Call a healthcare provider right away if you have any of the following s ymptoms, es pecially if they are new, wors e, or worry you:

Transcription

1 MEDICATION GUIDE EMSAM [EM sam] (selegiline transdermal system) Read this Medicatin Guide carefully befre yu start using EMSAM 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 cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut EMSAM? Antidepres s ant medicines may increas e s uicidal thughts r actins in s me 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 a particularly high ris k f having s uicidal thughts r actins. Thes e include peple wh have r have a family his try f biplar illness (als called manic-depressive illness) r suicidal thughts r actins. Hw can I watch fr and try t prevent s uicidal thughts and actins? Pay clse attentin t any changes, especially sudden changes in md, behavir, 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 yur 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 have any f the fllwing s ymptms, es pecially if they are new, wrs e, r wrry yu: thughts abut suicide r dying attempts t cmmit suicide new r wrse depressin new r wrse anxiety feeling agitated, restless, angry r irritable panic attacks truble sleeping new r wrse irritability acting aggressive, being angry r vilent acting n dangerus impulses an extreme increase in activity r talking (mania) ther unusual changes in behavir r md 3. EMSAM is nt fr children les s than 12 years f age. EMSAM may caus e a s evere increas e in bld pressure in children less than 12 years f age. What is EMSAM? EMSAM is a prescriptin medicine used t treat a certain type f depressin called Majr Depressive Disrder (MDD). EMSAM belngs t the class f medicines knwn as mnamine xidase inhibitrs

2 (MAOI). EMSAM is a patch yu apply t yur skin. It is imprtant t talk with yur healthcare prvider abut the risks f treating depressin and als the risk f nt treating it. Yu shuld discuss all treatment chices with yur healthcare prvider. Talk t yur healthcare prvider if yu d nt think that yur cnditin is getting better with EMSAM treatment. It is nt knwn if EMSAM is effective in children 12 t 17 years f age. Wh shuld nt use EMSAM? Using EMSAM with certain antidepressants and certain pain, cld and cugh symptm medicines may caus e a ptentially life-threatening prblem called s ertnin s yndrme (See What are the pssible side effects f EMSAM? ). D nt use EMSAM if yu: take certain medicines including: selective sertnin reuptake inhibitrs (SSRIs) such as fluxetine, sertraline, r parxetine sertnin and nrepinephrine reuptake inhibitrs (SNRI) such as venlafaxine r dulxetine clmipramine r imipramine (tricyclic antidepressants) meperidine, tramadl, methadne, pentazcine, prpxyphene (piid medicines) dextrmethrphan carbamazepine are less than 12 years f age have a tumr n yur adrenal gland called a phechrmcytma Ask yur healthcare prvider r pharmacist if yu are nt sure if yu take these medicines. What s huld I tell my healthcare prvider befre us ing EMSAM? Tell yur healthcare prvider if yu: have high bld pressure have mania r biplar disrder (manic depressin) have r had seizures r cnvulsins drink alchl have any ther medical cnditins are pregnant r plan t becme pregnant. It is nt knwn if EMSAM will harm yur unbrn baby. are breastfeeding r plan t breastfeed. It is nt knwn if EMSAM passes int yur breast milk. Talk t yur healthcare prvider abut the best way t feed yur baby if yu use EMSAM. Tell yur dctr abut all the medicines yu take including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. EMSAM and sme medicines may interact with each ther, may nt wrk as well, r may cause serius side effects when taken tgether. Es pecially tell yur healthcare prvider if yu take: ther medicines t treat depressin (antidepressants) including ther MAOI medicines decngestant medicines t treat cld r cugh symptms ver-the-cunter diet pills r herbal weight-lss prducts any herbal r dietary supplement that cntains tyramine

