Medication Guide CONTRAVE (CON-trayv) (naltrexone HCl and bupropion HCl) Extended-Release Tablets

Transcription

1 Page 1 f 8 Medicatin Guide CONTRAVE (CON-trayv) (naltrexne HCl and buprpin HCl) Extended-Release Tablets Read this Medicatin Guide befre yu start taking CONTRAVE and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking with yur healthcare prvider abut yur medical prblems r treatment. What is the mst imprtant infrmatin I shuld knw abut CONTRAVE? CONTRAVE can cause serius side effects, including: Suicidal thughts r actins. One f the ingredients in CONTRAVE is buprpin. Buprpin has caused sme peple t have suicidal thughts r actins r unusual changes in behavir, whether r nt they are taking medicines used t treat depressin. Buprpin may increase suicidal thughts r actins in sme children, teenagers, and yung adults within the first few mnths f treatment. If yu already have depressin r ther mental illnesses, taking buprpin may cause it t get wrse, especially within the first few mnths f treatment. Stp taking CONTRAVE and call a healthcare prvider right away if yu, r yur family member, have any f the fllwing symptms, especially if they are new, wrse, r wrry yu: thughts abut suicide r dying attempts t cmmit suicide new r wrse depressin new r wrse anxiety feeling very agitated r restless panic attacks truble sleeping (insmnia) new r wrse irritability acting aggressive, being angry, r vilent acting n dangerus impulses an extreme increase in activity and talking (mania) ther unusual changes in behavir r md While taking CONTRAVE, yu r yur family members shuld: Pay clse attentin t any changes, especially sudden changes, in md, behavirs, thughts, r feelings. This is very imprtant when yu start taking CONTRAVE r when yur dse changes. Keep all fllw-up visits with yur healthcare prvider as scheduled. Call yur healthcare prvider between visits as needed, especially if yu have cncerns abut symptms. CONTRAVE has nt been studied in and is nt apprved fr use in children under the age f 18.

2 What is CONTRAVE? Page 2 f 8 CONTRAVE is a prescriptin medicine which cntains 2 medicines (naltrexne and buprpin) that may help sme bese r verweight adults, wh als have weight related medical prblems, lse weight and keep the weight ff. CONTRAVE shuld be used with a reduced calrie diet and increased physical activity. It is nt knwn if CONTRAVE changes yur risk f heart prblems r strke r f death due t heart prblems r strke. It is nt knwn if CONTRAVE is safe and effective when taken with ther prescriptin, ver-the-cunter, r herbal weight lss prducts. It is nt knwn if CONTRAVE is safe and effective in children under 18 years f age. CONTRAVE is nt apprved t treat depressin r ther mental illnesses, r t help peple quit smking (smking cessatin). One f the ingredients in CONTRAVE, buprpin, is the same ingredient in sme ther medicines used t treat depressin and t help peple quit smking. Wh shuld nt take CONTRAVE? D nt take CONTRAVE if yu: have uncntrlled hypertensin have r have had seizures use ther medicines that cntain buprpin such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN have r have had an eating disrder called anrexia (eating very little) r bulimia (eating t much and vmiting t avid gaining weight) are dependent n piid pain medicines r use medicines t help stp taking piids such as methadne r buprenrphine, r are in piate withdrawal drink a lt f alchl and abruptly stp drinking, r use medicines called sedatives (these make yu sleepy), benzdiazepines, r anti-seizure medicines and yu stp using them all f a sudden are taking medicines called mnamine xidase inhibitrs (MAOIs). Ask yur healthcare prvider r pharmacist if yu are nt sure if yu take an MAOI, including linezlid. D nt start CONTRAVE until yu have stpped taking yur MAOI fr at least 14 days. are allergic t naltrexne r buprpin r any f the ingredients in CONTRAVE. See the end f this Medicatin Guide fr a cmplete list f ingredients in CONTRAVE. are pregnant r planning t becme pregnant. Tell yur healthcare prvider right away if yu becme pregnant while taking CONTRAVE. What shuld I tell my healthcare prvider befre taking CONTRAVE? Befre yu take CONTRAVE, tell yur healthcare prvider if yu: have r have had depressin r ther mental illnesses (such as biplar disrder)

