Calvasc

Main information

  • Trade name:
  • Calvasc 10 mg Tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, PVC/PE/PVdC-Al blister; 10 mg X 30, 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Cipla Ltd

Documents

Localization

  • Available in:
  • Calvasc 10 mg Tablet
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 11124
  • Authorization date:
  • 08-01-2003
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ConsumerMedicineInformation

Calvasc Tablets

Amlodipine5mgtabletsand10mgtablets

Whatisinthisleaflet

ThisleafletanswerssomecommonquestionsaboutCalvasctablets

Itdoesnotcontainalltheavailableinformation.Itdoesnottaketheplaceof

talkingtoyourdoctororpharmacist.

Allmedicineshaverisksandbenefits.Yourdoctorhasweighedtherisksof

youtakingCalvascagainstthebenefitstheyexpectitwillhaveforyou.

Ifyouhaveanyconcernsabouttakingthismedicine,askyourdoctoror

pharmacist.

Keepthisleafletwiththemedicine.Youmayneedtoreaditagain.

WhatareCalvasctabletsusedfor

Calvascisusedtotreathighbloodpressure(hypertension).Highblood

pressureusuallyhasnosymptoms.Havingyourbloodpressurecheckedona

regularbasisistheonlywayofknowingthatyouhavehypertension.

Untreatedhighbloodpressurecanleadtoserioushealthproblems.

Calvascbelongstoagroupofmedicinescalledcalciumchannelblockersor

calciumionantagonists.Thesemedicinesworkbywideningyourblood

vessels.Thismakesiteasierforyourhearttopumpbloodaroundthebody

whilealsoincreasingthesupplyofbloodandoxygentoyourheart.Calcium

channelblockersdonotchangetheamountofcalciuminyourbloodorbones.

Calvascisalsousedtotreatanginapectoris.Thispainisduetoyourheart

notreceivingenoughoxygen.Itisfeltasapainoruncomfortablefeelinginthe

chest,oftenspreadingtothearmsorneck,andsometimestotheshoulders

andback.

Calvasccannotbeusedforthereliefofasuddenattackofangina.Your

doctorwillhavegivenyouothermedicationtotreatsuddenattacks.

Calvaschasbeenapprovedfortheusesmentionedabove.However,your

doctormayprescribethismedicineforanotheruse.Ifyouwantmore

information,askyourdoctor.

Calvascisonlyavailablewithadoctor'sprescription.

CALVASCtabletsarenotknowntobeaddictive.

BeforeyoutakeCalvasctablets

Whenyoumustnottakeit

DonottakeCalvasctabletsif:

youareallergictotheactiveingredientoranyotheringredients

listedattheendofthisleaflet.(signsofallergyincludeaskinrash

similartohives,itching,shortnessofbreathand/orswollenface).

youareallergictoothercalciumchannelblockers.Examplesofsuch

medicinesincludefelodipine(PlendilER,AgonSR,FelodurER),or

nifedipine(Adalat,AdalatOros,Nifecard,Nifedipine-BC,Nifehexal,

Nyefax,SBPANifedipine)ordiltiazemhydrochloride(Dilzem,

Cardizem).

Checkwithyourdoctororpharmacistifyouareunsure.

thepackagingistornorshowssignsofbeingtamperedwith.

theexpirydatemarkedonthepackaginghaspassed

ifthetabletsdonotlookright.

Calvascisnotrecommendedforuseinchildren.Nostudiesofitseffects

inchildrenhavebeenperformed.

Beforeyoustarttotakeit

Tellyourdoctorif:

youhaveanyhealthproblems,including:

problemswithyourheart

problemswithyourliverorkidneys

allergiestoanyfoods,dyes,preservativesoranyother

medicines.

youarepregnantorplanningtobecomepregnant.

youarebreastfeeding

Medicinestakenduringpregnancyorwhilebreastfeedingmayaffect

thebaby.Yourdoctorwilldiscussthepossiblerisksandbenefitsof

takingCalvascduringpregnancyorwhilebreastfeeding.

