Diovan Comp 160 mg/25 mg

Primær information

  • Handelsnavn:
  • Diovan Comp 160 mg/25 mg 160 mg+25 mg filmovertrukne tabletter
  • Dosering:
  • 160 mg+25 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Diovan Comp 160 mg/25 mg 160 mg+25 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 36787
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Diovan® Comp 80 mg/12,5 mg filmovertrukne tabletter

Diovan® Comp 160 mg/12,5 mg filmovertrukne tabletter

Diovan® Comp 160 mg/25 mg filmovertrukne tabletter

Diovan® Comp 320 mg/12,5 mg filmovertrukne tabletter

Diovan® Comp 320 mg/25 mg filmovertrukne tabletter

valsartan/hydrochlorthiazid

Læs denne indlægsseddel grundigt inden du begynder at tage medicinen, da den indeholder

vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give medicinen

til andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.

Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,

som ikke er nævnt her. Se afsnit 4.

Vær opmærksom på, at indlægssedler opdateres jævnligt. Du kan altid finde den nyeste

indlægsseddel på www.indlaegsseddel.dk.

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du begynder at tage Diovan Comp

Sådan skal du tage Diovan Comp

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Diovan Comp filmovertrukne tabletter indeholder to aktive stoffer, der kaldes valsartan og

hydrochlorthiazid. Begge disse stoffer hjælper med at kontrollere forhøjet blodtryk (hypertension).

Valsartan tilhører en gruppe medicin, der kaldes ”angiotensin II-hæmmere”, der hjælper med

at sænke forhøjet blodtryk. Angiotensin II er et stof, som findes i kroppen og får blodkarrene til

at trække sig sammen sådan, at blodtrykket stiger. Valsartan hæmmer virkningen af angiotensin

II. Derved udvides blodkarrene, og blodtrykket falder.

Hydrochlorthiazid tilhører en gruppe medicin, der kaldes thiaziddiuretika (også kendt som

vanddrivende medicin). Hydrochlorthiazid øger urinmængden, som udskilles, hvilket ligeledes

sænker blodtrykket.

Diovan Comp bruges til behandling af forhøjet blodtryk, som ikke kontrolleres tilstrækkeligt af et

enkelt stof alene.

Forhøjet blodtryk øger belastningen af hjertet og blodkarrene. Hvis det ikke behandles, kan det føre

til, at blodkarrene i hjernen, hjertet og nyrerne beskadiges, hvilket kan ende med hjerneblødning,

hjertesvigt eller nyresvigt. Forhøjet blodtryk øger risikoen for hjerteanfald. Ved at sænke blodtrykket

til et normalt niveau nedsættes risikoen for at få disse lidelser.

Følg altid lægens anvisning og oplysningerne på doseringsetiketten. Lægen kan have foreskrevet

anden anvendelse eller dosering end angivet i denne information.

2.

Det skal du vide, før du begynder at tage Diovan Comp

Tag ikke Diovan Comp

hvis du er allergisk over for valsartan, hydrochlorthiazid, sulfonamidderivater (stoffer, der er

kemisk beslægtede med hydrochlorthiazid) eller over for et af de øvrige indholdsstoffer i dette

lægemiddel (se afsnit 6).

hvis du er mere end 3 måneder henne i graviditeten (det er også bedst at undgå Diovan

Comp tidligt i graviditeten – se afsnittet om graviditet).

hvis du har en alvorlig leversygdom, ødelæggelse af de små galdegange i leveren (biliær

cirrose) som fører til ophobning af galde i leveren (kolestase).

hvis du har en alvorlig nyresygdom.

hvis du ikke er i stand til at danne urin (anuri).

hvis du har gennemgået en nyretransplantation (modtaget en ny nyre).

hvis mængden af kalium eller natrium i dit blod er lavere end normalt, eller hvis mængden af

calcium i dit blod er højere end normalt på trods af behandling.

hvis du har urinsyregigt (podagra).

