Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - champix

Document Subject

Generated Narrative: MedicinalProductDefinition mpb9e406d2f0e8fcd3c2ddc68fcfd21aa0

identifier: http://ema.europa.eu/identifier/EU/1/06/360/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CHAMPIX 0.5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b9e406d2f0e8fcd3c2ddc68fcfd21aa0

identifier: http://ema.europa.eu/identifier/EU/1/06/360/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - champix

Attesters

What is in this leaflet

1. What CHAMPIX is and what it is used for
2. What you need to know before you take CHAMPIX
3. How to take CHAMPIX
4. Possible side effects
5. How to store CHAMPIX
6. Contents of the pack and other information

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 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 - 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

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

• Common: may affect up to 1 in 10 people

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

• Uncommon: may affect up to 1 in 100 people

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 * High blood sugar * Heart attack * Suicidal thoughts * Changes in thinking or behaviour (such as aggression)

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

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 * Diabetes * Sleep walking * Loss of contact with reality and unable to think or judge clearly (psychosis) * Abnormal behaviour * 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) * Serious allergic reactions including angioedema (swelling of the face, mouth, or throat)

• Not known

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 Triacetin

Tablet film coating - CHAMPIX 1 mg film-coated tablets
Hypromellose Titanium dioxide (E171) Macrogol 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 1050 Bruxelles Belgium

Manufacturer Pfizer Manufacturing Deutschland GmbH Betriebsst tte Freiburg Mooswaldallee 1 79090 Freiburg Germany

or Pfizer Italia S.r.l.
Localit Marino del Tronto, 63Ascoli Piceno (AP)
Italy

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

Belgi /Belgique/Belgien Pfizer S.A./N.V. T l/Tel: + 32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 5 2514
,

.: +359 2 970 4Luxembourg/Luxemburg Pfizer S.A. T l/Tel: + 32 (0)2 554 62 esk republika Pfizer, spol. s r.o. Tel: + 420 283 004 Magyarorsz g Pfizer Kft. Tel.: +36 1 488 37 Danmark Pfizer ApS Tlf: + 45 44 20 11 Malta Vivian Corporation Ltd. Tel: +356 21344Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055-51Nederland Pfizer bv Tel: +31 (0)10 406 43 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7Norge Pfizer AS Tlf: +47 67 52 61
PFIZER . .,
.: +30 210 67 85 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel.: +43 (0)1 521 15-0

Espa a Pfizer, S.L. Tel: + 34 91 490 99 Polska Pfizer Polska Sp. z o.o. Tel.: + 48 22 335 61 France Pfizer T l: + 33 (0)1 58 07 34 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Rom nia Pfizer Rom nia S.R.L. Tel: +40 (0)21 207 28 Ireland Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free) +44 (0) 1304 616Slovenija Pfizer Luxembourg SARL, Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 sland Icepharma hf. Simi: +354 540 8Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka
Tel: +421-2-3355 5Italia Pfizer S.r.l. Tel: +39 06 33 18 Suomi/Finland Pfizer Oy Puh/Tel: + 358 (0)9 43 00
PFIZER . . (CYPRUS BRANCH), : +357 22 817Sverige Pfizer AB Tel: + 46 (0)8 550 520 Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: + 371 670 35 United Kingdom (Northern Ireland) Pfizer Limited Tel: + 44 (0) 1304 616This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: