Co-Diovan

Glavne informacije

  • Zaščiteno ime:
  • Co-Diovan 160 mg/25 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • hidroklorotiazid 25 mg / 1 tableta; valsartan 160 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla z 28 tabletami (2 x 14 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Co-Diovan 160 mg/25 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • valsartan in diuretiki

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 5363-I-252/11
  • Datum dovoljenje:
  • 28-01-2011
  • EAN koda:
  • 3837000023718
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

NOVARTIS PHARMA AG

Navodilo za uporabo

Co-Diovan 80 mg/12,5 mg filmsko obložene tablete

Co-Diovan 160 mg/12,5 mg filmsko obložene tablete

Co-Diovan 160 mg/25 mg filmsko obložene tablete

Co-Diovan 320 mg/12,5 mg filmsko obložene tablete

Co-Diovan 320 mg/25 mg filmsko obložene tablete

valsartan/hidroklorotiazid

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne

podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo

škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte

se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte

poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Co-Diovan in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Co-Diovan

Kako jemati zdravilo Co-Diovan

Možni neželeni učinki

Shranjevanje zdravila Co-Diovan

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Co-Diovan in za kaj ga uporabljamo

Filmsko obložene tablete Co-Diovan vsebujejo dve zdravilni učinkovini, imenovani valsartan in

hidroklorotiazid. Obe učinkovini pomagata uravnavati visok krvni tlak (hipertenzijo).

Valsartan

sodi v skupino zdravil, znano pod imenom "antagonisti receptorjev angiotenzina II",

ki pomagajo uravnavati visok krvni tlak. Angiotenzin II je snov v telesu, ki povzroči, da se

krvne žile stisnejo, kar povzroči zvišanje krvnega tlaka. Valsartan deluje tako, da zavira

delovanje angiotenzina II. Zato se krvne žile sprostijo in krvni tlak se zniža.

Hidroklorotiazid

sodi v skupino zdravil z imenom tiazidni diuretiki (ki jim pravimo tudi

tablete za odvajanje vode). Hidroklorotiazid povečuje odvajanje vode, kar tudi zniža krvni tlak.

Zdravilo Co-Diovan je namenjeno zdravljenju visokega krvnega tlaka, ki ga ni mogoče uravnati z

uporabo posameznih učinkovin zdravila.

Visok krvni tlak povečuje obremenitev srca in arterij. Če ga ne zdravimo, lahko poškoduje krvne žile v

možganih, srcu in ledvicah, kar lahko povzroči možgansko kap, srčno popuščanje ali odpoved ledvic.

Visok krvni tlak povečuje tveganje za srčni infarkt. Z znižanjem krvnega tlaka se običajno zmanjša

tveganje za razvoj teh bolezni.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Co-Diovan

Ne jemljite zdravila Co-Diovan

če ste alergični (preobčutljivi) na valsartan, hidroklorotiazid, druga sulfonamidna zdravila

(snovi, ki imajo sorodno kemijsko strukturo kot hidroklorotiazd) ali katero koli sestavino tega

zdravila (navedeno v poglavju 6).

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NOVARTIS PHARMA AG

če ste

noseči več kot 3 mesece

(tudi v zgodnji nosečnosti se je bolje izogibati uporabi zdravila

Co-Diovan – glejte poglavje o nosečnosti).

če imate

hudo

bolezen jeter, okvaro malih žolčnih vodov znotraj jeter (biliarno cirozo), zaradi

katere pride do zastoja žolča v jetrih (holestaza).

če imate

hudo

bolezen ledvic.

če v vašem telesu ne more nastajati urin (anurija).

če ste na dializi.

če sta vaši ravni kalija ali natrija v krvi nižji od normalnih ali če je vaša raven kalcija v krvi

višja od normalne kljub zdravljenju.

če imate protin.

če imate sladkorno bolezen ali moteno delovanje ledvic in vas zdravijo z zdravilom za

zniževanje krvnega tlaka, ki vsebuje aliskiren.

