Amlodipin "Accord"

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  • Handelsnavn:
  • Amlodipin "Accord" 5 mg tabletter
  • Dosering:
  • 5 mg
  • Lægemiddelform:
  • tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Amlodipin "Accord" 5 mg tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 58723
  • Sidste ændring:
  • 22-02-2018

Produktresumé

23. marts 2018

PRODUKTRESUMÉ

for

Amlodipin "Accord", tabletter

0.

D.SP.NR.

27834

1.

LÆGEMIDLETS NAVN

Amlodipin "Accord"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Amlodipin "Accord" 5 mg tabletter

Hver tablet indeholder amlodipinbesilat svarende til 5 mg amlodipin.

Amlodipin "Accord" 10 mg tabletter

Hver tablet indeholder amlodipinbesilat svarende til 10 mg amlodipin.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Tabletter

5 mg: Hvide, runde (diameter: ca. 6.6 mm), bikonvekse tabletter

10 mg: Hvide, runde (diameter: ca. 8.5 mm), bikonvekse tabletter

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Hypertension.

Kronisk stabil angina pectoris.

Prinzmetals variant angina.

4.2

Dosering og indgivelsesmåde

Dosering

Voksne

Til både hypertension og angina er den sædvanlige initiale dosis 5 mg en gang om dagen.

Dosis øges til maksimalt 10 mg daglig som enkeltdosis, afhængigt af den enkelte patients

respons.

Amlodipin er blevet anvendt til hypertensive patienter i kombination med thiazid-

diuretikum, alfablokker, betablokkere eller ACE-(Angiotensin Converting Enzyme)-

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Side 1 af 12

hæmmer. Amlodipin kan anvendes mod angina som monoterapi eller i kombination med

andre lægemidler mod angina hos patienter, der ikke kan behandles med nitrater og/eller

adækvate doser betablokkere.

Dosisjustering er ikke nødvendig ved samtidig behandling med thiaziddiuretika,

betablokkere og ACE-hæmmere.

Særlige populationer

Ældre patienter

Amlodipin i samme doser tolereres lige godt af ældre som af yngre patienter. Normale

doser anbefales til ældre, men der skal udvises forsigtighed ved dosisøgning (se pkt. 4.4 og

5.2).

Patienter med nedsat leverfunktion

Der er ikke fastsat dosering til patienter med let til moderat nedsat leverfunktion.

Amlodipin bør derfor gives med forsigtighed og bør starte i den lave ende af dosis-

intervallet (se pkt. 4.4 og 5.2). Amlodipins farmakokinetik er ikke undersøgt hos patienter

med svært nedsat leverfunktion. Amlodipinbehandling af patienter med svært nedsat

leverfunktion bør derfor initieres med den laveste dosis og titreres langsomt.

Patienter med nedsat nyrefunktion

Ændringer i amlodipins plasmakoncentration er ikke korreleret til graden af nedsat

nyrefunktion. Amlodipin kan derfor bruges i normale doser. Amlodipin er ikke dialysabel.

Pædiatrisk population

Børn og unge i alderen 6 til 17 år med hypertension

Den anbefalede antihypertensive orale dosis til pædiatriske patienter i alderen 6-17 år er en

initialdosis på 2,5 mg 1 gang dagligt, stigende til 5 mg 1 gang dagligt, hvis målet for

blodtrykket ikke er nået efter 4 uger. Doser over 5 mg daglig er ikke blevet undersøgt hos

børn (se pkt. 5.1 og 5.2).

En dosis på 2,5 mg er ikke mulig med dette præparat.

Børn under 6 år

Der foreligger ingen undersøgelser.

Indgivelsesmåde

Tabletter til oral anvendelse.

4.3

Kontraindikationer

Amlodipin er kontraindiceret til patienter med:

overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af

hjælpestofferne anført i pkt. 6.1.

svær hypotension

shock (herunder kardiogent shock)

obstruktion af venstre ventrikels udløbskanal (f.eks. ved svær grad af aortastenose)

hæmodynamisk ustabil hjerteinsufficiens efter akut myokardieinfarkt.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

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Side 2 af 12

Sikkerhed og effekt af amlodipin ved hypertensiv krise er ikke fastslået.

Patients med hjertesvigt

Patienter med hjertesvigt bør behandles med forsigtighed. I et længerevarende placebo-

kontrolleret forsøg med patienter med svær hjerteinsufficiens (NYHA-klasse III og IV) var

den rapporterede forekomst af lungeødem højere i amlodipingruppen end i placebogruppen

(se pkt. 5.1).

Calciumantagonister, herunder amlodipin, skal anvendes med forsigtighed til patienter med

kongestiv hjerteinsufficiens, da de kan øge risikoen for fremtidige kardiovaskulære

hændelser og mortalitet.

