CHAMPIX 0.5, 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

CHAMPIX 0.5 mg film-coated tablets

CHAMPIX 1 mg film-coated tablets

varenicline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What CHAMPIX is and what it is used for
2. What you need to know before you take CHAMPIX
3. How to take CHAMPIX
4. Possible side effects
5. Storing CHAMPIX
6. Contents of the pack and other information

1. What CHAMPIX is and what it is used for

CHAMPIX contains the active substance varenicline. CHAMPIX is a medicine used in adults to help them stop smoking.

CHAMPIX can help to reduce the craving for smoking and the withdrawal symptoms, such as irritability and anxiety, that many people experience when they try to stop smoking.

CHAMPIX may also reduce the pleasure associated with smoking if you do smoke while taking the medicine.

2. What you need to know before you take CHAMPIX

Do not take CHAMPIX

• If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking CHAMPIX.

There have been reports of depression, suicidal thoughts and behaviour, and attempted suicide in patients taking CHAMPIX. If you are taking CHAMPIX and experience agitation, depressed mood, changes in behaviour that are of concern to you or your family, or if you develop suicidal thoughts or behaviour, you should stop taking CHAMPIX and contact your doctor immediately for evaluation of your treatment.

Effects of stopping smoking

The effects of the changes in your body due to stopping smoking, with or without treatment with CHAMPIX, may alter the action of other medicines. As a result, in some cases it may be necessary to adjust the dose of other medicines. See below for more details in “Other medicines and CHAMPIX”.

Stopping smoking, with or without treatment, has been associated in some people with an increased risk of experiencing changes in thinking or behaviour, feeling depressed or anxious, and can be associated with worsening of a psychiatric disorder. If you have a history of psychiatric disorder, you should discuss this with your doctor.

Cardiac symptoms

There have been reports of worsening or new cases of heart or blood vessel problems (cardiovascular) mainly in people who already had cardiovascular problems. Tell your doctor if you notice any change in symptoms during treatment with CHAMPIX. If you experience symptoms of a heart attack or stroke, seek immediate medical help.

Seizures

Tell your doctor before you start taking CHAMPIX if you have ever had seizures or if you are epileptic. Some people have experienced seizures during treatment with CHAMPIX.

Hypersensitivity reactions

Stop taking CHAMPIX and tell your doctor immediately if you experience any of the following symptoms that may indicate a severe allergic reaction: swelling of the face, lips, tongue, gums, throat, or body, or difficulty breathing, wheezing.

Skin reactions

There have been reports of potentially life-threatening skin reactions (Stevens-Johnson syndrome and erythema multiforme) with the use of CHAMPIX. If you develop a rash or blisters or your skin peels or sheds, you should stop taking CHAMPIX and seek urgent medical attention.

Children and adolescents

CHAMPIX is not recommended for use in children and adolescents under 18 years because its safety and efficacy have not been established.

Using CHAMPIX with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In some cases, as a result of stopping smoking, with or without CHAMPIX, it may be necessary to adjust the dose of other medicines. Examples include theophylline (a medicine for respiratory problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine for diabetes). If you are in doubt, consult your doctor or pharmacist.

If you have severe kidney disease, you should avoid taking cimetidine (a medicine for stomach problems) at the same time as CHAMPIX, as this may increase the levels of CHAMPIX in your blood.

Using CHAMPIX with other stop-smoking therapies

Consult your doctor before using CHAMPIX in combination with other stop-smoking therapies.

Using CHAMPIX with food and drink

There have been some reports of increased intoxicating effects of alcohol in patients taking CHAMPIX. However, it is not known whether CHAMPIX increases the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is recommended to avoid the use of CHAMPIX during pregnancy. Consult your doctor if you are planning to become pregnant.

Although it has not been studied, CHAMPIX may pass into human breast milk. You should consult your doctor or pharmacist before taking CHAMPIX.

Driving and using machines

CHAMPIX may be associated with dizziness, somnolence, and transient loss of consciousness. You should not drive, operate complex machinery, or engage in any other activity where such symptoms could be a problem until you know whether this medicine affects your ability to perform these activities.

