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CALCITRIOL 0.25MCG CAPSULES

Active substance(s): CALCITRIOL

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0ACKAGELEAFLET)NFORMATIONFORTHEUSER
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY
$ONOTPASSITONTOOTHERS)TMAYHARMTHEM
EVENIFTHEIRSIGNSOFILLNESSARETHESAMEAS
YOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANY
POSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET
3EESECTION
7HATISINTHISLEAFLET
1. What Calcitriol is and what it is used for
2. What you need to know before you take
Calcitriol
3. How to take Calcitriol
4. Possible side effects
5. How to store Calcitriol
6. Contents of the pack and other information

1

What Calcitriol is and what it is used
for

#ALCITRIOLISAVITAMIN$PRODUCT
#ALCITRIOLISUSEDTOTREATTHEFOLLOWING
s "ONEDISEASEINPEOPLEWITHKIDNEYPROBLEMS
RENALOSTEODYSTROPHY
s 7EAKENINGOFTHEBONESINWOMENAFTERTHE
MENOPAUSECHANGEOFLIFE 4HISISALSOKNOWN
ASPOST MENOPAUSALOSTEOPOROSIS
#ALCITRIOLWORKSBYMAKINGYOURBODYABSORB
MORECALCIUMFROMYOURDIET4HISHELPSTOFORM
HEALTHYBONESANDREDUCEBONEDAMAGE

