Package Insert: Information for the User

CHAMPIX 0.5 mg Film-Coated Tablets

CHAMPIX 1 mg Film-Coated Tablets

varenicline

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

CHAMPIX may help alleviate anxiety and withdrawal syndrome associated with quitting smoking.

CHAMPIX also may reduce the pleasure that cigarettes cause if smoked during treatment.

Do not take CHAMPIX

-If you are allergic to varenicline or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take CHAMPIX.

Cases of depression, ideation, and suicidal behavior, and suicide attempts have been reported in patients receiving CHAMPIX. If you are taking CHAMPIX and experience agitation, depressed mood, changes in behavior that concern you or your family, or if you develop suicidal thoughts or behavior, stop taking CHAMPIX and contact your doctor immediately for a treatment evaluation.

Effects of quitting smoking

The effects of changes in your body as a result of quitting smoking, with or without CHAMPIX treatment, may alter the action of other medications. Consequently, in some cases, a dose adjustment may be necessary. See below for more details in “Other medications and CHAMPIX”.

Quitting smoking, with or without treatment, has been associated in some people with a higher risk of experiencing changes in thinking or behavior, feelings of depression and anxiety, and may be associated with a worsening of a psychiatric disorder. If you have a history of a psychiatric disorder, discuss it with your doctor.

Cardiac symptoms

Reports of worsening or new cases of heart or blood vessel (cardiovascular) problems have been communicated, mainly in people who already had cardiovascular problems. Inform your doctor if you experience any changes in symptoms during CHAMPIX treatment. If you experience symptoms of a heart attack or stroke, seek emergency medical help immediately.

Seizures

Inform your doctor before starting CHAMPIX treatment if you have had seizures or are epileptic. Some people have experienced seizures during CHAMPIX treatment.

Hypersensitivity reactions

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

Skin reactions

Cases of potentially life-threatening skin rash (Stevens-Johnson syndrome and erythema multiforme) have been reported with the use of CHAMPIX. If you develop a rash or if blisters or skin peeling occur, stop taking CHAMPIX and seek urgent medical attention.

Children and adolescents

CHAMPIX is not recommended for pediatric patients as its efficacy has not been demonstrated.

Use of CHAMPIX with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In some cases, as a result of quitting smoking, with or without CHAMPIX, a dose adjustment of other medications may be necessary. Examples include theophylline (a medication for respiratory problems), warfarin (a medication to reduce blood clotting), and insulin (a medication for diabetes treatment). If you have any doubts, consult your doctor or pharmacist.

If you have severe kidney disease, avoid taking cimetidine (a medication for gastrointestinal problems) at the same time as CHAMPIX, as this may cause an increase in CHAMPIX blood levels.

Use of CHAMPIX with other smoking cessation therapies

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

Use of CHAMPIX with food and beverages

There have been some reports of increased intoxicating effects of alcohol in patients taking CHAMPIX. However, it is unknown whether CHAMPIX increases the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is preferable to avoid using CHAMPIX while pregnant. Consult your doctor if you plan to become pregnant.

Although not studied, CHAMPIX may pass into human breast milk. Consult your doctor or pharmacist before taking CHAMPIX.

Driving and operating machinery

CHAMPIX may be associated with dizziness, somnolence, and transient loss of consciousness. Do not drive, operate complex machinery, or perform any other potentially hazardous activity until you know if this medication affects your ability to perform these activities.

CHAMPIX contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is more likely that you will quit smoking if you are motivated to do so. Your doctor or pharmacist can provide you with advice, support, and additional information to help you ensure that your attempt to quit smoking is successful.

Normally, before starting your treatment with CHAMPIX, you should decide on a date during the second week of treatment (between day 8 and day 14) on which you will quit smoking. If you do not want or are unable to set a date to quit smoking within those 2 weeks, you can choose your quit date within the 5 weeks following the start of treatment. You should write this date on the packaging as a reminder.

CHAMPIX is presented as white tablets (0.5 mg) and light blue tablets (1 mg). You will start with the white tablets and normally switch to the light blue ones. See the following table with the usual administration instructions that you should follow from Day 1.

If you have quit smoking after 12 weeks of treatment, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg tablets twice a day to help you not smoke again.

If you cannot or are not willing to quit smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and quit at the end of that treatment period. You should then continue taking CHAMPIX 1 mg tablets twice a day for another 12 weeks, totaling 24 weeks of treatment.

If you experience adverse effects that you cannot tolerate, your doctor may decide to temporarily or permanently reduce your dose 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 administered orally.

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 accidentally taken more CHAMPIX than your doctor prescribed, consult your doctor immediately or go to the nearest hospital. Bring your packaging.

If you forget to take CHAMPIX

Do not take a double dose to compensate for the missed doses. It is essential to take CHAMPIX regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if there are 3 to 4 hours until your next dose, do not take the missed tablet.

If you interrupt treatment with CHAMPIX

It has been demonstrated in clinical trials that if you take all your medication doses at the right times and during the recommended treatment period and previously described, your chances of quitting smoking will increase. Therefore, unless your doctor gives you instructions to discontinue treatment, it is essential to continue taking CHAMPIX according to the instructions described in the table above.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stopping smoking with or without treatment may produce different symptoms, which may include mood changes (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 appearance of severe neuropsychiatric symptoms, such as agitation, depressive mood, or changes in behavior during an attempt to quit smoking with or without CHAMPIX, and you should contact a doctor or pharmacist if you experience these symptoms.

Severe side effects have occurred in people trying to quit smoking with CHAMPIX: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality, and inability to think or judge clearly (psychosis), changes in thinking or behavior (such as aggressive and abnormal behavior), sleepwalking, diabetes, and high blood sugar levels. Also, severe skin reactions have been reported, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious disease 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).

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

• Pharyngitis and laryngitis, abnormal dreams, difficulty sleeping, headache
• Nausea

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

• Chest infection, nasal congestion
• Weight gain, decreased appetite, increased appetite
• Dreams, dizziness, changes in taste
• Difficulty breathing, cough
• Acid reflux, vomiting, constipation, diarrhea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, myalgia, back pain
• Chest pain, fatigue

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

• Fungal infection, viral infection
• Panic sensation, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual impulse
• Seizures, tremor, feeling of apathy, decreased sensitivity to touch
• Conjunctivitis, eye pain,
• Tinnitus
• Angina, rapid heart rate, palpitations, increased heart rate
• High blood pressure, heat
• Nasal congestion, throat congestion, chest congestion, snoring, hay fever, throat irritation, nasal congestion, excessive nasal mucus with cough, rhinorrhea
• Bloody stools, irritated stomach, change in bowel habit, belching, mouth ulcers, toothache
• 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 weak or unwell
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thinking or behavior (such as aggression)

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

• Excessive thirst
• Discomfort or feeling unhappy, slow thinking
• Stroke
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern alteration
• Eye changes, eye discoloration, dilated pupils, light sensitivity, myopia, watery eyes
• Irregular heartbeat or heart rhythm changes
• Throat pain, snoring
• Blood in vomit, abnormal stools, tongue soreness
• Joint stiffness, chest pain
• Glucose in urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual ability
• Feeling cold, cyst
• Diabetes
• Sleepwalking
• Loss of contact with reality and inability to think or judge clearly (psychosis)
• Abnormal behavior
• Severe skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious disease with blisters on the skin, mouth, and around the eyes and genitals)
• Severe allergic reactions, including angioedema (swelling of the face, mouth, or throat)

• Unknown frequency

• Transient loss of consciousness

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister card or on the box after CAD. The expiration date is the last day of the month indicated.

Blister packs: Store below30°C

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of CHAMPIX

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

Appearance of the product and contents of the pack

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

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

CHAMPIX is available in the following pack sizes:

• Start of treatment pack containing 2 blisters; 1 transparent blister with 11 tablets of CHAMPIX 0.5 mg film-coated tablets and 1 transparent blister with 14 tablets of CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Start of treatment pack containing 2 blisters; 1 transparent blister with 11 tablets of CHAMPIX 0.5 mg film-coated tablets and 14 tablets of CHAMPIX 1 mg film-coated tablets and 1 transparent blister with 28 or 2 transparent blisters with 14 tablets of CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Start of treatment pack in an outer box containing 1 pack with 1 transparent blister with 11 tablets of CHAMPIX 0.5 mg film-coated tablets and 14 tablets of CHAMPIX 1 mg film-coated tablets and 1 transparent blister with 28 or 2 transparent blisters with 14 tablets of CHAMPIX 1 mg film-coated tablets in a cardboard box and 2 packs containing 2 transparent blisters with 28 or 4 transparent blisters with 14 tablets of CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Follow-up (maintenance) packs containing 2 or 4 transparent blisters with 14 or 2 transparent blisters with 28 tablets of CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Follow-up (maintenance) packs containing 2 or 4 transparent blisters with 14 or 2 transparent blisters with 28 tablets of CHAMPIX 0.5 mg film-coated tablets in a cardboard box.
• Start of treatment pack containing 2 blisters; 1 transparent blister with 11 tablets of CHAMPIX 0.5 mg film-coated tablets and 1 transparent blister with 14 tablets of CHAMPIX 1 mg film-coated tablets in a box.
• Follow-up (maintenance) packs containing 2, 4, 8 or 10 transparent blisters with 14 tablets of CHAMPIX 1 mg film-coated tablets in a box.
• HDPE bottle sealed with a child-resistant screw cap in a box, containing 56 tablets of CHAMPIX 1 mg film-coated tablets.
• HDPE bottle sealed with a child-resistant screw cap in a box, containing 56 tablets of CHAMPIX 0.5 mg film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Spain

Pfizer, S.L.

Tel: + 34 91 490 99 00

Last update of this leaflet:05/2023

Other sources of information

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