hvis du har sukkersyge eller nedsat nyrefunktion og du tager et blodtrykssænkende lægemiddel,

der indeholder aliskiren

Hvis noget af dette gælder for dig, skal du fortælle det til din læge og ikke tage Diovan Comp.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Diovan Comp

hvis du tager kaliumbesparende medicin, kaliumtilskud, salttilskud, der indeholder kalium, eller

anden medicin, der øger mængden af kalium i dit blod, for eksempel heparin. Din læge kan

være nødt til at måle indholdet af kalium i dit blod regelmæssigt.

hvis mængden af kalium i dit blod er lav.

hvis du har diarré eller voldsom opkastning.

hvis du tager høje doser af vanddrivende medicin (diuretika).

hvis du har en alvorlig hjertesygdom.

hvis du lider af hjertesvigt eller har haft et hjerteanfald. Følg nøje de anvisninger din læge har

givet dig for startdosis. Din læge vil måske også undersøge din nyrefunktion.

hvis du lider af forsnævring i blodårerne til nyrerne.

hvis du for nylig har fået en ny nyre.

hvis du lider af hyperaldosteronisme. Dette er en sygdom, hvor dine binyrer producerer for

meget af hormonet aldosteron. Hvis dette gælder for dig, frarådes det, at du tager Diovan

Comp.

hvis du har en lever- eller nyresygdom.

hvis du tidligere har oplevet hævelse af tunge og ansigt pga. en allergisk reaktion kaldet

angioødem, på grund af anden medicin (inkl. ACE-hæmmere), skal du fortælle det til din læge.

Hvis disse symptomer opstår, når du tager Diovan Comp, skal du øjeblikkeligt stoppe med at

tage Diovan Comp og aldrig tage det igen. Se også afsnit 4 ”Bivirkninger”.

hvis du har feber, udslæt og ledsmerter, hvilket kan være tegn på systemisk lupus

erythematosus (SLE, en såkaldt autoimmun sygdom).

hvis du har sukkersyge, urinsyregigt, for højt indhold af kolesterol eller fedtstoffer

(triglycerider) i blodet.

hvis du har haft allergiske reaktioner ved brug af andre blodtrykssænkende midler af denne type

(angiotensin II-hæmmere), eller hvis du har allergi eller astma.

hvis du oplever synsnedsættelse eller øjensmerter. Dette kan være symptomer på et øget tryk

inde i øjet og kan opstå inden for få timer til flere uger efter, du har taget Diovan Comp. Dette

kan føre til varigt synstab, hvis du ikke behandles for det. Der kan være en højere risiko for, at

du oplever disse symptomer, hvis du tidligere har haft en allergisk reaktion over for penicillin

eller sulfonamid.

hvis du tager noget af følgende medicin, der anvendes til at behandle forhøjet blodtryk:

en ACE-hæmmer (fx enalapril, lisinopril, ramipril), især hvis du har nyreproblemer i

forbindelse med sukkersyge

aliskiren

hvis du bliver behandlet med en ACE-hæmmer sammen med visse andre lægemidler

til at behandle dit hjertesvigt, der er kendt som mineralokortikoid

receptorantagonister (MRA) (fx spironolacton, eplerenon) eller betablokkere (fx

metoprolol)

Din læge vil eventuelt måle din nyrefunktion, dit blodtryk og elektrolytter (fx. kalium) i dit blod med

jævne mellemrum.

Se også information under overskriften ”Tag ikke Diovan Comp”.

Diovan Comp kan forårsage, at hudens følsomhed over for sol øges.

Brug af Diovan Comp til børn og unge (under 18 år) frarådes.

Du skal fortælle det til din læge, hvis du tror, du er (eller planlægger at blive) gravid. Diovan Comp

frarådes i den tidlige periode af graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i

graviditeten, da det kan medføre alvorlige skader på dit barn, hvis det bruges på dette tidspunkt (se

afsnittet om graviditet).