3 have attempted suicide in the past have r have had seizures have had a head injury have had a tumr r infectin f yur brain r spine (central nervus system) Page 3 f 8 have had a prblem with lw bld sugar (hypglycemia) r lw levels f sdium in yur bld (hypnatremia) have r have had liver prblems have high bld pressure have r have had a heart attack, heart prblems, r have had a strke have kidney prblems are diabetic taking insulin r ther medicines t cntrl yur bld sugar have r have had an eating disrder drink a lt f alchl abuse prescriptin medicines r street drugs are ver the age f 65 have any ther medical cnditins are breastfeeding r plan t breastfeed. CONTRAVE can pass int yur breast milk and may harm yur baby. Yu and yur healthcare prvider shuld decide if yu shuld take CONTRAVE r breastfeed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. CONTRAVE may affect the way ther medicines wrk and ther medicines may affect the way CONTRAVE wrks causing side effects. Ask yur healthcare prvider fr a list f these medicines if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider r pharmacist when yu get a new medicine.

4 Page 4 f 8 Hw shuld I take CONTRAVE? Hw t take CONTRAVE Mrning Dse Evening Dse Starting: Week 1 1 tablet Nne Week 2 1 tablet 1 tablet Week 3 2 tablets 1 tablet Week 4 Onward 2 tablets 2 tablets Take CONTRAVE exactly as yur healthcare prvider tells yu t. D nt change yur CONTRAVE dse withut talking with yur healthcare prvider. Yur healthcare prvider will change yur dse if needed. Yur healthcare prvider shuld tell yu t stp taking CONTRAVE if yu have nt lst a certain amunt f weight after 16 weeks f treatment. Swallw CONTRAVE tablets whle. D nt cut, chew, r crush CONTRAVE tablets. Tell yur healthcare prvider if yu cannt swallw CONTRAVE tablets whle. D nt take mre than 2 tablets in the mrning and 2 tablets in the evening. D nt take mre than 2 tablets at the same time r mre than 4 tablets in 1 day. D nt take CONTRAVE with high-fat meals. It may increase yur risk f seizures. If yu miss a dse f CONTRAVE, wait until yur next regular time t take it. D nt take mre than 1 dse f CONTRAVE at a time. If yu take t much CONTRAVE, call yur healthcare prvider r g t the nearest emergency rm right away. What shuld I avid while taking CONTRAVE? D nt drink a lt f alchl while taking CONTRAVE. If yu drink a lt f alchl, talk with yur healthcare prvider befre suddenly stpping. If yu suddenly stp drinking alchl, yu may increase yur chance f having a seizure. What are the pssible side effects f CONTRAVE? CONTRAVE may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut CONTRAVE? Seizures. There is a risk f having a seizure when yu take CONTRAVE. The risk f seizure is higher in peple wh: take higher dses f CONTRAVE have certain medical cnditins

5 take CONTRAVE with certain ther medicines Page 5 f 8 D nt take any ther medicines while yu are taking CONTRAVE unless yur healthcare prvider has said it is kay t take them. If yu have a seizure while taking CONTRAVE, stp taking CONTRAVE and call yur healthcare prvider right away. Yu shuld nt take CONTRAVE again if yu have a seizure. Risk f piid verdse. One f the ingredients in CONTRAVE (naltrexne) can increase yur chance f having an piid verdse if yu take piid medicines while taking CONTRAVE. Yu can accidentally verdse in 2 ways: Naltrexne blcks the effects f piids, such as herin, methadne r piid pain medicines. D nt take large amunts f piids, including piid-cntaining medicines, such as herin r prescriptin pain pills, t try t vercme the piidblcking effects f naltrexne. This can lead t serius injury, cma, r death. After yu take naltrexne, its blcking effect slwly decreases and cmpletely ges away ver time. If yu have used piid street drugs r piid-cntaining medicines in the past, using piids in amunts that yu used befre treatment with naltrexne can lead t verdse and death. Yu may als be mre sensitive t the effects f lwer amunts f piids: after yu have gne thrugh detxificatin when yur next dse f CONTRAVE is due if yu miss a dse f CONTRAVE after yu stp CONTRAVE treatment It is imprtant that yu tell yur family and the peple clsest t yu f this increased sensitivity t piids and the risk f verdse. Yu r smene clse t yu shuld get emergency medical help right away if yu: have truble breathing becme very drwsy with slwed breathing have slw, shallw breathing (little chest mvement with breathing) feel faint, very dizzy, cnfused, r have unusual symptms Sudden piid withdrawal. Peple wh take CONTRAVE must nt use any type f piid (must be piid-free) including street drugs, prescriptin pain medicines (including tramadl), cugh, cld, r diarrhea medicines that cntain piids, r piid dependence treatments, buprenrphine r methadne, fr at least 7 t 10 days befre starting CONTRAVE. Using piids in the 7 t 10 days befre yu start taking CONTRAVE may cause yu t suddenly have symptms f piid withdrawal when yu take it. Sudden piid withdrawal can be severe, and yu may need t g t the

