Patient Information MAXALT (max-awlt) and MAXALT-MLT rizatriptan benzoate Tablets and Orally Disintegrating Tablets

Transcription

1 Patient Infrmatin MAXALT (max-awlt) and MAXALT-MLT rizatriptan benzate Tablets and Orally Disintegrating Tablets Read this Patient Infrmatin befre yu start taking MAXALT and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur dctr abut yur medical cnditin r yur treatment. Unless therwise stated, the infrmatin in this Patient Infrmatin leaflet applies t bth MAXALT Tablets and t MAXALT-MLT Orally Disintegrating Tablets. What is MAXALT? MAXALT is a prescriptin medicine that belngs t a class f medicines called Triptans. MAXALT is available as a traditinal tablet (MAXALT) and as an rally disintegrating tablet (MAXALT-MLT). MAXALT and MAXALT-MLT are used t treat migraine attacks with r withut aura in adults and in children 6 t 17 years f age. MAXALT is nt t be used t prevent migraine attacks. MAXALT is nt fr the treatment f hemiplegic r basilar migraines. It is nt knwn if MAXALT is safe and effective fr the treatment f cluster headaches. It is nt knwn if taking mre than 1 dse f MAXALT in 24 hurs is safe and effective in children 6 t 17 years f age. It is nt knwn if MAXALT is safe and effective in children under 6 years f age. Wh shuld nt take MAXALT? D nt take MAXALT if yu: have r have had heart prblems have r have had a strke r a transient ischemic attack (TIA) have r have had bld vessel prblems including ischemic bwel disease have uncntrlled high bld pressure have taken ther Triptan medicines in the last 24 hurs have taken ergt-cntaining medicines in the last 24 hurs have hemiplegic r basilar migraines take mnamine xidase (MAO) inhibitr r have taken a MAO inhibitr within the last 2 weeks are allergic t rizatriptan benzate r any f the ingredients in MAXALT. See the end f this leaflet fr a cmplete list f ingredients in MAXALT. Talk t yur dctr befre taking this medicine if yu have any f the cnditins listed abve r if yu are nt sure if yu take any f these medicines. What shuld I tell my dctr befre taking MAXALT? Befre yu take MAXALT, tell yur dctr if yu: have r have had heart prblems, high bld pressure, chest pain, r shrtness f breath 1

2 have any risk factrs fr heart prblems r bld vessel prblems such as: high bld pressure high chlesterl smking besity diabetes family histry f heart prblems yu are pst menpausal yu are a male ver 40 have phenylketnuria (PKU). MAXALT-MLT rally disintegrating tablets cntain phenylalanine. have kidney r liver prblems have any ther medical cnditin are pregnant r plan t becme pregnant. It is nt knwn if MAXALT will harm yur unbrn baby. If yu becme pregnant while taking MAXALT, talk t yur healthcare prvider abut registering with the pregnancy registry at the Merck Natinal Service Center. Yu can enrll in this registry by calling The purpse f this registry is t cllect infrmatin abut the safety f MAXALT in pregnancy. are breastfeeding r plan t breastfeed. It is nt knwn if MAXALT passes int yur breast milk. Talk t yur dctr abut the best way t feed yur baby if yu take MAXALT. Tell yur dctr abut all the medicines yu take, including prescriptin and nnprescriptin medicines, vitamins, and herbal supplements. MAXALT and ther medicines may affect each ther causing side effects. MAXALT may affect the way ther medicines wrk, and ther medicines may affect hw MAXALT wrks. Especially tell yur dctr if yu take: prpranll cntaining medicines such as Inderal, Inderal LA, r Innpran XL medicines used t treat md disrders, including selective sertnin reuptake inhibitrs (SSRIs) r sertnin nrepinephrine reuptake inhibitrs (SNRIs). Ask yur dctr r pharmacist fr a list f these medicines, if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur dctr and pharmacist when yu get a new medicine. Hw shuld I take MAXALT? Take MAXALT exactly as yur dctr tells yu t take it. Yur dctr will tell yu hw much MAXALT t take and when t take it. T take MAXALT-MLT: Leave MAXALT-MLT rally disintegrating tablets in the package it cmes in until yu are ready t take it. When yu are ready t take it: Remve the blister frm the fil puch. D nt push the MAXALT-MLT rally disintegrating tablet thrugh the blister. Peel pen the blister pack with dry hands and place the MAXALT-MLT rally disintegrating tablet n yur tngue. The tablet will disslve and be swallwed with yur saliva. N liquid is needed t take the rally disintegrating tablet. If yur headache cmes back after yur first MAXALT dse: Fr adults: a secnd dse may be taken 2 hurs after the first dse. D nt take mre than 30 mg f MAXALT in a 24-hur perid (fr example, d nt take mre than 3 10-mg tablets in a 24-hur perid). Fr children 6 t 17 years f age: It is nt knwn if taking mre than 1 dse f MAXALT in 24 hurs is safe and effective. Talk t yur dctr abut what t d if yur headache des nt g away r cmes back. 2

3 If yu take t much MAXALT, call yur dctr r g t the nearest hspital emergency rm right away. What shuld I avid while taking MAXALT? MAXALT may cause dizziness, weakness, r fainting. If yu have these symptms, d nt drive a car, use machinery, r d anything that needs yu t be alert. What are the pssible side effects f MAXALT? MAXALT may cause serius side effects. Call yur dctr r g t the nearest hspital emergency rm right away if yu think yu are having any f the serius side effects f MAXALT including: heart attack. Symptms f a heart attack may include: chest discmfrt in the center f yur chest that lasts fr mre than a few minutes r that ges away and cmes back chest discmfrt that feels like uncmfrtable pressure, squeezing, fullness r pain pain r discmfrt in yur arms, back, neck, jaw r stmach shrtness f breath with r withut chest discmfrt breaking ut in a cld sweat nausea r vmiting feeling lightheaded strke. Symptms f a strke may include the fllwing sudden symptms: numbness r weakness in yur face, arm r leg, especially n ne side f yur bdy cnfusin, prblems speaking r understanding prblems seeing in 1 r bth f yur eyes prblems walking, dizziness, lss f balance r crdinatin severe headache with n knwn cause bld vessel prblems. Symptms f bld vessel prblems may include: stmach pain bldy diarrhea visin prblems cldness and numbness f hands and feet sertnin syndrme. A cnditin called sertnin syndrme can happen when Triptan medicines such as MAXALT are taken with certain ther medicines. Symptms f sertnin syndrme may include: agitatin hallucinatins cma fast heartbeat fast changes in yur bld pressure increased bdy temperature muscle spasm lss f crdinatin nausea, vmiting r diarrhea increased bld pressure. 3

4 The mst cmmn side effects f MAXALT in adults include: feeling sleepy r tired pain r pressure in yur chest r thrat dizziness Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. If yu take MAXALT t ften, this may result in yu getting chrnic headaches. In such cases, yu shuld cntact yur dctr, as yu may have t stp taking MAXALT. These are nt all the pssible side effects f MAXALT. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre MAXALT? Stre MAXALT at rm temperature between 59 F t 86 F (15 C t 30 C). Safely thrw away medicine that is ut f date r n lnger needed. Keep MAXALT and all medicines ut f the reach f children. General Infrmatin abut the safe and effective use f MAXALT. Medicines are smetimes prescribed fr purpses ther than thse listed in a Patient Infrmatin leaflet. D nt use MAXALT fr a cnditin fr which it was nt prescribed. D nt give MAXALT t ther peple, even if they have the same symptms that yu have. It may harm them. This Patient Infrmatin leaflet summarizes the mst imprtant infrmatin abut MAXALT. If yu wuld like mre infrmatin, talk t yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut MAXALT that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in MAXALT? Active ingredient in MAXALT and MAXALT-MLT rally disintegrating tablets: rizatriptan benzate. Inactive ingredients in MAXALT: lactse mnhydrate, micrcrystalline cellulse, pregelatinized starch, ferric xide (red), and magnesium stearate. Inactive ingredients in MAXALT-MLT rally disintegrating tablets: gelatin, mannitl, glycine, aspartame, and peppermint flavr. MAXALT-MLT rally disintegrating tablets cntain aspartame, a surce f phenylalanine. Phenylketnurics: MAXALT-MLT rally disintegrating tablets 5-mg cntain 1.1 mg f phenylalanine. MAXALT-MLT rally disintegrating tablets 10-mg cntain 2.1 mg f phenylalanine. This Patient Infrmatin has been apprved by the U.S. Fd and Drug Administratin. 4

5 MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are distributed by: Fr patent infrmatin: The brands listed are the trademarks f their respective wners. Cpyright 1998, 2011 Merck Sharp & Dhme Crp., a subsidiary f Merck & C., Inc. All rights reserved. Revised: 03/2015 usppi-mk0462-t-tl-1503r012 5