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FILNARINE SR 100MG PROLONGED RELEASE FILM-COATED TABLETS

Active substance(s): MORPHINE SULPHATE PENTAHYDRATE

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TEVA UK Ref:

231-30-10030-G LEA MORPHINE SUL (FILNARINE) A/S TAB TUK
Version:

1

FILNARINE® SR 10 mg, 30 mg, 60 mg, s MONOAMINEOXIDASEINHIBITORSUSEDTO
TREATDEPRESSION
100 mg AND 200 mg PROLONGED
s MEDICINESWHICHHAVEASIMILAROROPPOSITE
RELEASE FILM-COATED TABLETS
EFFECTTOMORPHINE EGBUPRENORPHINE
morphine sulphate

0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2

Read all of this leaflet carefully before you
start taking this medicine.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
AGAIN
s )FYOUHAVEANYFURTHERQUESTIONS PLEASE
ASKYOURDOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU
$ONOTPASSITONTOOTHERS)TMAYHARM
THEM EVENIFTHEIRSYMPTOMSARETHESAME
ASYOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOUR
DOCTORORPHARMACIST4HISINCLUDESANY
possible side effects not listed in this
LEAFLET3EESECTION
).4()3,%!&,%4

1. What Filnarine SR are and what they are
used for
2. Before you take Filnarine SR
3. How to take Filnarine SR
4. Possible side effects
5. How to store Filnarine SR
6. Further information

1

WHAT FILNARINE SR IS AND WHAT IT
IS USED FOR

s %ACHPROLONGEDRELEASEFILM COATEDTABLET
CONTAINSMG MG MG MGOR
MGOFMORPHINESULPHATEPENTAHYDRATE 
Prolonged release means the morphine is
slowly released into the bloodstream to
GIVEALONG TERMEFFECT
s -ORPHINEBELONGSTOAGROUPOFMEDICINES
called analgesics, which are used for pain
relief
s 9OURMEDICINEISUSEDTOPROVIDERELIEFFROM
SEVEREPAINPARTICULARLYTHATFOLLOWINGAN
OPERATIONORCANCERPAIN

2

BEFORE YOU TAKE FILNARINE SR

Do not take Filnarine SR prolonged release
tablets if you:
s ARESENSITIVEORALLERGICTOMORPHINE
sulphate or to any of the ingredients in
YOURMEDICINESEEALSO3ECTIONh&URTHER
INFORMATION 7HAT&ILNARINE32CONTAINSv
s HAVEBREATHINGDIFFICULTIES
s HAVEEPILEPSYORHAVEEVERHADASEIZUREOR
fit
s HAVEAHEADINJURY
s HAVEACUTEPROBLEMSWITHYOURLIVER
s SUFFERFROMSEVEREPROBLEMSWITHYOUR
digestion
s HAVEHADANOPERATIONONYOURGALLBLADDER
or bile ducts
s HAVEANYCONDITIONWHICHMAYLEADTO
pressure within the brain
s ARETOUNDERGOCORDOTOMYANOPERATIONON
THESPINALCORDTORELIEVEPERSISTENTPAIN IN
the next 24 hours
s DRINKLARGEAMOUNTSOFALCOHOLREGULARLY
s ARETAKINGAMONOAMINEOXIDASEINHIBITOR
EGMOCLOBEMIDEORPHENELZINEUSEDTO
TREATDEPRESSION ORHAVEDONESOWITHINTHE
last two weeks
s ARETAKINGANYMEDICINESWHICHHAVEA
SIMILAROROPPOSITEEFFECTTOMORPHINEEG
BUPRENORPHINE NALBUPHINE PENTAZOCINE
s Children under 6 years of age should not
take Filnarine SR Prolonged Release
Film-Coated Tablets.