Brug af anden medicin sammen med Diovan Comp

Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, har gjort det for nylig eller

muligvis kommer til det.

Virkningen af behandlingen kan blive påvirket, hvis du tager Diovan Comp sammen med visse andre

typer medicin. Det kan være nødvendigt at ændre dosis, at tage andre forholdsregler eller i nogle

tilfælde stoppe med at tage den ene medicin. Dette gælder især for følgende medicin:

lithium, medicin, som anvendes til behandling af visse typer psykiske sygdomme

medicin, der kan øge mængden af kalium i blodet, såsom kaliumtilskud, kaliumholdige

salterstatninger kaliumbesparende medicin og heparin

medicin, der kan mindske mængden af kalium i blodet, såsom diuretika (vanddrivende

medicin), kortikosteroider, afføringsmidler, carbenoxolon, amphotericin eller G-penicillin

nogle typer antibiotika (rifamycingruppe), medicin, som anvendes til at beskytte mod

afstødning af et transplantat (ciclosporin) eller antiretroviral medicin, som anvendes til

behandling af HIV/AIDS (ritonavir). Denne medicin kan øge effekten af Diovan Comp

medicin, der kan fremkalde ”torsades de pointes” (uregelmæssig hjerterytme), såsom

antiarytmika (medicin, der bruges til at behandle hjerteproblemer) og nogle antipsykotika

medicin, der kan mindske mængden af natrium i blodet, såsom antidepressiva, antipsykotika,

antiepileptika

medicin til behandling af urinsyregigt (podagra), såsom allopurinol, probenicid, sulfinpyrazon

lægeordineret D-vitamin eller kalktilskud

medicin mod sukkersyge (midler, der synkes såsom metformin, eller insulin)

anden medicin, der sænker blodtrykket, inklusive methyldopa, angiotensin converting enzyme

hæmmer (ACE-hæmmer som fx enalapril, lisinopril, osv.) eller aliskiren

(se også information

under overskrifterne ”Tag ikke Diovan Comp” og ”Advarsler og forsigtighedsregler”)

medicin, der øger blodtrykket, såsom noradrenalin eller adrenalin

digoxin eller andre digitalisglykosider (medicin, der bruges til at behandle hjerteproblemer)

medicin, der kan øge blodsukkeret, såsom diazoxid eller betablokkere

cytotoksisk medicin (mod kræft), såsom methotrexat eller cyclophosphamid

smertestillende midler, såsom non-steroide anti-inflammatoriske midler (NSAID) inklusive

selektive cyklooxygenase-2-hæmmere (Cox-2-hæmmere) og acetylsalicylsyre over 3 gram

muskelafslappende midler, såsom tubocurarin

antikolinerge midler (medicin, der bruges til at behandle forskellige lidelser såsom

mavekramper, urinblærekramper, astma, transportsyge, muskelkramper, Parkinsons sygdom og

som hjælpemiddel til narkose)

amantadin (medicin, der bruges til at behandle Parkinsons sygdom og som også bruges til at

behandle eller forebygge sygdom, som er opstået på grund af en virus)

colestyramin og colestipol (medicin, der hovedsagelig bruges til behandling af forhøjet indhold

af fedt i blodet)

ciclosporin, medicin, der bruges ved organtransplantation for at undgå afstødning

alkohol, sovemedicin og narkosemidler (medicin med søvndyssende eller smertestillende

virkning, der fx bruges under operation)

jod-baserede kontrastmidler (midler, der bruges ved billeddiagnostik)

Diovan Comp sammen med mad, drikke og alkohol

Undgå at indtage alkohol indtil du har talt med din læge. Alkohol kan få dit blodtryk til at falde mere

og/eller øge risikoen for, at du bliver svimmel eller føler, at du er ved at besvime.

Graviditet og amning

Du skal fortælle det til din læge, hvis du tror, du er (eller planlægger at blive) gravid.

