BUPRENORPHINE NALOXONE BNM - PDF document

BUPRENORPHINE NALOXONE BNM BUPRENORPHINE NALOXONE BNM Sublingual Tablets Buprenorphine Hydrochloride Naloxone Hydrochloride Consumer Medicine Information What is in this leaflet Please read this leaflet carefully before you are givenBUPRENORPHINE NALOXONE BNM. This leaflet answers some common questions about BUPRENORPHINE NALOXONE BNM. It does not contain all the Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking BUPRENORPHINE NALOXONE BNMagainst the benefits may gain and he/shebelieves it will help in yourtreatmentIf you have any concerns about What BUPRENORPHINE NALOXONE BNM is used for BUPRENORPHINE NALOXONE BNMis used aspart of a medical, socialand psychologicaltreatment program forpatients’ dependent onopioids like heroin,morphine,oxycodone orcodeine. Before you take BUPRENORPHINE NALOXONE BNM BUPRENORPHINE NALOXONE BNMis not suitablefor everyoneWhen you must not take it Do not take BUPRENORPHINE NALOXONE BNM: BUPRENORPHINE NALOXONE BNM Do not take BUPRENORPHINE NALOXONE BNM after the expiry date printed on the pack.If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking this medicine, talk to your doctor. Before you start to take BUPRENORPHINE NALOXONE BNM Tell your doctor if you haveany of the following beforetreatment, or develop themduring treatment, as doctor may need to adjustyour dose of BUPRENORPHINE NALOXONE BNMarepregnantif you are breastfeedingasthma or other breathing problemsthyroid problemsprostate problemsproblems withexcessalcohol useproblems withdrowsinessAdrenal gland problems(e.g. Addison's disease)Kyphoscoliosis(hunchback disease)low blood pressureurination problemskidney problemsliver problemsif you have head injuries or in a condition where you haveincreased pressurewithin your headif you have problems related to the biliary tractstomach (abdominalpains)if you have severemental problems orhallucinations(seeingor hearing things thatarenot really there)if you have a history ofseizuresSome people have diedfromrespiratory failure(inability tobreathe) whenusing benzodiazepines(medicines used to treatanxiety or sleepingproblems) at the same timeas buprenorphine naloxone tablets.While you are being treated with BUPRENORPHINE NALOXONE BNM, do not use benzodiazepines unless they have been prescribed by your doctor.BUPRENORPHINE NALOXONE BNMmay causefatal respiratory failure ifchildren accidently ingest it.Keep this medicine out of reach and sight of children. As BUPRENORPHINE ALOXONE BNM containsaloxone, it is highly likelyto produce strong opioidwithdrawal symptoms ifmi

sused as an injectionwhile you are stillexperiencing the effects ofother opioids.When taken sublinguallyBUPRENORPHINE NALOXONE BNMcan causewithdrawalsymptoms if youtake it less than six hoursafter you use a short actingopioid (such as morphine orheroin) or less than 24hours after a long actingopioid (such asmethadone).BUPRENORPHINE NALOXONE BNMcan causedrug dependence. Thismeans that you can getwithdrawal symptoms if youstop using the medicine tooquickly. Withdrawalsymptoms may be delayedin some cases.BUPRENORPHINE NALOXONE BNMis notintended for occasional useand should be taken onlyas prescribed.BUPRENORPHINE NALOXONE BNMmay causedrowsiness, which may bemade worse if you alsodrink alcohol or takesedatives or antinxietymedicines. If you aredrowsy, do not drive oroperate machinery. BUPRENORPHINE NALOXONE BNMmay causeyour blood pressure to dropsuddenly, causing you tofeel dizzy if you get up tooquickly from sitting or lyingdown.Athletes should be awarethat thismedicine maycause a positive reaction to“antidoping” tests.The safety andeffectiveness inpatientsover 65 years of age havenot been established.Your doctor may ask you tohave additional blood teststo see if this medication isright for you.If you have not told your doctor about any of the above, tell him/her before you start taking BUPRENORPHINE NALOXONE BNM.Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop, before you begin treatment with BUPRENORPHINE ALOXONE BNMSome medicines and BUPRENORPHINE NALOXONE BNMmay interfere with each other. These include: certain medicines fortreating HIV/AIDSmedicines certain medicines fortreatingfungal andbacterial infectionsstrong pain killerscough medicines containing opioid related substancecertain antidepressantsincluding monoamineoxidase inhibitorscertain medicines usedto treat fits or epilepsy(anticonvulsants)sedating antihistaminessedativesantianxiety medicinescertain medicines forhigh blood pressuremedicines used to treatalcohol dependenceantipsychoticmedicinesnaltrexone.Tell your doctor if you arescheduled to have surgeryusing a generalanaesthetic. BUPRENORPHINE NALOXONE BNM Do not drink alcohol or take medicines that contain alcohol while you are being treated with BUPRENORPHINE NALOXONE BNM.Alcohol and certain othermedicines (as listed above)may increase thesedativeeffects of buprenorphine,which can make driving andoperating machineryhazardous.Some people have diedwhen using sedatives(benzodiazepines) or otherdepressants or alcohol orother opioids at the sametime asBUPRENORPHINE NALOXONE BNM. Youshould not usebenzodiazepines(medicines used to