Če karkoli od zgoraj navedenega velja za vas, povejte svojemu zdravniku in ne jemljite zdravila

Co-Diovan.

Opozorila in previdnostni ukrepi

Pogovorite se z zdravnikom

če jemljete zdravila, ki varčujejo s kalijem, kalijeve nadomestke, nadomestke soli, ki vsebujejo

kalij, ali druga zdravila, ki zvišujejo količino kalija v krvi, kot je heparin. Zdravnik vam bo

moral verjetno redno pregledovati količino kalija v krvi.

če imate znižano raven kalija v krvi.

če imate drisko ali hudo bruhate.

če jemljete visoke odmerke zdravil za odvajanje vode (diuretikov).

če imate hudo srčno bolezen.

če imate srčno popuščanje ali ste preživeli srčni infarkt: natančno upoštevajte zdravnikova

navodila glede začetnega odmerka. Zdravnik vam bo verjetno pregledal tudi delovanje ledvic.

če imate zožanje ledvične arterije.

če so vam pred kratkim presadili ledvico.

če imate hiperaldosteronizem. To je bolezen, pri kateri vaše nadledvične žleze tvorijo preveč

hormona aldosterona. Če pride do tega pri vas, uporaba zdravila Co-Diovan ni priporočena.

če imate bolezen jeter ali ledvic.

če ste že kdaj v času jemanja drugega zdravila (lahko tudi katerega od zaviralcev ACE) otekli v

jezik ali obraz zaradi alergijske reakcije, ki jo imenujemo angioedem, povejte svojemu

zdravniku. Če pride do teh simptomov pri jemanju zdravila Diovan, ga takoj prenehajte jemati

in tega zdravila ne jemljite nikoli več. Glejte tudi poglavje 4 "Možni neželeni učinki",

če imate zvišano telesno temperaturo, izpuščaj in bolečine v sklepih, kar so lahko znaki

sistemskega eritematoznega lupusa (avtoimunska bolezen, ki ji rečemo tudi SLE).

če imate sladkorno bolezen, protin, visoke ravni holesterola ali trigliceridov v krvi.

če ste imeli alergijsko reakcijo, ko ste uporabljali druga zdravila za zniževanje krvnega tlaka iz

te skupine (antagonistov angiotenzinskih receptorjev II) ali če imate alergijo ali astmo.

če se vam poslabša vid ali začutite bolečine v očesu. To so lahko simptomi zvišanega očesnega

tlaka, pojavijo pa se lahko v času nekaj ur do enega tedna uporabe zdravila Co-Diovan. Če

stanje ni zdravljeno, lahko vodi v trajno okvaro vida. Če ste v preteklosti imeli alergijo na

penicilin ali na sulfonamide, je lahko pri vas večje tveganje, da pride do tega.

če jemljete katero od naslednjih zdravil za zdravljenje visokega krvnega tlaka:

“zaviralci ACE” (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne

težave z ledvicami, ki so povezane s sladkorno boleznijo.

aliskiren,

Zdravnik vam bo morda v rednih presledkih kontroliral delovanje ledvic, krvni tlak in količino

elektrolitov (npr. kalija) v krvi.

Glejte tudi informacije pod naslovom “Ne jemljite zdravila Co-Diovan“.

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NOVARTIS PHARMA AG

Zdravilo

Co-Diovan lahko povzroči povečano občutljivost kože na sončno svetlobo.

Uporaba zdravila Co-Diovan pri otrocih in mladostnikih (starih manj kot 18 let) ni priporočena.

Zdravniku morate povedati če mislite, da ste noseči (ali da bi lahko zanosili

). Uporaba zdravila

Co-Diovan v zgodnjem obdobju nosečnosti ni priporočljiva, po tretjem mesecu nosečnosti pa zdravila

ne smete jemati, saj lahko resno škoduje vašemu otroku, če ga jemljete v tem obdobju (glejte poglavje

o nosečnosti).

