Do not inject ( shoot-up ) BUNAVAIL. o

Transcription

1 MEDICATION GUIDE BUNAVAIL (bue-nah-vale) (buprenrphine and nalxne) Buccal Film (CIII) IMPORTANT: Keep BUNAVAIL in a secure place away frm children. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses BUNAVAIL, get emergency help right away. Read this Medicatin Guide befre yu start taking BUNAVAIL 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 BUNAVAIL. Share the imprtant infrmatin in this Medicatin Guide with members f yur husehld. What is the mst imprtant infrmatin I shuld knw abut BUNAVAIL? BUNAVAIL 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 BUNAVAIL t ther medicines that cntain buprenrphine withut talking with yur dctr. The amunt f buprenrphine in a dse f BUNAVAIL is nt the same as the amunt f buprenrphine in ther medicines that cntain buprenrphine. Yur dctr will prescribe a starting dse f buprenrphine that may be different than ther buprenrphine cntaining medicines yu may have been taking. BUNAVAIL cntains an piid that can cause physical dependence. D nt stp taking BUNAVAIL 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. BUNAVAIL is nt fr ccasinal r as needed use. An verdse, and even death, can happen if yu take benzdiazepines, sedatives, tranquilizers, r alchl while using BUNAVAIL. 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: Feel sleepy and uncrdinated Have blurred visin Have slurred speech Cannt think well r clearly Have slwed reflexes and breathing

2 D nt inject ( sht-up ) BUNAVAIL. Injecting BUNAVAIL may cause life-threatening infectins and ther serius health prblems. Injecting BUNAVAIL may cause serius withdrawal symptms such as pain, cramps, vmiting, diarrhea, anxiety, sleep prblems, and cravings. In an emergency, have family members tell the emergency department staff that yu are physically dependent n an piid and are being treated with BUNAVAIL. What is BUNAVAIL? BUNAVAIL 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. BUNAVAIL 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 BUNAVAIL in a safe place t prtect it frm theft. Never give yur BUNAVAIL 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 BUNAVAIL is safe r effective in children. Wh shuld nt take BUNAVAIL? D nt take BUNAVAIL if yu are allergic t buprenrphine r nalxne. What shuld I tell my dctr befre taking BUNAVAIL? BUNAVAIL may nt be right fr yu. Befre taking BUNAVAIL, tell yur dctr if yu: 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 liver r kidney prblems Have gallbladder prblems Have adrenal gland prblems 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. It is nt knwn if BUNAVAIL will harm yur unbrn baby. If yu take BUNAVAIL while pregnant, yur baby may have symptms f

3 withdrawal at birth. Talk t yur dctr if yu are pregnant r plan t becme pregnant. Are breastfeeding r plan t breastfeed. BUNAVAIL can pass int yur breast milk and may harm yur baby. Talk t yur dctr abut the best way t feed yur baby if yu take BUNAVAIL. Mnitr yur baby fr increased drwsiness and breathing prblems. Tell yur dctr abut all the medicines yu take, including prescriptin and ver-thecunter medicines, vitamins, and herbal supplements. BUNAVAIL may affect the way ther medicines wrk and ther medicines may affect hw BUNAVAIL wrks. Sme medicines may cause serius r life-threatening medical prblems when taken with BUNAVAIL. Smetimes the dses f certain medicines and BUNAVAIL may need t be changed if used tgether. D nt take any medicine while using BUNAVAIL until yu have talked with yur dctr. Yur dctr will tell yu if it is safe t take ther medicines while yu are taking BUNAVAIL. 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 BUNAVAIL? Always take BUNAVAIL 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 BUNAVAIL mre ften than prescribed by yur dctr. Take BUNAVAIL 1 time a day. Yu may be prescribed a dse f 2 r mre BUNAVAIL buccal films t be taken at the same time. Use the entire BUNAVAIL buccal film. D nt cut, tear, chew, r swallw the buccal film. Yur dctr shuld shw yu hw t use BUNAVAIL the right way. Fllw the same instructins every time yu take a dse f BUNAVAIL buccal film. BUNAVAIL cmes in a child-resistant fil package. D nt pen the fil package until yu are ready t use the BUNAVAIL buccal film. After pening the fil package, use BUNAVAIL buccal film right away. Take the dse prescribed by yur dctr as fllws: T pen the BUNAVAIL buccal film fil package, fld alng the dtted lines and tear dwn at slits r cut with scissrs in the directin f the arrws (See Figure A).

