MEDICATION GUIDE SUBOXONE (Sub OX own) (buprenorphine and naloxone) Sublingual Film for Sublingual or Buccal Administration (CIII)

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1 MEDICATION GUIDE SUBOXONE (Sub OX wn) (buprenrphine and nalxne) Sublingual Film fr Sublingual r Buccal Administratin (CIII) IMPORTANT: Keep SUBOXONE sublingual film in a secure place away frm children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally uses SUBOXONE sublingual film, get emergency help right away. Read this Medicatin Guide that cmes with SUBOXONE (buprenrphine and nalxne) sublingual film befre yu start taking it and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur dctr. Talk t yur dctr r pharmacist if yu have questins abut SUBOXONE sublingual film. Share the imprtant infrmatin in this Medicatin Guide with members f yur husehld. What is the mst imprtant infrmatin I shuld knw abut SUBOXONE sublingual film? SUBOXONE sublingual film can cause serius and life threatening breathing prblems. Call yur dctr right away r get emergency help if: Yu feel faint, dizzy, r cnfused Yur breathing gets much slwer than is nrmal fr yu These can be signs f an verdse r ther serius prblems. D nt switch frm SUBOXONE sublingual film t ther medicines that cntain buprenrphine withut talking with yur dctr. The amunt f buprenrphine in a dse f SUBOXONE sublingual film is nt the same as the amunt f buprenrphine in ther medicines that cntain buprenrphine. Yur dctr will prescribe a starting dse f SUBOXONE sublingual film that may be different than ther buprenrphine cntaining medicines yu may have been taking. SUBOXONE sublingual film cntains an piid that can cause physical dependence. D nt stp taking SUBOXONE sublingual film withut talking t yur dctr. Yu culd becme sick with uncmfrtable withdrawal signs and symptms because yur bdy has becme used t this medicine. Physical dependence is nt the same as drug addictin. SUBOXONE sublingual film is nt fr ccasinal r as needed use. An verdse and even death can happen if yu take benzdiazepines, sedatives, tranquilizers, antidepressants, r alchl while using SUBOXONE sublingual film. Ask yur dctr what yu shuld d if yu are taking ne f these. Call a dctr r get emergency help right away if yu:

2 Feel sleepy and uncrdinated Have blurred visin Have slurred speech Cannt think well r clearly Have slwed reflexes and breathing D nt inject ( sht up ) SUBOXONE sublingual film. Injecting SUBOXONE may cause life threatening infectins and ther serius health prblems. Injecting SUBOXONE may cause serius withdrawal symptms such as pain, cramps, vmiting, diarrhea, anxiety, sleep prblems, and cravings. In an emergency, have family members tell emergency department staff that yu are physically dependent n an piid and are being treated with SUBOXONE sublingual film. What is SUBOXONE sublingual film? SUBOXONE sublingual film is a prescriptin medicine used t treat adults wh are addicted t (dependent n) piid drugs (either prescriptin r illegal) as part f a cmplete treatment prgram that als includes cunseling and behaviral therapy. SUBOXONE sublingual film is a cntrlled substance (CIII) because it cntains buprenrphine, which can be a target fr peple wh abuse prescriptin medicines r street drugs. Keep yur SUBOXONE sublingual film in a safe place t prtect it frm theft. Never give yur SUBOXONE sublingual film t anyne else; it can cause death r harm them. Selling r giving away this medicine is against the law. It is nt knwn if SUBOXONE sublingual film is safe r effective in children. Wh shuld nt take SUBOXONE sublingual film? D nt take SUBOXONE sublingual film if yu are allergic t buprenrphine r nalxne. What shuld I tell my dctr befre taking SUBOXONE sublingual film? SUBOXONE sublingual film may nt be right fr yu. Befre taking SUBOXONE sublingual film, tell yur dctr if yu: Have liver r kidney prblems Have truble breathing r lung prblems Have an enlarged prstate gland (men) Have a head injury r brain prblem Have prblems urinating Have a curve in yur spine that affects yur breathing Have gallbladder prblems Have adrenal gland prblems