2

What you need to know before you
take Calcitriol

18 August 2014

THEREMAYBEDEPOSITSOFCALCIUMINAREASOTHER
How to take Calcitriol
THANYOURBONEFOREXAMPLE INYOURKIDNEYS
!LWAYSTAKETHISMEDICINEEXACTLYASYOURDOCTOR AS@KIDNEYSTONES 9OURDOCTORMAYCHANGE
YOURDOSEOF#ALCITRIOLIFTHISHAPPENS
HASTOLDYOU#HECKWITHYOURDOCTOROR
PHARMACISTIFYOUARENOTSURE
Kidney
#HANGESINHOWWELLYOURKIDNEYISWORKING
3WALLOWTHECAPSULESWHOLEWITHALITTLEWATER
7HILEYOUARETAKING#ALCITRIOL YOURDOCTORWILLWANT SHOWNBYBLOODTESTS 
Allergic reactions
YOUTOHAVEREGULARBLOODTESTSTOCHECKTHATTHE
LEVELOFCALCIUMINYOURBLOODDOESNOTGETTOOHIGH 4HESIGNSCANINCLUDEITCHYSKIN SKINRASHESAND
REDDENINGOFTHESKINWHICHMAYBESEVERE 
Bone disease in people with kidney problems
(renal osteodystrophy)
Reporting of side effects
s 4HERECOMMENDEDSTARTINGDOSEFORADULTS
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
ANDELDERLYPEOPLEISONEMICROGRAM
ORPHARMACISTORNURSE4HISINCLUDESANY
CAPSULEONCEADAY
POSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET
s !FTERTOWEEKSYOURDOCTORMAYSTART
9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIATHE
INCREASINGYOURDOSESLOWLYBYMICROGRAM 9ELLOW#ARD3CHEMEAT
ATATIME
WWWMHRAGOVUKYELLOWCARD"YREPORTING
s %VENTUALLY DEPENDINGONYOURBLOODTEST
SIDEEFFECTSYOUCANHELPPROVIDEMORE
RESULTS YOURDOCTORMAYNEEDTOADJUSTYOUR INFORMATIONONTHESAFETYOFTHISMEDICINE
DOSEAGAIN(EORSHEMAYASKYOUTOTAKE
How to store Calcitriol
#ALCITRIOLTWOORTHREETIMESAWEEKINSTEADOF
EVERYDAY4HEMAXIMUMDOSEEACHWEEKIS Keep this medicine out of the sight and reach
MICROGRAMS
of children.
Bone disease after the menopause (post4HESECAPSULESSHOULDBESTOREDINTHEPACKAGE
menopausal osteoporosis)
ORCONTAINERSUPPLIED$ONOTSTOREABOVEยช#
s 4HERECOMMENDEDDOSEFORADULTANDELDERLY $ONOTTRANSFERTHEMTOANOTHERCONTAINER
WOMENISONEMICROGRAMCAPSULETWICE $ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATE
ADAY
WHICHISSTATEDONTHEOUTERPACKAGINGAFTER%80
4HEEXPIRYDATEREFERSTOTHELASTDAYOFTHAT
Use in children
#ALCITRIOLISNOTRECOMMENDEDFORUSEINCHILDREN MONTH
$ONOTTHROWAWAYANYMEDICINESVIAWASTEWATER
If you take more Calcitriol than you should
)FYOUTAKEMORE#ALCITRIOLTHANYOUSHOULD TALK ORHOUSEHOLDWASTE!SKYOURPHARMACISTHOWTO
THROWAWAYMEDICINESYOUNOLONGERUSE4HESE
TOADOCTORORGOTOAHOSPITALSTRAIGHTAWAY
MEASURESWILLHELPPROTECTTHEENVIRONMENT
4AKETHEMEDICINEPACKWITHYOU
)FYOUTAKETOOMANYCAPSULES YOUMAYGETTOO
Contents of the pack and other
MUCHCALCIUMINYOURBLOODHYPERCALCAEMIA 
information
4HESIGNSINCLUDELOSSOFAPPETITE WEIGHTLOSS
FEELINGSICK BEINGSICK CONSTIPATION HEADACHE What Calcitriol Capsules contains:
s 4HEACTIVESUBSTANCEISCALCITRIOL
ANDFEELINGSLUGGISH DROWSYORWEAK
s 4HEOTHERINGREDIENTSAREFRACTIONATEDCOCONUT
If you forget to take Calcitriol
OIL BUTYLATEDHYDROXYANISOLE% BUTYLATED
)FYOUFORGETTOTAKEADOSE SKIPTHEMISSEDDOSE
HYDROXYTOLUENE% GELATINE GLYCEROL
4HENTAKEYOURNEXTDOSEASNORMAL$ONOTTAKE
% SORBITOL% ANDTHEDYESTITANIUM
ADOUBLEDOSETWODOSESATTHESAMETIME TO
DIOXIDE% ANDQUINOLINEYELLOW% 
MAKEUPFORAFORGOTTENDOSE
4HEMICROGRAMCAPSULEALSOINCLUDESTHE
If you stop taking Calcitriol
DYEPATENTBLUE% 
$ONOTSTOPTAKING#ALCITRIOLWITHOUTTALKINGTO
"OTHSTRENGTHSOFCAPSULEAREPRINTEDWITH
YOURDOCTOR4HISISBECAUSEWEAKNESSOFYOUR
BLACKINKTHATCONTAINSSHELLAC% GLAZE
BONESNEEDSLONGTERMTREATMENT
ANDBLACKIRONOXIDE% 
)FSOMEONEELSETAKESYOUR#ALCITRIOLCAPSULES
What Calcitriol Capsules looks like and
BYMISTAKE THEYSHOULDTALKTOADOCTORORGOTO contents of the pack:
AHOSPITALSTRAIGHTAWAY
s 4HE#ALCITRIOLMICROGRAM#APSULESARE
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOF
OPAQUE YELLOW OVAL SOFTGELATINECAPSULES
THISMEDICINE ASKYOURDOCTORORPHARMACIST
IMPRINTED@
s 4HE#ALCITRIOLMICROGRAM#APSULESARE
Possible side effects
OPAQUE GREEN OBLONG SOFTGELATINCAPSULES
IMPRINTED@
,IKEALLMEDICINES THISMEDICINECANCAUSESIDE
s 4HEPRODUCTISAVAILABLEINPACKSIZESOF 
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
           