Patienter med nedsat leverfunktion

Amlodipins halveringstid er forlænget og AUC større hos patienter med nedsat

leverfunktion. Der er ikke fastsat dosisanbefalinger. Initialdosis bør derfor være i den lave

ende af dosisintervallet, og der skal udvises forsigtighed både initialt og ved dosisøgning.

Langsom dosistitrering og omhyggelig monitorering kan være nødvendig hos patienter

med svært nedsat leverfunktion.

Ældre patienter

Dosisøgning skal ske med forsigtighed til ældre patienter (se pkt. 4.2 og 5.2).

Patienter med nedsat nyrefunktion

Amlodipin kan bruges hos denne patientkategori i normale doser. Ændringer i amlodipins

plasmakoncentration er ikke korreleret til graden af nedsat nyrefunktion. Amlodipin er ikke

dialysabel.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Andre lægemidlers effekt på amlodipin

CYP3A4-hæmmere:

Samtidig administration af kraftige eller moderate CYP3A4-hæmmere (proteasehæmmere,

svampemidler af azoltypen, makrolider som f.eks. erythromycin og clarithromycin,

verapamil og diltiazem) kan give anledning til en signifikant stigning i eksponeringen for

amlodipin resulterende i en øget risiko for hypotension. Den kliniske betydning af disse

farmakokinetiske variationer kan være mere udtalt hos ældre. Monitorering og

dosisjustering kan være nødvendig.

CYP3A4-induktorer:

Der foreligger ingen data vedrørende effekten af CYP3A4-induktorer på amlodipin.

Samtidig brug af CYP3A4-induktorer (f.eks. rifampicin, prikbladet perikon) kan give en

lavere plasmakoncentration af amlodipin. Forsigtighed bør udvises ved samtidig

anvendelse af amlodipin og CYP3A4-induktorer.

Samtidig indtagelse af amlodipin og grapefrugt eller grapefrugtjuice kan ikke anbefales, da

biotilgængeligheden og derved den hypotensive virkning kan øges hos nogle patienter.

Dantrolen (infusion): Hos dyr er der set letal ventrikelflimren og kardiovaskulært kollaps i

forbindelse med hyperkaliæmi efter indgift af verapamil og dantrolen i.v. Grundet risiko

for hyperkaliæmi anbefales det, at samtidig indgift af calciumantagonister, såsom

amlodipin, undgås hos patienter mistænkt for malign hypertermi og patienter, der

behandles for malign hypertermi.

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Side 3 af 12

Amlodipins effekt på andre lægemidler

Amlodipins blodtrykssænkende effekt er additiv til den blodtrykssænkende effekt af andre

lægemidler med antihypertensiv virkning.

Tacrolimus

Der er risiko for øgede blodniveauer af tacrolimus ved administration samtidig med

amlodipin, men den farmakokinetiske mekanisme bag denne interaktion er ikke

fuldstændig klarlagt. For at undgå toksicitet fra tacrolimus kræver administration af

amlodipin til en patient behandlet med tacrolimus monitorering af blodniveauerne af

tacrolimus og dosisjustering af tacrolimus efter behov.

Cyclosporin

Der er ikke udført interaktionsstudier med ciclosporin og amlodipin hos raske frivillige

forsøgspersoner eller andre populationer med undtagelse af nyretransplanterede patienter,

hvor der sås en variabel stigende dalkoncentration af ciclosporin (gennemsnit 0 %-40 %).

Det bør derfor overvejes at monitorere ciclosporinkoncentrationerne hos nyretrans-

planterede patienter, som får amlodipin, og ciclosporindosen bør reduceres efter behov.

Simvastatin: Administration af gentagne 10 mg amlodipin-doser sammen med 80 mg

simvastatin resulterede i en stigning på 77 % i simvastatin-eksporeringen sammenlignet

med, når simvastatin blev administreret alene. Simvastatin-dosen til patienter, der få

amlodipin, skal begrænses til 20 mg dagligt.

I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin,

digoxin, warfarin eller ciclosporin.

4.6

Graviditet og amning

Fertilitet

Der er rapporteret om reversible biokemiske ændringer i spermatozoers hoveder hos visse

patienter behandles med calciumantagonister. De kliniske data er utilstrækkelige til at

afklare amlodipins potentielle virkning på fertiliteten. Et rottestudie viste påvirkning af

fertiliteten hos hanner (se pkt. 5.3).

Graviditet

Sikkerheden af amlodipin under graviditet er ikke fastslået.

Dyrestudier har påvist reproduktionstoksicitet ved høje doser (se pkt. 5.3).

Brug under graviditet bør kun finde sted, når der ikke er et mere sikkert alternativ, og når

selve sygdommen indebærer en større risiko for moderen og fosteret.

Amning

Amlodipin er blevet fundet hos spædbørn ammet af behandlede kvinder. Virkningen af

amlodipin på spædbørn kendes ikke.

