Some people have had serious side effects while using CHANTIX to help them quit smoking, including:

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1 breastfeeding, and the benefits f smking cessatin with and withut CHANTIX [see Use in Specific Ppulatins (8.1 and 8.3)]. This prduct s label may have been updated. Fr full prescribing infrmatin, please visit LAB X MEDICATION GUIDE CHANTIX (CHANT-iks) (varenicline) Tablets What is the mst imprtant infrmatin I shuld knw abut CHANTIX? Sme peple have had serius side effects while using CHANTIX t help them quit smking, including: New r wrse mental health prblems, such as changes in behavir, hstility, agitatin, depressed md, and suicidal thughts r actins. Sme peple had these symptms when they began taking CHANTIX, and thers develped them after several weeks f treatment, r after stpping CHANTIX. Befre taking CHANTIX, tell yur dctr if yu have ever had depressin r ther mental health prblems. Yu shuld als tell yur dctr abut any symptms yu had during ther times yu tried t quit smking, with r withut CHANTIX. Stp taking CHANTIX and call yur dctr right away if yu, yur family, r caregiver ntice agitatin, hstility, depressin r changes in yur behavir r thinking that are nt typical fr yu, r yu develp any f the fllwing symptms: thughts abut suicide r dying, r attempts t cmmit suicide new r wrse depressin, anxiety, r panic attacks feeling very agitated r restless acting aggressive, being angry, r vilent acting n dangerus impulses an extreme increase in activity and talking (mania) abnrmal thughts r sensatins seeing r hearing things that are nt there (hallucinatins) feeling peple are against yu (parania) feeling cnfused ther unusual changes in behavir r md When yu try t quit smking, with r withut CHANTIX, yu may have symptms that may be due t nictine withdrawal, including urge t smke, depressed md, truble sleeping, irritability, frustratin, anger, feeling anxius, difficulty cncentrating, restlessness, decreased heart rate, and increased appetite r weight gain. Sme peple have even experienced suicidal thughts when trying t quit smking withut medicatin. Smetimes quitting smking can lead t wrsening f mental health prblems that yu already have, such as depressin. See What are the pssible side effects f CHANTIX? fr mre infrmatin abut ther side effects. What is CHANTIX? CHANTIX is a prescriptin medicine t help peple stp smking.

2 Quitting smking can lwer yur chances f having lung disease, heart disease r getting certain types f cancer that are related t smking. It is nt knwn if CHANTIX is safe and effective in children. It is nt knwn if CHANTIX is safe and effective when used with ther stp-smking medicines. Wh shuld nt take CHANTIX? D nt take CHANTIX if yu have had a serius allergic r skin reactin t CHANTIX. Symptms may include: swelling f the face, muth (tngue, lips, gums), thrat r neck truble breathing rash, with peeling skin blisters in yur muth What shuld I tell my dctr befre taking CHANTIX? See What is the mst imprtant infrmatin I shuld knw abut CHANTIX? Befre yu take CHANTIX, tell yur dctr if yu: use ther treatments t quit smking. Using CHANTIX with a nictine patch may cause nausea, vmiting, headache, dizziness, upset stmach, and tiredness t happen mre ften than if yu just use a nictine patch alne. have kidney prblems r get kidney dialysis. Yur dctr may prescribe a lwer dse f CHANTIX fr yu. have a histry f seizures drink alchl have heart r bld vessel prblems have any ther medical cnditins are pregnant r plan t becme pregnant. It is nt knwn if CHANTIX will harm yur unbrn baby. are breastfeeding. It is nt knwn if CHANTIX passes int breast milk. Yu and yur dctr shuld decide if yu will breastfeed r take CHANTIX. Yu shuld nt d bth. Tell yur dctr abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins and herbal supplements. Yur dctr may need t change the dse f sme f yur medicines when yu stp smking. Yu shuld nt use CHANTIX while using ther medicines t quit smking. Tell yur dctr if yu use ther treatments t quit smking. Knw the medicines yu take. Keep a list f them with yu t shw yur dctr and pharmacist when yu get a new medicine. Hw shuld I take CHANTIX? There are 2 ways that yu can use CHANTIX t help yu quit smking. Talk t yur dctr abut the fllwing 2 ways t use

