CHAMPIX 1 mg film-coated tablets

What is it and how is it used?

CHAMPIX is a a non-nicotine medicine which is used to help you stop smoking.

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

Although you are not recommended to smoke after your quit date, CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment. (The quit date is the day in the second week of treatment when you will stop smoking, see Section 3.)

What do you have to consider before using it?

Do not take CHAMPIX

◾If you are allergic (hypersensitive) to varenicline tartrate or any of the other ingredients of CHAMPIX

Take special care with 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, your family or doctor or if you develop suicidal thoughts or behaviours you should stop your treatment and contact your doctor immediately.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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 drugs work. Therefore, in some cases an adjustment of the dose 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.

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 illness. If you have a history of psychiatric illness you should discuss this with your doctor or pharmacist.

Depressed mood may appear during smoking cessation with or without treatment. Depression, rarely including suicidal thoughts and suicide attempt, has been reported in patients undergoing a smoking cessation attempt. These feelings have also been reported while attempting to quit smoking with CHAMPIX. If these symptoms persist when you stop taking CHAMPIX, your doctor should continue to monitor you closely until you are feeling better.

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.

Effect of CHAMPIX on other drugs

CHAMPIX is not expected to affect the way other drugs work.

Effect of other drugs on CHAMPIX

Due to the way in which varenicline tartrate is removed from the body, it is not expected that other drugs will affect the way in which CHAMPIX works.

Use of CHAMPIX with other therapies for smoking cessation

The safety and benefits of taking CHAMPIX in combination with other medicines for stopping smoking have not been studied. CHAMPIX in combination with other smoking cessation therapies is therefore not recommended.

CHAMPIX is not recommended for use in children or adolescents below 18 years.

Taking CHAMPIX with food and drink

CHAMPIX can be taken with or without food.

Pregnancy

You should not take CHAMPIX while you are pregnant.

Talk to your doctor if you are intending to become pregnant. If you want to start treatment with CHAMPIX, your treatment should be timed so that you have completed the course before becoming pregnant.

Breast-feeding

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 produce dizziness and sleepiness. You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.

How is it used?

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.

Always take CHAMPIX exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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 tablets should be swallowed whole with water.

The usual dose for adults which you should follow from Day 1 is described in the following table:

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.

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.

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.

In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment. Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.

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

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 almost time for 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.

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

What are possible side effects?

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.

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

If you are taking CHAMPIX and develop agitation, depressed mood, changes in behaviour or suicidal thoughts you should stop your treatment and contact your doctor immediately.
◾Very common side effects which may affect more than 1 person in 10 are listed below:
◾Headache, difficulty sleeping, abnormal dreams
◾Nausea
◾Common side effects which may affect more than 1 person in 100 are listed below:
◾Increased appetite, changes in the way things taste, dry mouth
◾Sleepiness, tiredness, dizziness
◾Vomiting, constipation, diarrhoea, feeling bloated, stomach discomfort, indigestion, flatulence
◾Uncommon side effects which may affect more than 1 person in 1, 000 are listed below:
◾Chest infection, discomfort or pain, inflammation of the sinuses,
◾Fever, feeling cold, feeling weak or unwell, viral infection, shortness of breath, cough, hoarseness, throat pain and irritation, congested sinuses, runny nose, snoring
◾Loss of appetite, feeling thirsty, increased weight
◾Feeling of panic, difficulty thinking, mood swings
◾Tremor, difficulty with coordination, difficulty with speech, less sensitive to touch, increased muscle tension, restlessness,
◾Heart rhythm disturbances, increased blood pressure, increased heart rate
◾Disturbed vision, eyeball discolouration, eye pain, dilated pupils, shortsightedness, sensitivity to light, watery eyes
◾Ringing in the ears
◾Blood in vomit, irritated stomach and heartburn, abdominal pain, abnormal stools, red blood in stools, belching, mouth ulcers, pain in the gums, coated tongue
◾Skin rash, cyst, fungal infection, reddening of the skin, itching, acne, increased sweating
◾Chest wall and rib pain, stiff joints, muscle spasms
◾Glucose in urine, increased urine volume and frequency
◾Increased menstrual flow, vaginal discharge, changes in sex drive or ability
◾There have been post-marketing reports of heart attack, hallucinations, changes in thinking or behaviour (such as aggression and irrational behaviour), depression, and suicidal thoughts in people attempting to quit smoking with CHAMPIX. There have also been reports of serious allergic reactions including angioedema (swelling of the face, mouth, or throat) and 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). You should stop taking CHAMPIX and contact your doctor immediately if you develop swelling of the face, mouth or throat, or if your skin starts to peel or blister.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use CHAMPIX after the expiry date which is stated on the card packaging or carton. The expiry date refers to the last day of that month.
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.

