Package leaflet: Infrmatin fr the user CHAMPIX 0.5 mg film-cated tablets CHAMPIX 1 mg film-cated tablets Varenicline Read all f this leaflet carefully befre yu start taking this medicine because it cntains imprtant infrmatin fr yu. - Keep this leaflet. Yu may need t read it again. - If yu have any further questins, ask yur dctr r pharmacist. - This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them, even if their signs f illness are the same as yurs. - If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet 1. What CHAMPIX is and what it is used fr 2. What yu need t knw befre yu take CHAMPIX 3. Hw t take CHAMPIX 4. Pssible side effects 5. Hw t stre CHAMPIX 6. Cntents f the pack and ther infrmatin 1. What CHAMPIX is and what it is used fr CHAMPIX cntains the active substance varenicline. CHAMPIX is a medicine which is used in adults t help them stp smking. CHAMPIX can help t relieve the craving and withdrawal symptms assciated with stpping smking. CHAMPIX can als reduce the enjyment f cigarettes if yu d smke when n treatment. 2. What yu need t knw befre yu take CHAMPIX D nt take CHAMPIX: - If yu are allergic t varenicline r any f the ther ingredients f this medicine (listed in sectin 6) Warnings and precautins Talk t yur dctr r pharmacist befre taking CHAMPIX. There have been reprts f depressin, suicidal ideatin and behaviur and suicide attempts in patients taking CHAMPIX. If yu are taking CHAMPIX and develp agitatin, depressed md, changes in behaviur that are f cncern t yu r yur family r if yu develp suicidal thughts r behaviurs yu shuld stp taking CHAMPIX and cntact yur dctr immediately fr treatment assessment. Page 1 f 8
The effects f stpping smking The effects f changes in yur bdy resulting frm stpping smking, with r withut treatment with CHAMPIX, may alter the way ther medicines wrk. Therefre, in sme cases an adjustment f the dse may be necessary. See belw under Other medicines and CHAMPIX fr further details. Fr sme peple, stpping smking with r withut treatment has been assciated with an increased risk f experiencing changes in thinking r behaviur, feelings f depressin and anxiety and can be assciated with a wrsening f psychiatric disrder. If yu have a histry f psychiatric disrder yu shuld discuss this with yur dctr. Heart symptms New r wrse heart r bld vessel (cardivascular) prblems have been reprted primarily in peple wh already have cardivascular prblems. Tell yur dctr if yu have any changes in symptms during treatment with CHAMPIX. Get emergency medical help right away if yu have symptms f a heart attack r strke. Seizures Tell yur dctr if yu have experienced seizures r have epilepsy befre yur start CHAMPIX treatment. Sme peple have reprted seizures while taking CHAMPIX. Hypersensitivity reactins Stp taking CHAMPIX and tell yur dctr immediately if yu experience any f the fllwing signs and symptms that may indicate a serius allergic reactin: swelling f the face, lips, tngue, gums, thrat r bdy and/r difficulty breathing, wheezing. Skin reactins Ptentially life-threatening skin rashes (Stevens-Jhnsn syndrme and Erythema Multifrme) have been reprted with the use f CHAMPIX. If yu develp a rash r if yur skin starts t peel r blister yu shuld stp taking CHAMPIX and seek emergency medical help. Children and adlescents CHAMPIX is nt recmmended fr use in children r adlescents belw 18 years as safety and efficacy have nt yet been established. Other medicines and CHAMPIX Tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines. In sme cases as a result f stpping smking, with r withut CHAMPIX, an adjustment f the dse f ther medicines may be necessary. Examples include thephylline (a medicine t treat breathing prblems), warfarin (a medicine t reduce bld cltting), and insulin (a medicine t treat diabetes). If in dubt, yu shuld cnsult yur dctr r pharmacist. If yu have severe kidney disease yu shuld avid taking cimetidine (a medicine used fr gastric prblems) at the same time as CHAMPIX as this may cause increased bld levels f CHAMPIX. Use f CHAMPIX with ther therapies fr smking cessatin Cnsult yur dctr befre using CHAMPIX in cmbinatin with ther smking cessatin therapies. CHAMPIX with fd and drink There have been sme reprts f increased intxicating effects f alchl in patients taking CHAMPIX. Hwever, it is nt knwn if CHAMPIX actually increases alchl intxicatin. Pregnancy and breast-feeding If yu are pregnant r breast-feeding, think yu may be pregnant r are planning t have a baby, ask yur dctr r pharmacist fr advice befre taking this medicine. Page 2 f 8
It is preferable t avid the use f CHAMPIX while yu are pregnant. Talk t yur dctr if yu are intending t becme pregnant. Althugh it was nt studied, CHAMPIX may pass int breast milk. Yu shuld ask yur dctr r pharmacist fr advice befre taking CHAMPIX. Driving and using machines CHAMPIX may prduce dizziness and sleepiness. Yu shuld nt drive, perate cmplex machinery r engage in any ther ptentially hazardus activities until yu knw whether this medicine affects yur ability t perfrm these activities. 3. Hw t take CHAMPIX Always take this medicine exactly as yur dctr has tld yu. Check with yur dctr r pharmacist if yu are nt sure. Yu are mre likely t stp smking if yu are mtivated t stp. Yur dctr and pharmacist can prvide advice, supprt and surces f further infrmatin t help ensure yur attempt t stp smking is successful. Befre starting yur curse f CHAMPIX yu shuld usually decide n a date in the secnd week f treatment (between day 8 and day 14) when yu will stp smking. If yu are nt willing r able t set a target quit date within 2 weeks, yu may chse yur wn target quit date within 5 weeks after starting treatment. Yu shuld write this date n the pack as a reminder. CHAMPIX cmes as a white tablet (0.5 mg) and a light blue tablet (1 mg). Yu start with the white tablet and then usually g t the light blue tablet. See the chart belw fr the usual dsing instructins which yu shuld fllw frm Day 1. Week 1 Day 1-3 Day 4-7 Week 2 Day 8 14 Dse Frm day 1 t day 3, yu shuld take ne white CHAMPIX 0.5 mg film-cated tablet nce a day. Frm day 4 t day 7, yu shuld take ne white CHAMPIX 0.5 mg film-cated tablet twice daily, nce in the mrning and nce in the evening, at abut the same time each day. Frm day 8 t day 14, yu shuld take ne light blue CHAMPIX 1 mg film-cated tablet twice daily, nce in the mrning and nce in the evening, at abut the same time each day. Weeks 3-12 Day 15 - end f treatment Frm day 15 until the end f treatment, yu shuld take ne light blue CHAMPIX 1 mg film-cated tablet twice daily, nce in the mrning and nce in the evening, at abut the same time each day. After 12 weeks f treatment, if yu have stpped smking, yur dctr may recmmend an additinal 12 weeks f treatment with CHAMPIX 1 mg film-cated tablets twice daily t help avid returning back t smking. Page 3 f 8
If yu are nt able r willing t quit smking straight away, yu shuld reduce smking during the first 12 weeks f treatment and quit by the end f that treatment perid. Yu shuld then cntinue t take CHAMPIX 1 mg film-cated tablets twice daily fr a further 12 weeks resulting in a ttal f 24 weeks f treatment. Shuld yu experience adverse effects that yu cannt tlerate yur dctr may decide t reduce yur dse temprarily r permanently t 0.5 mg twice daily. If yu have prblems with yur kidneys, yu shuld speak t yur dctr befre taking CHAMPIX. Yu may need a lwer dse. Champix is fr ral use. The tablets shuld be swallwed whle with water and can be taken with r withut fd. If yu take mre CHAMPIX than yu shuld If yu accidentally take mre CHAMPIX than yur dctr prescribed, yu must seek medical advice r g t the nearest hspital casualty department immediately. Take yur bx f tablets with yu. If yu frget t take CHAMPIX D nt take a duble dse t make up fr a frgtten tablet. It is imprtant that yu take CHAMPIX regularly at the same time each day. If yu frget t take a dse, take it as sn as yu remember. If, it is within 3-4 hurs befre yur next dse, d nt take the tablet that yu have missed. If yu stp taking CHAMPIX It has been shwn in clinical trials that taking all dses f yur medicine at the apprpriate times and fr the recmmended duratin f treatment described abve will increase yur chances f stpping smking. Therefre, unless yur dctr instructs yu t stp treatment, it is imprtant t keep taking CHAMPIX, accrding t the instructins described in the table abve. In smking cessatin therapy, risk f returning t smking may be elevated in the perid immediately fllwing the end f treatment. Yu may temprarily experience increased irritability, urge t smke, depressin and/r sleep disturbances when yu stp taking CHAMPIX. Yur dctr may decide t gradually lwer yur dse f CHAMPIX at the end f treatment. If yu have any further questins n the use f this medicine, ask yur dctr r pharmacist. 4. Pssible side effects Like all medicines, this medicine can cause side effects, althugh nt everybdy gets them. Giving up smking with r withut treatment can cause varius symptms. These culd include changes f md (like feeling depressed, irritable, frustrated r anxius), sleeplessness, difficulty cncentrating, decreased heart rate and increased appetite r weight gain. Yu shuld be aware f the pssible emergence f serius neurpsychiatric symptms, such as agitatin, depressed md, r changes in behaviur during a quit attempt with r withut CHAMPIX and yu shuld cntact a dctr r pharmacist if yu experience such symptms. Serius side effects f either an uncmmn r rare frequency have ccurred in peple attempting t quit smking with CHAMPIX: seizure, strke, heart attack, suicidal thughts, lss f cntact with reality and unable t think r judge clearly (psychsis), changes in thinking r behaviur (such as aggressin and abnrmal behaviur). There have als been reprts f severe skin reactins including Erythema Multifrme (a type f rash) and Stevens-Jhnsn Syndrme (a serius illness with blistering f the skin, muth, arund the eyes r genitals) and serius allergic reactins including angiedema (swelling f the face, muth, r thrat). Page 4 f 8
- Very cmmn: may affect mre than 1 in 10 peple Inflammatin f the nse and thrat, abnrmal dreams, difficulty sleeping, headache, Nausea - Cmmn: may affect up t 1 in 10 peple Chest infectin, inflammatin f the sinuses Increased weight, decreased appetite, increased appetite Sleepiness, dizziness, changes in the way things taste Shrtness f breath, cugh Heartburn, vmiting, cnstipatin, diarrhea, feeling blated, abdminal pain, tthache, indigestin, flatulence, dry muth Skin rash, itching Jint ache, muscle ache, back pain Chest pain, tiredness - Uncmmn: may affect up t 1 in 100 peple Fungal infectin, viral infectin Feeling f panic, difficulty thinking, restlessness, md swings, depressin, anxiety, hallucinatins, changes in sex drive Seizure, tremr, feeling sluggish, less sensitive t tuch Cnjunctivitis, eye pain Ringing in the ears Angina, rapid heart rate, palpitatins, increased heart rate Increased bld pressure, ht flush Inflammatin f nse, sinuses and thrat, cngestin f nse, thrat and chest, harseness, hay fever, thrat irritatin, cngested sinuses, excess mucus frm nse causing cugh, runny nse Red bld in stls, irritated stmach, change f bwel habit, belching, muth ulcers, pain in the gums Reddening f the skin, acne, increased sweating, night sweats Muscle spasms, chest wall pain Abnrmally frequent urinatin, urinatin at night Increased menstrual flw Chest discmfrt, flu like illness, fever, feeling weak r unwell High bld sugar Heart attack Suicidal thughts Changes in thinking r behaviur (such as aggressin) - Rare: may affect up t 1 in 1,000 peple Excessive thirst Feeling unwell r unhappy, slw thinking Strke Increased muscle tensin, difficulty with speech, difficulty with crdinatin, reduced sense f taste, altered sleep pattern Disturbed visin, eyeball discluratin, dilated pupils, sensitivity t light, shrtsightedness, watery eyes Irregular heart beat r heart rhythm disturbances Thrat pain, snring Bld in vmit, abnrmal stls, cated tngue Stiff jints, rib pain Page 5 f 8
Glucse in urine, increased urine vlume and frequency Vaginal discharge, changes in sexual ability Feeling cld, cyst Diabetes Sleep walking Lss f cntact with reality and unable t think r judge clearly (psychsis) Abnrmal behaviur Severe skin reactins including Erythema Multifrme (a type f rash) and Stevens- Jhnsn Syndrme (a serius illness with blistering f the skin, muth, arund the eyes r genitals) Serius allergic reactins including angiedema (swelling f the face, muth, r thrat) Reprting f side effects If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly (see details belw). By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. United Kingdm Yellw Card Scheme website: www.mhra.gv.uk/yellwcard Ireland HPRA Pharmacvigilance, Earlsfrt Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Malta ADR Reprting Website: www.medicinesauthrity.gv.mt/adrprtal 5. Hw t stre CHAMPIX Keep this medicine ut f the sight and reach f children. D nt use this medicine after the expiry date which is stated n the card packaging r cartn after EXP. The expiry date refers t the last day f that mnth. Blisters: Stre belw 30 C Bttle: This medicine des nt require any special strage cnditins. D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines yu n lnger use. These measures will help prtect the envirnment. 6. Cntents f the pack and ther infrmatin What CHAMPIX cntains - The active substance is varenicline. - Each 0.5 mg film-cated tablet cntains 0.5 mg f varenicline (as tartrate). Page 6 f 8
- Each 1 mg film-cated tablet cntains 1 mg f varenicline (as tartrate). - The ther ingredients are: Tablet Cre - CHAMPIX 0.5 mg and 1 mg film-cated tablets Cellulse, Micrcrystalline Calcium Hydrgen Phsphate Anhydrus Crscarmellse Sdium Silica, Cllidal Anhydrus Magnesium Stearate Tablet film cating - CHAMPIX 0.5 mg film-cated tablets Hyprmellse Titanium dixide (E171) Macrgl 400 Triacetin Tablet film cating - CHAMPIX 1 mg film-cated tablets Hyprmellse Titanium dixide (E171) Macrgl 400 Indig Carmine Aluminium Lake (E132) Triacetin What CHAMPIX lks like and cntents f the pack - CHAMPIX 0.5 mg film-cated tablets are white, film-cated, mdified capsular shaped tablets, marked Pfizer and CHX 0.5 - CHAMPIX 1 mg film-cated tablets are light blue film-cated, mdified capsular shaped tablets, marked Pfizer and CHX 1.0 CHAMPIX is available in the fllwing pack presentatins: - A treatment initiatin pack cntaining 2 blisters; 1 clear blister f 11 x CHAMPIX 0.5 mg film-cated tablets and 1 clear blister f 14 x CHAMPIX 1 mg film-cated tablets in card packaging. - A treatment initiatin pack cntaining 2 blisters; 1 clear blister f 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-cated tablets and 1 clear blister f 28 x CHAMPIX 1 mg film-cated tablets in card packaging. - A fllw-n (maintenance) pack cntaining 2 clear blisters f 14 x CHAMPIX 1 mg film-cated tablets in card packaging. - A fllw-n (maintenance) pack cntaining 2 clear blisters f 28 x CHAMPIX 1 mg film-cated tablets in card packaging. - A fllw-n (maintenance) pack cntaining 2 clear blisters f 14 x CHAMPIX 0.5 mg film-cated tablets in card packaging. - A fllw-n (maintenance) pack cntaining 2 clear blisters f 28 x CHAMPIX 0.5 mg film-cated tablets in card packaging. - A treatment initiatin pack cntaining 2 blisters; 1 clear blister f 11 x CHAMPIX 0.5 mg film-cated tablets and 1 clear blister f 14 x CHAMPIX 1 mg film-cated tablets in a cartn. - A fllw-n (maintenance) pack cntaining 2 clear blisters f 14 x CHAMPIX 1 mg film-cated tablets in a cartn. - A fllw-n (maintenance) pack cntaining 4 clear blisters f 14 x CHAMPIX 1 mg film-cated tablets in a cartn. - A fllw-n (maintenance) pack cntaining 8 clear blisters f 14 x CHAMPIX 1 mg film-cated tablets in a cartn. Page 7 f 8
- A fllw-n (maintenance) pack cntaining 10 clear blisters f 14 x CHAMPIX 1 mg film-cated tablets in a cartn. - A sealed blue white HDPE bttle pack, with a child resistant screw cap, in a cartn, cntaining 56 x CHAMPIX 1 mg film-cated tablets. - A sealed blue white HDPE bttle pack, with a child resistant screw cap, in a cartn, cntaining 56 x CHAMPIX 0.5 mg film-cated tablets. Nt all pack sizes may be marketed. Marketing Authrisatin Hlder Pfizer Limited Ramsgate Rad Sandwich Kent CT13 9NJ United Kingdm Manufacturer R-Pharm Germany GmbH Heinrich-Mack-Str. 35 89257 Illertissen Germany Fr any infrmatin abut this medicine, please cntact the lcal representative f the Marketing Authrisatin Hlder: United Kingdm Pfizer Limited Tel: + 44 (0) 1304 616161 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (tll free) +44 (0) 1304 616161 Malta V.J. Salmne Pharma Ltd. Tel : +356 21220174 This leaflet was last revised in 06/2017 Other surces f infrmatin Detailed infrmatin n this medicine is available n the Eurpean Medicines Agency website: http://www.ema.eurpa.eu/ Ref: CI 32_2 Page 8 f 8