PACKAGE LEAFLET: INFORMATION FOR THE USER CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets. Varenicline

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR 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. - 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. D nt pass it n t thers. It may harm them, even if their symptms are the same as yurs. - If any f the side effects gets serius, r if yu ntice any side effects nt listed in this leaflet, please tell yur dctr r pharmacist. In this leaflet: 1. What CHAMPIX is and what it is used fr 2. Befre yu take CHAMPIX 3. Hw t take CHAMPIX 4. Pssible side effects 5. Hw t stre CHAMPIX 6. Further infrmatin 1. WHAT CHAMPIX IS AND WHAT IT IS USED FOR 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. Althugh yu are nt recmmended t smke after yur quit date, CHAMPIX can als reduce the enjyment f cigarettes if yu d smke when n treatment. (The quit date is the day in the secnd week f treatment when yu will stp smking, see Sectin 3.) 2. BEFORE YOU TAKE CHAMPIX D nt take CHAMPIX - If yu are allergic (hypersensitive) t varenicline tartrate r any f the ther ingredients f CHAMPIX Take special care with 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, yur family r dctr r if yu develp suicidal thughts r behaviurs yu shuld stp yur treatment and cntact yur dctr immediately.

2 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 Taking ther medicines 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 illness. If yu have a histry f psychiatric illness yu shuld discuss this with yur dctr r pharmacist. Depressed md may appear during smking cessatin with r withut treatment. Depressin, rarely including suicidal thughts and suicide attempt, has been reprted in patients underging a smking cessatin attempt. These feelings have als been reprted while attempting t quit smking with CHAMPIX. If these symptms persist when yu stp taking CHAMPIX, yur dctr shuld cntinue t mnitr yu clsely until yu are feeling better. Cardivascular 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. Stpping treatment with CHAMPIX 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. Taking ther medicines Please tell yur dctr r pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin. 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. 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 The safety and benefits f taking CHAMPIX in cmbinatin with ther medicines fr stpping smking have nt been studied. CHAMPIX in cmbinatin with ther smking cessatin therapies is therefre nt recmmended. CHAMPIX is nt recmmended fr use in children r adlescents belw 18 years as safety and efficacy have nt been established in this age grup.

3 Taking CHAMPIX with fd and drink CHAMPIX can be taken with r withut fd. Pregnancy and breast-feeding Yu shuld nt take CHAMPIX while yu are pregnant. Talk t yur dctr if yu are intending t becme pregnant. If yu want t start treatment with CHAMPIX, yur treatment shuld be timed s that yu have cmpleted the curse befre becming 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. HOW TO TAKE CHAMPIX 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. Always take CHAMPIX exactly as yur dctr has tld yu. Yu shuld check with yur dctr r pharmacist if yu are nt sure. 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 tablets shuld be swallwed whle with water. CHAMPIX cmes as a white tablet (0.5 mg) and a blue tablet (1 mg). Yu start with the white tablet and then usually g t the 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.

4 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. If yu have prblems with yur kidneys, yu shuld speak t yur dctr befre taking CHAMPIX. Yu may need a lwer dse. 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. 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. In smking cessatin therapy, risk f returning t smking may be elevated in the perid immediately fllwing the end f treatment. Yur dctr may decide t gradually lwer yur dse f CHAMPIX at the end f treatment. 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 almst time fr 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. If yu have any further questins n the use f this prduct, ask yur dctr r pharmacist. 4. POSSIBLE SIDE EFFECTS 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. Like all medicines, CHAMPIX can cause side effects, althugh nt everybdy gets them.

5 If yu are taking CHAMPIX and develp agitatin, depressed md, changes in behaviur r suicidal thughts yu shuld stp yur treatment and cntact yur dctr immediately. - Very cmmn side effects which may affect mre than 1 persn in 10 are listed belw: Headache, difficulty sleeping, abnrmal dreams Nausea - Cmmn side effects which may affect mre than 1 persn in 100 are listed belw: Increased appetite, changes in the way things taste, dry muth Sleepiness, tiredness, dizziness Vmiting, cnstipatin, diarrhea, feeling blated, stmach discmfrt, indigestin, flatulence - Uncmmn side effects which may affect mre than 1 persn in 1, 000 are listed belw: Chest infectin, discmfrt r pain, inflammatin f the sinuses, Fever, feeling cld, feeling weak r unwell, viral infectin, shrtness f breath, cugh, harseness, thrat pain and irritatin, cngested sinuses, runny nse, snring Lss f appetite, feeling thirsty, increased weight Depressin, anxiety, hallucinatins Feeling f panic, difficulty thinking, md swings Seizure, tremr, difficulty with crdinatin, difficulty with speech, less sensitive t tuch, increased muscle tensin, restlessness, Heart rhythm disturbances, increased bld pressure, increased heart rate Disturbed visin, eyeball discluratin, eye pain, dilated pupils, shrtsightedness, sensitivity t light, watery eyes Ringing in the ears Bld in vmit, irritated stmach and heartburn, abdminal pain, abnrmal stls, red bld in stls, belching, muth ulcers, pain in the gums, cated tngue Skin rash, cyst, fungal infectin, reddening f the skin, itching, acne, increased sweating Chest wall and rib pain, stiff jints, muscle spasms Glucse in urine, increased urine vlume and frequency Increased menstrual flw, vaginal discharge, changes in sex drive r ability - Rare side effects which may affect less than 1 persn in 1, 000 is strke. Other side effects have ccurred in a small number f peple attempting t quit smking with CHAMPIX, but their exact frequency is unknwn: heart attack, changes in thinking r behaviur (such as aggressin and abnrmal behaviur), suicidal thughts, diabetes, high bld sugar and sleep walking. There have als been reprts f serius allergic reactins including angiedema (swelling f the face, muth, r thrat) and 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). Yu shuld stp taking CHAMPIX and cntact yur dctr immediately if yu develp swelling f the face, muth r thrat, r if yur skin starts t peel r blister.

