MEDICATION GUIDE LAMOTRIGINE TABLETS USP Read this Medication Guide before you start taking H=IKPNECEJA P=>HAPO =J@ A=?D PEIA UKQ CAP = NAłHH 1DANAI=U>AJASEJBKNI=PEKJ1DEOEJBKNI=PEKJ@KAO not take the place of talking with your healthcare LNKRE@AN=>KQPUKQNIA@E?=H?KJ@EPEKJKNPNA=PIAJP&B you have questions about lamotrigine tablets, ask your DA=HPD?=NALNKRE@ANKNLD=NI=?EOP What is the most important information I should know about Lamotrigine tablets? 1. Lamotrigine tablets may cause a serious skin rash that may cause you to be hospitalized or to stop lamotrigine tablets; it may rarely cause death. There is no way to tell if a mild rash will develop into =IKNAOANEKQONA=?PEKJ1DAOAOANEKQOOGEJNA=?PEKJO are more likely to happen when you begin taking H=IKPNEPEJA P=>HAPO SEPDEJ PDA łNOP PK SAAGO KB PNA=PIAJP QPEP?=JD=LLAJEJLAKLHASDKD=RAP=GAJ H=IKPNECEJA P=>HAPO BKN =JU LANEK@ KB PEIA DEH@NAJ >APSAAJ PK UA=NO KB =CA D=RA = DECDAN ?D=J?A of getting this serious skin reaction while taking H=IKPNECEJAP=>HAPO The risk of getting a serious skin rash is higher if you: xtake lamotrigine tablets while taking valproate (valproic acid or divalproex sodium) xtake a higher starting dose of lamotrigine tablets than your healthcare provider prescribed xincrease your dose of lamotrigine tablets faster than LNAO?NE>A@ Lamotrigine tablets can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following: xa skin rash xhives xfever xswollen lymph glands xpainful sores in the mouth or around your eyes xswelling of your lips or tongue xyellowing of your skin or eyes xunusual bruising or bleeding xsevere fatigue or weakness xsevere muscle pain xfrequent infections 1DAOAOUILPKIOI=U>APDAłNOPOECJOKB=OANEKQO NA=?PEKJ DA=HPD?=NA LNKRE@AN ODKQH@ AT=IEJA UKQ to decide if you should continue taking lamotrigine P=>HAPO 2. Like other antiepileptic drugs, lamotrigine tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: xthoughts about suicide or dying xattempt to commit suicide xnew or worse depression xnew or worse anxiety xfeeling agitated or restless xpanic attacks xtrouble sleeping (insomnia) xnew or worse irritability xacting aggressive, being angry, or violent xacting on dangerous impulses xan extreme increase in activity and talking (mania) xother unusual changes in behavior or mood !KJKPOPKLH=IKPNECEJAP=>HAPOSEPDKQPłNOPP=HGEJC to a healthcare provider. xStopping lamotrigine tablets suddenly can cause OANEKQOLNK>HAIO xSuicidal thoughts or actions can be caused by things KPDANPD=JIA@E?EJAO&BUKQD=RAOQE?E@=HPDKQCDPO or actions, your healthcare provider may check for KPDAN?=QOAO How can I watch for early symptoms of suicidal thoughts and actions? xPay attention to any changes, especially sudden ?D=JCAO EJIKK@ >AD=REKNO PDKQCDPO KNBAAHEJCO xKeep all follow-up visits with your healthcare provider =OO?DA@QHA@ x =HH UKQN DA=HPD?=NA LNKRE@AN >APSAAJ REOEPO as needed, especially if you are worried about OUILPKIO 3. Lamotrigine tablets may rarely cause aseptic IAJEJCEPEO =OANEKQOEJŃ=II=PEKJKBPDALNKPA?PERA membrane that covers the brain and spinal cord. Call your healthcare provider right away if you have any of the following symptoms: xheadache xfever xnausea xvomiting xstiff neck xrash xunusual sensitivity to light xmuscle pains xchills xconfusion xdrowsiness Meningitis has many causes other than lamotrigine tablets, which your doctor would check for if you @ARAHKLA@IAJEJCEPEOSDEHAP=GEJCH=IKPNECEJAP=>HAPO Lamotrigine tablets can have other serious side effects. For more information ask your healthcare LNKRE@ANKNLD=NI=?EOP1AHHUKQNDA=HPD?