Normalt vil din læge råde dig til at stoppe med at tage Diovan Comp, før du bliver gravid, eller så

snart du ved, at du er gravid, og råde dig til at tage anden medicin i stedet for Diovan Comp. Diovan

Comp frarådes i den tidlige periode af graviditeten, og du må ikke tage det, hvis du er mere end

3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på dit barn, hvis det bruges efter

graviditetens tredje måned.

Fortæl det til din læge, hvis du ammer eller skal til at begynde med at amme.

Diovan Comp frarådes til mødre, der ammer, og din læge kan vælge en anden behandling, hvis du

gerne vil amme, især hvis dit barn er nyfødt eller er født for tidligt.

Trafik- og arbejdssikkerhed

Du skal være sikker på, hvordan Diovan Comp påvirker dig, før du kører bil, bruger værktøj eller

betjener maskiner eller udfører andre aktiviteter, der kræver koncentration. Diovan Comp kan, som

megen anden medicin mod forhøjet blodtryk, i sjældne tilfælde give svimmelhed og påvirke evnen til

at koncentrere sig.

3.

Sådan skal du tage Diovan Comp

Tag altid dette lægemiddel nøjagtigt efter lægens anvisning. Det vil hjælpe dig til at opnå den bedste

behandling og mindske risikoen for bivirkninger. Er du i tvivl, så spørg lægen eller på apoteket.

Folk med forhøjet blodtryk har ofte ingen tegn på denne lidelse. Mange føler sig helt raske. Det er

derfor vigtigt, at du overholder dine lægebesøg, selvom du føler dig rask.

Din læge vil fortælle dig helt nøjagtigt, hvor mange Diovan Comp tabletter du skal tage. Afhængig af,

hvordan du reagerer på behandlingen, vil din læge måske foreslå en højere eller lavere dosis.

Den anbefalede dosis Diovan Comp er én tablet daglig.

Du må ikke ændre denne dosis eller holde op med at tage tabletterne uden at tale med din læge.

Medicinen skal tages på samme tidspunkt hver dag, som regel om morgenen.

Du kan tage Diovan Comp med eller uden mad.

Tag tabletten sammen med et glas vand.

Hvis du har taget for meget Diovan Comp

Hvis du oplever kraftig svimmelhed og/eller besvimer, skal du lægge dig ned og omgående kontakte

lægen. Kontakt lægen, skadestuen eller apoteket, hvis du er kommet til at tage for mange tabletter.

Hvis du har glemt at tage Diovan Comp

Hvis du har glemt at tage en dosis, så tag den så snart du kommer i tanker om det. Hvis du snart skal

tage den næste dosis, så spring den glemte dosis over.

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.

Hvis du holder op med at tage Diovan Comp

Dit forhøjede blodtryk kan blive værre, hvis du holder op med at tage Diovan Comp. Du må ikke

stoppe med at tage din medicin, medmindre du har talt med din læge om det.

Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling:

Du skal omgående kontakte din læge, hvis du får symptomer på angioødem, som fx

hævelse i ansigt, tunge eller svælg

synkebesvær

kløende udslæt og svært ved at trække vejret

Svær hudlidelse, der forårsager udslæt, rød hud, blærer på læber, øjne eller mund, afskallende

hud, feber (toksisk epidermal nekrolyse)

Nedsat syn eller øjensmerter på grund af øget tryk i øjet (mulige symptomer på akut lukket-

vinklet glaukom)

Feber, ondt i halsen, hyppigere forekomst af infektioner (agranulocytose)

Disse bivirkninger forekommer meget sjældent eller med en ikke kendt hyppighed (hyppigheden kan

ikke bestemmes ud fra de tilgængelige data).

Hvis du får nogle af disse symptomer, skal du stoppe med at tage Diovan Comp og omgående

kontakte din læge (se også afsnit 2 ”Advarsler og forsigtighedsregler”).

