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LAMOTRIGINE TEVA 50MG TABLETS

Active substance(s): LAMOTRIGINE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTOROR
pharmacist.
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY$ONOTPASSIT
ONTOOTHERS)TMAYHARMTHEM EVENIFTHEIRSIGNSOFILLNESS
are the same as yours.
s )FYOUGETANYOFTHESIDEEFFECTSTALKTOYOURDOCTOROR
pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

IN THIS LEAFLET:
1.
2.
3.
4.
5.
6.

What Lamotrigine is and what it is used for
What you need to know before you take Lamotrigine
How to take Lamotrigine
Possible side effects
How to store Lamotrigine
Contents of the pack and other information

1

WHAT LAMOTRIGINE IS AND WHAT IT IS USED FOR

(Main)

Pharma code 446

Lamotrigine belongs to a group of medicines called
anti-epileptics. It is used to treat epilepsy.
Lamotrigine treats epilepsy by blocking the signals in the brain
THATTRIGGEREPILEPTICSEIZURESFITS 
s &ORADULTSANDCHILDRENAGEDYEARSANDOVER ,AMOTRIGINE
can be used on its own or with other medicines, to treat
epilepsy. Lamotrigine can also be used with other medicines
TOTREATTHESEIZURESTHATOCCURWITHACONDITIONCALLED
,ENNOX 'ASTAUTSYNDROME
s &ORCHILDRENAGEDBETWEENANDYEARS ,AMOTRIGINECANBE
used with other medicines, to treat those conditions. It can be
used on its own to treat a type of epilepsy called typical
ABSENCESEIZURES

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LAMOTRIGINE

Important information about potentially life-threatening reactions
!SMALLNUMBEROFPEOPLETAKING,AMOTRIGINEHAVEEXPERIENCED
ANALLERGICREACTIONORPOTENTIALLYLIFE THREATENINGSKINREACTION
WHICHMAYDEVELOPINTOMORESERIOUSPROBLEMSIFTHEYARENOT
TREATED4HESECANINCLUDE3TEVENSn*OHNSONSYNDROME3*3
TOXICEPIDERMALNECROLYSIS4%. ANDDRUGREACTIONWITH
EOSINOPHILIAANDSYSTEMICSYMPTOMS$2%33 9OUNEEDTOKNOW
the symptoms to look out for while you are taking Lamotrigine.
Read the description of these symptoms in Section 4 of this
leaflet UNDER@0OTENTIALLYLIFE THREATENINGREACTIONSGETA
doctor’s help straight away’.
DO NOT take Lamotrigine:
s IFYOUAREALLERGICHYPERSENSITIVE TOLAMOTRIGINEORANYOFTHE
other ingredients of lamotrigine (listed in section 6).
If this applies to you, tell your doctor, and don’t take
Lamotrigine.
Take special care with Lamotrigine
Warnings and precautions
Talk to your doctor before taking before you take Lamotrigine if
you:
s HAVEPROBLEMSWITHYOURKIDNEYS
s HAVEEVERDEVELOPEDARASHWHENYOUVETAKENLAMOTRIGINEOR
other medicines for epilepsy
s are already taking medicine that contains lamotrigine.
If any of these applies to you, tell your doctor, who may decide
to lower your dose, or that Lamotrigine is not suitable for you.
Watch out for important symptoms
If you develop a rash or these skin symptoms, stop taking
Lamotrigine, seek urgent advice from a doctor and tell him that
you are taking this medicine:
s 0OTENTIALLYLIFE THREATENINGSKINRASHES3TEVENS *OHNSON
SYNDROME TOXICEPIDERMALNECROLYSISOR$2%33 HAVEBEEN
reported with the use of Lamotrigine, appearing initially as
REDDISHTARGET LIKESPOTSORCIRCULARPATCHESOFTENWITHCENTRAL
blisters on the trunk. For more information on these reactions,
please read section 4 (Possible side effects).
s !DDITIONALSIGNSTOLOOKFORINCLUDEULCERSINTHEMOUTH THROAT
NOSE GENITALSANDCONJUNCTIVITISREDANDSWOLLENEYES
s 4HESEPOTENTIALLYLIFE THREATENINGSKINRASHESAREOFTEN
ACCOMPANIEDBYFLU LIKESYMPTOMSANDARASHONTHEFACE
then an extended rash with a high temperature, increased
LEVELSOFLIVERENZYMESSEENINBLOODTESTSANDANINCREASEIN
a type of white blood cell (eosinophilia) and enlarged lymph
nodes. The rash may progress to widespread blistering or
peeling of the skin.
s 4HEHIGHESTRISKFOROCCURRENCEOFSERIOUSSKINREACTIONSIS
within the first weeks of treatment
s )FYOUHAVEDEVELOPED3TEVENS *OHNSONSYNDROME TOXIC
epidermal necrolysis or a drug reaction with eosinophilia and
SYSTEMICSYMPTOMS$2%33 WITHTHEUSEOF,AMOTRIGINE YOU
MUSTNOTBERE STARTEDON,AMOTRIGINEATANYTIME
s AHIGHTEMPERATUREFEVER
s DROWSINESS
These symptoms are more likely to happen during the first few
months of treatment with Lamotrigine, especially if you start on
TOOHIGHADOSEORIFYOURDOSEISINCREASEDTOOQUICKLY ORIF
you’re taking Lamotrigine with another medicine called
valproate. Children are more likely to be affected than adults.

if they are not treated. If you notice any of these symptoms, see
a doctor as soon as possible. Your doctor may decide to carry
OUTTESTSONYOURLIVER KIDNEYSORBLOOD ANDMAYTELLYOUTOSTOP
taking Lamotrigine.
Thoughts of harming yourself or suicide
)FYOUHAVEDISTRESSINGTHOUGHTSOREXPERIENCES ORIFYOUNOTICE
THATYOUFEELWORSEORDEVELOPNEWSYMPTOMSWHILEYOURE
taking Lamotrigine:
See a doctor as soon as possible or go to the nearest hospital
for help.
!SMALLNUMBEROFPEOPLEBEINGTREATEDWITHANTI EPILEPTICSSUCH
AS,AMOTRIGINEHAVEHADTHOUGHTSOFHARMINGORKILLING
THEMSELVESIf at any time you have these thoughts, immediately
contact your doctor.
Risk of increased or severe seizures
4HESEIZURESINSOMETYPESOFEPILEPSYMAYOCCASIONALLYBECOME
worse or happen more often while you’re taking Lamotrigine.
3OMEPATIENTSMAYEXPERIENCESEVERESEIZURES WHICHMAY
cause serious health problems. If your seizures happen more
often, or if you experience a severe seizure while you’re taking
Lamotrigine, see a doctor as soon as possible.
Other medicines and Lamotrigine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines including herbal
medicines or other medicines bought without a prescription.
s oxcarbazepine, felbamate, gabapentin, levetiracetam,
pregabalin, topiramate or zonisamide, used to treat epilepsy
s lithium, used to treat mental health problems
s bupropion, used to treat mental health problems or to stop
smoking.
If you start or stop taking certain medicines whilst you are taking
Lamotrigine, your doctor may need to check your dose of
Lamotrigine. These include:
s ATAZANAVIRINCOMBINATIONWITHRITONAVIR
s LOPINAVIRINCOMBINATIONWITHRITONAVIR
Tell your doctor if you start or stop taking any of these.
Some medicines interact with Lamotrigine or make it more likely
THATYOULLHAVESIDEEFFECTS4HESEINCLUDE
s valproate, used to treat epilepsy and mental health problems
s CARBAMAZEPINE used to treat epilepsy and mental health
problems
s PHENYTOIN PRIMIDONEor phenobarbital, used to treat epilepsy
s OLANZAPINE used to treat mental health problems
s RISPERIDONE used to treat mental health problems
s RIFAMPICIN which is an antibiotic
s a combination of lopinavir and ritonavir, used to treat Human
Immunodeficiency Virus (HIV) infection
s HORMONALCONTRACEPTIVES such as the Pill (see below).
Tell your doctor if you are taking, or if you start or stop taking,
any of these.
Hormonal contraceptives (such as the Pill) can affect the way
Lamotrigine works
s 9OURDOCTORMAYRECOMMENDTHATYOUUSEAPARTICULARTYPEOF
HORMONALCONTRACEPTIVE ORANOTHERMETHODOFCONTRACEPTION
such as condoms, a cap or a coil. If you are using a hormonal
CONTRACEPTIVELIKETHE0ILL YOURDOCTORMAYTAKESAMPLESOF
YOURBLOODTOCHECKTHELEVELOF,AMOTRIGINE If you plan to
start using a hormonal contraceptive, talk to your doctor,
who will discuss suitable methods of contraception with you.
s ,AMOTRIGINECANALSOAFFECTTHEWAYHORMONALCONTRACEPTIVES
WORK ALTHOUGHITSUNLIKELYTOMAKETHEMLESSEFFECTIVE)FYOU
AREUSINGAHORMONALCONTRACEPTIVEANDYOUnotice any
changes in your menstrual pattern, such as breakthrough
bleeding or spotting between periods, tell your doctor. These
may be signs that Lamotrigine is affecting the way your
CONTRACEPTIVEISWORKING
Pregnancy, breast-feeding and fertility
s )FYOUAREPREGNANT THINKYOUMAYBEPREGNANTORARE
PLANNINGTOHAVEABABY ASKYOURDOCTORORPHARMACISTFOR
ADVICEBEFORETAKINGTHISMEDICINE
You should not stop treatment for your epilepsy while you’re
PREGNANT(OWEVER THEREISANINCREASEDRISKOFBIRTHDEFECTS
in babies whose mothers took Lamotrigine during pregnancy.
These defects include cleft lip or cleft palate. Your doctor may
ADVISEYOUTOTAKEEXTRAFOLICACIDIFYOUREPLANNINGTO
become pregnant and while you’re pregnant.
0REGNANCYMAYALSOALTERTHEEFFECTIVENESSOF,AMOTRIGINE SO
YOURDOCTORMAYTAKESAMPLESOFYOURBLOODTOCHECKTHELEVEL
of Lamotrigine, and may adjust your dose.
s Talk to your doctor if you’re breast-feeding or planning to
breast-feed4HEACTIVEINGREDIENTOF,AMOTRIGINEPASSESINTO
breast milk and may affect your baby. Your doctor will discuss
the risks and benefits of breast feeding while you’re taking
Lamotrigine, and will check your baby from time to time if you
decide to breast feed.
Driving and using machines
s ,AMOTRIGINECANCAUSEDIZZINESSANDDOUBLEVISIONDon’t
drive or operate machines unless you are sure you’re not
affected.
s If you have epilepsy, talk to your doctor about driving and
using machines.
Important information about some of the ingredients of
Lamotrigine
Lamotrigine tablets contain small amounts of a sugar called
lactose)FYOUHAVEINTOLERANCETOLACTOSEORANYOTHERSUGARS
tell your doctor, and don’t take Lamotrigine.
,AMOTRIGINEMGANDMGTABLETSALSOCONTAIN%SUNSET
yellow FCF), which may cause allergic reactions.

Top of page cut-off to middle of registration mark: 44 mm.

LAMOTRIGINE TEVA 25 mg, 50 mg, 100 mg 4HESYMPTOMSLISTEDABOVECANDEVELOPINTOMORESERIOUS
PROBLEMS SUCHASORGANFAILUREORAVERYSEVERESKINCONDITION
AND 200 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

3

HOW TO TAKE LAMOTRIGINE

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
How much Lamotrigine to take
It may take a while to find the best dose of Lamotrigine for you.
The dose you take will depend on:
s YOURAGE
s WHETHERYOUARETAKING,AMOTRIGINEWITHOTHERMEDICINES
s WHETHERYOUHAVEPROBLEMSWITHYOURKIDNEYSORLIVER
Your doctor will start you on a low dose, and gradually increase
THEDOSEOVERAFEWWEEKSUNTILYOUREACHADOSETHATWORKSFOR
you (called the effective dose). Never take more Lamotrigine
than your doctor tells you to.
The recommended effective dose of Lamotrigine for adults and
children aged over 12 years is between 100 mg and 400 mg each
day.
For children aged 2 to 12 years THEEFFECTIVEDOSEDEPENDSON
their body weight — usually, it’s between 1 mg and 15 mg for
each kilogram of the child’s weight, up to a maximum of 400 mg
daily.
Lamotrigine is not recommended for children aged under 2
years.
How to take your dose of Lamotrigine
Take your dose of Lamotrigine once or twice a day, as your
DOCTORADVISES9OUCANTAKEITWITHORWITHOUTFOOD
9OURDOCTORMAYALSOADVISEYOUTOSTARTORSTOPTAKINGOTHER
medicines, depending on what condition you’re being treated for
and the way you respond to treatment.
s Swallow your tablets whole. Don’t break, chew or crush
them.
s Always take the full dose that your doctor has prescribed.
.EVERTAKEONLYPARTOFATABLET
If you take more Lamotrigine than you should
If anyone takes too much Lamotrigine, contact a doctor or
pharmacist immediately. If possible, show them the Lamotrigine
packet.
3OMEONEWHOHASTAKENTOOMUCH,AMOTRIGINEMAYHAVEANYOF
these symptoms:
s RAPID UNCONTROLLABLEEYEMOVEMENTSNYSTAGMUS
s CLUMSINESSANDLACKOFCO ORDINATION AFFECTINGTHEIRBALANCE
(ataxia)
s LOSSOFCONSCIOUSNESSORCOMA
If you forget to take Lamotrigine
Don’t take extra tablets or a double dose to make up for a
forgotten dose. If you have missed taking a dose of this
medicine ask your doctor for advice on how to start taking it
again. It’s important that you do this.
Don’t stop taking Lamotrigine without advice
Take Lamotrigine for as long as your doctor recommends. Don’t
STOPUNLESSYOURDOCTORADVISESYOUTO
To stop taking Lamotrigine, it is important that your dose is
reduced gradually OVERABOUTWEEKS)FYOUSUDDENLYSTOP
taking Lamotrigine, your epilepsy may come back or get worse.

Common side effects
These may affect up to 1 in 10 people:
s AGGRESSIONORIRRITABILITY
s RAPID UNCONTROLLABLEEYEMOVEMENTSNYSTAGMUS
s SHAKINGORTREMORS
s DIFFICULTYINSLEEPING
s DIARRHOEA
s FEELINGTIRED
Rare side effects
These may affect up to 1 in 1,000 people:
s ITCHYEYES WITHDISCHARGEANDCRUSTYEYELIDSCONJUNCTIVITIS
Very rare side effects
These may affect up to 1 in 10,000 people:
s HALLUCINATIONS@SEEINGOR@HEARINGTHINGSTHATARENTREALLY
there)
s CONFUSIONORAGITATION
s FEELING@WOBBLYORUNSTEADYWHENYOUMOVEABOUT
s UNCONTROLLABLEBODYMOVEMENTSTICS UNCONTROLLABLEMUSCLE
spasms affecting the eyes, head and torso (choreoathetosis),
OROTHERUNUSUALBODYMOVEMENTSSUCHASJERKING SHAKINGOR
stiffness
s INPEOPLEWHOALREADYHAVEEPILEPSY SEIZURESHAPPENING
more often
s CHANGESINLIVERFUNCTION WHICHWILLSHOWUPINBLOODTESTS OR
LIVERFAILURE
s CHANGESWHICHMAYSHOWUPINBLOODTESTSˆINCLUDING
reduced numbers of red blood cells (anaemia), reduced
numbers of white blood cells (leucopenia, neutropenia,
agranulocytosis), reduced numbers of platelets
(thrombocytopenia), reduced numbers of all these types of
cell (pancytopenia), and a disorder of the bone marrow called
aplastic anaemia
s INPEOPLEWHOALREADYHAVE0ARKINSONSDISEASE WORSENINGOF
the symptoms.
Frequency not known
4HEFREQUENCYOFTHESESIDEEFFECTSCANNOTBEESTIMATEDFROM
THECURRENTLYAVAILABLEDATA
s 4HEREHAVEBEENREPORTSOFBONEDISORDERSINCLUDING
osteopenia and osteoporosis (thinning of the bone) and
fractures. Check with your doctor or pharmacist if you are on
LONG TERMANTIEPILEPTICMEDICATION HAVEAHISTORYOF
osteoporosis, or take steroids.
s SWOLLENGLANDSLYMPHADENOPATHY
s ASEPTICMENINGITIS
s $2%33
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
CANALSOREPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD3CHEME
ATWWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMOREINFORMATION
on the safety of this medicine.