Druga zdravila in zdravilo Co-Diovan

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli

jemati katero koli drugo zdravilo.

Sočasno jemanje nekaterih drugih zdravil lahko vpliva na učinek zdravljenja z zdravilom Co-Diovan.

V nekaterih primerih bo treba spremeniti odmerek, izvesti druge ukrepe ali celo prekiniti jemanje

katerega od teh zdravil. To še posebno velja za naslednja zdravila:

litij, zdravilo za zdravljenje nekaterih vrst psihiatričnih bolezni

zdravila oziroma snovi, ki lahko zvišajo količino kalija v krvi, med katere sodijo kalijevi

nadomestki, nadomestki soli, ki vsebujejo kalij, zdravila, ki varčujejo s kalijem, in heparin

zdravila, ki lahko znižajo količino kalija v krvi, kot so diuretiki (zdravila za odvajanje vode),

kortikosteroidi, odvajala, karbenoksolon, amfotericin ali penicilin G

nekatere antibiotike (iz skupine rifamicinov), zdravilo, s katerim preprečujemo zavrnitev

presadka (ciklosporin) in zdravilo, ki deluje proti retrovirusom in ga uporabljamo pri

zdravljenju okužbe z virusom HIV oziroma bolezni AIDS (ritonavir). Navedena zdravila lahko

okrepijo delovanje zdravila Co-Diovan

zdravila, ki lahko sprožijo "torsades de pointes" (nepravilen ritem bitja srca), kot so antiaritmiki

(zdravila za zdravljenje težav s srcem) in nekateri antipsihotiki

zdravila, ki lahko znižajo količino natrija v krvi, kot so antidepresivi, antipsihotiki,

antiepileptiki

zdravila za zdravljenje protina, na primer alopurinol, probenecid, sulfinpirazon

terapevtski nadomestki vitamina D in kalcija

zdravila za zdravljenje sladkorne bolezni (peroralna zdravila, kot je metformin ali insulini)

druga zdravila za zniževanje krvnega tlaka, vključno z metildopo, zaviralci ACE (kot sta

enalapril, lizinopril in podobni) ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite

zdravila Co-Diovan" in "Opozorila in previdnostni ukrepi")

zdravila, ki zvišujejo krvni tlak, kot sta noradrenalin ali adrenalin

digoksin ali drugi glikozidi digitalisa (zdravila za zdravljenje težav s srcem)

zdravila, ki lahko zvišajo raven sladkorja v krvi, kot so diazoksid ali zaviralci adrenergičnih

receptorjev beta

citotoksična zdravila (zdravila za zdravljenje raka), kot sta metotreksat in ciklofosfamid

zdravila proti bolečinam, kot so nesteroidna protivnetna zdravila (NSAIDi), vključno s

selektivnimi zaviralci cikolooksigenaze-2 (COX-2 zaviralci) in acetilsalicilno kislino v odmerku

nad 3 g

zdravila za preprečevanje krčenja mišic, kot je tubokurarin

antiholinergična zdravila (zdravila za zdravljenje različnih bolezni, na primer krčev v prebavilih

ali sečilih, astme, potovalne slabosti, mišičnih krčev, Parkinsonove bolezni in kot dodatno

zdravilo pri anesteziji)

amantadin (zdravilo za zdravljenje Parkinsonove bolezni, uporabljamo pa ga tudi za zdravljenje

ali preprečevanje določenih bolezni, ki jih povzročajo virusi)

holestiramin in holestipol (zdravili, ki ju uporabljamo zlasti pri zdravljenju zvišanih ravni

lipidov v krvi)

ciklosporin, zdravilo, ki preprečuje zavrnitev presajenega organa

alkohol, uspavala in anestetiki (zdravila z uspavalnimi ali protibolečinskimi učinki, ki

omogočajo izvajanje, na primer, kirurških postopkov)

jodirana kontrastna sredstva (sredstva, ki jih uporabljamo pri slikovnih preiskavah)

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NOVARTIS PHARMA AG

Zdravilo Co-Diovan skupaj s hrano, pijačo in alkoholom

Izogibajte se uživanju alkohola, dokler se ne posvetujete s svojim zdravnikom. Zaradi uživanja

alkohola se vam lahko krvni tlak še bolj zniža in/ali se poveča možnost, da postanete vrtoglavi ali

omotični.