6 If any f the side effects gets serius, r if yu ntice any side effects nt listed in this leaflet, please tell yur dctr r pharmacist. 5. HOW TO STORE CHAMPIX Keep ut f the reach and sight f children. D nt use CHAMPIX after the expiry date which is stated n the card packaging r cartn. 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. Medicines shuld nt be dispsed f via wastewater r husehld waste. Ask yur pharmacist hw t dispse f medicines n lnger required. These measures will help t prtect the envirnment. 6. FURTHER INFORMATION What CHAMPIX cntains - The active substance is 0.5 mg varenicline and 1 mg varenicline respectively - 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) Macrgls Triacetin Tablet film cating - CHAMPIX 1 mg film-cated tablets Hyprmellse Titanium dixide (E171) Macrgls Indig Carmine Aluminium Lake (E132) Triacetin What CHAMPIX 0.5 mg and 1 mg film-cated tablets lk 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 CHAMPIX 1 mg film-cated tablets are light blue film-cated, mdified capsular shaped tablets, marked Pfizer and CHX 1.0

7 CHAMPIX is available in the fllwing pack presentatins: Nt all pack sizes may be marketed. - 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 filmcated 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. - 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. Marketing Authrisatin Hlder Pfizer Limited Sandwich Kent CT13 9NJ United Kingdm Manufacturer Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Str. 35 D Illertissen Germany Fr any infrmatin abut this medicinal prduct, please cntact the lcal representative f the Marketing Authrisatin Hlder:

8 België/Belgique/Belgien Pfizer S.A./N.V. Tél/Tel: + 32 (0) Luxemburg/Luxemburg Pfizer S.A. Tél/Tel: + 32 (0) България Пфайзер Люксембург САРЛ, Клон България Тел.: Česká republika Pfizer s.r.. Tel: Magyarrszág Pfizer Kft. Tel.: Malta V.J. Salmne Pharma Ltd. Tel : Danmark Pfizer ApS Tlf: Nederland Pfizer bv Tel: +31 (0) Deutschland Pfizer Pharma GmbH Tel: +49 (0) Eesti Pfizer Luxemburg SARL Eesti filiaal Tel: Nrge Pfizer AS Tlf: Österreich Pfizer Crpratin Austria Ges.m.b.H. Tel.: +43 (0) Ελλάδα PFIZER ΕΛΛΑΣ Α.Ε., Τηλ.: España Pfizer, S.L. Tel: Plska Pfizer Plska Sp. z.. Tel.: Prtugal Labratóris Pfizer, Lda. Tel: France Pfizer Tél: + 33 (0) Rmânia Pfizer Rmânia S.R.L. Tel: +40 (0) Ireland Pfizer Healthcare Ireland Tel: (tll free) +44 (0) Slvenija Pfizer Luxemburg SARL, Pfizer, pdružnica za svetvanje s pdrčja farmacevtske dejavnsti, Ljubljana Tel: (0)

9 Ísland Icepharma hf. Simi: Italia Pfizer Italia S.r.l. Tel: Κύπρος PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), Τηλ: Slvenská republika Pfizer Luxemburg SARL, rganizačná zlžka Tel: Sumi/Finland Pfizer Oy Puh/Tel: (0) Sverige Pfizer AB Tel: + 46 (0) Latvija Pfizer Luxemburg SARL filiāle Latvijā Tel: United Kingdm Pfizer Limited Tel: + 44 (0) Lietuva Pfizer Luxemburg SARL filialas Lietuvje Tel This leaflet was last apprved in 03/2013 Detailed infrmatin n this medicine is available n the Eurpean Medicines Agency web site: CI 21_0