CHAMPIX contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take CHAMPIX

Follow exactly the instructions given to you by your doctor for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

You are more likely to stop smoking if you are motivated to do so. Your doctor or pharmacist can provide you with advice, support, and further information to help you to make your attempt to stop smoking successful.

Normally, before you start taking CHAMPIX, you should set a date to stop smoking, which should be between 8 and 14 days after you start taking the medicine. If you are not ready or able to set a date to stop smoking within the first 2 weeks, you can choose a date to stop smoking within the next 5 weeks. You should write this date on the pack as a reminder.

CHAMPIX is available as white tablets (0.5 mg) and light blue tablets (1 mg). You will start with the white tablets and will normally move to the light blue tablets. See below for the usual instructions to follow from Day 1.

If you have stopped smoking after 12 weeks of treatment, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice a day to help you to stay smoke-free.

If you are not able or willing to stop smoking immediately, you should reduce your smoking during the first 12 weeks of treatment and then stop smoking at the end of this period. You should then continue to take CHAMPIX 1 mg film-coated tablets twice a day for another 12 weeks, making a total treatment duration of 24 weeks.

If you experience side effects that you cannot tolerate, your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice a day.

If you have kidney problems, you should consult your doctor before taking CHAMPIX. You may need a lower dose.

CHAMPIX is taken by mouth.

The tablets should be swallowed whole with water or can be taken with or without food.

If you take more CHAMPIX than you should

If you have taken more CHAMPIX than you should, contact your doctor or go to the nearest hospital immediately. Take the pack with you.

If you forget to take CHAMPIX

Do not take a double dose to make up for a forgotten dose. 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. However, if it is almost time for your next dose, do not take the missed dose.

If you stop taking CHAMPIX

It has been shown in clinical trials that if you take all the doses of your medicine at the right times and for the recommended treatment period, and as described above, you will increase your chances of stopping smoking. Therefore, unless your doctor tells you to stop treatment, it is important to continue taking CHAMPIX as described above.

In smoking cessation therapy, the risk of relapse to smoking may be high in the period immediately after stopping treatment. Temporarily, when you stop taking CHAMPIX, you may experience increased irritability, nicotine craving, depression, and/or sleep disturbance. Your doctor may decide to gradually reduce your dose of CHAMPIX at the end of treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stopping smoking, with or without treatment, may cause various symptoms, which can include changes in mood (such as feeling depressed, irritable, frustrated, or anxious), insomnia, difficulty concentrating, decreased heart rate, and increased appetite or weight gain.

You should be aware of the possible occurrence of severe neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during an attempt to stop smoking with or without CHAMPIX, and you should contact a doctor or pharmacist if you experience these symptoms.

Serious side effects have been reported rarely in people trying to stop smoking with CHAMPIX: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality, and inability to think clearly or make judgments (psychosis), changes in thinking or behaviour (such as aggressive or abnormal behaviour), sleepwalking, diabetes, and high blood sugar levels. Serious skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a severe skin condition with blisters on the skin, mouth, and around the eyes and genitals), and severe allergic reactions, including angioedema (swelling of the face, mouth, or throat), have also been reported.

• Very common side effects: may affect more than 1 in 10 people:

• Nasal congestion, abnormal dreams, difficulty sleeping, headache
• Nausea

• Common side effects: may affect up to 1 in 10 people:

• Chest infection, sinusitis
• Weight gain, decreased appetite, increased appetite
• Sleepiness, dizziness, changes in taste
• Difficulty breathing, cough
• Acid reflux, vomiting, constipation, diarrhoea, bloating, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, muscle pain, back pain
• Chest pain, fatigue

• Uncommon side effects: may affect up to 1 in 100 people:

• Fungal infection, viral infection
• Panic attacks, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual desire
• Seizures, tremor, feeling of lethargy, decreased sensitivity to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heart rate, palpitations, increased heart rate
• High blood pressure, hot flushes
• Nasal congestion, sinusitis, sore throat, hoarseness, hay fever, sore throat, nasal congestion, excessive mucus production with cough, runny nose
• Blood in stools, stomach upset, change in bowel habit, belching, mouth ulcers, gum pain
• Redness of the skin, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Frequent urination, nocturia
• Increased menstrual flow
• Chest discomfort, flu-like illness, fever, feeling of weakness or illness
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thinking or behaviour (such as aggression)

• Rare side effects: may affect up to 1 in 1,000 people:

• Excessive thirst
• Malaise or feeling of unhappiness, slow thinking
• Stroke
• Increased muscle tone, difficulty speaking, difficulty coordinating, decreased sense of taste, altered sleep pattern
• Visual disturbances, discolouration of the eyeball, dilated pupils, sensitivity to light, myopia, watery eyes
• Irregular heartbeat or changes in heart rhythm
• Sore throat, snoring
• Blood in vomit, abnormal stools, coated tongue
• Stiff joints, rib pain
• Glucose in urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual ability
• Feeling of coldness, cyst
• Diabetes
• Sleepwalking
• Loss of contact with reality and inability to think clearly or make judgments (psychosis)
• Abnormal behaviour
• Serious skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a severe skin condition with blisters on the skin, mouth, and around the eyes and genitals)
• Severe allergic reactions, including angioedema (swelling of the face, mouth, or throat)

• Frequency not known

• Transient loss of consciousness

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing CHAMPIX

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister pack after EXP. The expiry date refers to the last day of that month.

Blister packs: Store below 30°C

Bottle: This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

CHAMPIX Composition

• The active ingredient is varenicline.
• Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate)
• Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate)
• The other ingredients are:

Product Appearance and Package Contents

• CHAMPIX 0.5 mg film-coated tablets are modified capsule-shaped, film-coated, and white, marked with "Pfizer" and "CHX 0.5"

• CHAMPIX 1 mg film-coated tablets are modified capsule-shaped, film-coated, and light blue, marked with "Pfizer" and "CHX 1.0"

CHAMPIX is available in the following package presentations:

• Treatment initiation package containing 2 blisters; 1 transparent blister with 11 CHAMPIX 0.5 mg film-coated tablets and 1 transparent blister with 14 CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Treatment initiation package containing 2 blisters; 1 transparent blister with 11 CHAMPIX 0.5 mg film-coated tablets and 14 CHAMPIX 1 mg film-coated tablets and 1 transparent blister with 28 or 2 transparent blisters with 14 CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Treatment initiation package in an outer box containing 1 package with 1 transparent blister with 11 CHAMPIX 0.5 mg film-coated tablets and 14 CHAMPIX 1 mg film-coated tablets and 1 transparent blister with 28 or 2 transparent blisters with 14 CHAMPIX 1 mg film-coated tablets in a cardboard box and 2 packages that contain 2 transparent blisters with 28 or 4 transparent blisters with 14 CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Maintenance (follow-up) packages containing 2 or 4 transparent blisters with 14 or 2 transparent blisters with 28 CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Maintenance (follow-up) packages containing 2 or 4 transparent blisters with 14 or 2 transparent blisters with 28 CHAMPIX 0.5 mg film-coated tablets in a cardboard box.
• Treatment initiation package containing 2 blisters; 1 transparent blister with 11 CHAMPIX 0.5 mg film-coated tablets and 1 transparent blister with 14 CHAMPIX 1 mg film-coated tablets in a box.
• Maintenance (follow-up) packages containing 2, 4, 8, or 10 transparent blisters with 14 CHAMPIX 1 mg film-coated tablets in a box.
• HDPE white bottle with a child-resistant, screw-on cap in a box, containing 56 CHAMPIX 1 mg film-coated tablets.
• HDPE white bottle with a child-resistant, screw-on cap in a box, containing 56 CHAMPIX 0.5 mg film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

or

Pfizer Italia S.r.l.

Località Marino del Tronto, 63100

Ascoli Piceno (AP)

Italy

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the Last Revision of this Leaflet:05/2023

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.