NALBUPHINE PENTAZOCINE
s CLOMIPRAMINEORAMITRIPTYLINEUSEDTOTREAT
DEPRESSION 
Please inform your doctor or pharmacist if you
ARETAKINGORHAVERECENTLYTAKENANYOTHER
medicines, including medicines obtained
WITHOUTPRESCRIPTION
Taking Filnarine SR with food and drink:
$O./4CONSUMEALCOHOLICBEVERAGESOR
PRESCRIPTIONORNON PRESCRIPTIONMEDICATIONS
CONTAININGALCOHOLWHILETAKING&ILNARINE32
#ONSUMPTIONOFALCOHOLWHILETAKING
Filnarine SR may result in the rapid release
ANDABSORPTIONOFTHEACTIVEINGREDIENT
morphine sulphate and therefore, may lead
TOAPOTENTIALLYFATALDOSE
Pregnancy and breast-feeding:
Filnarine SR is not recommended if you are
PREGNANT5SEOFMORPHINEMAYCAUSE
WITHDRAWALSYMPTOMSINTHEBABYAFTERLONG
TERMTREATMENTOFTHEMOTHER ORRESPIRATORY
DEPRESSIONBREATHINGDIFFICULTIES INTHEBABY
IFMORPHINESULPHATEISUSEDDURINGLABOUR 
!SKYOURDOCTORORPHARMACISTFORADVICE
BEFORETAKINGANYMEDICINE
Morphine sulphate is excreted in the human
MILK
4HEREFORE &ILNARINE32ISNOTRECOMMENDED
IFYOUAREBREAST FEEDING
!SKYOURDOCTORORPHARMACISTFORADVICE
BEFORETAKINGANYMEDICINE
Driving and using machines:
4HEMEDICINECANAFFECTYOURABILITYTODRIVE
ASITMAYMAKEYOUSLEEPYORDIZZY
s $ONOTDRIVEWHILETAKINGTHISMEDICINE
until you know how it affects you
s )TISANOFFENCETODRIVEIFTHISMEDICINE
AFFECTSYOURABILITYTODRIVE
(OWEVER YOUWOULDNOTBECOMMITTINGAN
offence if:
s 4HEMEDICINEHASBEENPRESCRIBEDTOTREATA
medical or dental problem and
s 9OUHAVETAKENITACCORDINGTOTHE
INSTRUCTIONSGIVENBYTHEPRESCRIBERORIN
THEINFORMATIONPROVIDEDWITHTHEMEDICINE
and
s )TWASNOTAFFECTINGYOURABILITYTODRIVE
SAFELY
4ALKTOYOURDOCTORORPHARMACISTIFYOUARE
NOTSUREWHETHERITISSAFEFORYOUTODRIVE
WHILETAKINGTHISMEDICINE
s &ILNARINE32MAYAFFECTYOURCONCENTRATION
and reaction times
s $O./4DRIVEOROPERATEANYTOOLSOR
machines
s $RINKINGALCOHOLORTAKINGTRANQUILLISERS
MAYMAKETHESESYMPTOMSWORSE3EEALSO
h4AKING&ILNARINE32WITHFOODANDDRINKv 