3 medicines called stimulants r uppers (amphetamines) buspirne, an anxiety medicine Sme f these medicines need t be stpped fr at least ne week befre yu can start using EMSAM and fr 2 weeks after yu s tp us ing EMSAM. Ask yur healthcare prvider r pharmacist if yu are nt sure if yu take these medicines. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider r pharmacist when yu get a new medicine. Hw shuld I use EMSAM? Read the Ins tructins fr Us e at the end f this Medicatin Guide fr infrmatin abut the right way t use EMSAM. Use EMSAM exactly as yur healthcare prvider tells yu t use it. Use nly ne patch at a time. Apply yur patch right after yu pen the sealed puch. Change yur patch ne time each day at the same time each day. Chse a time f day that wrks best fr yu. Yur healthcare prvider may need t change yur dse f EMSAM until it is the right dse fr yu. If yu use t much EMSAM (verdse) yu may have the fllwing symptms: drwsiness dizziness fainting irritable hyperactive agitated severe headache seeing things that are nt there stiff jaw yur head, neck and spine arch backwards seizures cma fast r irregular pulse high bld pressure lw bld pressure bld circulatin prblem chest pain truble breathing high fever sweating cl, clammy skin If yu have any f these symptms f EMSAM verdsage, remve yur patch right away and call yur healthcare prvider r g t the nearest hspital emergency rm right away. It may take up t 12 hurs befre yu have these symptms, and they may be wrse 24 t 48 hurs after yu apply yur EMSAM patch. What shuld I avid while using EMSAM? Avid expsing the EMSAM applicatin site t external surces f direct heat, such as heating pads r electric blankets, heat lamps, saunas, ht tubs, heated water beds, and prlnged direct sunlight. D nt eat fds r drink beverages that cntain high amunts f tyramine while using EMSAM 9 mg r EMSAM 12 mg r fr 2 weeks after yu stp using EMSAM 9 mg r EMSAM 12 mg. Yu d nt have t make any diet changes when yu use EMSAM 6 mg.

4 The table belw lists fds and drinks yu shuld avid while yu use EMSAM 9 mg and EMSAM 12 mg. Type f Fd and Drink Meat, Pultry, and Fish Fds and drinks yu shuld avid that cntain Tyramine air dried, aged and fermented meats, sausages and salamis pickled herring any spiled r imprperly stred meat, pultry, and fish. These are fds that have a change in clr, dr, r becme mldy. spiled r imprperly stred animal livers Vegetables brad bean pds (fava bean pds) Dairy (milk prducts) aged cheeses Drinks all tap beers and ther beers that have nt been pasteurized Other cncentrated yeast extract (such as Marmite) sauerkraut mst sybean prducts (including sy sauce and tfu) ver-the-cunter supplements cntaining tyramine All fds yu eat must be fresh r prperly frzen. Avid fds when yu d nt knw hw thse fds shuld be stred. Ask yur healthcare prvider if yu are nt sure if certain fds and drinks cntain tyramine. D nt drive, perate heavy machinery r d ther dangerus activities until yu knw hw EMSAM affects yu. Yu shuld nt drink alchl while using EMSAM. What are the pssible side effects f EMSAM? EMSAM may caus e s erius s ide effects, including: See What is the mst imprtant infrmatin I shuld knw abut EMSAM? s ertnin s yndrme. A ptentially life-threatening prblem called sertnin syndrme can happen when yu use EMSAM while yu take certain medicines called MAOIs. Symptms f sertnin syndrme include: agitatin fever

5 seeing things that are nt there (hallucinatins) seizures cnfusin tremrs cma stiff muscles rapid pulse muscle twitching lw bld pressure becme unstable dizziness nausea sweating vmiting flushing diarrhea If yu suddenly have these symptms, g t the nearest hspital emergency rm right away. a sudden, severe increase in bld pressure (hypertensive crisis). A hypertensive crisis can happen when yu eat certain fds and drink certain beverages while yu use EMSAM. A hypertensive crisis can lead t strke and death. See What s huld I avid while us ing EMSAM? A hypertensive crisis can als happen if yu use EMSAM with certain ther medicines. See Wh shuld nt use EMSAM? Symptms f a hypertensive crisis include: sudden, severe headache nausea vmiting stiff r sre neck a fast heartbeat (palpitatins) r a change in the way yur heart beats excessive sweating, smetimes with fever r cld, clammy skin the pupils in yur eyes increase in size light bthers yur eyes fast r slw heart beat with chest pain bleeding in yur brain If yu suddenly have these symptms, g t the nearest hspital emergency rm right away. mania r hypmania (manic episdes) in peple wh have a histry f mania. Symptms f manic episdes include:

6 greatly increased energy severe prblems sleeping racing thughts reckless behavir unusually grand ideas excessive happiness r irritability talking mre r faster than usual Cmmn side effects in peple wh use EMSAM include: a skin reactin where the patch is placed. Yu may see mild redness at the site when a patch is remved. This redness shuld g away within several hurs after remving the patch. If irritatin r itching cntinues, tell yur healthcare prvider. headache diarrhea indigestin truble sleeping (insmnia) dry muth rash sre thrat sinus infectin Tell yur healthcare prvider if yu have any side effect that bthers yu r des nt g away. These are nt all the side effects f EMSAM. 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 d I stre EMSAM? Stre EMSAM at rm temperature between 68 F t 77 F (20 C t 25 C). Stre EMSAM in the sealed puch it cmes in until yu are ready t use it. Keep EMSAM and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f EMSAM. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use EMSAM fr a cnditin fr which it was nt prescribed. D nt give EMSAM 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 EMSAM. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut EMSAM that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in EMSAM? Active Ingredient: selegiline Inactive Ingredients: acrylic adhesive, ethylene vinyl acetate, plyethylene, plyester, plyurethane, and silicne cated plyester

