Champix

Package leaflet: Information for the user

CHAMPIX 0.5 mg film-coated tablets, 1 mg film-coated tablets

varenicline
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side 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 called varenicline. CHAMPIX is a medicine used in adults to help them stop smoking.
CHAMPIX can help relieve the symptoms of craving and withdrawal associated with stopping smoking.
CHAMPIX can also reduce the pleasure derived from smoking cigarettes if you smoke while being treated.

2. What you need to know before taking CHAMPIX

Do not use 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 taking CHAMPIX.
Cases of depression, suicidal thoughts and behaviour, and suicide attempts have been reported in patients taking CHAMPIX. If you are taking CHAMPIX and develop agitation, depressed mood, or changes in behaviour that cause concern to you, your family, or your doctor, or if you develop suicidal thoughts or behaviours, you must stop taking CHAMPIX and contact your doctor immediately for a treatment evaluation.
Effects of smoking cessation
Changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may affect how other medicines work. Therefore, in some cases, a dose adjustment may be necessary. For further details, see the section below “Other medicines and CHAMPIX”.
In some individuals, stopping smoking, with or without treatment, has been associated with an increased risk of changes in thinking or behaviour, feelings of depression and anxiety, and may be associated with worsening of psychiatric illness. If you have a history of psychiatric illness, discuss this with your doctor.
Cardiac symptoms
New cardiovascular problems or worsening of existing heart or blood vessel (cardiovascular) conditions have been reported, especially in people who already have cardiovascular disease. Inform your doctor if you experience any changes in symptoms during treatment with CHAMPIX. If you experience 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 suffer from epilepsy. Some people have experienced seizures while taking CHAMPIX.
Hypersensitivity reactions
Stop taking CHAMPIX and contact your doctor immediately if you experience any of the following signs or symptoms, which could indicate a severe allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.
Skin reactions
Potentially life-threatening skin reactions (Stevens-Johnson syndrome and erythema multiforme) have been reported with the use of CHAMPIX. If you develop a skin rash or if skin peeling or blistering occurs, stop treatment with CHAMPIX and seek urgent medical attention.
Children and adolescents
The use of CHAMPIX is not recommended in pediatric patients, as efficacy has not been demonstrated.
Other medicines and CHAMPIX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In some cases, as a consequence of smoking cessation, with or without CHAMPIX, a dose adjustment of other medicines may be required. These include theophylline (a medicine used to treat respiratory problems), warfarin (a medicine used to reduce blood clot formation), and insulin (a medicine for diabetes). If in doubt, consult your doctor or pharmacist.
If you have severe kidney disease, you should avoid taking cimetidine (a medicine for gastric disorders) while taking CHAMPIX, as this could lead to increased levels of CHAMPIX in the blood.
Use of CHAMPIX with other smoking cessation therapies
Talk to your doctor before using CHAMPIX in combination with other smoking cessation therapies.
CHAMPIX with food and drink
Cases of increased effects of alcohol intoxication have been reported in patients taking CHAMPIX. However, it is not known whether CHAMPIX actually increases alcohol intoxication.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using CHAMPIX during pregnancy. Talk to your doctor if you are planning a pregnancy.
Although not studied, CHAMPIX may pass into breast milk. Consult your doctor or pharmacist before taking CHAMPIX.
Driving and using machines
CHAMPIX may be associated with dizziness, drowsiness, and transient loss of consciousness. You must not drive, operate complex machinery, or perform any other potentially hazardous activities until you know whether this medicine affects your ability to perform these tasks.
CHAMPIX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take CHAMPIX

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your chances of successfully quitting smoking are greater if you are motivated. Your doctor or
pharmacist can provide you with advice, support, and further information to help make your
attempts to quit smoking successful.
Before starting treatment with CHAMPIX, you should usually choose a date during the second
week of treatment (between day 8 and day 14) on which to stop smoking. If you do not wish or
are unable to choose a quit date within the first 2 weeks, you may choose your own individual
quit date within 5 weeks of starting treatment. You should write this date on the pack to help
you remember it.
CHAMPIX is available as white tablets (0.5 mg) and light blue tablets (1 mg). Treatment is started
with the white tablet, and you will usually progress to the light blue tablet. See the table below
for instructions on the usual dosing regimen to follow starting from day 1.

After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12-week treatment cycle with CHAMPIX 1 mg film-coated tablets twice daily to help prevent you from starting to smoke again.

If you are unable or unwilling to stop smoking immediately, you should reduce smoking during the first 12 weeks of treatment and stop completely by the end of this period. You should then continue taking CHAMPIX 1 mg film-coated tablets twice daily for another 12 weeks, for a total of 24 weeks of treatment.

If you experience adverse events 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 must talk to your doctor before taking CHAMPIX. You may need a lower dose.

Champix is for oral use.

