/0515 Medication Guide Aripiprazole Tablets

Transcription

1 /0515 Medicatin Guide Aripiprazle Tablets (air-eh-pip-rah-zle) Read this Medicatin Guide befre yu start taking aripiprazle tablets and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r treatment. What is the mst imprtant infrmatin I shuld knw abut aripiprazle tablets? (Fr ther side effects, als see "What are the pssible side effects f aripiprazle tablets?"). Serius side effects may happen when yu take aripiprazle tablets, including: Increased risk f death in elderly patients with dementia-related psychsis: Medicines like aripiprazle tablets can raise the risk f death in elderly peple wh have lst tuch with reality (psychsis) due t cnfusin and memry lss (dementia). Aripiprazle tablets are nt apprved fr the treatment f patients with dementia-related psychsis. Risk f suicidal thughts r actins: Antidepressant medicines, depressin and ther serius mental illnesses, and suicidal thughts r actins: Antidepressant medicines may increase suicidal thughts r actins in sme children, teenagers, and yung adults within the first few mnths f treatment. Depressin and ther serius mental illnesses are the mst imprtant causes f suicidal thughts and actins. Sme peple may have particularly high risk f having suicidal thughts r actins. These include peple wh have (r have a family histry f) biplar illness (als called manic-depressive illness) r suicidal thughts r actins. Hw can I watch fr and try t prevent suicidal thughts and actins in myself r a family member? Pay clse attentin t any changes, especially sudden changes, in md, behavirs, thughts, r feelings. This is very imprtant when an antidepressant medicine is started r when the dse is changed. Call the healthcare prvider right away t reprt new r sudden changes in md, behavir, thughts, r feelings. Keep all fllw-up visits with the healthcare prvider as scheduled. Call the healthcare prvider between visits as needed, especially if yu have cncerns abut symptms. Call a healthcare prvider right away if yu r yur family member has 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

2 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 What else d I need t knw abut antidepressant medicines? Never stp an antidepressant medicine withut first talking t a healthcare prvider. Stpping an antidepressant medicine suddenly can cause ther symptms. Antidepressants are medicines used t treat depressin and ther illnesses. It is imprtant t discuss all the risks f treating depressin and als the risks f nt treating it. Patients and their families r ther caregivers shuld discuss all treatment chices with the healthcare prvider, nt just the use f antidepressants. Antidepressant medicines have ther side effects. Talk t the healthcare prvider abut the side effects f the medicine prescribed fr yu r yur family member. Antidepressant medicines can interact with ther medicines. Knw all f the medicines that yu r yur family member takes. Keep a list f all medicines t shw the healthcare prvider. D nt start new medicines withut first checking with yur healthcare prvider. Nt all antidepressant medicines prescribed fr children are FDA apprved fr use in children. Talk t yur child s healthcare prvider fr mre infrmatin. What are aripiprazle tablets? Aripiprazle tablets are prescriptin medicine used t treat: Schizphrenia manic r mixed episdes that happen with biplar I disrder It is nt knwn if aripiprazle tablets are safe r effective in children: under 13 years f age with schizphrenia under 10 years f age with biplar I disrder Wh shuld nt take Aripiprazle tablets? D nt take aripiprazle tablets if yu are allergic t aripiprazle r any f the ingredients in aripiprazle tablets. See the end f this Medicatin Guide fr a cmplete list f ingredients in aripiprazle tablets. What shuld I tell my healthcare prvider befre taking aripiprazle tablets? Befre taking aripiprazle tablets, tell yur healthcare prvider if yu have r had: diabetes r high bld sugar in yu r yur family; yur healthcare prvider shuld check yur bld sugar befre yu start aripiprazle tablets and als during therapy. seizures (cnvulsins). lw r high bld pressure. heart prblems r strke. pregnancy r plans t becme pregnant. It is nt knwn if aripiprazle tablets will harm yur unbrn baby. breast-feeding r plans t breast-feed. Aripiprazle can pass int yur breast milk and may harm yur baby. Talk t yur healthcare prvider abut the best way t feed yur baby if yu receive aripiprazle tablets. lw white bld cell cunt.