Takingothermedicines

Tellyourdoctorifyouaretakinganyothermedicines,including

medicinesyoubuywithoutaprescriptionfromapharmacy,supermarket

orhealthfoodshop.

SomemedicinesmayinterferewithCALVASCormayaffecthowwellitworks.

Yourdoctororpharmacisthasmoreinformationonmedicinestobecareful

withoravoidwhiletakingCALVASC.

UsingCalvasctablets

Howmuchtotake

YourdoctorwilldecidewhatdoseandforhowlongyouwillneedCALVASC

tablets.

TheusualdoseofCalvascisone5mgtableteachday.Yourdoctormay

increasethistoone10mgtableteachdayortoadosethatisrequiredfor

you.

Howtotakeit

CALVASCtabletsmustbeswallowedwholewithafullglassofwater.

Calvasccanbetakenwithorwithoutfood.

Takeyourtabletataboutthesametimeeachday,eithermorningor

evening.

Takingyourtabletatthesametimeeachdaywillhavethebesteffect.Itwill

alsohelpyoutorememberwhentotakeit.

Howlongtotakeit

DonottakeCALVASCtabletsforlongerthanyourdoctorsays.

YoumusttakeCalvasceveryday.Continuetakingyourmedicineforaslong

asyourdoctortellsyou.

Ifyouforgettotakeit

IfyouhaveforgottentotakeonedoseofCALVASCtabletsanditislessthan

12hoursfromwhenyoushouldtakeit,takeitstraightaway,thencontinueas

normalthenextday.

Otherwise,skipthatday'sdosebutbesuretotakethenextday'sdosewhen

itisdue.

Donottakeadoubledosetomakeupforthedosethatyoumissed.

Ifyoutaketoomuch(overdose)

ImmediatelytelephoneyourdoctororPoisonsInformationCentre

(telephone0800POISONor0800764766)orgotoyournearestAccident

andEmergencydepartmentorclinicifyouthinkyouoranyoneelsemay

havetakentoomuchCALVASC.Dothiseveniftherearenosignsof

discomfortorpoisoning.Youmayneedurgentmedicalattention.

IfyouhavetakentoomuchCALVASC,youmay:

feeldizzy

feellightheaded

faintorfeelfaint

haveanirregularheartbeat.

WhileyouareusingCalvasc

Thingsyoumustdo

Tellallthedoctors,dentistsandpharmacistswhoaretreatingyouthatyouare

takingCALVASC.

TellyourdoctororpharmacistthatyouaretakingCALVASCifyouareabout

tostartanynewmedicine.

TellyourdoctorifyoubecomepregnantwhiletakingCALVASC.

Thingsyoumustnotdo

DonotuseCalvasctotreatanyothercomplaintsunlessyourdoctortellsyou

to.

Donotgivethismedicinetoanyoneelse,eveniftheyhavethesame

conditionasyou.

Thingstobecarefulof

BecarefuldrivingoroperatingmachineryuntilyouknowhowCALVASC

affectsyou.

Calvascmaycausedizzinessand/ordrowsinessandaffectalertnessinsome

individuals.Ifthisoccurs,avoidoperatingmachinery,drivingacaror

doinganythingthatcouldbedangerous.

Importantself-helpmeasuresthatmayassistyourcondition:

Talktoyourdoctorabouttheseformoreinformation.

Weight-ifneedbe,yourdoctormaysuggestlosingsomeweight.A

dieticiancanplanasuitablediettohelpwithweightloss.

Exercise-regularexercisehelpslowerbloodpressureandstrengthen

theheartbutitisimportantnottooverdoit.Beforecommencingregular

exercise,youmustconsultyourdoctortofindasuitableexercise

routineforyou.Ifyoufeeluncomfortablewhenexercisingor

experiencesymptomssuchasunusualchestpainorbreathlessness

seeyourdoctor.

Alcohol-youmaybeadvisedbyyourdoctortolimityouralcohol

intake.

Salt-yourdoctormayadviseyoutowatchtheamountofsaltinyour

diet.Toreduceyoursaltintake,youshouldavoidusingsaltatthetable

orincooking.

Smoking-youmaybeadvisedbyyourdoctortoreduceorstop

smoking.