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

If you take more CHAMPIX than you should

If you accidentally take more CHAMPIX than prescribed, you must contact your doctor or go to the nearest emergency room. Take the tablet pack with you.

If you forget to take CHAMPIX

Do not take a double dose to make up for the missed tablet. It is important to take CHAMPIX tablets regularly every day at the same time. If you forget to take a dose, take it as soon as you remember. If less than 3–4 hours remain before your next scheduled dose, do not take the missed tablet.

If you stop taking CHAMPIX

Clinical studies have shown that taking all doses of the medicine at the correct time and for the recommended duration described above increases the likelihood of successfully quitting smoking. Therefore, unless your doctor has instructed you to stop treatment, it is important to continue taking CHAMPIX according to the instructions described in the table above.

During smoking cessation therapy, the risk of resuming smoking may be high in the period immediately following the end of treatment. When you stop treatment with CHAMPIX, you may temporarily experience increased irritability, a strong urge 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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stopping smoking, with or without treatment, may cause various symptoms. These may include mood changes (such as feeling depressed, irritable, frustrated, or anxious), insomnia, difficulty concentrating, reduced 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 while trying to stop smoking, with or without CHAMPIX, and you should contact your doctor or pharmacist if such symptoms occur.

In people who have attempted to stop smoking using CHAMPIX, serious side effects have been observed, with uncommon or rare frequency: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality, and inability to think or judge clearly (psychosis), changes in thought or behaviour (such as aggression or abnormal behaviour). Cases of serious skin reactions have also been reported, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness involving blistering of the skin, mouth, around the eyes or genitals), as well as serious allergic reactions, including angioedema (swelling of the face, mouth or throat).

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

• Inflammation of the nose and throat, altered dreams, sleep disturbances, headache.

• Nausea.

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

• Chest infections, sinusitis.

• Weight gain, decreased appetite, increased appetite.

• Drowsiness, dizziness, altered taste.

• Shortness of breath, cough.

• Heartburn, vomiting, constipation, diarrhoea, bloating sensation, abdominal pain, toothache, indigestion, flatulence, dry mouth.

• 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 sensation, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sexual impulses.

• Seizures, tremors, feeling of apathy, loss of sensitivity to touch.

• Conjunctivitis, eye pain.

• Ringing in the ears.

• Angina, increased heart rate, palpitations, increased heart frequency.

• Increased blood pressure, hot flushes.

• Inflammation of the nose, sinuses and throat, nasal, throat and chest congestion, hoarseness, hay fever, throat irritation, congested sinuses, excess mucus in the nose causing cough, runny nose.

• Presence of bright red blood in stools, stomach irritation, changes in bowel habits, belching, 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, influenza-like syndrome, fever, feeling of weakness or malaise.

• High blood sugar levels.

• Heart attack.

• Suicidal thoughts.

• Changes in thought or behaviour (such as aggression).

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

• Excessive thirst.

• Feeling of discomfort or unhappiness, slowness of thought.

• Stroke.

• Increased muscle tension, difficulty speaking, coordination difficulties, reduced sense of taste, changes in sleep rhythm.

• Vision disorders, change in eye colour, dilated pupils, light sensitivity, myopia, excessive tearing.

• Irregular heartbeat or cardiac rhythm disorders.

• Sore throat, snoring.

• Blood in vomit, altered stools, coated tongue.

• Joint stiffness, rib pain.

• Glucose in urine, increased volume and frequency of urination.

• Vaginal discharge, altered sexual performance.

• Feeling cold, cysts.

• Diabetes.

• Sleepwalking.

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

• Abnormal behaviour.

• Serious skin reactions, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness involving blistering of the skin, mouth, around the eyes or genitals).

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

• Side effects with unknown frequency:

• Transient loss of consciousness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CHAMPIX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging or
on the carton after Exp. The expiry date refers to the last day of the month.
Blister: Store below 30°C.
Bottle: This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CHAMPIX contains

• 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 excipients are:

Tablet core - CHAMPIX 0.5 mg and 1 mg film-coated tablets
Microcrystalline cellulose
Anhydrous calcium hydrogen phosphate
Sodium croscarmellose
Anhydrous colloidal silica
Magnesium stearate

Tablet coating - CHAMPIX 0.5 mg film-coated tablets
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Triacetin

Tablet coating - CHAMPIX 1 mg film-coated tablets
Hypromellose
Titanio dioxide (E171)
Macrogol 400
Aluminium lake containing indigo carmine (E132)
Triacetin

Description of the appearance of CHAMPIX and package contents

• CHAMPIX 0.5 mg film-coated tablets are white, modified capsule-shaped, with the inscription “Pfizer” engraved on one side and “CHX 0.5” on the other.
• CHAMPIX 1 mg film-coated tablets are light blue, modified capsule-shaped, with the inscription “Pfizer” engraved on one side and “CHX 1.0” on the other.

CHAMPIX is available in the following pack sizes:

• Starter pack containing 2 blisters; 1 transparent blister with 11 film-coated tablets of CHAMPIX 0.5 mg and 1 transparent blister with 14 film-coated tablets of CHAMPIX 1 mg, contained in a secondary cardboard packaging.

• Starter pack containing 2 blisters; 1 transparent blister with 11 film-coated tablets of CHAMPIX 0.5 mg and 14 film-coated tablets of CHAMPIX 1 mg, and 1 transparent blister with 28 tablets or 2 transparent blisters each with 14 film-coated tablets of CHAMPIX 1 mg, contained in a secondary cardboard packaging.

• Starter pack in a secondary cardboard packaging containing 1 pack with 1 transparent blister of 11 film-coated tablets of CHAMPIX 0.5 mg and 14 film-coated tablets of CHAMPIX 1 mg, and 1 transparent blister containing 28 tablets or 2 transparent blisters each with 14 film-coated tablets of CHAMPIX 1 mg, in a secondary cardboard packaging, and 2 packs each containing 2 transparent blisters of 28 tablets or 4 transparent blisters of 14 film-coated tablets of CHAMPIX 1 mg in a secondary cardboard packaging.

• Maintenance packs containing 2 or 4 transparent blisters of 14 tablets or 2 transparent blisters of 28 film-coated tablets of CHAMPIX 1 mg in a secondary cardboard packaging.

• Maintenance packs containing 2 or 4 transparent blisters of 14 tablets or 2 transparent blisters of 28 film-coated tablets of CHAMPIX 0.5 mg in a secondary cardboard packaging.

• Starter pack containing 2 blisters; 1 transparent blister with 11 film-coated tablets of CHAMPIX 0.5 mg and 1 transparent blister with 14 film-coated tablets of CHAMPIX 1 mg, contained in a carton.

• Maintenance packs containing 2, 4, 8 or 10 transparent blisters of 14 film-coated tablets of CHAMPIX 1 mg in a carton.

• Pack containing 1 white HDPE bottle sealed with child-resistant closure containing 56 tablets of CHAMPIX 1 mg in a carton.

• Pack containing 1 white HDPE bottle sealed with child-resistant closure containing 56 tablets of CHAMPIX 0.5 mg in a carton.

Not all 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
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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Pfizer S.A./N.V. Pfizer Luxembourg SARL filialas Lietuvoje
Tél/Tel: + 32 (0)2 554 62 11 Tel. +3705 2514000

България Luxembourg/Luxemburg
Пфайзер Люксембург САРЛ, Pfizer S.A.
Клон България Tél/Tel: + 32 (0)2 554 62 11
Тел.: +359 2 970 4333

Česká republika Magyarország
Pfizer, spol. s r.o. Pfizer Kft.
Tel: + 420 283 004 111 Tel.: +36 1 488 37 00

Danmark Malta
Pfizer ApS Vivian Corporation Ltd.
Tlf: + 45 44 20 11 00 Tel: +356 21344610

Deutschland Nederland
Pfizer Pharma GmbH Pfizer bv
Tel: +49 (0)30 550055 51000 Tel: +31 (0)10 406 43 01

Eesti Norge
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 52 61 00

Ελλάδα Österreich
PFIZER ΕΛΛΑΣ Α.Ε., Pfizer Corporation Austria Ges.m.b.H.
Τηλ.: +30 210 67 85 800 Tel.: +43 (0)1 521 15-0

España Polska
Pfizer, S.L. Pfizer Polska Sp. z o.o.
Tel: + 34 91 490 99 00 Tel.: + 48 22 335 61 00

France Portugal
Pfizer Laboratoires Pfizer, Lda.
Tél: + 33 (0)1 58 07 34 40 Tel: +351 21 423 5500

Hrvatska România
Pfizer Croatia d.o.o. Pfizer România S.R.L.
Tel: + 385 1 3908 777 Tel: +40 (0)21 207 28 00

Ireland Slovenija
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, Pfizer, podružnica za
Tel: 1800 633 363 (toll free) svetovanje s področja farmacevtske dejavnosti,
+44 (0) 1304 616161 Ljubljana
Tel: + 386 (0) 1 52 11 400

Ísland Slovenská republika
Icepharma hf. Pfizer Luxembourg SARL, organizačná zložka
Simi: +354 540 8000 Tel: +421-2-3355 550

Italia Suomi/Finland
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: + 358 (0)9 43 00 40

Κύπρος Sverige
PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), Pfizer AB
Τηλ: +357 22 817690 Tel: + 46 (0)8 550 520 00

Latvija United Kingdom (Northern Ireland)
Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited
Tel: + 371 670 35 775 Tel: + 44 (0) 1304 616161

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