treatanxiety or sleepingproblems) whilst you aretakingBUPRENORPHINE NALOXONE BNM unlessthey are prescribed bydoctor. How to take BUPRENORPHINE NALOXONE BNM Do not take BUPRENORPHINE NALOXONE BNM to treat any condition other than the one prescribed for by your doctor. Do not give BUPRENORPHINE NALOXONE BNM to anyone else, even if their symptoms seem the same as yours. It may harm them. The tablets are takensublingually. This meansthat you place the tabletunder your tongue andallow it to dissolve, whichmay take 2 to 10 minutes.This is the only way thetablets should be taken.Do not swallow or consumefood or drink until the tabletis completely dissolved Youmay take the tablets all atonce or in two lots, thesecond after the first lot hasdissolved. Do not split orbreak the tablets.The tablets will not work if you chew or swallow them whole. Do not inject BUPRENORPHINE NALOXONE BNM; patients have died from injecting buprenorphine and naloxone. Additionally, when injecting buprenorphine and naloxone and also taking benzodiazepines (medicines used to treat anxiety or sleeping problems), people were even more likely to die. How much to take BUPRENORPHINE NALOXONE BNM is only for adults and children over the age of 16 years. Your doctor will tell you how much BUPRENORPHINE NALOXONE BNM to take and you should always follow medical advice.Each BUPRENORPHINE ALOXONE BNMsublingual tablet containsbuprenorphine andnaloxone. BUPRENORPHINE ALOXONE BNMcontaining 2mgbuprenorphine and 0.5mgnaloxoneis referred to asthe ‘2mg’ tablets andBUPRENORPHINE NALOXONE BNMcontaining8mgbuprenorphine and2mg naloxone is referred tothe ‘8mg’ tablets.On the first day, the usualstarting dose is 4BUPRENORPHINEALOXONE BNMwithadditionaldependingneeds,determined by yourtreating doctor.For patients who arestill usingshort actingopioids such as heroin,morphine, oxycodone orcodeine: when startingtreatment, the dose ofBUPRENORPHINEALOXONE BNMshould be taken when the first signs of craving appearor at least 6 hours afteryour last use of opioidwhen the first signs ofcravingappear.For atients receivingmethadone:eforebeginning treatmentwith BUPRENORPHINE ALOXONE BNM, yourdoctor will probablyreduce your dose ofmethadone to the minimum methadone daily dose that youcan tolerate.The first dose ofBUPRENORPHINE ALOXONE BNMshouldpreferably be takenwhen the first signs ofcraving appear and atleast 24 hours afteryour last dose ofmethadone.BUPRENORPHINE NALOXONE BNMmay causewithdrawalsymptoms iftaken too soon aftermethadone or an illicitopioid.During your treatment, yourdoctor may increase yourdose ofBUPRENORPHINE NALOXONE BNMto amaximum daily dose of32mg, depending uponyour response to treatment.After a period of successfultreatm