De øvrige bivirkninger omfatter:

Ikke almindelig (forekommer hos op til 1 ud af 100 patienter):

hoste

lavt blodtryk

svimmelhed

dehydrering (med symptomer som tørst, tør mund og tunge, sjældne vandladninger, mørk urin,

tør hud)

muskelsmerter

træthed

stikken/prikken eller følelsesløshed

sløret syn

lyde (fx hvæsen, summen) i ørerne

Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter):

diarré

ledsmerter

Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data):

vejrtrækningsbesvær

kraftigt nedsat vandladningsmængde

lavt natriumindhold i blodet (som kan medføre træthed, forvirring, muskeltrækning og/eller i

alvorlige tilfælde muskelkramper)

lavt kaliumindhold i blodet (undertiden med muskelsvaghed, muskelkramper, unormal

hjerterytme)

lavt antal hvide blodlegemer i blodet (med symptomer som feber, infektioner i huden, ondt i

halsen eller mundsår pga. infektion, svaghed)

for meget bilirubin i blodet (hvilket i alvorlige tilfælde kan farve hud og det hvide i øjnene gult)

for meget blodureanitrogen og kreatinin i blodet (hvilket kan være tegn på unormal

nyrefunktion)

for meget urinsyre i blodet (hvilket i alvorlige tilfælde kan give podagra)

synkope (følelse af at være ved at besvime)

Følgende bivirkninger er set med lægemidler, der indeholder valsartan eller hydrochlorthiazid

alene:

Valsartan

Ikke almindelig (forekommer hos op til 1 ud af 100 patienter):

snurrende følelse

mavesmerter

Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data):

udslæt med eller uden kløe sammen med nogle af de følgende tegn eller symptomer: feber,

ledsmerter, muskelsmerter, hævede lymfekirtler og/eller influenzalignende symptomer

udslæt, purpurfarvede pletter, feber, kløe (symptomer på betændelse i blodkar)

lavt antal blodplader (undertiden med usædvanlige blødninger eller blå mærker)

for meget kalium i blodet (undertiden med muskelkramper, unormal hjerterytme)

allergiske reaktioner (med symptomer såsom udslæt, kløe, nældefeber, vejrtrækningsbesvær

eller synkebesvær, svimmelhed)

hævelser, især i ansigt og hals, udslæt, kløe

forhøjede levertal

nedsat hæmoglobintal og procentdel røde blodlegemer i blodet (som begge i alvorlige tilfælde

kan give blodmangel)

nyresvigt

lavt natriumindhold i blodet (som kan medføre træthed, forvirring, muskeltrækning og/eller i

alvorlige tilfælde muskelkramper)

Hydrochlorthiazid

Meget almindelig

(forekommer hos mere end 1 ud af 10 patienter):

lavt indhold af kalium i blodet

øget indhold af fedtstoffer (lipider) i blodet

Almindelig (forekommer hos op til 1 ud af 10 patienter):

lavt indhold af natrium i blodet

lavt indhold af magnesium i blodet

højt indhold af urinsyre i blodet

kløende udslæt og andre typer udslæt

nedsat appetit

let kvalme og opkastning

svimmelhed, besvimelse, når man rejser sig op

manglende evne til at få eller bibeholde erektion

Sjælden (forekommer hos op til 1 ud af 1.000 patienter):

hævelser og blæredannelse i huden (pga. øget følsomhed over for sol)

højt indhold af calcium i blodet

højt indhold af sukker i blodet

sukker i urinen

forværring af den metaboliske tilstand ved diabetes

forstoppelse, diarré, mave- og tarmbesvær, leversygdomme som kan forekomme samtidig med

gulfarvning af hud eller af det hvide i øjnene

uregelmæssigt hjerteslag (puls)

hovedpine

søvnforstyrrelser

tristhed (depression)

lavt antal blodplader (undertiden med blødninger eller blå mærker under huden)

svimmelhed

prikkende fornemmelse eller følelsesløshed

synsforstyrrelse

Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter):

betændelse i blodkar med symptomer såsom udslæt, purpurrøde pletter, feber (vasculitis)