5

HOW TO STORE LAMOTRIGINE

Keep this medicine out of the sight and sight of children.
$ONOTSTOREABOVEŽ#3TOREINTHEORIGINALBLISTERPACKTO
POSSIBLE SIDE EFFECTS
protect from moisture.
Like all medicines, this medicine can cause side effects, but not Do not use this medicine after the expiry date which is stated on
EVERYONEGETSTHEM
the outer packaging. The expiry date refers to the last day of that
month.
Allergic reaction or potentially serious skin reaction: get a
doctor’s help straight away
$ONOTTHROWAWAYANYMEDICINEVIAWASTEWATERORHOUSEHOLD
A small number of people taking Lamotrigine get an allergic
waste. Ask your pharmacist how to throw away medicines you
reaction or potentially serious skin reaction WHICHMAYDEVELOP no longer use. These measures will help to protect the
INTOMORESERIOUS ANDEVENLIFE THREATENING PROBLEMSIFTHEYARE ENVIRONMENT
not treated. Symptoms of these reactions include:
CONTENTS OF THE PACK AND OTHER INFORMATION
s skin rashes or rednessWHICHMAYDEVELOPINTO
LIFE THREATENING skin reactions including widespread rash with
What Lamotrigine Teva Tablets contain:
blisters and peeling skin, particularly occurring around the
MOUTH NOSE EYESANDGENITALS3TEVENSn*OHNSONSYNDROME s 4HEACTIVEINGREDIENTISLAMOTRIGINE
s 4HEOTHERINGREDIENTSARELACTOSEMONOHYDRATE
EXTENSIVEPEELINGOFTHESKINMORETHANOFTHEBODY
MICROCRYSTALLINECELLULOSE PREGELATINISEDSTARCH POVIDONE
SURFACEnTOXICEPIDERMALNECROLYSIS OREXTENDEDRASHESWITH
+  COLLOIDALANHYDROUSSILICA SODIUMSTARCHGLYCOLATE4YPE
LIVER BLOODANDOTHERBODYORGANSINVOLVEMENT$2%33
A) and magnesium stearate. In addition, the 100 mg and
s a sore mouth or eyesCONJUNCTIVITIS
MGTABLETSCONTAINSUNSETYELLOW&#&% ANDTHE
s a high temperatureFEVER FLU LIKESYMPTOMSORDROWSINESS
MGTABLETSCONTAININDIGOCARMINE% 
s swelling around your face, or swollen glands in your neck,
armpit or groin
What Lamotrigine Teva Tablets look like and contents of the
s unexpected bleeding or bruising, or your fingers turning blue pack:
s a sore throat, or more infections (such as colds) than usual
s ,AMOTRIGINEMGTABLETSAREWHITETOOFFWHITE DIAMOND
s INCREASEDLEVELSOFLIVERENZYMESSEENINBLOODTESTS
SHAPEDTABLETS DEBOSSEDWITHTHENUMBERhvONONESIDE
s ANINCREASEINATYPEOFWHITEBLOODCELLEOSINOPHILS
ANDSCOREDBETWEENTHETWONUMBERS DEBOSSEDhvONTHE
s ENLARGEDLYMPHNODES
other side.
s INVOLVEMENTOFTHEORGANSOFTHEBODYINCLUDINGLIVERANDKIDNEYS s ,AMOTRIGINEMG4ABLETSAREWHITETOOFFWHITE ROUND
SHAPEDTABLET DEBOSSEDWITHTHENUMBERhvONONESIDE
0OTENTIALLYLIFE THREATENINGSKINRASHES3TEVENS *OHNSON
ANDDEBOSSEDh,4vONTHEOTHERSIDE
syndrome, toxic epidermal necrolysis, or extended rashes with
s ,AMOTRIGINEMGTABLETSAREPEACH DIAMONDSHAPED
LIVER BLOODANDOTHERBODYORGANSINVOLVEMENT$2%33 HAVE
TABLETS DEBOSSEDWITHTHENUMBERhvONONESIDEAND
been reported (see section 2).
SCOREDBETWEENTHETWONUMBERS DEBOSSEDhvONTHE
4HESEAREVERYSERIOUSBUTRAREORVERYRARESIDEEFFECTS9OU
other side.
may need urgent medical attention or hospitalisation. In many
s
,AMOTRIGINEMGTABLETSAREBLUE DIAMONDSHAPEDTABLETS
cases, your symptoms will be signs of less serious side effects.
DEBOSSEDWITHTHENUMBERhvONONESIDEANDSCORED
But you must be aware that they are potentially serious — so, if
BETWEENTHETWONUMBERS DEBOSSEDhvONTHEOTHERSIDE
you notice any of these symptoms, see a doctor as soon as
s ,AMOTRIGINEPACKSAREBLISTERPACKSOFTRANSPARENTORWHITE
possible.
OPAQUE06#06$# ALUMINIUMLIDDEDWITHALUMINIUMFOILFOR
9OURDOCTORMAYDECIDETOCARRYOUTTESTSONYOURLIVER KIDNEYS
 CALENDAR   CALENDAR    ORTABLETS
or blood, and may tell you to stop taking Lamotrigine.
Marketing Authorisation Holder and Manufacturer
Very common side effects
Marketing Authorisation holder and company responsible for
These may affect more than 1 in 10 people:
MANUFACTURE4%6!5+,IMITED %ASTBOURNE ".!'
s HEADACHE
This leaflet was last revised: 
s FEELINGDIZZY
0, 
s FEELINGSLEEPYORDROWSY
s CLUMSINESSANDLACKOFCO ORDINATIONATAXIA
s DOUBLEVISIONORBLURREDVISION
84100-ZB
s FEELINGSICKNAUSEA ORBEINGSICKVOMITING
s SKINRASH
160 x 323

4

6

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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