Important information about some of the
ingredients of Filnarine SR:
s 4HE ANDMG&ILNARINE32
0ROLONGED2ELEASE&ILM #OATED4ABLETS
contain lactoseMONOHYDRATE$O./4TAKE
Filnarine SR Prolonged Release
&ILM #OATED4ABLETSIFYOUHAVEBEENTOLD
BYYOURDOCTORTHATYOUHAVEANYOFTHE
following rare hereditary problems,
galactose intolerance, the LAPP lactase
Take special care with Filnarine SR if you
DEFICIENCYORGLUCOSE GALACTOSE
have:
MALABSORPTION
s PROBLEMSWITHYOURGALLBLADDER BILEDUCTS s 4HEMG&ILNARINE320ROLONGED2ELEASE
or urinary ducts
&ILM #OATED4ABLETSCONTAINACOLORANT
s ANENLARGEDPROSTATE
% WHICHCANCAUSEALLERGICREACTIONS
s ANUNDERACTIVETHYROIDGLANDYOUMAY
s 4HEMG&ILNARINE320ROLONGED2ELEASE
REQUIREALOWERDOSE
&ILM #OATED4ABLETSCONTAINCOLORANTS%
s PROBLEMSWITHYOURADRENALGLAND
AND% WHICHCANCAUSEALLERGIC
s PROBLEMSWITHBOWELFUNCTIONS
REACTIONS
s PANCREATITISINFLAMMATIONOFTHEPANCREAS
s LOWBLOODPRESSUREWITHLOWBLOODVOLUME 3 HOW TO TAKE FILNARINE SR
USUALLYDUETOSEVEREBLOODLOSS
s PROBLEMSWITHYOURCONSCIOUSNESS
Your doctor has decided the dose which is
s ASIGNIFICANTLYDECREASEDFUNCTIONOFYOUR
suited to you. Always take Filnarine SR
LIVERORKIDNEYSYOUMAYREQUIREALOWER
exactly as your doctor has told you. You
dose
should check with your doctor or pharmacist
s HADANOPERATIONOFYOURABDOMENORARE
if you are not sure.
to undergo an operation
)FYOUHAVETHEIMPRESSIONTHATTHEEFFECTOF
s DRINKINGALCOHOLWHILSTTAKINGTHISPRODUCT Filnarine SR is too strong or too weak, talk to
can make you feel more sleepy or increase YOURDOCTORORPHARMACIST
the risk of serious side effects such as
shallow breathing with a risk of stopped
4HETABLETSSHOULDBESWALLOWEDWHOLEWITH
BREATHING ANDLOSSOFCONSCIOUSNESS)TIS ADRINKOFWATER$ONOTBREAK CRUSH DISSOLVE
recommended not to drink alcohol while
ORCHEWTHEM
YOURETAKING&ILNARINE32SEEALSOSECTION $ONOTTAKEMORETHANTHEPRESCRIBED
h4AKING&ILNARINE32WITHFOODANDDRINKv  QUANTITYOFTABLETS
s USED&ILNARINE32FORALONGTIMEPERIOD
the usage of these tablets should not be
4HEUSUALDOSAGEINSTRUCTIONSAREGIVENBELOW
stopped suddenly, but should be
diminished gradually, according to the
Adults and adolescents from 12 years of
INSTRUCTIONOFTHEDOCTOR
age:
)NITIALLYnMGEVERYHOURS9OURDOCTOR
Taking other medicines:
MAYINCREASETHISACCORDINGTOYOURNEEDS
An interaction means that medicines which
are simultaneously used may influence each Children (aged 6-11 years):
OTHERSEFFECTSANDSIDEEFFECTS
4HEDOSEDEPENDSONTHEWEIGHTOFTHECHILD
An interaction may occur when these tablets )NITIALLYMGnMGOFMORPHINEKG
are simultaneously used with:
BODYWEIGHTEVERYHOURS4HEDOCTORMAY
s TRANQUILLISERSORSEDATIVES
INCREASETHISDOSEASNECESSARY
s MUSCLERELAXANTS
s ANTIHYPERTENSIVESUSEDTOTREATHIGHBLOOD Elderly patients, those with low body weight
PRESSURE
and patients with an underactive thyroid or
s CIMETIDINEANANTI ULCERDRUG
liver or kidney problemsMAYREQUIREALOWER
s RIFAMPICINUSEDTOTREATTUBERCULOSIS
DOSE

21 August 2014

TEVA UK Ref:

231-30-10030-G LEA MORPHINE SUL (FILNARINE) A/S TAB TUK
Pain relief after an operation:
24 hours after your operation, or when your
bowels are working normally again, your
doctor may recommend the following:
s )FYOUWEIGHLESSTHANKG
MGEVERYHOURS
s )FYOUWEIGHMORETHANKG
MGEVERYHOURS
s %LDERLYPATIENTSMAYNEEDALOWERDOSE
s 4HISUSEIS./4RECOMMENDEDFORCHILDREN
If you take more Filnarine SR than you should
)FYOUORSOMEONEELSE SWALLOWALOTOFTHE
tablets all together or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
DOCTORIMMEDIATELY)FYOUORANYONEELSEHAS
taken too many tablets, the following effects
may occur: constricted pupils, shallow
BREATHING LOWBLOODPRESSUREDIZZINESS
SHOCKANDLOSSOFCONSCIOUSNESS)NADDITION
fast heartbeats, dropping of body
temperature, relaxation of skeletal muscles
ANDINCHILDRENSEIZURESWEREOBSERVED
If you forget to take Filnarine SR
)FYOUFORGETTOTAKEATABLET TAKEONEASSOON
as you remember, unless it is nearly time to
TAKETHENEXTONE$ONOTTAKEADOUBLEDOSE
TOMAKEUPFORFORGOTTENINDIVIDUALDOSES
4AKETHEREMAININGDOSESATTHECORRECTTIME