eksem, kløen, udslæt, vejrtrækningsbesvær eller synkebesvær, svimmelhed

(overfølsomhedsreaktioner)

udslæt i ansigtet, ledsmerter, muskelsygdomme, feber (lupus erythematosus)

kraftige smerter øverst i maven (betændelse i bugspytkirtlen)

vejrtrækningsbesvær sammen med feber, hoste, hiven efter vejret, åndenød

(vejrtrækningsbesvær inklusive lungebetændelse og pulmonært ødem)

bleg hud, træthed, stakåndethed, mørkfarvet urin (hæmolytisk anæmi)

feber, ondt i halsen eller mundsår pga. infektioner (leukopeni)

forvirring, træthed, muskelspjæt og kramper, hurtigt åndedræt (hypokloræmisk alkalose)

Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data):

svaghed, rødmen og hyppige infektioner (aplastisk anæmi)

meget nedsat vandladning (mulige symptomer på nedsat nyrefunktion eller nyresvigt)

udslæt, rød hud, blæredannelse i læber, øjne eller mund, afskallende hud, feber (mulige

symptomer på erythema multiforme)

muskelkramper

feber (pyreksi)

svaghed (asteni)

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder

også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan

også indberette bivirkninger direkte til Lægemiddelstyrelsen (se detaljer herunder). Ved at

indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette

lægemiddel.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

5.

Opbevaring

Opbevar dette lægemiddel utilgængeligt for børn.

Brug ikke Diovan Comp efter den udløbsdato, der står på pakningen. Udløbsdatoen (Exp) er

den sidste dag i den nævnte måned.

Opbevar ikke Diovan Comp ved temperaturer over 30 °C. Opbevares i original pakning for at

beskytte mod fugt.

Brug ikke pakninger af dette lægemiddel, der er beskadiget eller viser tegn på at have været

åbnet.

Spørg på apoteket, hvordan du skal aflevere medicinrester. Af hensyn til miljøet må du ikke

smide medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Diovan Comp 80 mg/12,5 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 80 mg valsartan og

12,5 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 8000, talcum, titandioxid (E 171), rød

jernoxid (E 172) og gul jernoxid (E 172).

Diovan Comp 160 mg/12,5 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 160 mg valsartan og

12,5 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 8000, talcum, titandioxid (E 171) og rød

jernoxid (E 172).

Diovan Comp 160 mg/25 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 160 mg valsartan og

25 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 4000, talcum, titandioxid (E 171), rød

jernoxid (E 172), gul jernoxid (E 172) og sort jernoxid (E 172).

Diovan Comp 320 mg/12,5 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 320 mg valsartan og

12,5 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 4000, talcum, titandioxid (E 171); sort

jernoxid (E 172) og rød jernoxid (E 172).

Diovan Comp 320 mg/25 mg indeholder:

De aktive stoffer er valsartan og hydrochlorthiazid. Hver tablet indeholder 320 mg valsartan og

25 mg hydrochlorthiazid.

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon,

magnesiumstearat.

Filmovertrækket indeholder hypromellose, macrogol 4000, talcum, titandioxid (E 171), gul

jernoxid (E 172).

Udseende og pakningsstørrelser

Diovan Comp 80 mg/12,5 mg

Lys orange, ovale filmovertrukne tabletter, påtrykt ”HGH” på den ene side og ”CG” på den anden

side.

Diovan Comp 160 mg/12,5 mg

Mørkerøde, ovale filmovertrukne tabletter, påtrykt ”HHH” på den ene side og ”CG” på den anden

side.

Diovan Comp 160 mg/25 mg

Brune, ovale filmovertrukne tabletter, påtrykt ”HXH” på den ene side og ”NVR” på den anden side.

Diovan Comp 320 mg/12,5 mg

Lyserøde, ovale, filmovertrukne tabletter med facetslebne kanter, mærket med ”NVR” på den ene side

og ”HIL” på den anden side.

Diovan Comp 320 mg/25 mg

Gule, ovale, filmovertrukne tabletter, mærket med ”NVR” på den ene side og ”CTI” på den anden

side.

Tabletterne findes i blisterpakninger med 7, 14, 28, 56, 98 eller 280 tabletter.

Perforeret enkeltdosis blisterpakninger med 56x1, 98x1 eller 280x1 tabletter er også tilgængelige.

Ikke alle styrker og pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 København S

E-mail: skriv.til@novartis.com

Dette lægemiddel er godkendt i EU/EØSs medlemslande under følgende navne:

Belgien, Luxembourg

Co-Diovane

Bulgarien, Cypern, Den Tjekkiske republik,

Estland, Grækenland, Holland, Irland,

Kroatien, Letland, Litauen, Malta, Polen,

Rumænien, Slovakiet, Slovenien,

Storbritannien

Co-Diovan

Danmark, Finland, Island, Norge, Sverige

Diovan

Comp

Frankrig, Italien

Cotareg

Portugal, Spanien, Tyskland

Co-Diovan

Co-Diovan

forte

Ungarn

Diovan

Østrig

Co-Diovan

Co-Diovan

forte

Co-Diovan

fortissimum

Denne indlægsseddel blev senest ændret januar/2016

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

FDA - U.S. Food and Drug Administration

22-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

FDA - U.S. Food and Drug Administration

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA - U.S. Food and Drug Administration

21-9-2018

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

CVM Update describing FDA Dear Veterinarian Letter about the differences between FDA-approved Mirataz (mirtazapine transdermal ointment), an animal drug with demonstrated safety and effectiveness to manage undesired weight loss in cats, and compounded formulations of transdermal mirtazapine.

FDA - U.S. Food and Drug Administration

18-9-2018

FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids

FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids

FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.

FDA - U.S. Food and Drug Administration

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

13-9-2018

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

13-9-2018

Health Canada advises of a second impurity linked to recalled valsartan drugs

Health Canada advises of a second impurity linked to recalled valsartan drugs

OTTAWA - Health Canada is advising Canadians that a second impurity, called N-nitrosodiethylamine (NDEA) has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China.

Health Canada

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

10-9-2018

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine (NDMA). Health Canada scientists have assessed the available data to determine the potential increased risk of developing cancer, to help put the risk into context for Canadians.

Health Canada

7-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

22-8-2018

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

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

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

16-7-2018

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

13-7-2018

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA - U.S. Food and Drug Administration

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Health Canada

5-7-2018

Recall of valsartan blood pressure medicine

Recall of valsartan blood pressure medicine

Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible to be switched to another type of medicine.

Danish Medicines Agency

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

11-9-2018

Agenda:  Agenda - COMP agenda of the 11-13 September 2018 meeting

Agenda: Agenda - COMP agenda of the 11-13 September 2018 meeting

Europe - EMA - European Medicines Agency

17-8-2018

 Minutes of the COMP meeting of 22-24 May 2018

Minutes of the COMP meeting of 22-24 May 2018

Europe - EMA - European Medicines Agency

17-8-2018

 Minutes of the COMP meeting of 19-21 June 2018

Minutes of the COMP meeting of 19-21 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

17-7-2018

Agenda:  Agenda - COMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - COMP agenda of the 17-19 July 2018 meeting

Draft agenda for the meeting on 17-19 July 2018

Europe - EMA - European Medicines Agency

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration

28-6-2018

 Minutes of the COMP meeting of 17-19 April 2018

Minutes of the COMP meeting of 17-19 April 2018

Europe - EMA - European Medicines Agency

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

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

18-6-2018

Agenda:  Agenda - COMP agenda of the 19-21 June 2018 meeting

Agenda: Agenda - COMP agenda of the 19-21 June 2018 meeting

Committee for Orphan Medicinal Products (COMP) draft agenda for the meeting on 19-21 June 2018

Europe - EMA - European Medicines Agency