=NALNKRE@AN EBUKQD=RA=JUOE@AABBA?PPD=P>KPDANOUKQ AOQNAPK read the section below entitled “What are the possible side effects of lamotrigine tablets?” 4. Patients prescribed lamotrigine tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine tablets, so always check that you receive lamotrigine tablets. Taking the wrong medication can cause serious health LNK>HAIO4DAJUKQNDA=HPD?=NALNKRE@ANCERAOUKQ= prescription for lamotrigine tablets: x*=GAOQNAUKQ?=JNA=@EP?HA=NHU xTalk to your pharmacist to check that you are given PDA?KNNA?PIA@E?EJA x"=?DPEIAUKQłHHUKQNLNAO?NELPEKJ ?DA?GPDAP=>HAPO UKQNA?AERA=C=EJOPPDALE?PQNAOKBPDAP=>HAPO>AHKS These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right OPNAJCPDKBH=IKPNECEJAP=>HAPO&IIA@E=PAHU?=HHUKQN pharmacist if you receive a lamotrigine tablet that does not look like one of the tablets shown below, as you I=UD=RANA?AERA@PDASNKJCIA@E?=PEKJ Lamotrigine Tablets USP
25 mg, White 100 mg, White
150 mg, White 200 mg, Light blue What is Lamotrigine tablet? Lamotrigine tablet is a prescription medicine used: PKCAPDANSEPDKPDANIA@E?EJAOPKPNA=P?ANP=EJPULAO of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of )AJJKT$=OP=QP OUJ@NKIA EJ LAKLHA UA=NO KN KH@AN =HKJASDAJ?D=JCEJCBNKIKPDANIA@E?EJAOQOA@PK PNA=PL=NPE=HOAEVQNAOEJLAKLHAUA=NOKNKH@AN BKNPDAHKJCPANIPNA=PIAJPKB ELKH=N&!EOKN@ANPK lengthen the time between mood episodes in people UA=NOKNKH@ANSDKD=RA>AAJPNA=PA@BKNIKK@ ALEOK@AOSEPDKPDANIA@E?EJA &PEOJKPGJKSJEBH=IKPNECEJAP=>HAPO=NAO=BAKNABBA?PERA EJ?DEH@NAJKNPAAJ=CANOQJ@ANPDA=CAKBSEPDIKK@ @EOKN@ANOOQ?D=O>ELKH=N@EOKN@ANKN@ALNAOOEKJ &P EO JKP GJKSJ EB H=IKPNECEJA P=>HAPO =NA O=BA KN ABBA?PERA SDAJ QOA@ =HKJA =O PDA łNOP PNA=PIAJP KB OAEVQNAOEJ=@QHPO Who should not take Lamotrigine tablets? You should not take lamotrigine tablets if you have had an allergic reaction to lamotrigine or to any of PDAEJ=?PERAEJCNA@EAJPOEJH=IKPNECEJAP=>HAPO0AAPDA AJ@KBPDEOHA=ŃAPBKN=?KILHAPAHEOPKBEJCNA@EAJPOEJ H=IKPNECEJAP=>HAPO What should I tell my healthcare provider before taking Lamotrigine tablets? ABKNAP=GEJCH=IKPNECEJAP=>HAPO PAHHUKQNDA=HPD?=NA provider about all of your medical conditions, including if you: xhave had a rash or allergic reaction to another =JPEOAEVQNAIA@E?EJA xhave or have had depression, mood problems or OQE?E@=HPDKQCDPOKN>AD=REKN xare taking oral contraceptives (birth control pills) KN KPDAN BAI=HA DKNIKJ=H IA@E?EJAO !K JKP OP=NP or stop taking birth control pills or other female hormonal medicine until you have talked with your DA=HPD?=NA LNKRE@AN 1AHH UKQN DA=HPD?=NA LNKRE@AN if you have any changes in your menstrual pattern OQ?D=O>NA=GPDNKQCD>HAA@EJC0PKLLEJCKNOP=NPEJC these medicines may cause side effects (such as dizziness, lack of coordination, or double vision) or HAOOAJDKSSAHHH=IKPNECEJAP=>HAPOSKNG x=NALNACJ=JPKNLH=JPK>A?KIALNACJ=JP&PEOJKP known if lamotrigine tablets will harm your unborn >=>U&BUKQ>A?KIALNACJ=JPSDEHAP=GEJCH=IKPNECEJA tablets, talk to your healthcare provider about NACEOPANEJC SEPD PDA +KNPD IANE?=J JPEALEHALPE? !NQC -NACJ=J?U /ACEOPNU 6KQ ?=J AJNKHH EJ PDEO NACEOPNU>U?=HHEJC1DALQNLKOAKB this registry is to collect information about the safety KB=JPEALEHALPE?@NQCO@QNEJCLNACJ=J?U x=NA>NA=OPBAA@EJC)=IKPNECEJA?=JL=OOEJPK>NA=OP IEHG=J@I=U?=QOAOE@AABBA?POEJ=>NA=OPBA@>=>U&B you breastfeed while taking lamotrigine tablets, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor OQ?GEJC =HH UKQN >=>UO DA=HPD?