ent, your doctor maygradually reduce your dose.Depending on yourcondition, your dose maycontinue to be reducedunder careful medicalsupervision, until it isstopped altogether.Do not suddenly stop taking tablets, as this may cause withdrawal ymptoms. If you forget to take it If you forget to take a dose of BUPRENORPHINE NALOXONE BNM, take it as soon as you remember. If you are unsure consult your doctor. In an emergencyHave family members orfriends tell hospital orambulance staff that youare dependent on opioids(narcotics) and are beingtreated withBUPRENORPHINE NALOXONE BNMIf you take too much (overdose) If you think that you oranyone else may havetaken too muchBUPRENORPHINE NALOXONE BNM, immediatelytelephone your doctor orNational Poison Centre telephone 0800 POISON or0800 764 766), or go toAccident and Emergency atyournearest hospital.this even if there are nosigns of discomfort orisoning. BUPRENORPHINE NALOXONE BNM You may need urgent medical attention. Keep telephone numbersfor these places handy.If you take too muchBUPRENORPHINE NALOXONE BNM, some of thesymptoms which may ormay not occur are listed inthe side effects sectionof this leaflet. Side effects Like all medicines,BUPRENORPHINEALOXONE BNMmay haveunwanted sideeffectswhich may need medicaltreatment.Ask your doctor or pharmacist to answer any questions you may have. Do not be alarmed by the following lists of side effects. You may not experience any of them.Very common side effects reported with the use of BUPRENORPHINE ALOXONE BNMwere:difficulty sleepingheadacheconstipationnauseasweatingMany of the common sideeffects reported with theuse of BUPRENORPHINEALOXONE BNMwererelated to opioid withdrawalsymptoms, such as:anxiety, nervousnessdepression, lossappetite, abnormalthinking,losslibido,drowsiness,dizzinessmalaise, fatigue,pain in the abdomen,back, joints andmuscles, leg cramps,muscle weakness,flu like symptoms, such as chills, fever, sore throat, coughing, runny nose, watery eyessorethroatandsweating,upset stomach anddiarrhoeapinsandneedlesvomiting, diarrhea,wind,indigestionrash anditchingdifficultyurinating,impotencechestpainOther side effects whichhave occurred are:migraine,abnormal vision,tremorreduced sex drive,chest, back, stomach,muscle, joint pain,vomiting, decreasedweight,hives,flushing, swelling of thelegs and arms,cough, respiratoryinfectionurinarytrackinfection,vaginal infectionanaemiaeyeinfectionpalpitationasthmablood in vomitjaundiceswollen jointsthoughtssuicideIf you think you areexperiencing any of theabove side effects, or anyother side effects, youshould tell yourdoctorimmediately. If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need ur

gent medical attention.There have been rarecases oflifethreateningseverehypersensitivityreactions withsymptoms of severedifficulty inbreathing,swelling, of theface,lips, mouth or throat.Some serious cases ofsevere liver problemshave occurred duringtreatment. If youdevelop severe fatigue,have no appetite or ifyour skin or eyes lookyellow,you have lightcoloured bowel motionsor dark coloured urine,tell your doctorimmediatelyOther side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. After using BUPRENORPHINE NALOXONE BNM If you stop takingBUPRENORPHINE ALOXONE BNMand starttaking heroin again, you areat risk of being moresensitive to opioids, whichcould be dangerous. Youshould talk to your doctor ifyou start taking heroinagain. Storage BUPRENORPHINE NALOXONEBNMis packed inAluAlu blistersBUPRENORPHINE NALOXONE BNMcontains anarcotic that can be a targetfor people who abuseprescription medicines orstreetdrugs. Therefore,keep your tablets in a safeplace to protect them fromtheft. Keep out of reach andsight of children. Never givethem to anyone else.The tablets should bestored below C in theoriginal package.BUPRENORPHINE NALOXONE BNMshould beprotected frommoistureand prolonged exposure tolight. As with all medicines,keep out of the reach children. Do not useBUPRENORPHINE ALOXONE BNMafter theexpiry date that isstampedon the pack.Disposal If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your BUPRENORPHINE NALOXONE BNM pharmacist what to do with any medicine that is left over. Product description What BUPRENORPHINE NALOXONE BNM looks likeBUPRENORPHINE NALOXONE BNM is available in blister packs of 28 tablets. BUPRENORPHINE NALOXONE BNM/0.5mg arehite to offwhite, round and biconvex tablets, with embossing “L”on one sideanda diameter of about 6.5 mm.BUPRENORPHINE NALOXONE BNM8mg2mg arehite to offwhite, round and biconvex tablets, with embossing “H”on one side anda diameter of about .5 mmIngredients Each BUPRENORPHINE ALOXONE BNM/0.5mg sublingual tablet contains2mg buprenorphine(as hydrochloride) and0.5mgnaloxone (as hydrochloridedihydrate) asactiveingredients. EachBUPRENORPHINE ALOXONE BNMsublingualtablet contains 8mgbuprenorphine (as hydrochloride) and2mgnaloxone (as hydrochloridedihydrate) as activeingredients.BUPRENORPHINENALOXONE BNMtablets also contain the following inactive ingredients:Lactose monohydratemannitolmaize starchpovidonecitric acid monohydratesodium citratemagnesium stearateacesulfame potassium a lemon flavour lime flavou ponsor details BNM Group39 Anzac RoadBrowns BayAuckland 0753Phone 0800 565 633This leaflet was prepared 7 January 2020