Further information

What CHAMPIX contains

◾The active substance is 0.5 mg varenicline and 1 mg varenicline respectively
◾The other ingredients are:

Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets

Cellulose, Microcrystalline
Calcium Hydrogen Phosphate Anhydrous
Croscarmellose Sodium
Silica, Colloidal Anhydrous
Magnesium Stearate

Tablet film coating - CHAMPIX 0.5 mg film-coated tablets

Hypromellose
Titanium dioxide (E171)
Macrogols
Triacetin

Tablet film coating - CHAMPIX 1 mg film-coated tablets

Hypromellose
Titanium dioxide (E171)
Macrogols
Indigo Carmine Aluminium Lake (E132)
Triacetin

What CHAMPIX 0.5 mg and 1 mg film-coated tablets look 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:

Not all pack sizes may be marketed.
◾A 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.
◾A 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 x CHAMPIX 1 mg film-coated tablets in card packaging.
◾A follow-on (maintenance) pack containing 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
◾A follow-on (maintenance) pack containing 2 clear blisters of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
◾A follow-on (maintenance) pack containing 2 clear blisters of 14 x CHAMPIX 0.5 mg film-coated tablets in card packaging.
◾A follow-on (maintenance) pack containing 2 clear blisters of 28 x CHAMPIX 0.5 mg film-coated tablets in card packaging.
◾A 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.
◾A follow-on (maintenance) pack containing 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
◾A follow-on (maintenance) pack containing 4 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
◾A follow-on (maintenance) pack containing 8 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
◾A follow-on (maintenance) pack containing 10 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
◾A sealed blue white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 1 mg film-coated tablets.
◾A sealed blue white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 0.5 mg film-coated tablets.

Marketing Authorisation Holder

Pfizer Limited
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Heinrich-Mack-Str. 35
D-89257 Illertissen
Germany

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

BelgiëBelgiqueBelgien Pfizer S.A.N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. TélTel 32 02 554 62 11

Magyarország Pfizer Kft. Tel. 36 1 488 37 00 , . 359 2 970 4333

eská republika Pfizer s.r.o. Tel 420 283 004 111 Malta V.J. Salomone Pharma Ltd. Tel 356 21220174

Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer bv Tel 31 010 406 43 01

Deutschland Pfizer Pharma GmbH Tel 49 030 550055-51000 Norge Pfizer AS Tlf 47 67 52 61 00

Eesti Pfizer Luxembourg SARL Eesti filiaal Tel 372 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel. 43 01 521 15-0

Pfizer Hellas A.E. 30 210 6785 800 Polska Pfizer Polska Sp. z o.o. Tel. 48 22 335 61 00

España Pfizer S.A. Tel 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 214 235 500

France Pfizer Tél 33 01 58 07 34 40 România Pfizer România S.R.L. Tel 40 021 207 28 00

Ireland Pfizer Healthcare Ireland Tel 1800 633 363 toll free 44 0 1304 616161 Slovenija Pfizer Luxembourg SARL, Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel 386 0 1 52 11 400

Ísland Icepharma hf. Simi 354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 421-2-3355 5500

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy PuhTel 358 09 43 00 40

GEO. PAVLIDES ARAOUZOS LTD 35 722 818 087 Sverige Pfizer AB Tel 46 08 550 520 00

Latvija Pfizer Luxembourg SARL filile Latvij Tel 371 670 35 775 United Kingdom Pfizer Limited Tel 44 0 1304 616161

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000