4 Figure A Use yur tngue t wet the inside f yur cheek r rinse yur muth with water t misten the area in yur muth befre yu place BUNAVAIL. Hld the BUNAVAIL buccal film with clean, dry fingers with the text (BN2, BN4, r BN6) facing up (See Figure B). Place the BUNAVAIL buccal film inside yur muth with the text (BN2, BN4, r BN6) against the inside f yur mistened cheek (See Figure C). With yur finger, press the BUNAVAIL buccal film against yur cheek. Hld it there fr 5 secnds. Take yur finger away frm the BUNAVAIL buccal film. It will stick t the inside f yur cheek (See Figure D). Leave the film in place until it disslves. If yur dctr tells yu t use mre than ne BUNAVAIL buccal film at the same time, place the next film n the inside f yur ther cheek fllwing the instructins abve. D nt place mre than tw buccal films t the inside f ne cheek at a time.

5 Figure B Figure C Figure D Avid tuching r mving the buccal film with yur tngue r fingers. Avid drinking r eating fd until after the buccal film has disslved. If yu miss a dse f BUNAVAIL, 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 BUNAVAIL 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 BUNAVAIL the right way. If yu take t much BUNAVAIL r verdse, call Pisn Cntrl r get emergency medical help right away. What shuld I avid while taking BUNAVAIL? 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 BUNAVAIL. Yu shuld nt drink alchl while using BUNAVAIL, as this can lead t lss f cnsciusness r even death. What are pssible side effects f BUNAVAIL? BUNAVAIL can cause serius side effects including: See What is the mst imprtant infrmatin I shuld knw abut BUNAVAIL? Respiratry prblems. Yu have a higher risk f death and cma if yu take BUNAVAIL with ther medicines, such as benzdiazepines. Sleepiness, dizziness, and prblems with crdinatin

6 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 BUNAVAIL. Allergic Reactin. Yu may have a rash, hives, swelling f yur face, wheezing, r lss f bld pressure and cnsciusness. Call a dctr r get emergency help right away. 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 BUNAVAIL include: Headache Drug withdrawal syndrme Nausea Decrease in sleep (insmnia) Vmiting Pain Increased sweating Cnstipatin 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 BUNAVAIL. 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 BUNAVAIL? Stre BUNAVAIL at rm temperature between 68 F t 77 F (20 C t 25 C). Keep BUNAVAIL dry. D nt freeze BUNAVAIL. D nt use BUNAVAIL buccal film if the fil package has been damaged. Keep BUNAVAIL in a safe place, ut f sight and reach f children. Hw shuld I dispse f unused BUNAVAIL? Dispse f unused BUNAVAIL buccal film as sn as yu n lnger need them. Remve the unused BUNAVAIL buccal film frm the fil packages. Drp the BUNAVAIL buccal films int the tilet and flush.

7 D nt flush the BUNAVAIL fil packages r cartns dwn the tilet. If yu need help with dispsal f BUNAVAIL, call General infrmatin abut the safe and effective use f BUNAVAIL. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use BUNAVAIL fr a cnditin fr which it was nt prescribed. D nt give BUNAVAIL 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 BUNAVAIL. 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 BUNAVAIL? Active ingredients: buprenrphine hydrchlride, nalxne hydrchlride dihydrate Inactive ingredients: carbxymethylcellulse sdium, citric acid, citrus blend flavr, dibasic sdium phsphate, blue ink, hydrxyethyl cellulse, hydrxyprpyl cellulse, methylparaben, mnbasic sdium phsphate, plycarbphil, prpylene glycl, prpylparaben, yellw irn xide, sdium benzate, sdium hydrxide, sdium saccharin, vitamin E acetate, and purified water. The blue ink cntains FD&C blue #1, ethanl, purified shellac, acetne, ammnium hydrxide and water. Manufactured fr: BiDelivery Sciences Internatinal, Inc., Raleigh, Nrth Carlina USA BBF-001-MG Issued: June 2014