4HEFOLLOWINGSIDEEFFECTSMAYHAPPENRARELY
   ANDCAPSULES
WITHTHISMEDICINE
.OTALLPACKSIZESMAYBEMARKETED
High levels of calcium in your blood
4HESIGNSINCLUDELOSSOFAPPETITE WEIGHTLOSS Marketing Authorisation Holder and Manufacturer
4HE-ARKETING!UTHORISATIONHOLDERIS4%6!5+
FEELINGSICK BEINGSICK HEADACHEANDFEELING
,IMITED %ASTBOURNE ".!'
SLUGGISH DROWSYORWEAK
4HECOMPANYRESPONSIBLEFORMANUFACTUREIS
6ERYHIGHLEVELSOFCALCIUMINYOURBLOODMAY
LEADTOHIGHTEMPERATUREFEVER FEELINGTHIRSTY 4%6!5+,IMITED %ASTBOURNE ".!'
DEHYDRATION PASSINGMOREWATERTHANNORMAL This leaflet was last revised: August 2014.
WETTINGTHEBED CONSTIPATION STOMACHPAIN
BLOCKAGEOFTHEBOWELANDANUNEVENHEARTBEAT 0, 
4HEREMAYBEINFECTIONSINTHEBLADDERAND
NORMALGROWTHMAYSTOP
85810-X
/CCASIONALLY MENTALPROBLEMSMAYOCCUR!LSO
322K055900814

3

5

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132

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Do not take Calcitriol if you are allergic to:
s CALCITRIOLORANYOFTHEOTHERINGREDIENTSOF
THISMEDICINELISTEDINSECTION
s ANYOTHERhVITAMIN$METABOLITEvMEDICINES
USEDTOTREATBONEDISEASE 4HESEINCLUDE
ALFACALCIDOLANDCOLECALCIFEROL
$ONOTTAKE#ALCITRIOLIFANYOFTHEABOVEAPPLY
TOYOU)FYOUARENOTSURE TALKTOYOURDOCTOR
ORPHARMACISTBEFORETAKING#ALCITRIOL
Do not take Calcitriol if you:
s HAVEHIGHLEVELSOFCALCIUMINYOURBLOOD
HYPERCALCAEMIA
s HAVEEXTRADEPOSITSOFCALCIUMINYOURBODY
METASTATICCALCIFICATION
s AREUNWELLBECAUSEOFHIGHLEVELSOFVITAMIN$
INYOURBODY
s $ONOTTAKE#ALCITRIOLIFANYOFTHEABOVEAPPLY
TOYOU)FYOUARENOTSURE TALKTOYOURDOCTOR
ORPHARMACISTBEFORETAKING#ALCITRIOL
Warnings and precautions
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKING
#ALCITRIOLIFYOU
s AREFINDINGITDIFFICULTTOMOVEABOUTFOR
EXAMPLE AFTERANOPERATION
s HAVEKIDNEYPROBLEMSTHEDOCTORMAYNEEDTO
MONITORTHEPHOSPHATELEVELSINYOURBLOOD
ANDDIET 