Nosečnost in dojenje

Svojemu zdravniku morate povedati, če mislite da ste noseči ali če načrtujete nosečnost.

Zdravnik vam bo praviloma svetoval, da prenehate jemati zdravilo Co-Diovan preden nameravate

zanositi ali takoj, ko izveste, da ste noseči. Svetoval vam bo jemanje drugega zdravila namesto

zdravila Co-Diovan. Jemanje zdravila Co-Diovan v zgodnjem obdobju nosečnosti ni priporočeno. Če

ste noseči več kot tri mesece, zdravila Co-Diovan ne smete jemati, ker lahko jemanje zdravila po

tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.

Povejte svojemu zdravniku, če dojite ali nameravate začeti dojiti.

Uporaba zdravila Co-Diovan ni priporočena za matere, ki dojijo, zato lahko vaš zdravnik izbere drugo

zdravljenje, če želite dojiti, še zlasti, če gre za novorojenčka ali nedonošenčka.

Vpliv na sposobnost upravljanja vozil in strojev

Preden začnete voziti, uporabljati orodje, upravljati stroje ali izvajati druge dejavnosti, ki zahtevajo

zbranost, morate zagotovo vedeti, kako zdravilo Co-Diovan deluje na vas. Kot številna druga zdravila

za zdravljenje visokega krvnega tlaka lahko zdravilo Co-Diovan v redkih primerih povzroči

omotičnost in vpliva na sposobnost koncentracije.

3.

Kako jemati zdravilo Co-Diovan

Pri jemanju tega zdravila natančno upoštevajte zdravnikova navodila. Tako bodo rezultati najboljši in

tveganje neželenih učinkov najmanjše. Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.

Ljudje z visokim krvnim tlakom pogosto ne čutijo nobenih težav, povezanih s tem. Veliko se jih lahko

počuti povsem normalno. Zato je zelo pomembno, da hodite na preglede k svojemu zdravniku, tudi če

se počutite dobro.

Zdravnik vam bo povedal točno koliko tablet zdravila Co-Diovan morate jemati. Glede na vaš odziv

na zdravilo vam bo zdravnik nato morda svetoval višji ali nižji odmerek.

Priporočeni odmerek zdravila Co-Diovan je ena tableta na dan.

Ne spreminjajte odmerka in ne prenehajte jemati tablet, ne da bi se prej pogovorili z

zdravnikom.

Zdravilo je treba vzeti vsak dan ob istem času, običajno je to zjutraj.

Zdravilo Co-Diovan je mogoče jemati s hrano ali brez nje.

Tableto zaužijte s kozarcem vode.

Če ste vzeli večji odmerek zdravila Co-Diovan, kot bi smeli

Če občutite hudo omotičnost in/ali omedlevico, lezite in se takoj povežite s svojim zdravnikom.

Če nehote vzamete preveč tablet, pokličite svojega zdravnika, farmacevta ali v bolnišnico.

Če ste pozabili vzeti zdravilo Co-Diovan

Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite. Če je že skoraj čas za naslednji

odmerek, preskočite odmerek, ki ste ga pozabili vzeti.

Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če prenehate jemati zdravilo Co-Diovan

Prenehanje zdravljenja z zdravilom Co-Diovan lahko povzroči poslabšanje vašega visokega krvnega

tlaka. Ne prenehajte jemati zdravila, razen če vam je tako naročil zdravnik.

