Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or pharmacist.
1. Lamivudine
Readall of thisleafletcarefullybefore youstarttakingthismedicine becauseitcontainsimportant
informationforyou.
Keepthisleaflet.Youmayneedtoreadit again.
If you have furtherquestions,askyourdoctoror pharmacist.
Thismedicine hasbeenprescribedforyouonly.Donotpass iton to others.It mayharm themeven
if theirsignsof illnessare the same asyours.
If you getany side effects,talktoyourdoctoror pharmacist.Thisincludesanypossible side effects
not listedinthisleaflet.Seesection4.
What Lamivudine isandwhatitis usedfor
Lamivudine isusedtotreatlongterm(chronic) hepatitisBinfectioninadults.
2. The active ingredientinLamivudineislamivudine.Lamivudine is anantiviral drugthatsuppresses
the hepatitisBvirusand Lamivudine belongstoa groupof medicinescallednucleosideanalogue
reverse transcriptase inhibitors(NRTIs).HepatitisBisa viruswhichinfectsthe liver,causeslongterm
(chronic) infection,andcanleadto liverdamage.Lamivudine canbe usedinpeople whose liveris
damagedbutstill functionsnormally(compensatedliverdisease) andinpeople whoseliveris
damagedanddoesnot functionnormally(decompensatedliverdisease).
TreatmentwithLamivudinecanreduce the amountof hepatitisBvirusinyour body.Thisshould
leadto a reductioninliverdamage andanimprovementinyourliverfunction.Noteveryone
respondstotreatmentwithLamivudineinthe same way.Yourdoctor will monitorthe effectiveness
of yourtreatment.
What youneedto knowbefore youtake Lamivudine
Do not take Lamivudine:
3. if you are allergic(hypersensitive) tolamivudineortoany of the otheringredientsof thismedicine
(listedinsection6).
Checkwithyourdoctor if you thinkthisappliestoyou.
Take special care withLamivudine
Some people takingLamivudineorothersimilarmedicinesare more atrisk of seriousside effects.
You needtobe aware of the extrarisks:
if you have everhadothertypesof liverdisease,suchashepatitisC.
if you?re seriouslyoverweight(especiallyif you?re awoman).
Talk to yourdoctor if any of these applytoyou.
You may needextracheck-ups,includingbloodtests,while you?retakingyourmedication.See
Section4 for more information.
4. Don?t stoptakingLamivudine
withoutyourdoctor?sadvice,asthere isa riskof your hepatitisgettingworse.Whenyoustoptaking
Lamivudine yourdoctorwill monitoryouforat leastfourmonthsto checkfor any problems.Thiswill
meantakingbloodsamplestocheckfor anyabnormal liverenzymes,indicatingliverdamage.
Look outfor importantsymptoms
Some people takingmedicinesforhepatitisBinfectiondevelopother conditions,whichcanbe
serious.Youneedtoknowaboutimportantsignsandsymptomsto lookoutfor while you?re taking
Lamivudine.
Readthe informationOtherpossible sideeffectsof therapyforHepatitisB?
Protectotherpeople
5. Hepatitis Binfectionisspreadbysexual contactwithsomeonewhohasthe infection,orbytransfer
of infectedblood(forexample,bysharinginjectionneedles).Lamivudine will notstopyoupassing
hepatitisBinfectionontootherpeople.Toprotectotherpeople frombecominginfectedwith
hepatitis
Use a condom
whenyouhave oral or penetrativesex.
Don?t riskbloodtransfer— forexample,don?tshare needles.
There isan effective vaccineavailable toprotectthose atriskfrombecominginfectedwithhepatitis
B virus.
OthermedicinesandLamivudine
Tell yourdoctor or pharmacistif you?re takinganyothermedicines,
if you?ve takenanyrecently,includingherbalmedicinesorothermedicinesyouboughtwithouta
prescription.
6. Rememberto tell yourdoctoror pharmacistif you begintakinganew medicine while you?re taking
Lamivudine.
These medicinesshouldnotbe usedwithLamivudine:
zalcitabine orlamivudine,usedtotreatHIV infectionHIV hepatitisBinfection
emtricitabineused totreator
cladribine,usedtotreathairycell leukaemia.
Tell yourdoctor if you?re beingtreatedwithanyof these.
Pregnancy
If you are pregnant,if youbecome pregnant,orif you?re planningtobecome pregnant:
Talk to yourdoctor immediatelyaboutthe risksandbenefitsof takingLamivudineduringyour
pregnancy.
8. How to take Lamivudine
Alwaystake this medicineexactlyasyourdoctor has toldyouto.
Checkwithyourdoctor or pharmacistif you?re not sure.
Swallowthe tabletwhole,withsome water.Lamivudinecanbe takenwithor withoutfood.
Stay inregularcontact withyourdoctor
Lamivudine helpstocontrol yourhepatitisBinfection.Youneedtokeeptakingiteverydayto
control your infectionandstopyourillnessgettingworse.
Keepintouchwithyour doctor,and don?tstoptakingLamivudine withoutyourdoctor?sadvice.
9. How muchto take
The usual dose of Lamivudine isone tablet(100mg lamivudine)once aday.
Your doctor mayprescribe a lowerdose if youhave problemswithyourkidneys.Anoral solutionof
Lamivudine isavailable forpeople whoneedalowerthanusual dose,orwhocan?t take tablets.
Talk to yourdoctor if thisappliestoyou.
If you are alreadytakinganothermedicine thatcontainslamivudine forHIV infection,yourdoctor
will continue totreatyouwiththe higherdose,(usually150 mg twice a day),because the dose of
lamivudineinLamivudine (100mg) is notenoughto treatHIV infection.If youare planningto
change your HIV treatment,discussthischange withyourdoctorfirst.
If you take too much Lamivudine
10. AccidentallytakingtoomuchLamivudine isunlikelytocause anyseriousproblems.If you
accidentallytake toomuch,tell yourdoctoror your pharmacist,orcontact your nearesthospital
emergencydepartmentforfurtheradvice.
If you forgetto take Lamivudine
If you forgetto take a dose,take it as soonas youremember.Thencontinue yourtreatmentas
before.Don?ttake a double dose tomake upfor a misseddose.
Don?t stoptakingLamivudine
You mustnot stoptakingLamivudine withoutconsultingyourdoctor.
Possible sideeffects
Like all medicines,thismedicinecancause side effects,butnoteveryonegetsthem.
As well asthe side effectslistedbelow forLamivudine,
otherconditionscandevelopduringtherapyforhepatitisB.
11. It isimportantto readthe informationunder?Otherpossible side effectsof therapyforhepatitisB?.
Side effectsthatwere commonlyreportedinLamivudineclinical trialswere tiredness,respiratory
tract infections,throatdiscomfort,headache,stomachdiscomfortandpain,nausea,vomitingand
diarrhoea,increasesinliverenzymesandenzymesproducedinthe muscles(see below).
Allergicreaction
These are veryrare in people takingLamivudine.Signsinclude:
suddenwheezinessandchestpainortightening
swellingof eyelids,face orlips
skinrash or ?hives?anywhere onthe body.
Contact a doctor immediatelyif yougetthese symptoms.Stoptaking
Lamivudine.
12. Side effectsthoughttobe causedbyLamivudine
A verycommonside effect(thesemayaffectmore than1 in 10 people) whichmayshow upinblood
testsis:
an increase inthe level of some liverenzymes(transaminases),whichmaybe asignof inflammation
or damage in the liver.
A commonside effect(thesemayaffectupto1 in10 people)is:
cramps and muscle pains.
A commonside effectwhichmayshowupinbloodtestsis: (creatine
an increase inthe level of anenzyme producedinthe musclesphosphokinase)whichmaybe a sign
that bodytissue isdamaged.
Otherside effects
13. Otherside effectshave occurredinaverysmall numberof people buttheirexactfrequencyis
unknown
breakdownof muscle tissue
a worseningof liverdisease afterLamivudine isstoppedorduringtreatmentif the hepatitisBvirus
becomes resistanttoLamivudine.Thiscanbe fatal insome people
lacticacidosis(see the nextsection,?Otherpossibleside effectsof therapyforHepatitisB?).
A side effectwhichmayshowupinbloodtestsis:
a decrease inthe numberof cellsinvolved inbloodclotting
(thrombocytopenia).
Reportingof side effectsIf yougetanyside ffects
14. Talk to yourdoctor or pharmacist.Thisincludesanypossible sideeffectsnotlistedinthisleaflet.You
can alsoreport side effectsdirectlyviathe Yellow CardScheme (www.mhra.gov.uk/yellowcard).By
reportingside effectsyoucanhelpprovide more informationonthe safetyof thismedicine.
Otherpossible sideeffectsof therapyforHepatitisB
Lamivudine andrelatedmedicines(NRTIs) maycause otherconditionstodevelopduringhepatitisB
treatment.
Lactic acidosisisa rare but seriousside effect
Some people takingLamivudine,orothermedicineslike it(NRTIs),developaconditioncalledlactic
acidosis,togetherwithan enlargedliver.
15. Lactic acidosisiscausedby a build-upof lacticacidinthe body.It israre; if it happens,itusually
developsafterafewmonthsof treatment.Itcanbe life-threatening,causingfailureof internal
organs.
Lactic acidosisismore likelytodevelopinpeople whohave liverdisease,orinobese (very
overweight) people,especiallywomen.
Signsof lactic acidosisinclude:
deep,rapid,difficultbreathing
drowsiness
numbnessorweaknessinthe limbs
feelingsick(nausea),beingsick(vomiting)
stomachpain.
Duringyour treatment,yourdoctorwill monitoryouforsignsof lacticacidosis.If youhave any of
the symptomslistedabove,oranyothersymptomsSeeyourdoctorthatworryassoonyou:aspossible.
How to store Lamivudine
16. Keepthismedicineoutof the sightandreach of children
Do not use thismedicine afterthe expirydate whichisstatedonthe label andcartonafter EXP
(month,year).
The expirydate referstothe last dayof that month.
Thismedicinal productdoesnotrequire anyspecial storage conditions
Do not throwaway anymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthow to
throwaway medicinesyounolongeruse.These measureswillhelpprotectthe environment.
For more informationvisitusourwebsite:mymedistore.com