Patient Information Leaflet Champix (Varenicline) 0.5mg 1mg Film-Coated Tablets

1. What CHAMPIX is and what it is used for

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.
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.)

2. What you need to know before you take CHAMPIX

Do not take CHAMPIX:
– If you are allergic to varenicline tartrate 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, your family or doctor or if you develop suicidal thoughts or behaviours you should stop your treatment and contact your doctor immediately.

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 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.

Cardiovascular 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.

Stopping treatment with CHAMPIX
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.

Children and adolescents
CHAMPIX is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.

Other medicines and CHAMPIX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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. 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
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 with food and drink
CHAMPIX can be taken with or without food.

CHAMPIX may increase the effects of alcohol.

Pregnancy and breast-feeding
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.

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 medicine affects your ability to perform these activities.

3. How to take CHAMPIX

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 this medicine exactly as your doctor has told you. 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.

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

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

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

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

• Fungal infection, viral infection
• Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sex drive
• Seizure, tremor, feeling sluggish, less sensitive to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heart rate, palpitations, increased heart rate
• Increased blood pressure, hot flush
• 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
• Red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers, pain in the gums
• Reddening of the skin, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Abnormally frequent urination, urination at night
• Increased menstrual flow,
• Chest discomfort, flu like illness, fever, feeling weak or unwell

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

Other side effects have occurred in a small number of people attempting to quit smoking with CHAMPIX, but their exact frequency is unknown: 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), sleep walking, diabetes and high blood sugar. 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). You should stop taking CHAMPIX and contact your doctor immediately if your skin starts to peel or blister, or if you develop swelling of the face, mouth or throat.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard

Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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 which is stated on the card packaging or carton. 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.

6. Contents of the pack and other 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 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:
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 and Manufacturer

Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35
89257 Illertissen
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Pfizer Limited
Tel: + 44 (0) 1304 616161

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0) 1304 616161

Malta
V.J. Salomone Pharma Ltd.
Tel : +356 21220174