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NOVARTIS PHARMA AG

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravstveno oskrbo:

Takoj morate k zdravniku, če pride do simptomov angioedema, kot so:

oteklina obraza, jezika ali žrela

težave s požiranjem

koprivnica in težave z dihanjem

huda kožna bolezen, ki povzroča izpuščaj, rdečo kožo, mehurjast izpuščaj na ustnicah, očeh ali

v ustih, luščenje kože, zvišano telesno temperaturo (toksična epidermalna nekroliza)

poslabšanje vida ali bolečine v očeh zaradi zvišanega očesnega tlaka (možni znaki akutnega

glavkoma zaprtega zakotja)

zvišana telesna temperatura, vneto grlo oziroma žrelo, pogostejše okužbe (agranulocitoza)

Ti neželeni učinki so zelo redki ali pa je njihova pogostnost neznana.

Če opazite katerega koli od teh simptomov, takoj prenehajte jemati zdravilo Co-Diovan in se

posvetujte z zdravnikom (glejte tudi poglavje 2 " Opozorila in previdnostni ukrepi").

Drugi neželeni učinki so:

Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov)

kašelj

nizek krvni tlak

omotičnost

dehidracija (s simptomi žeje, suhih ust in jezika, poredkim mokrenjem, temno obarvanostjo

urina in suho kožo)

bolečine v mišicah

utrujenost

mravljinčenje ali odrevenelost

zamegljen vid

zvoki (na primer sikanje ali brenčanje) v ušesih

Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov)

vrtoglavost

driska

bolečine v sklepih

Neznana pogostnost (je ni mogoče oceniti iz razpoložljivih podatkov)

oteženo dihanje

zelo zmanjšano izločanje urina

znižana koncentracija natrija v krvi (kar lahko povzroči utrujenost, zmedenost in v hujših

primerih trzanje mišic in/ali napad mišičnih krčev)

nizka raven kalija v krvi (včasih z oslabelostjo mišic, mišičnimi krči in nenormalnim ritmom

bitja srca)

zmanjšano število levkocitov v krvi (s simptomi, kot so zvišana telesna temperatura, kožne

okužbe, boleče grlo oziroma žrelo ali razjede v ustih zaradi okužbe, oslabelost)

zvišana raven bilirubina v krvi (ki v hujših primerih lahko povzroči rumene oči in kožo)

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NOVARTIS PHARMA AG

zvišana koncentracija sečninskega dušika in koncentracija kreatinina v krvi (kar lahko kaže na

nepravilno delovanje ledvic)

zvišana raven sečne kisline v krvi (kar v hujših primerih lahko sproži protin)

sinkopa (kratkotrajna izguba zavesti)

Pri zdravilih, ki vsebujejo valsartan ali hidroklorotiazid posamezno, so poročali o naslednjih

neželenih učinkih:

Valsartan

Občasni (lahko se pojavijo pri največ 1 od 100

bolnikov

)

vrtoglavica

bolečine v trebuhu

Neznana pogostnost (je ni mogoče oceniti iz razpoložljivih podatkov)

mehurčasta koža (znaki buloznega dermatitisa)

kožni izpuščaj s srbenjem ali brez njega s pridruženimi naslednjimi znaki ali simptomi: zvišana

telesna temperatura, bolečine v sklepih, bolečine v mišicah, povečane bezgavke in/ali gripi

podobni simptomi

izpuščaj, vijolično rdeče lise, zvišana telesna temperatura, srbenje (simptomi vnetja krvnih žil)

znižano število trombocitov (včasih z neobičajno krvavitvijo ali modrico)

zvišana raven kalija v krvi (včasih z mišičnimi krči, nenormalnim ritmom bitja srca)

alergijske reakcije (s simptomi, kot so izpuščaj, srbenje, urtikarija, oteženo dihanje ali požiranje,

omotičnost)

otekanje pretežno v obraz in žrelo oziroma grlo, izpuščaj, srbenje

zvišane vrednosti jetrnih testov

znižana vrednost hemoglobina in odstotka eritrocitov v krvi (oboje lahko v hujših primerih

sproži slabokrvnost)

odpoved ledvic

znižana koncentracija natrija v krvi (kar lahko povzroči utrujenost, zmedenost in v hujših

primerih trzanje mišic in/ali napad mišičnih krčev)