Sideeffects

Tellyourdoctororpharmacistassoonaspossibleifyoudonotfeel

wellwhileyouaretakingCalvasctablets.

Allmedicinescanhavesideeffects.Someoftheseareserious,mostofthem

arenot.Youmayneedmedicaltreatmentifyougetsomeofthesideeffects.

Calvascisgenerallywelltoleratedandsideeffectsareoftenhardto

distinguishfromthediseasesymptoms.

BelowisthelistofpossiblesideeffectsyoucouldgetwhiletakingCalvasc

tablets

swellingoftheankles,feet,faceorhands

headache

flushing

fastheartrate

tirednessanddrowsiness

abdominalpain

nausea.

ThesearethemorecommonsideeffectsseenwhentakingCalvasctablets

andaregenerallynotharmful.However,docontactyourdoctoriftheybother

youtoomuch.

Thefollowingsymtomsmayoccurlessoften:

musclestiffness

muscleaches

changeinsexualfunctions

swellingofthegums

constipation

weightgain

inabilitytosleep

feelingnervous,

depression

blurredvision

thinningorlossofhair

tinnitus(ringingintheears).

ThesemayormaynotbeduetoCalvascbutyoushouldtellyourdoctorif

theyworryyou.

Thefollowingmayoccurrarely.Tellyourdoctorimmediately.

fastorslowchangesinheartbeat

chestpain

dizziness

shortnessofbreath

allergicreaction

jaundice

Donothesitatetoreportanyothersideeffectstoyourdoctoror

pharmacist.

Patientswhoare65yearsoroldershouldbeespeciallycarefulwhiletaking

Calvasc.Reportanysideeffectspromptlytoyourdoctor.

Peopleinthisagegroupmaybemorelikelytoexperiencesideeffectssuch

asswellingofthefeetandankles,musclecrampsanddizziness.

Storage

Keepyourtabletsintheoriginalcontaineruntilitistimetotakethem.If

youleaveyourtabletsoutoftheoriginalcontainer,theywillnotkeepwell.

Keepyourtabletsinacooldryplacewheretemperaturesstaybelow

25°C.

DonotstoreCalvascoranyothermedicineinthebathroomorneara

sink.Donotleaveitinthecaroronawindowsill.

Heatanddampnesscandestroysomemedicines.

Alwayskeepthetabletsoutofreachofyoungchildren.

Alockedcupboardatleastone-and-a-halfmetresabovethegroundisagood

placetostoremedicines.

Disposal

Ifyourdoctortellsyoutostoptakingthismedicine,orifthetabletshave

passedtheexpirydate,askyourpharmacistwhattodowithanythatare

leftover.

Productdescription

Whatitlookslike

CalvascTabletsareavailableintwostrengths:

Calvasc5mg-whitetooffwhite,round,biconvextablets;embossed

with"5"ononeside.

Calvasc10mg-whitetooffwhite,round,biconvextablets;scoredon

onesideandembossedwith"10"ontheotherside.

Ingredients

Activeingredients

Calvasc5mgTabletscontainamlodipinemesilateequivalentto

amlodipine5mg.

Calvasc10mgTabletscontainamlodipinemesilateequivalentto

amlodipine10mg.

Otheringredients

microcrystallinecellulose

anhydrouscalciumhydrogenphosphate

sodiumstarchglycollate

magnesiumstearate

Calvascdoesnotcontaingluten,sugarorlactose.

Supplier

CalvascissuppliedinNewZealandby:

DouglasPharmaceuticalsLimited

POBox45027

Auckland0651

pH:(09)8350660

Thisleafletwaspreparedon26April2007

1-1-2019

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Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

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FDA - U.S. Food and Drug Administration

4-12-2018

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7-9-2018

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29-8-2018

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22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

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18-8-2018

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7-12-2018


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6-12-2018


Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

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12-11-2018

Spinraza (Biogen Netherlands B.V.)

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Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

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Europe -DG Health and Food Safety

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

21-5-2018

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Active substance: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)) - Transfer of orphan designation - Commission Decision (2018)3136 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/089/07/T/01

Europe -DG Health and Food Safety