Other medicines and Calcitriol
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKING
HAVERECENTLYTAKENORMIGHTTAKEANYOTHER
MEDICINES4HISINCLUDESMEDICINESTHATYOUBUY
WITHOUTAPRESCRIPTIONANDHERBALMEDICINES
4HISISBECAUSE#ALCITRIOLCANAFFECTTHEWAY
SOMEMEDICINESWORK!LSOSOMEOTHER
MEDICINESCANAFFECTTHEWAY#ALCITRIOLWORKS
)NPARTICULAR TELLYOURDOCTORORPHARMACISTIF
YOUARETAKINGANYOFTHEFOLLOWINGMEDICINES
s /THERMEDICINESCONTAININGVITAMIN$
s $IURETICS ALSOCALLED@WATERTABLETSUSEDTO
TREATHIGHBLOODPRESSURE 4HESEINCLUDE
BENDROFLUMETHIAZIDE CHLORTALIDONEAND
INDAPAMIDE
s -EDICINESLIKEDIGOXINORDIGITOXINUSEDTO
TREATHEARTDISEASE
s -EDICINESCONTAININGMAGNESIUM SUCHAS
ANTACIDSUSEDTOTREATINDIGESTION
s 3TEROIDMEDICINES SUCHASHYDROCORTISONE
PREDNISOLONEANDDEXAMETHASONE
s #HOLESTYRAMINE OROTHER@ION EXCHANGERESINS
USEDTOTREATHIGHLEVELSOFCHOLESTEROLIN
YOURBLOOD
s 0HOSPHATETHEDOCTORMAYNEEDTOMONITOR
PHOSPHATELEVELSINYOURBLOOD 
!LSOTELLYOURDOCTORORPHARMACISTIFYOUHAVE
TAKENAMEDICINECONTAININGVITAMIN$OVERTHE
LASTFEWMONTHSTHATHASLONG LASTINGEFFECTS
4HESEMEDICINESINCLUDEERGOCALCIFEROLAND
COLECALCIFEROL
Calcitriol with food and drink
s $/./4TAKEANYVITAMINORFOODSUPPLEMENTS
THATCONTAINVITAMIN$WHILEYOUARETAKING
#ALCITRIOL
s $/./4EATFOODWHICHHASVITAMIN$ADDED
FOODWHICHIS@FORTIFIEDWITHVITAMIN$ WHILE
YOUARETAKING#ALCITRIOL
s )TISVERYIMPORTANTTOKEEPTOANYDIETTHAT
YOURDOCTORHASGIVENTOYOU
s )FYOUCHANGEHOWMUCHCALCIUMORVITAMIN$
YOUHAVEINYOURDIETTHISCANINCREASETHERISK
OFSIDEEFFECTSFOREXAMPLE IFYOUEATMORE
DAIRYPRODUCTSLIKEMILKANDCHEESE ORTAKE
VITAMINSWITHOUTYOURDOCTORKNOWING
s $RINKPLENTYOFFLUIDSSUCHASWATER ASITIS
IMPORTANTNOTTOBECOMEDEHYDRATED4HIS
DOESNOTAPPLYIFYOUHAVEKIDNEYPROBLEMS
Pregnancy and breast-feeding
)FYOUAREPREGNANTORBREAST FEEDING THINKYOU
MAYBEPREGNANTORAREPLANNINGTOHAVEABABY
ASKYOURDOCTORORPHARMACISTFORADVICEBEFORE
TAKINGTHISMEDICINE
Pregnancy
s 4ALKTOYOURDOCTORBEFORETAKING#ALCITRIOLIF
YOUAREPREGNANT THINKYOUMAYBEPREGNANT
ORAREPLANNINGTOHAVEABABY PLANTOGET
PREGNANT9OURDOCTORWILLTHENDECIDEIFYOU
SHOULDTAKE#ALCITRIOL
Breast-feeding
s 9OUCANTAKE#ALCITRIOLIFYOUAREBREAST FEEDING
(OWEVER YOURDOCTORWILLTAKEBLOODSAMPLES
FROMYOUANDYOURCHILDTOCHECKTHATTHERE
ARENOUNWANTEDEFFECTS
Driving and using machines
s #ALCITRIOLISNOTLIKELYTOAFFECTYOUBEINGABLE
TODRIVEORUSEANYTOOLSORMACHINES
Calcitriol contains sorbitol
#ALCITRIOL#APSULESCONTAINSSORBITOL WHICHISA
TYPEOFSUGAR)FYOURDOCTORHASTOLDYOUTHAT
YOUHAVEANINTOLERANCETOSOMESUGARS CONTACT
YOURDOCTORBEFORETAKINGTHISMEDICINE

1

4

132

CALCITRIOL 0.25 microgram AND
0.5 microgram CAPSULES

Version:

231-30-85810-X LEA CALCITRIOL 0.25 & 0.5 mcg CAPS TUK
132

TEVA UK Ref:

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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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