Hidroklorotiazid

Zelo pogosti (lahko se pojavijo pri več kot 1 od 10

bolnikov

)

znižana raven kalija v krvi

zvišana raven lipidov v krvi

Pogosti (lahko se pojavijo pri največ 1 od 10

bolnikov

)

znižana raven natrija v krvi

znižana raven magnezija v krvi

zvišana raven sečne kisline v krvi

srbeč izpuščaj ali druga vrsta izpuščaja

zmanjšan apetit

blaga slabost in bruhanje

omotičnost, izguba zavesti pri vstajanju

nezmožnost za doseganje ali ohranjanje erekcije

Redki lahko se pojavijo pri največ 1 od 1.000 bolnikov)

otekanje kože in pojavljanje mehurjev (zaradi povečane občutljivosti na sončno svetlobo)

zvišana raven kalcija v krvi

zvišana raven sladkorja v krvi

sladkor v urinu

poslabšanje urejenosti glikemije pri sladkorni bolezni

zaprtost, driska, bolečine v želodcu ali črevesju, bolezni jeter, ki jih spremlja porumenevanje

JAZMP-WS/099_(WS/070) - 09.04.2015

NOVARTIS PHARMA AG

kože in oči

nepravilno bitje srca

glavobol

motnje spanja

potrtost (depresija)

znižano število trombocitov (včasih s krvavitvijo ali z modrico pod kožo)

omotičnost

mravljinčenje ali odrevenelost

motnje vida

Zelo redki( lahko se pojavijo pri največ 1 od 10.000 bolnikov)

vnetje krvnih žil s simptomi, kot so izpuščaj, vijolično rdeče lise, zvišana telesna temperatura

(vaskulitis)

izpuščaj, srbenje, koprivnica, oteženo dihanje ali požiranje, omotičnost (preobčutljivostne

reakcije)

izpuščaj na obrazu, bolečine v sklepih, bolezen mišic, zvišana telesna temperatura (eritematozni

lupus)

huda bolečina v zgornjem delu trebuha (vnetje trebušne slinavke)

oteženo dihanje z zvišano telesno temperaturo, kašljanje, piskajoče dihanje, zadihanost (dihalna

stiska, ki vključuje tudi pljučnico in pljučni edem)

bledica, utrujenost, zadihanost, urin temne barve (hemolitična anemija)

zvišana telesna temperatura, vneto grlo oziroma žrelo ali razjede v ustih zaradi okužbe

(levkopenija)

zmedenost, utrujenost, trzanje mišic in mišični krči, pospešeno dihanje (hipokloremična

alkaloza)

Neznana pogostnost (je ni mogoče oceniti iz razpoložljivih podatkov)

šibkost, modrice in pogoste okužbe (aplastična anemija)

zelo zmanjšano izločanje urina (možni znaki bolezni ledvic ali ledvične odpovedi)

izpuščaj, rdeča koža, mehurjast izpuščaj na ustnicah, očeh ali v ustih, luščenje kože, zvišana

telesna temperatura (možni znaki multiformnega eritema)

mišični krči

zvišana telesna temperatura (vročina)

šibkost (astenija)

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih

lahko poročate tudi neposredno na v nadaljevanju naveden naslov. S tem, ko poročate o neželenih

učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: +386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si

5.

Shranjevanje zdravila Co-Diovan

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.

Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Shranjujte pri temperaturi do 30

C. Shranjujte v originalni ovojnini za zagotovitev zaščite pred

vlago.