6 hspital. Tell yur healthcare prvider yu are taking CONTRAVE befre a medical prcedure r surgery. Page 6 f 8 Severe allergic reactins. Sme peple have had a severe allergic reactin t buprpin, ne f the ingredients in CONTRAVE. Stp taking CONTRAVE and call yur healthcare prvider r g t the nearest hspital emergency rm right away if yu have any f the fllwing signs and symptms f an allergic reactin: rash painful sres in yur muth r arund itching yur eyes hives swelling f yur lips r tngue fever chest pain swllen lymph glands truble breathing Increases in bld pressure r heart rate. Sme peple may get high bld pressure r have a higher heart rate when taking CONTRAVE. Yur healthcare prvider shuld check yur bld pressure and heart rate befre yu start taking, and while yu take CONTRAVE. Liver damage r hepatitis. One f the ingredients in CONTRAVE, naltrexne can cause liver damage r hepatitis. Stp taking CONTRAVE and tell yur healthcare prvider if yu have any f the fllwing symptms f liver prblems: stmach area pain lasting mre than a few days dark urine yellwing f the whites f yur eyes tiredness Yur healthcare prvider may need t stp treating yu with CONTRAVE if yu get signs r symptms f a serius liver prblem. Manic episdes. One f the ingredients in CONTRAVE, buprpin can cause sme peple wh were manic r depressed in the past t becme manic r depressed again. Visual prblems (angle-clsure glaucma). One f the ingredients in CONTRAVE, buprpin, can cause sme peple t have visual prblems (angle-clsure glaucma). Signs and symptms f angle-clsure glaucma may include: eye pain changes in visin swelling r redness in r arund the eye Talk with yur healthcare prvider t find ut if yu are at risk fr angle-clsure glaucma and t get treatment t prevent it if yu are at risk. Increased risk f lw bld sugar (hypglycemia) in peple with type 2 diabetes mellitus wh als take medicines t treat their diabetes. Weight lss can cause lw bld sugar in peple with type 2 diabetes mellitus wh als take medicines used t treat type 2 diabetes mellitus (such as insulin r sulfnylureas). Yu shuld check yur bld sugar befre yu start taking CONTRAVE and while yu take CONTRAVE.

7 The mst cmmn side effects f CONTRAVE include: Page 7 f 8 nausea dizziness cnstipatin truble sleeping headache dry muth vmiting diarrhea Tell yur healthcare prvider abut any side effect that bthers yu r des nt g away. These are nt all the pssible side effects f CONTRAVE. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre CONTRAVE? Stre CONTRAVE at rm temperature between 59 F t 86 F (15 C t 30 0 C). Keep CONTRAVE and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f CONTRAVE. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use CONTRAVE fr a cnditin fr which it was nt prescribed. D nt give CONTRAVE t ther peple, even if they have the same symptms r cnditin that yu have. It may harm them. If yu take a urine drug screening test, CONTRAVE may make the test result psitive fr amphetamines. If yu tell the persn giving yu the drug screening test that yu are taking CONTRAVE, they can d a mre specific drug screening test that shuld nt have this prblem. This Medicatin Guide summarizes the mst imprtant infrmatin abut CONTRAVE. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut CONTRAVE that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in CONTRAVE? Active ingredients: naltrexne hydrchlride and buprpin hydrchlride Inactive ingredients: micrcrystalline cellulse, hydrxyprpyl cellulse, lactse anhydrus, L-cysteine hydrchlride, crspvidne, magnesium stearate, hyprmellse, edetate disdium, lactse mnhydrate, cllidal silicn dixide, Opadry II Blue and FD&C Blue #2 aluminum lake This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin.

8 Page 8 f 8 Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL Manufactured fr: Orexigen Therapeutics, Inc. La Jlla, CA CONTRAVE is a trademark f Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. All ther trademarks are the prperty f their respective wners Takeda Pharmaceuticals America, Inc. Apprved: 2014