varenicline: package leaflet

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

CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking.

CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment.

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 taking CHAMPIX.

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

The effects of stopping smoking
The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other medicines work. Therefore, in some cases an adjustment of the dose may be necessary. See below under ‘Other medicines and CHAMPIX’ for further details.

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

Heart symptoms
New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX. Get emergency medical help right away if you have symptoms of a heart attack or stroke.

Seizures
Tell your doctor if you have experienced seizures or have epilepsy before your start CHAMPIX treatment. Some people have reported seizures while taking 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 serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.

Skin reactions
Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of CHAMPIX. If you develop a rash or if your skin starts to peel or blister you should stop taking CHAMPIX and seek emergency medical help.

Children and adolescents
CHAMPIX is not recommended for use in paediatric patients as efficacy was not demonstrated.

Other medicines and CHAMPIX
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, an adjustment of the dose of other medicines may be necessary. Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes). If in doubt, you should consult your doctor or pharmacist.

If you have severe kidney disease you should avoid taking cimetidine (a medicine used for gastric problems) at the same time as CHAMPIX as this may cause increased blood levels of CHAMPIX.

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

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 if CHAMPIX actually increases alcohol intoxication.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 preferable to avoid the use of CHAMPIX while you are pregnant. Talk to your doctor if you are intending to become pregnant.

Although it was not studied, CHAMPIX may pass into breast milk. You should ask your doctor or pharmacist for advice before taking CHAMPIX.

Driving and using machines
CHAMPIX may be linked with dizziness, sleepiness 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 these activities.

CHAMPIX contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You are more likely to stop smoking if you are motivated to stop. Your doctor and pharmacist can provide advice, support and sources of further information to help ensure your attempt to stop smoking is successful.

Before starting your course of CHAMPIX you should usually decide on a date in the second week of treatment (between day 8 and day 14) when you will stop smoking. If you are not willing or able to set a target quit date within 2 weeks, you may choose your own target quit date within 5 weeks after starting treatment. You should write this date on the pack as a reminder.

CHAMPIX comes as a white tablet (0.5 mg) and a light blue tablet (1 mg). You start with the white tablet and then usually go to the light blue tablet. See the chart below for the usual dosing instructions which you should follow from Day 1.

Week 1
Dose
Day 1 - 3
From day 1 to day 3, you should take one white CHAMPIX 0.5 mg film-coated tablet once a day.

Day 4 - 7
From day 4 to day 7, you should take one white CHAMPIX 0.5 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.

Week 2

Day 8 – 14
From day 8 to day 14, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.

Weeks 3 - 12

Day 15 - end of treatment
From day 15 until the end of treatment, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.

After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice daily to help avoid returning back to smoking.

If you are not able or willing to quit smoking straight away, you should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. You should then continue to

take CHAMPIX 1 mg film-coated tablets twice daily for a further 12 weeks resulting in a total of 24 weeks of treatment.

Should you experience adverse effects that you cannot tolerate your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice daily.

If you have problems with your kidneys, you should speak to your doctor before taking CHAMPIX.
You may need a lower dose.

Champix is for oral use.
The tablets should 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 your doctor prescribed, you must seek medical advice or go to the nearest hospital casualty department immediately. Take your box of tablets with you.

If you forget to take CHAMPIX
Do not take a double dose to make up for a forgotten tablet. 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. If, it is within 3-4 hours before your next dose, do not take the tablet that you have missed.

If you stop taking CHAMPIX
It has been shown in clinical trials that taking all doses of your medicine at the appropriate times and for the recommended duration of treatment described above will increase your chances of stopping smoking. Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CHAMPIX, according to the instructions described in the table above.

In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment. You may temporarily experience increased irritability, urge to smoke, depression and/or sleep disturbances when you stop taking CHAMPIX. Your doctor may decide to gradually lower 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.

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

Giving up smoking with or without treatment can cause various symptoms. These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.

You should be aware of the possible emergence of serious neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during a quit attempt with or without CHAMPIX and you should contact a doctor or pharmacist if you experience such symptoms.

Serious side effects of either an uncommon or rare frequency have occurred in people attempting to quit smoking with CHAMPIX: seizure, stroke, heart attack, suicidal thoughts, loss of contact with reality and unable to think or judge clearly (psychosis), changes in thinking or behaviour (such as aggression and abnormal behaviour). There have also been reports of severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) and serious allergic reactions including angioedema (swelling of the face, mouth, or throat).

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

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

• Common: may affect up to 1 in 10 people

o
Chest infection, inflammation of the sinuses o
Increased weight, decreased appetite, increased appetite o
Sleepiness, dizziness, changes in the way things taste o
Shortness of breath, cough o
Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth o Skin rash, itching o Joint ache, muscle ache, back pain o Chest pain, tiredness

• Uncommon: may affect up to 1 in 100 people

o
Fungal infection, viral infection o
Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sex drive o Seizure, tremor, feeling sluggish, less sensitive to touch o Conjunctivitis, eye pain o Ringing in the ears o Angina, rapid heart rate, palpitations, increased heart rate o Increased blood pressure, hot flush o Inflammation of nose, sinuses and throat, congestion of nose, throat and chest, hoarseness, hay fever, throat irritation, congested sinuses, excess mucous from nose causing cough, runny nose o Red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers, pain in the gums o Reddening of the skin, acne, increased sweating, night sweats o Muscle spasms, chest wall pain o Abnormally frequent urination, urination at night o Increased menstrual flow o Chest discomfort, flu like illness, fever, feeling weak or unwell o High blood sugar o Heart attack o Suicidal thoughts o Changes in thinking or behaviour (such as aggression)

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

o
Excessive thirst o
Feeling unwell or unhappy, slow thinking o
Stroke o
Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern o Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light, shortsightedness, watery eyes o Irregular heart beat or heart rhythm disturbances o Throat pain, snoring o Blood in vomit, abnormal stools, coated tongue o Stiff joints, rib pain o Glucose in urine, increased urine volume and frequency o Vaginal discharge, changes in sexual ability

o
Feeling cold, cyst o
Diabetes o
Sleep walking o
Loss of contact with reality and unable to think or judge clearly (psychosis) o
Abnormal behaviour o
Severe skin reactions including Erythema Multiforme (a type of rash) and Stevens- Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) o Serious allergic reactions including angioedema (swelling of the face, mouth, or throat)
- Not known o
Transient loss of consciousness
Reporting of side effects
If you get 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 card packaging or carton after EXP. The expiry date refers to the last day of that month.
Blisters: Store below 30°C
Bottle: This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 other ingredients are:
Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets
Cellulose, Microcrystalline
Calcium Hydrogen Phosphate Anhydrous
Croscarmellose Sodium (see section 2 “CHAMPIX contains sodium”
Silica, Colloidal Anhydrous
Magnesium Stearate

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

Tablet film coating - CHAMPIX 1 mg film-coated tablets
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Indigo Carmine Aluminium Lake (E132)
Triacetin

What CHAMPIX looks like and contents of the pack
- CHAMPIX 0.5 mg film-coated tablets are white, film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 0.5”

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

CHAMPIX is available in the following pack presentations:

• Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
• Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
• Treatment initiation pack in an outer carton containing 1 pack with 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging and 2 packs each containing 2 clear blisters of 28 or 4 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
• Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
• Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 0.5 mg film-coated tablets in card packaging.
• Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
• Follow-on (maintenance) packs containing 2, 4, 8, or 10 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
• Sealed white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 1 mg film-coated tablets.
• Sealed white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 0.5 mg film-coated tablets.

Not all 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
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany

or

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Pfizer S.A./N.V.
Tél/Tel: + 32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +370 5 2514000

България
Пфайзер Люксембург САРЛ,
Клон България
Тел.: +359 2 970 4333

Luxembourg/Luxemburg
Pfizer S.A.
Tél/Tel: + 32 (0)2 554 62 11

Česká republika
Pfizer, spol. s r.o.
Tel: + 420 283 004 111

Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00

Danmark
Pfizer ApS
Tlf.: + 45 44 20 11 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Deutschland
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)10 406 43 01

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
PFIZER ΕΛΛΑΣ Α.Ε.,
Τηλ.: +30 210 67 85 800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel.: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: + 34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.
Tel.: + 48 22 335 61 00

France
Pfizer
Tél: + 33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777
România
Pfizer România S.R.L.
Tel: +40 (0)21 207 28 00
Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0) 1304 616161
Slovenija
Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400 Ísland Icepharma hf.
Simi: +354 540 8000
Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421-2-3355 5500
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Suomi/Finland
Pfizer Oy
Puh/Tel: + 358 (0)9 43 00 40
Κύπρος
PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH),
Τηλ: +357 22 817690
Sverige
Pfizer AB
Tel: + 46 (0)8 550 520 00
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.