JAZMP-WS/099_(WS/070) - 09.04.2015

NOVARTIS PHARMA AG

Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu

odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi

pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Co-Diovan

Zdravilni učinkovini sta valsartan in hidroklorotiazid. Vsaka tableta vsebuje 80 mg, 160 mg ali

320 mg valsartana in 12,5 mg ali 25 mg hidroklorotiazida.

Jedro tablete vsebuje mikrokristalno celulozo, krospovidon, brezvodni koloidni silicijev dioksid,

magnezijev stearat.

Obloga tablete vsebuje hipromelozo, makrogol 8000 (samo 80 mg/12,5 mg in 160 mg/12,5 mg),

makrogol 4000 (samo 160 mg/25 mg, 320 mg/12,5 mg in 320 mg/25 mg), smukec, rdeči železov

oksid (E172, ne 320 mg/25 mg), rumeni železov oksid (E172, samo 80 mg/12,5 mg,

160 mg/25 mg in 320 mg/25 mg ), črni železov oksid (E172, samo 160 mg/25 mg,

320 mg/12,5 mg), titanov dioksid (E171).

Izgled zdravila Co-Diovan in vsebina pakiranja

Co-Diovan 80 mg/12,5 mg filmsko obložene tablete so svetlo oranžne, ovalne tablete z vtisnjeno

oznako HGH na eni in CG na drugi strani.

Co-Diovan 160 mg/12,5 mg filmsko obložene tablete so temno rdeče, ovalne tablete z vtisnjeno

oznako HHH na eni in CG na drugi strani.

Co-Diovan 160 mg/25 mg filmsko obložene tablete so rjave, ovalne tablete z vtisnjeno oznako HXH

na eni in NVR na drugi strani.

Co-Diovan 320 mg/12,5 mg filmsko obložene tablete so roza, ovalne tablete s prirezanimi robovi, z

vtisnjeno oznako NVR na eni in HIL na drugi strani.

Co-Diovan 320 mg/25 mg filmsko obložene tablete so rumene, ovalne tablete s prirezanimi robovi, z

vtisnjeno oznako NVR na eni in CTI na drugi strani.

Tablete so na voljo v pretisnih omotih po 7 tablet (samo 320 mg/12,5 mg in 320 mg/25 mg), 14 tablet,

28 tablet v koledarskem pakiranju, 30 tablet (samo Co-Diovan 80 mg/12,5 mg), 56 tablet, 98 tablet v

koledarskem pakiranju ali 280 tablet. Na voljo so tudi perforirani pretisni omoti z razdelki za

posamezni odmerek s 56x1, 98x1 in 280x1 tableto.

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila Co-Diovan

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Nemčija

Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika

dovoljenja za promet z zdravilom:

Novartis Pharma Services Inc.

Podružnica v Sloveniji

Verovškova 57

SI-1000 Ljubljana

JAZMP-WS/099_(WS/070) - 09.04.2015

NOVARTIS PHARMA AG

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Danska, Finska, Islandija, Norveška, Švedska

Diovan Comp

Avstrija ,Bolgarija, Ciper, Češka, Estonija, Nemčija,

Grčija, Hrvaška, Irska, Latvija, Litva, Malta, Nizozemska,

Poljska, Portugalska, Romunija, Slovaška, Slovenija,

Španija, Velika Britanija

Co-Diovan

Avstrija, Nemčija, Luksemburg, Portugalska, Španija

Co-Diovan forte

Avstrija

Co-Diovan fortissimum

Belgija, Luksemburg

Co-Diovane

Francija, Italija

Co-Tareg

Madžarska

Diovan HCT

Navodilo je bilo nazadnje revidirano dne

09.04.2015

JAZMP-WS/099_(WS/070) - 09.04.2015

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

Peer review of the pesticide risk assessment of the active substance ethoprophos

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 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 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 Member State...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

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

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

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

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

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

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

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

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

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

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

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

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

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

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

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

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

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

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety