Champix 0.5 mg, 1 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

CHAMPIX 0.5 mg film-coated tablets

CHAMPIX 1 mg film-coated tablets

varenicline

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents:

1. What CHAMPIX is and what it is used for
2. What you need to know before taking CHAMPIX
3. How to take CHAMPIX
4. Possible adverse effects
5. How to store 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 relieve the craving and withdrawal symptoms associated with quitting smoking.

CHAMPIX may also reduce the pleasure derived from cigarettes if you smoke during treatment.

2. What you need to know before taking CHAMPIX

Do not take CHAMPIX

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take CHAMPIX.

Cases of depression, suicidal ideation and behaviour, and suicide attempts have been reported in patients receiving 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 must stop taking CHAMPIX and contact your doctor immediately for a treatment evaluation.

Effects of smoking cessation

Changes in your body resulting from quitting smoking, with or without treatment with CHAMPIX, may alter the action of other medicines. Therefore, in some cases, a dose adjustment may be necessary. See below for more details in “Other medicines and CHAMPIX”.

Quitting smoking, with or without treatment, has been associated in some individuals with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety, 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

Worsening or new onset of heart or blood vessel (cardiovascular) problems has been reported, primarily in individuals who already had cardiovascular conditions. Inform your doctor if you experience any changes in symptoms during treatment with CHAMPIX. If you have symptoms of a heart attack or stroke, seek emergency medical help immediately.

Seizures

Before starting treatment with CHAMPIX, inform your doctor if you have ever had seizures or if you have epilepsy. Some people have experienced seizures during treatment with CHAMPIX.

Hypersensitivity reactions

Stop taking CHAMPIX and contact your doctor immediately if you experience any of the following signs or symptoms which 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 appear or your skin starts peeling, you must stop taking CHAMPIX and seek urgent medical attention.

Children and adolescents

The use of CHAMPIX is not recommended in paediatric patients, as efficacy has not been demonstrated.

Taking CHAMPIX with other medicines

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

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

If you have severe renal impairment, you should avoid taking cimetidine (a medicine for gastric problems) at the same time as CHAMPIX, as this may lead to increased blood levels of CHAMPIX.

Use of CHAMPIX with other smoking cessation therapies

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

Taking 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 become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using CHAMPIX during pregnancy. Consult your doctor if you are planning to become pregnant.

Although not 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 potentially hazardous activities until you know whether this medicine affects your ability to perform such activities.

CHAMPIX contains sodium

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

3. How to take CHAMPIX

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, 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 additional information to help ensure your attempt to quit smoking is successful.

Normally, before starting treatment with CHAMPIX, you should choose a date during the second week of treatment (between day 8 and day 14) on which you will stop smoking. If you do not wish or are unable to set a quit date within those 2 weeks, you may choose your quit date within the following 5 weeks after starting treatment. 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 normally progress to the light blue ones. See the table below for the usual dosing 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 daily to help you remain abstinent from 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 smoking completely by the end of that treatment period. After that, you should continue taking CHAMPIX 1 mg film-coated tablets twice daily for another 12 weeks, for a total treatment duration of 24 weeks.

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 daily.

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

CHAMPIX is administered orally.

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

If you take more CHAMPIX than you should

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

If you forget to take CHAMPIX

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

If you stop taking CHAMPIX

Clinical trials have shown that taking all doses of your medication at the correct times and for the recommended treatment period described above increases your chances of successfully quitting smoking. Therefore, unless your doctor instructs otherwise, it is important to continue taking CHAMPIX as directed in the table above.

In smoking cessation therapy, the risk of relapse may be high immediately after treatment ends. Temporarily, after stopping CHAMPIX, you may experience increased irritability, craving to smoke, depression, and/or sleep disturbances. Your doctor may decide to gradually reduce your CHAMPIX dose at the end of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stopping smoking, with or without treatment, may produce various symptoms, which may include mood changes (such as feeling depressed, irritable, frustrated, or anxious), insomnia, difficulty concentrating, slowed 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 behavior during an attempt to quit smoking with or without CHAMPIX, and you should contact a doctor or pharmacist if you experience these symptoms.

Serious adverse effects have occurred infrequently or rarely in people attempting to stop smoking with CHAMPIX: seizures, stroke, heart attack, suicidal thoughts, loss of touch with reality, and inability to think or judge clearly (psychosis), changes in thinking or behavior (such as aggressive or abnormal behavior), sleepwalking, diabetes, and high blood sugar levels. Serious skin reactions have also been reported, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious illness with blisters on the skin, mouth, and around the eyes and genitals), as well as serious allergic reactions including angioedema (swelling of the face, mouth, or throat).

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

• Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache

• Nausea

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

• Chest infection, inflammation of the sinuses

• Weight gain, decreased appetite, increased appetite

• Sleepiness, dizziness, changes in taste sensation

• Difficulty breathing, cough

• Stomach acid, vomiting, constipation, diarrhea, bloating, abdominal pain, toothache, indigestion, flatulence, dry mouth

• Skin rash, itching

• Joint pain, myalgia, back pain

• Chest pain, fatigue

• Uncommon adverse effects: 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 desire

• Seizures, tremor, feeling of lethargy, reduced sensitivity to touch

• Conjunctivitis, eye pain

• Ringing in the ears

• Angina, rapid heart rate, palpitations, increased heart rate

• Increased blood pressure, flushing

• Inflammation of the nose, sinuses, and throat, nasal, throat, and chest congestion, hoarseness, hay fever, sore throat, congested sinuses, excess nasal mucus with cough, rhinorrhea

• Red blood in stools, irritated stomach, change in bowel habit, burping, mouth ulcers, gum pain

• Skin redness, acne, increased sweating, night sweats

• Muscle spasms, chest wall pain

• Abnormally frequent urination, nocturnal urination

• Increased menstrual flow

• Chest discomfort, flu-like illness, fever, feeling of weakness or malaise

• High blood sugar levels

• Heart attack

• Suicidal thoughts

• Changes in thinking or behavior (such as aggression)

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

• Excessive thirst

• Malaise or feeling of unhappiness, slowed thinking

• Stroke

• Increased muscle tension, speech difficulties, coordination difficulties, reduced sense of taste, sleep pattern disturbances

• Vision disturbances, discoloration of the eyeball, dilated pupils, light sensitivity, myopia, watery eyes

• Irregular heartbeat or disturbances in heart rhythm

• Sore throat, snoring

• Blood in vomit, abnormal stools, coated tongue

• Numb joints, rib pain

• Glucose in urine, increased urine volume and frequency

• Vaginal discharge, changes in sexual ability

• Feeling cold, cyst

• Diabetes

• Sleepwalking

• Loss of touch with reality and inability to think or judge clearly (psychosis)

• Abnormal behavior

• Serious skin reactions including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious illness with blisters on the skin, mouth, and around the eyes and genitals)

• Serious allergic reactions including angioedema (swelling of the face, mouth, or throat)

• Frequency not known:

• Transient loss of consciousness

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the carton or on the blister pack after EXP. The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of CHAMPIX

• The active substance 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:

Appearance of the product and contents of the container

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

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

CHAMPIX is available in the following pack presentations:

• 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.
• Maintenance (follow-up) packs 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) packs 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 carton.
• Maintenance (follow-up) packs containing 2, 4, 8 or 10 transparent blisters with 14 CHAMPIX 1 mg film-coated tablets, in a carton.
• White HDPE bottle sealed with child-resistant screw cap in a carton, containing 56 CHAMPIX 1 mg film-coated tablets.
• White HDPE bottle sealed with child-resistant screw cap in a carton, containing 56 CHAMPIX 0.5 mg film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

or

Pfizer Italia S.r.l.
Località Marino del Tronto, 63100
Ascoli Piceno (AP)
Italy

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

Date of the most recent revision of this leaflet: <{MM/YYYY}>

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.