3 Have Addisn s disease Have lw thyrid (hypthyridism) Have a histry f alchlism Have mental prblems such as hallucinatins (seeing r hearing things that are nt there) Have any ther medical cnditin Are pregnant r plan t becme pregnant. If yu take SUBOXONE sublingual film while pregnant, yur baby may have signs f piid withdrawal at birth. Nenatal piid withdrawal syndrme (NOWS) is an expected and treatable utcme f prlnged use f piids during pregnancy. Talk t yur dctr if yu are pregnant r plan t becme pregnant. Are breastfeeding r plan t breastfeed. The active ingredients f SUBOXONE sublingual film can pass int yur milk and may harm yur baby. Talk t yur dctr abut the best way t feed yur baby if yu take SUBOXONE sublingual film. Mnitr yur baby fr increased sleepiness and breathing prblems. Tell yur dctr abut all the medicines yu take, including prescriptin and ver the cunter medicines, vitamins, and herbal supplements. SUBOXONE sublingual film may affect the way ther medicines wrk, and ther medicines may affect hw SUBOXONE sublingual film wrks. Sme medicines may cause serius r life threatening medical prblems when taken with SUBOXONE sublingual film. Smetimes the dses f certain medicines and SUBOXONE sublingual film may need t be changed if used tgether. D nt take any medicine while using SUBOXONE sublingual film until yu have talked with yur dctr. Yur dctr will tell yu if it is safe t take ther medicines while yu are taking SUBOXONE sublingual film. Be especially careful abut taking ther medicines that may make yu sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines r antihistamines. Knw the medicines yu take. Keep a list f them t shw yur dctr r pharmacist each time yu get a new medicine. Hw shuld I take SUBOXONE sublingual film? Always take SUBOXONE sublingual film exactly as yur dctr tells yu. Yur dctr may change yur dse after seeing hw it affects yu. D nt change yur dse unless yur dctr tells yu t change it. D nt take SUBOXONE sublingual film mre ften than prescribed by yur dctr. Take SUBOXONE sublingual film 1 time a day. When yu are beginning treatment, take SUBOXONE sublingual film nly under the tngue (sublingual administratin). After a few days, yu can chse whether yu will take SUBOXONE sublingual film n the inside f yur cheek (buccal administratin) r by sublingual administratin.

4 SUBOXONE sublingual film must be taken whle. D nt cut, chew, r swallw SUBOXONE sublingual film. Yur dctr shuld shw yu hw t take SUBOXONE sublingual film the right way. Each SUBOXONE sublingual film cmes in a sealed child resistant fil puch. D nt pen the fil puch until yu are ready t use it. Taking SUBOXONE sublingual film: T pen yur SUBOXONE sublingual film fil puch, fld alng the dtted line (see Figure 1). Figure 1 Tear dwn at slit r cut with scissrs alng the arrw (see Figure 2). Figure 2 Befre taking SUBOXONE sublingual film, drink water t misten yur muth. This helps the film disslve mre easily. T take SUBOXONE sublingual film under yur tngue (sublingual administratin):

5 Hld the film between tw fingers by the utside edges. Place the SUBOXONE sublingual film under yur tngue, clse t the base either t the left r right f the center (see Figure 3). Figure 3 If yur dctr tells yu t take 2 films at a time, place the secnd film under yur tngue n the ppsite side. Avid letting the films tuch. Keep the films in place until they have cmpletely disslved. If yur dctr tells yu t take a third film, place it under yur tngue n either side after the first 2 films have disslved. T take SUBOXONE sublingual film n the inside f yur cheek (buccal administratin): Hld the film between tw fingers by the utside edges. Place ne film n the inside f yur right r left cheek (see Figure 4). Figure 4 If yur dctr tells yu t take 2 films at a time, place the ther film n the inside f the ppsite cheek. Keep the films in place until they have cmpletely disslved.

