CHAMPIX 0.5 mg FILM-COATED TABLETS

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

Talk to 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 concern 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 as a result of stopping smoking, with or without treatment with CHAMPIX, may alter the action of other medicines. Therefore, 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 may 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

Before starting treatment with CHAMPIX, tell your doctor if you have had seizures or if you are epileptic. Some people have observed seizures during treatment with CHAMPIX.

Hypersensitivity reactions

Stop taking CHAMPIX and tell 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

There have been reports of potentially life-threatening skin rash (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 immediate medical attention.

Children and adolescents

CHAMPIX is not recommended for use in paediatric patients as its efficacy has not been demonstrated.

Using CHAMPIX with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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, talk to 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 cause increased levels of CHAMPIX in the 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. Talk to your doctor if you plan to become pregnant.

Although it has not been studied, CHAMPIX may pass into human breast milk. You should talk to 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 potentially hazardous activity until you know whether this medicine affects your ability to perform these activities.

CHAMPIX contains sodium

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

3. How to take CHAMPIX

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, talk to 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 additional information to help you make sure your attempt to stop 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) when you will stop smoking. If you do not wish to or cannot set a date to stop smoking within these 2 weeks, you can choose your quit date between 5 weeks after the start of treatment. You should write this date on the pack as a reminder.

CHAMPIX is available as white (0.5 mg) and light blue (1 mg) film-coated tablets. You will start with the white tablets and normally move to the light blue tablets. See below the table with the usual administration instructions that you should 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 avoid going back to smoking.

If you are unable or unwilling to stop smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and stop 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 of 24 weeks of treatment.

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 talk to 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 accidentally taken more CHAMPIX than your doctor prescribed, talk to 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 forgotten doses. 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 can. However, if it is between 3 and 4 hours before your next dose, do not take the missed tablet.

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 keep taking CHAMPIX as instructed in the table above.

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

If you have any further questions about 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, can cause various 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 occurrence of serious 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.

There have been reports of serious side effects in people trying to stop 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 behaviour (such as aggressive or abnormal behaviour), sleepwalking, diabetes, and high blood sugar levels. There have also been reports of serious 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), and severe allergic reactions, including angioedema (swelling of the face, mouth, or throat).

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

• Nasal and throat inflammation, abnormal dreams, difficulty sleeping, headache
• Nausea

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

• Chest infection, nasal sinus inflammation
• Weight gain, decreased appetite, increased appetite
• Sleepiness, dizziness, changes in taste
• Difficulty breathing, coughing
• Acid reflux, vomiting, constipation, diarrhoea, feeling bloated, 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 impulse
• Seizures, tremors, feeling lethargic, decreased sensitivity to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heart rate, palpitations, increased heart rate
• Increased blood pressure, hot flushes
• Nasal, sinus, and throat inflammation, nasal congestion, throat and chest congestion, hoarseness, hay fever, throat irritation, nasal sinus congestion, excess 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 weak or unwell
• 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 unhappy, 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, furry tongue
• Stiff joints, back 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 behaviour
• 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)

• 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 package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month shown.

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 to protect the environment.

6. Container Content 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 components are:

Product Appearance and Container Content

• 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 pack sizes:

• Starter pack 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.
• Starter pack 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.
• Starter pack in an outer carton containing 1 pack 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 packs containing 2 transparent blisters with 28 or 4 transparent blisters with 14 CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Follow-up packs (maintenance) containing 2 or 4 transparent blisters with 14 or 2 transparent blisters with 28 CHAMPIX 1 mg film-coated tablets in a cardboard box.
• Follow-up packs (maintenance) 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.
• Starter pack 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.
• Follow-up packs (maintenance) 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, tamper-evident screw cap in a carton, containing 56 CHAMPIX 1 mg film-coated tablets.
• HDPE white bottle with a child-resistant, tamper-evident screw cap in a carton, containing 56 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 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Spain

Pfizer, S.L.

Tel: + 34 91 490 99 00

Date of 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/.