3 CHANTIX: Chse a quit date when yu will stp smking. Start taking CHANTIX 1 week (7 days) befre yur quit date. OR Start taking CHANTIX befre yu chse a quit date. Pick a date t quit smking that is between days 8 and 35 f treatment. Starting CHANTIX befre yur quit date gives CHANTIX time t build up in yur bdy. Yu can keep smking during this time. Take CHANTIX exactly as prescribed by yur dctr. CHANTIX 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 dsing instructins fr adults. Day 1 t Day 3 Day 4 t Day 7 Day 8 t end f treatment White tablet (0.5 mg) Take 1 tablet each day White tablet (0.5 mg) Take 1 in the mrning and 1 in the evening Blue tablet (1 mg) Take 1 in the mrning and 1 in the evening Make sure that yu try t stp smking n yur quit date. If yu slip-up and smke, try again. Sme peple need t take CHANTIX fr a few weeks fr CHANTIX t wrk best. Mst peple will take CHANTIX fr up t 12 weeks. If yu have cmpletely quit smking by 12 weeks, yur dctr may prescribe CHANTIX fr anther 12 weeks t help yu stay cigarette-free. Take CHANTIX after eating and with a full glass (8 unces) f water. This dsing schedule may nt be right fr everyne. Talk t yur dctr if yu are having side effects such as nausea, strange dreams, r sleep prblems. Yur dctr may want t reduce yur dse. If yu miss a dse f CHANTIX, take it as sn as yu remember. If it is almst time fr yur next dse, skip the missed dse. Just take yur next dse at yur regular time. What shuld I avid while taking CHANTIX? Use cautin when driving r perating machinery until yu knw hw CHANTIX affects yu. CHANTIX may make yu feel sleepy, dizzy, r have truble cncentrating, making it hard t drive r perfrm ther activities safely. Decrease the amunt f alchlic beverages that yu drink during treatment with CHANTIX until yu knw if CHANTIX affects yur ability t tlerate alchl. Sme peple have experienced the fllwing when drinking alchl during treatment with CHANTIX: increased drunkenness (intxicatin) unusual r smetimes aggressive behavir n memry f things that have happened

4 What are the pssible side effects f CHANTIX? Serius side effects f CHANTIX may include: See What is the mst imprtant infrmatin I shuld knw abut CHANTIX? Seizures. Sme peple have had seizures during treatment with CHANTIX. In mst cases, the seizures have happened during the first mnth f treatment with CHANTIX. If yu have a seizure during treatment with CHANTIX, stp taking CHANTIX and cntact yur healthcare prvider right away. New r wrse heart r bld vessel (cardivascular) prblems, mstly in peple, wh already have cardivascular prblems. Tell yur dctr if yu have any changes in symptms during treatment with CHANTIX. Get emergency medical help right away if yu have any f the fllwing symptms f a heart attack, including: chest discmfrt (uncmfrtable pressure, squeezing, fullness r pain) that lasts mre than a few minutes, r that ges away and cmes back pain r discmfrt in ne r bth arms, back, neck, jaw r stmach shrtness f breath, sweating, nausea, vmiting, r feeling lightheaded assciated with chest discmfrt Allergic reactins can happen with CHANTIX. Sme f these allergic reactins can be life-threatening. Serius skin reactins, including rash, swelling, redness, and peeling f the skin. Sme f these skin reactins can becme life-threatening. Stp taking CHANTIX and get medical help right away if yu have any f the fllwing symptms: swelling f the face, muth (tngue, lips, and gums), thrat r neck truble breathing rash with peeling skin blisters in yur muth The mst cmmn side effects f CHANTIX include: nausea sleep prblems (truble sleeping r vivid, unusual, r strange dreams) cnstipatin gas vmiting Tell yur dctr abut side effects that bther yu r that d nt g away. These are nt all the side effects f CHANTIX. Ask yur dctr r pharmacist fr mre infrmatin. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre CHANTIX? Stre CHANTIX at rm temperature, between 68 F t 77 F (20 C t 25 C). Keep CHANTIX and all medicines ut f the reach f children. General infrmatin abut CHANTIX

5 Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use CHANTIX fr a cnditin fr which it was nt prescribed. D nt give yur CHANTIX t ther peple, even if they have the same symptms that yu have. It may harm them. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut CHANTIX that is written fr healthcare prfessinals. Fr mre infrmatin abut CHANTIX and tips n hw t quit smking, g t r call What are the ingredients in CHANTIX? Active ingredient: varenicline tartrate Inactive ingredients: micrcrystalline cellulse, anhydrus dibasic calcium phsphate, crscarmellse sdium, cllidal silicn dixide, magnesium stearate, Opadry White (fr 0.5 mg), Opadry Blue (fr 1 mg), and Opadry Clear. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Revised September 2014 LAB X