breathing problems, or pain in your legs when you are taking varenicline, see a doctor immediately.

Bear in mind that smoking increases the risk of heart disease or stroke — while people who quit smoking halve their risk of experiencing a heart attack 1 year after quitting.

If you have heart problems (cardiovascular disease) already, ask your doctor about your options for quitting.

Skin reactions are very rare but can be serious

Stop taking varenicline and see a doctor as soon as possible at the first sign of rash or red blisters, or swelling around your face, mouth or neck.

Wait before driving or using machinery

Varenicline can cause drowsiness. Wait to see how varenicline affects you before driving or operating machinery. 

7. What else you should know about varenicline

Using nicotine replacement therapy at the same time as varenicline can cause some side effects like nausea, headache and dizziness — or it can make them worse. It’s not yet known if the combination of varenicline and bupropion is safe to use.

So the best approach is to avoid using other quit-smoking medicines at the same time as varenicline.

8. Other medicines available for quitting smoking

Talk to your doctor about all of the options for quitting.  Call the Quitline on 137 848.

In Australia, two other types of medicine are available to help people quit smoking.

Nicotine replacement therapy (sometimes called NRT) is safe for most people, and doctors and pharmacists know a great deal about using it. It’s often the first medicine tried to help people quit smoking. It is also suitable for people with mental health problems.

Nicotine replacement therapy works by reducing cigarette cravings. It comes in several different forms including lozenges, mini-lozenges or micro-tabs, inhalers, chewing gum, and patches. There are several brands available (for example, Chemists’ Own Nicotine, Nicabate CQ, Nicorette and QuitX). Talk to your pharmacist about the different types available and which best suits you. The side effects — like dizziness, headache and nausea — are usually short-lived and minor. Different forms can have different side effects. For example, the chewing gum may cause stomach upset, and the patch can cause skin irritation.

You can get nicotine patches through the PBS if you have a prescription.

Bupropion is a tablet that works differently to varenicline. It is about as effective as nicotine replacement therapy. When you first start taking bupropion (brand name Prexaton or Zyban SR), you may get some mild side effects like headache, dry mouth, upset stomach and problems with sleeping. But these are usually short-lived.

Bupropion has some important side effects and interactions with other medicines that make it unsuitable for some people. Seizures (fits) are a rare side effect. The risk of having a seizure is higher in people who:

• have had a seizure before (epilepsy)
• take other medicines that increase the risk of having a seizure
• have diabetes
• have previously had a head injury
• drink too much alcohol.   

9. How to decide between varenicline and other medicines

A clinical trial is a research study of how well a medicine works for people taking it, and what side effects it has.

To find out more about clinical trials, see What are clinical trials and why are they important?

Personal preference is an important factor when choosing between different quitting options. You may prefer to wear a patch than take a tablet, or you may want to avoid a particular side effect. Other people may be willing to put up with a side effect if the medicine is working well for them. Think about what matters most to you, and discuss your preferences with your doctor.

Is varenicline more effective than other options?

There is not enough good information from clinical trials to know if varenicline is better than nicotine replacement therapy. The results from one clinical trial suggest that they are about as good as each other. But varenicline is more effective than bupropion. Nearly 1 year after completing their treatment course, 23% of people who took varenicline were not smoking, compared with 15% who took bupropion and 10% who took a placebo.

Consider side effects when choosing

Comparing the side effects can also help you decide between varenicline and other options. For example, because varenicline can affect mood and behaviour it’s unlikely to be suitable for people with a mental health problem (see section 6: Important side effects to consider).

10. What does varenicline cost?

Cost to the Government

The full cost of varenicline to the Australian Government is:

• $103.12 for a box containing 11 varenicline tablets (0.5 milligram [mg] strength) and 14 varenicline tablets (1 mg strength) in the first pack and 28 tablets (1 mg strength) in the second pack. The tablets in this box are for the first 4 weeks of treatment
• $231.70 for two packs of varenicline, each containing 56 tablets (1 mg strength). These tablets are for the next 8 weeks of treatment
• $120.42 for one pack of varenicline containing 56 tablets (1 mg strength). You will need three packs to cover this further 12 weeks of treatment.
  

Cost to you

If you get varenicline through the Pharmaceutical Benefits Scheme (PBS), the Australian Government pays most of the cost and you will pay only a part, called the co-payment.

At the time of publication, the co-payment for people who are entitled to get varenicline through the PBS was:

• $34.20 for people without a concession card
• $5.60 for concession card holders.

If you are not eligible to get varenicline through the PBS, you will need to pay the full price for a prescription.

11. Other ways to stop smoking

While medicines play an important role in helping some people quit, most people do it without medicines.

Non-medicine approaches include:

• going cold turkey
• gradually cutting down, then quitting
• counselling.

Making up your mind

Different methods work for different people, but the most important first step is deciding to quit. That’s the key — you have to want to stop smoking. The next step is planning how to do it.

Getting support

The Quitline (137 848) or your doctor can help you increase your chance of success and learn from any past quit attempts. Also ask your friends and family for support.

Cutting down

If you are not confident about quitting immediately, you can try to gradually reduce smoking, while using nicotine replacement therapy, with the aim of quitting in the future.

Counselling

Counselling can help, whether it is in a group or one to one. Quitline (137 848) offers free telephone counselling for smokers who want to quit.

It’s worth it!

Quitting at any time helps — the health of people who quit starts to improve within days. It often takes more than one attempt to be successful, even with all the best support and medicines. If the first attempt doesn’t work, try again. It’s worth it!