Version:

1

Gastrointestinal disorders
Common
.AUSEA VOMITINGANDCONSTIPATION
Uncommon
$RYMOUTHANDCOLICPAINFULSPASMOFTHEGUT 
Skin and subcutaneous tissue disorders
Uncommon
3WEATINGANDFLUSHINGOFTHEFACE
Rare
#HILLS
Renal and urinary disorders
Uncommon
$IFFICULTYPASSINGURINE SEVEREPAININTHE
UPPERABDOMENORDOWNTHEBACKBILIARYOR
URETERICSPASM 
General disorders and administration site
conditions
Rare
General weakness and loss of strength
POSSIBLYLEADINGTOFAINTING
As with any morphine product, addiction can
OCCURWITHINAPPROPRIATEUSE
Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANY
POSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET
9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIA
THE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD

If you stop taking Filnarine SR
Using morphine can lead to tolerance and
DEPENDENCE4OLERANCEMEANSTHATHIGHER
doses are necessary in order to obtain the
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
SAMERESULT$EPENDENCEMEANSTHATIFYOU more information on the safety of this
suddenly stop your treatment this leads to
MEDICINE
withdrawal effects such as restlessness,
SPASMS FEVER MUSCULARPAIN SWEATINGAND
5 HOW TO STORE FILNARINE SR
SHIVERING#ONSULTYOURDOCTORWHENYOUSTOP
PROLONGED RELEASE TABLETS
taking Filnarine SR and do not stop taking
YOURTABLETSSUDDENLY)FYOUDO YOUMAY
Keep out of the reach and sight of children.
SUFFERFROMWITHDRAWALSYMPTOMS)FYOUR
$ONOTUSE&ILNARINE32AFTERTHEEXPIRYDATE
doctor decides to stop your tablets he/she will WHICHISSTATEDONTHECARTONAFTER%XP4HE
REDUCETHEDOSEGRADUALLY
EXPIRYDATEREFERSTOTHELASTDAYOFTHATMONTH
+EEPTHE&ILNARINE32MGBLISTERCARDIN
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSE THEOUTERCARTONINORDERTOPROTECTFROMLIGHT
OFTHISPRODUCT ASKYOURDOCTORORPHARMACIST -EDICINESSHOULDNOTBEDISPOSEDOFVIA
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
pharmacist how to dispose of medicines no
4 POSSIBLE SIDE EFFECTS
LONGERREQUIRED4HESEMEASURESWILLHELPTO
,IKEALLMEDICINES &ILNARINE32CANHAVESIDE PROTECTTHEENVIRONMENT
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
)FANYOFTHEFOLLOWINGHAPPENSTOPTAKING
Filnarine SR and tell your doctor immediately
or go to the casualty department at your
NEARESTHOSPITAL
s !SUDDENFEELINGOFILLNESS ANXIETY SHIVERS
itch, a pale or red skin, sweating, sometimes
BREATHLESSNESS QUICKHEARTBEATANDSHOCK
ANAPHYLACTICANDANAPHYLACTOIDREACTION
s 3WELLINGOFTHEFACE LIPS MOUTHORTHROAT
which may cause difficulty in swallowing or
BREATHING
4HESEARERAREBUTSERIOUSSIDEEFFECTS)FYOU
HAVETHEM YOUMAYHAVEHADASERIOUS
ALLERGICREACTIONTO&ILNARINE329OUMAYNEED
URGENTMEDICALATTENTIONORHOSPITALISATION

6

FURTHER INFORMATION

What Filnarine SR contains
s 4HEACTIVESUBSTANCEISMORPHINESULPHATE
s %ACHPROLONGEDRELEASEFILM COATEDTABLET
CONTAINSMGOFMORPHINESULPHATE
CORRESPONDINGTOMGMORPHINE
s %ACHPROLONGEDRELEASEFILM COATEDTABLET
contains MGOFMORPHINESULPHATE
CORRESPONDINGTOMG morphine
s %ACHPROLONGEDRELEASEFILM COATEDTABLET
CONTAINSMGOFMORPHINESULPHATE
CORRESPONDINGTOMGMORPHINE
s %ACHPROLONGEDRELEASEFILM COATEDTABLET
CONTAINSMGOFMORPHINESULPHATE
CORRESPONDINGTOMG morphine
s %ACHPROLONGEDRELEASEFILM COATEDTABLET
CONTAINSMGOFMORPHINESULPHATE
CORRESPONDINGTOMGMORPHINE

4ELLYOURDOCTORIFYOUHAVEANYOFTHE
following:
very commonAFFECTSMORETHANUSERIN
s 4HEOTHERINGREDIENTSAREHYPROMELLOSE
commonAFFECTSTOUSERSIN
stearic acid, magnesium stearate, colloidal
uncommonAFFECTSTOUSERSIN 
ANHYDROUSSILICA MACROGOLAND
rareAFFECTSTOUSERSIN 
TITANIUMDIOXIDE%
very rareAFFECTSLESSTHANUSERIN 
s 4HEMGTABLETSALSOCONTAINBLACKIRON
NOTKNOWNFREQUENCYCANNOTBEESTIMATED
OXIDE%
FROMTHEAVAILABLEDATA
s 4HEMGTABLETSALSOCONTAINLACTOSE
MONOHYDRATE SUNSETYELLOW% AND
Immune system disorders
PONCEAU2%
Rare
s 4HEMGTABLETSALSOCONTAINLACTOSE
)TCHINGANDNETTLERASH
MONOHYDRATE PONCEAU2% AND
INDIGOCARMINE%
Psychiatric disorders
s 4HEMGTABLETSALSOCONTAINLACTOSE
Uncommon
monohydrate and yellow and brown iron
#ONFUSION MOODCHANGES HALLUCINATIONS
OXIDE% 
AGITATION FEELINGSLEEPY
Nervous system disorders
Common
$ROWSINESS
Uncommon
$IZZINESSVERTIGO HEADACHE
Rare
Sleeplessness, raised pressure in the brain
LEADINGTOHEADACHES VOMITINGANDLOSSOF
VISION
Eye disorders
Common
#ONSTRICTIONOFTHEPUPILS
Rare
"LURREDVISION
Cardiac disorders
Uncommon
0ALPITATIONS
Rare
&ASTORSLOWHEARTRATE
Vascular disorders
Rare
,OWERINGOFBLOODPRESSURE
Respiratory, thoracic and mediastinal
disorders
Uncommon
0ROBLEMSWITHBREATHING
Rare
!STHMAATTACKSINSUSCEPTIBLEPATIENTS

What Filnarine SR looks like and contents of
the pack
s MGTABLETSAREGREYISHPINKFILM COATED
TABLETSWITHINSCRIPTIONhv
MGTABLETSAREGREYISHBLUEFILM COATED
TABLETSWITHINSCRIPTIONhv
MGTABLETSAREPINKFILM COATEDTABLETS
WITHINSCRIPTIONhv
MGTABLETSAREOFF WHITEFILM COATED
TABLETSWITHINSCRIPTIONhvANDTHE
MGTABLETSAREWHITETOOFF WHITE
FILM COATEDTABLETSWITHOUTINSCRIPTION
s 4HEPRODUCTISAVAILABLEINPACKSIZESOF
       ORTABLETS
4HEMGTABLETSAREALSOAVAILABLEINA
PACKSIZEOFTABLETS
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder:
4%6!5+,IMITED %ASTBOURNE ".!'
Manufacturer:
4EVA0HARMACEUTICAL7ORKS0RIVATE,IMITED
#OMPANY 0ALLAGI3TREET ( $EBRECEN
(UNGARY
This leaflet was last revised in 08/2014.
0,
0,
0,
0,
0,
 '

21 August 2014

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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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