7 Ins tructins fr Us e EMSAM [EM sam] (selegiline transdermal system) Step 1. Where t apply EMSAM Place yur EMSAM patch n ne f the fllwing areas (sites) n yur bdy. See Figure A. Fig ure A Figure A D nt put the patch near yur waist. Clthing and mvement may make yur patch rub ff. Chse a new site each time yu change yur patch. D nt use the same site 2 days in a rw. Step 2. Befre yu apply EMSAM Make sure the area n yur skin where yu apply yur patch: is freshly washed with sap and warm water, then dried with a twel des nt have any pwder, il r ltin des nt have any cuts r irritatin, including rashes, swelling, redness, r ther skin prblems is nt hairy, scared r callused Step 3. Hw t apply EMSAM Remve EMSAM frm its sealed puch by tearing at the ntches (d nt used scissrs). Pull the puch pen. See Figure B.

8 Fig ure B Lk at the patch t make sure it is nt damaged. The patch shuld separate easily frm the prtective liner. Thrw away the patch if the prtective liner is hard t remve. D nt keep r stre yur EMSAM utside f the sealed puch. D nt cut yur EMSAM int smaller pieces. The EMSAM patch has three layers. See Figures C and D. Fig ure C Fig ure D Layers: Prtective liner: The prtective liner is the layer that yu remve befre yu put the patch n. See Figure C. Adhes ive with medicine: The adhesive with medicine is the layer that sticks t yur skin. See Figure C. Outs ide backing: The utside backing is the layer yu see after yu put the patch n yur skin. See Figure D. Apply the patch right away after yu remve the patch frm its s ealed puch. Hld the patch with the prtective liner facing yu. Gently peel half f the prtective liner ff the patch and thrw it away. See Figure E.

9 Fig ure E Figure E Avid tuching the sticky side f the patch with yur fingers. If yu accidently tuch the sticky side f the patch, wash yur hands right away s the medicine des nt g int the skin n yur hands. Using the ther half f the prtective liner as a handle, apply the sticky side f the patch t yur selected area. See Figure F. Fig ure F Hld an edge f the remaining half f the prtective liner and slwly peel it ff. See Figure G. Fig ure G After the prtective liner is remved, there shuld nt be any adhesive sticking t the liner. Using yur fingers and palm f yur hand, press the entire patch firmly int place against yur

10 skin. See Figure H. Fig ure H Figure H Make sure the patch firmly sticks t yur skin. Gently rub the edges f yur patch with yur fingers t make sure the patch sticks t yur skin. Wash yur hands well with sap and water after yu apply yur patch t remve any medicine. D nt tuch yur eyes until after yu have was hed yur hands. If the patch becmes lse, press it back in place. If yur EMSAM patch falls ff, apply a new EMSAM patch t a new site and fllw yur nrmal schedule fr changing patches. If yu frget t change yur patch after 24 hurs, remve the ld patch. Put n a new patch in a different area and cntinue t fllw yur nrmal schedule fr changing patches. Step 4. Remving and dis ps ing f yur patch After 24 hurs, remve yur patch slwly and carefully t avid damaging yur skin. If the patch is t sticky n yur skin and yu need smething t help yu remve it: Gently wash the area with warm water and mild sap. A small amunt f il-based prduct (petrleum jelly, live il, r mineral il) may be needed t help remve the patch. Gently apply and spread the il underneath the patch edges. Apply an il-based prduct r ltin t yur skin if any adhesive (glue) remains after yu remve yur patch. This will gently lsen and remve any adhesive that is left ver. If yu still cannt easily remve the patch, ask yur dctr r pharmacist abut what t d fr this prblem. Fld the used EMSAM patch in half and press it tgether firmly s that the sticky side sticks t itself. Safely thrw away the flded patch in a cntainer with a lid right away s that children and pets cannt reach it. Safely thrw away any unused EMSAM patches that are left ver frm the prescriptin as sn as they are n lnger needed. T safely thrw away the patches: Remve the leftver patches frm their prtective puches and remve the prtective liners. Fld the patches in half with the sticky sides tgether and thrw the patches away in a

11 Fld the patches in half with the sticky sides tgether and thrw the patches away in a cntainer with a lid. Wash yur hands with sap and water. This Medicatin Guide and Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin. DISTRIBUTED BY: Mylan Specialty L.P. Mrgantwn, WV U.S.A. MANUFACTURED FOR: Smerset Pharmaceuticals, Inc. Mrgantwn, WV U.S.A. REVISED MARCH 2015 EMSAM:PIR13