6 If yur dctr tells yu t take a third film, place it n the inside f yur right r left cheek after the first 2 films have disslved. While SUBOXONE sublingual film is disslving, d nt chew r swallw the film because the medicine will nt wrk as well. Talking while the film is disslving can affect hw well the medicine in SUBOXONE sublingual film is absrbed. If yu miss a dse f SUBOXONE sublingual film, take yur medicine when yu remember. If it is almst time fr yur next dse, skip the missed dse and take the next dse at yur regular time. D nt take 2 dses at the same time unless yur dctr tells yu t. If yu are nt sure abut yur dsing, call yur dctr. D nt stp taking SUBOXONE sublingual film suddenly. Yu culd becme sick and have withdrawal symptms because yur bdy has becme used t the medicine. Physical dependence is nt the same as drug addictin. Yur dctr can tell yu mre abut the differences between physical dependence and drug addictin. T have fewer withdrawal symptms, ask yur dctr hw t stp using SUBOXONE sublingual film the right way. If yu take t much SUBOXONE sublingual film r verdse, call Pisn Cntrl r get emergency medical help right away. What shuld I avid while taking SUBOXONE sublingual film? D nt drive, perate heavy machinery, r perfrm any ther dangerus activities until yu knw hw this medicatin affects yu. Buprenrphine can cause drwsiness and slw reactin times. This may happen mre ften in the first few weeks f treatment when yur dse is being changed, but can als happen if yu drink alchl r take ther sedative drugs when yu take SUBOXONE sublingual film. Yu shuld nt drink alchl while using SUBOXONE sublingual film, as this can lead t lss f cnsciusness r even death. What are the pssible side effects f SUBOXONE sublingual film? SUBOXONE sublingual film can cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut SUBOXONE sublingual film? Respiratry prblems. Yu have a higher risk f death and cma if yu take SUBOXONE sublingual film with ther medicines, such as benzdiazepines. Sleepiness, dizziness, and prblems with crdinatin Dependency r abuse Liver prblems. Call yur dctr right away if yu ntice any f these signs f liver prblems: Yur skin r the white part f yur eyes turning yellw (jaundice), urine turning dark, stls turning light in clr, yu have less f an appetite, r yu have stmach (abdminal) pain r nausea. Yur dctr shuld d tests befre yu start taking and while yu take SUBOXONE sublingual film. Allergic reactin. Yu may have a rash, hives, swelling f the face, wheezing, r a lss f bld pressure and cnsciusness. Call a dctr r get emergency help right away.

7 Opiid withdrawal. This can include: shaking, sweating mre than nrmal, feeling ht r cld mre than nrmal, runny nse, watery eyes, gse bumps, diarrhea, vmiting, and muscle aches. Tell yur dctr if yu develp any f these symptms. Decrease in bld pressure. Yu may feel dizzy if yu get up t fast frm sitting r lying dwn. Cmmn side effects f SUBOXONE sublingual film include: Nausea Vmiting Drug withdrawal syndrme Headache Sweating Numb muth Cnstipatin Swllen and/r painful tngue The inside f yur muth is mre red than nrmal Intxicatin (feeling lightheaded r drunk) Disturbance in attentin Irregular heart beat (palpitatins) Decrease in sleep (insmnia) Blurred visin Back pain Fainting Dizziness Sleepiness Tell yur dctr abut any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f SUBOXONE sublingual film. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre SUBOXONE sublingual film? Stre SUBOXONE sublingual film at rm temperature between 68 F t 77 F (20 C t 25 C). Keep SUBOXONE sublingual film in a safe place, ut f the sight and reach f children. Hw shuld I dispse f unused SUBOXONE sublingual film?

8 Dispse f unused SUBOXONE sublingual film as sn as yu n lnger need them. Unused films shuld be remved frm the fil puch and flushed dwn the tilet. D nt flush the SUBOXONE sublingual film fil puch dwn the tilet. If yu need help with dispsal f SUBOXONE sublingual film, call General infrmatin abut the safe and effective use f SUBOXONE sublingual film. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt take SUBOXONE sublingual film fr a cnditin fr which it was nt prescribed. D nt give SUBOXONE sublingual film t ther peple, even if they have the same symptms yu have. It may harm them and it is against the law. This Medicatin Guide summarizes the mst imprtant infrmatin abut SUBOXONE sublingual film. If yu wuld like mre infrmatin, talk t yur dctr r pharmacist. Yu can ask yur dctr r pharmacist fr infrmatin that is written fr health prfessinals. Fr mre infrmatin, call What are the ingredients in SUBOXONE sublingual film? Active ingredients: buprenrphine and nalxne. Inactive ingredients: plyethylene xide, hydrxyprpyl methylcellulse, maltitl, acesulfame ptassium, lime flavr, citric acid, sdium citrate, FD&C yellw #6, and white ink. Manufactured fr Indivir Inc. Richmnd, VA by: MnSl Rx, LLC, Warren, NJ Distributed by: Indivir Inc. Richmnd, VA This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. SUBOXONE is a registered trademark f Indivir UK Limited Revised: Cpyright 2016 Indivir Inc. Printed in USA

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