3 any ther medical cnditins. Tell yur healthcare prvider abut all the medicines that yu take, including prescriptin and ver-thecunter medicines, vitamins, and herbal supplements. Aripiprazle tablets and ther medicines may affect each ther causing pssible serius side effects. Aripiprazle tablets may affect the way ther medicines wrk, and ther medicines may affect hw aripiprazle tablets wrks. Yur healthcare prvider can tell yu if it is safe t take aripiprazle tablets with yur ther medicines. D nt start r stp any medicines while taking aripiprazle tablets withut talking t yur healthcare prvider first. Knw the medicines yu take. Keep a list f yur medicines t shw yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take aripiprazle tablets? Take aripiprazle tablets exactly as yur healthcare prvider tells yu t take it. D nt change the dse r stp taking aripiprazle tablets yurself. Aripiprazle tablets can be taken with r withut fd. Aripiprazle tablets shuld be swallwed whle. If yu miss a dse f aripiprazle tablets, take the missed dse as sn as yu remember. If it is almst time fr the next dse, just skip the missed dse and take yur next dse at the regular time. D nt take tw dses f aripiprazle tablets at the same time. If yu take t much aripiprazle tablets, call yur healthcare prvider r pisn cntrl center at right away, r g t the nearest hspital emergency rm. What shuld I avid while taking aripiprazle tablets? D nt drive, perate heavy machinery, r d ther dangerus activities until yu knw hw aripiprazle tablets affects yu. Aripiprazle tablets may make yu drwsy. Avid getting ver-heated r dehydrated. D nt ver-exercise. In ht weather, stay inside in a cl place if pssible. Stay ut f the sun. D nt wear t much r heavy clthing. Drink plenty f water. What are the pssible side effects f aripiprazle tablets? Aripiprazle tablets may cause serius side effects, including: See "What is the mst imprtant infrmatin I shuld knw abut aripiprazle tablets?" Strke in elderly peple (cerebrvascular prblems) that can lead t death Neurleptic malignant syndrme (NMS): Tell yur healthcare prvider right away if yu have sme r all f the fllwing symptms: high fever, stiff muscles, cnfusin, sweating, changes in pulse, heart rate, and bld pressure. These may be symptms f a rare and serius cnditin that can lead t death. Call yur healthcare prvider right away if yu have any f these symptms. Uncntrlled bdy mvements (tardive dyskinesia). Aripiprazle tablets may cause mvements that yu cannt cntrl in yur face, tngue, r ther bdy parts. Tardive dyskinesia may nt g away, even if yu stp receiving aripiprazle tablets. Tardive dyskinesia may als start after yu stp receiving aripiprazle tablets. Prblems with yur metablism such as:

4 high bld sugar (hyperglycemia) and diabetes: Increases in bld sugar can happen in sme peple wh take aripiprazle tablets. Extremely high bld sugar can lead t cma r death. If yu have diabetes r risk factrs fr diabetes (such as being verweight r a family histry f diabetes), yur healthcare prvider shuld check yur bld sugar befre yu start aripiprazle tablets and during yur treatment. Call yur healthcare prvider if yu have any f these symptms f high bld sugar while taking aripiprazle tablets: feel very thirsty need t urinate mre than usual feel very hungry feel weak r tired feel sick t yur stmach feel cnfused, r yur breath smells fruity. increased fat levels (chlesterl and triglycerides) in yur bld. weight gain. Yu and yur healthcare prvider shuld check yur weight regularly. Orthstatic hyptensin (decreased bld pressure): Lightheadedness r fainting may happen when rising t quickly frm a sitting r lying psitin. Lw white bld cell cunt Seizures (cnvulsins) prblems with cntrl f yur bdy temperature especially when yu exercise a lt r are in an area that is very ht. It is imprtant fr yu t drink water t avid dehydratin. See "What shuld I avid while receiving aripiprazle tablets?" difficulty swallwing that can cause fd r liquid t get int yur lungs. The mst cmmn side effects with aripiprazle tablets in adults include: nausea dizziness vmiting anxiety cnstipatin insmnia headache restlessness blurred visin inner sense f restlessness/ upper respiratry illness need t mve (akathisia) The mst cmmn side effects with aripiprazle tablets in children include: feeling sleepy insmnia headache nausea vmiting stuffy nse fatigue weight gain increased r decreased uncntrlled mvement appetite such as restlessness, increased saliva r drling tremr, muscle stiffness These are nt all the pssible side effects f aripiprazle tablets. Fr mre infrmatin, ask yur healthcare prvider r pharmacist.

5 Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre aripiprazle tablets? Stre aripiprazle tablets at 20º t 25º C (68º t 77ºF) [see USP Cntrlled Rm Temperature]. Keep aripiprazle tablets and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f aripiprazle tablets Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use aripiprazle tablets fr a cnditin fr which it was nt prescribed. D nt give aripiprazle tablets t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut aripiprazle tablets. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut aripiprazle tablets that was written fr healthcare prfessinals. What are the ingredients in aripiprazle tablets? Active ingredient: aripiprazle USP Inactive ingredients: crn starch, FD&C Blue #2/Indig Carmine Al, ferric xide red, ferric xide yellw, hydrxyprpyl cellulse, lactse mnhydrate, magnesium stearate and micrcrystalline cellulse Additinal pediatric use infrmatin is apprved fr Otsuka America Pharmaceutical, Inc.'s ABILIFY (aripiprazle) prduct. Hwever, due t Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug prduct is nt labeled with that infrmatin. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. ABILIFY is a trademark f Otsuka Pharmaceutical Cmpany. Packaged and Distributed by: American Health Packaging Clumbus, OH /0515