=NA LNKRE@AN NECDP =S=UEBUKQOAA=JUKBPDAOALNK>HAIO1=HGPKUKQN healthcare provider about the best way to feed your >=>UEBUKQP=GAH=IKPNECEJAP=>HAPO Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, REP=IEJO =J@DAN>=HOQLLHAIAJPO2OEJCH=IKPNECEJA tablets with certain other medicines can affect each KPDAN ?=QOEJCOE@AABBA?PO How should I take Lamotrigine tablets? x1=GAH=IKPNECEJAP=>HAPOAT=?PHU=OLNAO?NE>A@ x6KQN DA=HPD?=NA LNKRE@AN I=U ?D=JCA UKQN @KOA !K JKP ?D=JCA UKQN @KOA SEPDKQP P=HGEJC PK UKQN DA=HPD?=NALNKRE@AN x!KJKPOPKLP=GEJCH=IKPNECEJAP=>HAPOSEPDKQPP=HGEJC PK UKQN DA=HPD?=NA LNKRE@AN 0PKLLEJC H=IKPNECEJA P=>HAPO OQ@@AJHU I=U ?=QOA OANEKQO LNK>HAIO #KN example, if you have epilepsy and you stop taking lamotrigine tablets suddenly, you may get seizures PD=P@KJKPOPKL1=HGSEPDUKQNDA=HPD?=NALNKRE@AN =>KQPDKSPKOPKLH=IKPNECEJAP=>HAPOOHKSHU x&BUKQIEOO=@KOAKBH=IKPNECEJAP=>HAPO P=GAEP=O OKKJ=OUKQNAIAI>AN&BEPEO=HIKOPPEIABKNUKQN JATP@KOA FQOPOGELPDAIEOOA@@KOA1=GAPDAJATP @KOA=PUKQNNACQH=NPEIADo not take two doses at the same time. xYou may not feel the full effect of lamotrigine tablets BKNOARAN=HSAAGO x&BUKQD=RAALEHALOU PAHHUKQNDA=HPD?=NALNKRE@ANEB your seizures get worse or if you have any new types KBOAEVQNAO x0S=HHKSH=IKPNECEJAP=>HAPOSDKHA x&BUKQD=RAPNKQ>HAOS=HHKSEJCH=IKPNECEJAP=>HAPO tell your healthcare provider because there may be =JKPDANBKNIKBH=IKPNECEJAUKQ?=JP=GA What should I avoid while taking Lamotrigine tablets? x!K JKP @NERA = ?=N KN KLAN=PA ?KILHAT D=V=N@KQO machinery until you know how lamotrigine tablets =BBA?PUKQ What are possible side effects of Lamotrigine tablets? x0AA ļ4D=P EO PDA IKOP EILKNP=JP EJBKNI=PEKJ & should know about lamotrigine tablets?” KIIKJOE@AABBA?POKBH=IKPNECEJAP=>HAPOEJ?HQ@Aġ x dizziness x tremor x headache x rash x blurred or double vision x fever x lack of coordination x abdominal pain x sleepiness x back pain x nausea, vomiting x tiredness x insomnia x dry mouth Tell your healthcare provider about any side effect that >KPDANOUKQKNPD=P@KAOJKPCK=S=U These are not all the possible side effects of lamotrigine P=>HAPO #KN IKNA EJBKNI=PEKJ =OG UKQN DA=HPD?=NA LNKRE@ANKNLD=NI=?EOP =HHUKQN@K?PKNBKNIA@E?=H=@RE?A=>KQPOE@AABBA?PO 6KQI=UNALKNPOE@AABBA?POPK#! =P#! How should I store Lamotrigine tablets? x0PKNAH=IKPNECEJAP=>HAPO=P0PK0 Ġ0PK0# ĥ0AA20- KJPNKHHA@/KKI1AILAN=PQNA9 xKeep lamotrigine tablets and all medicines out of the reach of children. General information about Lamotrigine tablets Medicines are sometimes prescribed for purposes KPDANPD=JPDKOAHEOPA@EJ=*A@E?=PEKJ$QE@A!KJKP use lamotrigine tablets for a condition for which it S=OJKPLNAO?NE>A@!KJKPCERAH=IKPNECEJAP=>HAPOPK other people, even if they have the same symptoms UKQD=RA&PI=UD=NIPDAI This Medication Guide summarizes the most important EJBKNI=PEKJ=>KQPH=IKPNECEJAP=>HAPO&BUKQSKQH@HEGA IKNAEJBKNI=PEKJ P=HGSEPDUKQNDA=HPD?=NALNKRE@AN You can ask your healthcare provider or pharmacist for information about lamotrigine tablets that is written BKNDA=HPD?=NALNKBAOOEKJ=HO What are the ingredients in Lamotrigine tablets? ?PERAEJCNA@EAJPġ)=IKPNECEJA20- &J=?PERAEJCNA@EAJPOġH=?PKOAIKJKDU@N=PA I=CJAOEQI stearate, microcrystalline cellulose, povidone and OK@EQI OP=N?D CHU?KH=PA &J =@@EPEKJ PDA IC P=>HAPO?KJP=EJ#! HQA+K)=GA This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured by: UNICHEM LABORATORIES LTD. -EHANJA&J@"OP=PA -EHANJA =N@AV $K= &J@E=
Marketed by:
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