454-8 (Insert) MEDICATION GUIDE ZUBSOLV (Zub-solve) (buprenorphine and naloxone) Sublingual Tablet (CIII) IMPORTANT: Keep ZUBSOLV in a secure place

Transcription

1 MEDICATION GUIDE ZUBSOLV (Zub-slve) (buprenrphine and nalxne) Sublingual Tablet (CIII) IMPORTANT: Keep ZUBSOLV 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 ZUBSOLV, get emergency help right away. Read this Medicatin Guide befre yu start taking ZUBSOLV 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 ZUBSOLV. Share the imprtant infrmatin in this Medicatin Guide with members f yur husehld. What is the mst imprtant infrmatin I shuld knw abut ZUBSOLV? ZUBSOLV 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 ZUBSOLV t ther medicines that cntain buprenrphine withut talking with yur dctr. The amunt f buprenrphine in a dse f ZUBSOLV 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. ZUBSOLV cntains an piid that can cause physical dependence. D nt stp taking ZUBSOLV 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. ZUBSOLV 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 ZUBSOLV. 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. D nt inject ( sht-up ) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infectins and ther serius health prblems. Injecting ZUBSOLV 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 ZUBSOLV. What is ZUBSOLV? ZUBSOLV is a prescriptin medicine used t treat adults wh are addicted t piid drugs (either prescriptin r illegal); as part f a cmplete treatment prgram that als includes cunseling and behaviral therapy. ZUBSOLV 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 ZUBSOLV in a safe place t prtect it frm theft. Never give yur ZUBSOLV 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 ZUBSOLV is safe r effective in children. Wh shuld nt take ZUBSOLV? D nt take ZUBSOLV if yu are allergic t buprenrphine r nalxne. What shuld I tell my dctr befre taking ZUBSOLV? ZUBSOLV may nt be right fr yu. Befre taking ZUBSOLV, tell yur dctr if yu:

2 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. If yu take ZUBSOLV while pregnant, yur baby may have symptms f piid withdrawal r respiratry depressin at birth. Talk t yur dctr if yu are pregnant r plan t becme pregnant. Are breastfeeding r plan t breastfeed. ZUBSOLV 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 ZUBSOLV. 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. ZUBSOLV may affect the way ther medicines wrk and ther medicines may affect hw ZUBSOLV wrks. Sme medicines may cause serius r life-threatening medical prblems when taken with ZUBSOLV. Smetimes the dses f certain medicines and ZUBSOLV may need t be changed if used tgether. D nt take any medicine while using ZUBSOLV until yu have talked with yur dctr. Yur dctr will tell yu if it is safe t take ther medicines while yu are using ZUBSOLV. Be especially careful abut taking ther medicines that may make yu sleepy, such as pain medicines, tranquilizers, 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 ZUBSOLV? Always take ZUBSOLV 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 ZUBSOLV mre ften than prescribed by yur dctr. Yu may be prescribed a dse f 2 r mre ZUBSOLV sublingual tablets at the same time. After inductin (yur first day f dsing), take ZUBSOLV 1 time a day. D nt cut, crush, break, chew r swallw the tablet. Yur dctr shuld shw yu hw t take ZUBSOLV the right way. Fllw the same instructins every time yu take a dse f ZUBSOLV. ZUBSOLV cmes in a blister pack with 10 blister units. Each blister unit cntains a ZUBSOLV tablet. Take the dse prescribed by yur dctr as fllws: Pull apart 1 f the blister units frm the blister pack by tearing alng the dtted lines (perfratins) until it is fully separated (See Figure A).

3 When the blister unit is fully separated, fld the single unit dwn at dtted line tward the blister (See Figure B). Slwly tear dwn at ntch t pen the blister unit (See Figure C). D nt push ZUBSOLV tablets thrugh the fil. This culd cause the tablet t break. As sn as yu remve yur prescribed dse f ZUBSOLV frm the blister pack place the tablet under yur tngue (See Figures D, E, and F). If mre than 1 tablet is required, place the tablets in different places under yur tngue at the same time.

4 Let the tablet disslve cmpletely. ZUBSOLV usually disslves in yur muth within 5 minutes. If yur muth is dry, take a sip f water t misten it. Spit ut r swallw the water and dry yur hands if they are wet befre yu place the ZUBSOLV tablet under yur tngue. While ZUBSOLV is disslving, d nt chew r swallw the tablet because the medicine will nt wrk as well. D nt eat r drink anything until the ZUBSOLV tablet has cmpletely disslved. Talking while the tablet is disslving can affect hw well the medicine in ZUBSOLV is absrbed. If yu miss a dse f ZUBSOLV, 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 ZUBSOLV 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 ZUBSOLV the right way. If yu take t much ZUBSOLV g t the nearest hspital emergency rm right away. What shuld I avid while taking ZUBSOLV? 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 ZUBSOLV. Yu shuld nt drink alchl while taking ZUBSOLV, as this can lead t lss f cnsciusness r even death. What are the pssible side effects f ZUBSOLV? ZUBSOLV can cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut ZUBSOLV? Respiratry prblems. Yu have a higher risk f death and cma if yu take ZUBSOLV 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 ZUBSOLV. 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. The mst cmmn side effects f ZUBSOLV include: Headache Increased sweating Decrease in sleep (insmnia) Nausea Cnstipatin Pain Vmiting Drug withdrawal syndrme Swelling f the extremities 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 ZUBSOLV. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t the FDA at FDA Hw shuld I stre ZUBSOLV? Stre ZUBSOLV at rm temperature between 68 F t 77 F (20 C t 25 C). Keep ZUBSOLV in a safe place, ut f the sight and reach f children. Hw shuld I dispse f unused ZUBSOLV? Dispse f unused ZUBSOLV sublingual tablets as sn as yu n lnger need them. Flush unused tablets dwn the tilet.

5 General infrmatin abut the safe and effective use f ZUBSOLV. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use ZUBSOLV fr a cnditin fr which it was nt prescribed. D nt give ZUBSOLV 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 ZUBSOLV. 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 ZUBSOLV ( ). What are the ingredients in ZUBSOLV? Active Ingredients: buprenrphine and nalxne. Inactive Ingredients: mannitl, citric acid, sdium citrate, micrcrystalline cellulse, crscarmellse sdium, sucralse, silicn dixide, sdium stearyl fumarate, and menthl flavr. Manufactured fr and distributed by Orex US, Inc. Mrristwn, NJ USA ZUBSOLV is a licensed trademark f Orex US, Inc Orex US, Inc. All rights reserved. Printed in USA This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Revised: 12/2016