Beslutningen om at fortsætte/ophøre med amning eller fortsætte/ophøre med amlodipin-

behandling bør ske ved afvejning af fordelene ved amning for barnet og fordelene ved

amlodipinbehandling for moderen.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

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Amlodipin kan have mindre til moderat indvirkning på evnen til at føre motorkøretøj eller

betjene maskiner. Hvis patienter, som tager amlodipin, lider af svimmelhed, hovedpine,

træthed eller kvalme kan reaktionsevnen være nedsat. Der skal udvises forsigtighed,

særligt i starten af behandlingen.

4.8

Bivirkninger

enfatning

af sikkerhedsprofilen

De almindeligste bivirkninger set under behandling er søvnighed,

svimmelhed, hovedpine, palpitationer, flushing, abdominalsmerter, kvalme,

hævede ankler, ødemer og træthed.

De følgende bivirkningshyppigheder er observeret og rapporteret ved behandling med

amlodipin: meget almindelig: (

1/10), almindelig: (

1/100 til <1/10), ikke almindelig:

1/1.000 til <1/100), sjælden: (

1/10.000 til <1/1.000), meget sjælden: (<1/10.000).

Inden for hver hyppighedsgruppe er bivirkningerne anført efter grad af alvorlighed, med de

alvorligste bivirkninger først.

Blod og lymfesystem

Meget sjælden: Leukocytopeni, trombocytopeni

Immunsystemet

Meget sjælden: Allergiske reaktioner

Metabolisme og ernæring

Meget sjælden: Hyperglykæmi

Psykiske forstyrrelser

Ikke almindelig: Insomni, humørændringer (herunder angst), depression

Sjælden: Konfusion

Nervesystemet

Almindelig: Søvnighed, svimmelhed, hovedpine (især i begyndelsen af behandlingen)

Ikke almindelig: Rysten, dysgeusi, synkope, hypoæstesi, paræstesi

Meget sjælden: Hypertoni, perifer neuropati

Øjne

Almindelig: Synsforstyrrelser (herunder diplopi)

Øre og labyrint

Ikke almindelig: Tinnitus

Hjerte

Almindelig: Palpitationer

Ikke almindelig: Arytmi (herunder bradykardi, ventrikulær takykardi og atrieflimmer)

Meget sjælden: Myokardieinfarkt

Vaskulære sygdomme

Almindelig: Rødmen

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Side 5 af 12

Ikke almindelig: Hypotension

Meget sjælden: vaskulitis

Luftveje, thorax og mediastinum

Almindelig: Dyspnø

Ikke almindelig: Hoste, rhinitis

Mave-tarm-kanalen

Almindelig: Abdominalsmerter, kvalme, dyspepsi, ændrede tarmvaner (herunder diarré og

obstipation)

Ikke almindelig: Opkastning, mundtørhed

Meget sjælden: Pancreatitis, gastritis, gingival hyperplasi

Lever og galdeveje

Meget sjælden: Gulsot, hepatitis, stigning i leverenzymer*

Hud og subkutane væv

Ikke almindelig: Alopeci, purpura, misfarvning af huden, hyperhidrose, pruritus, udslæt,

exantem

Meget sjælden: Angiødem, erythema multiforme, urticaria, eksfoliativ dermatitis, Stevens-

Johnsons syndrome, Quincke-ødem, fotosensitivitet

Knogler, led, muskler og bindevæv

Almindelig: Hævede ankler, muskelkramper

Ikke almindelig: Myalgi, artralgi, rygsmerter

Nyrer og urinveje

Ikke almindelig: Vandladningslidelser, nykturi, øget vandladningsfrekvens

Det reproduktive system og mammae

Ikke almindelig: Impotens, gynækomasti

Almene symptomer og reaktioner på administrationsstedet

Meget almindelig: Ødem

Almindelig: Træthed, asteni

Ikke almindelig: Brystsmerter, smerter, ubehag

Undersøgelser

Ikke almindelig: Vægtstigning, vægttab, *hyppigst som følge af kolestase

Der er set enkelte tilfælde af ekstrapyramidale symptomer.

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle formodede bivirkninger via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

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E-mail: dkma@dkma.dk

4.9

Overdosering

Erfaringerne med overdosis til mennesker er begrænsede.

Symptomer:

De tilgængelige data tyder på, at stærk overdosering kan resultere i udtalt perifer

vasodilatation og mulig refleks-takykardi. Der er rapporteret markant og sandsynligvis

langvarig systemisk hypotension op til og inklusive shock med dødelig udgang.

Behandling:

Klinisk signifikant hypotension som følge af amlodipin-overdosering kræver aktiv

kardiovaskulær støtte, herunder hyppig monitorering af hjerte- og vejrtrækningsfunktion,

elevation af ekstremiteter og opmærksomhed på cirkulerende væskevolumen og

urinproduktion.

En vasokonstriktor kan være gavnlig til genoprettelse af vaskulær tonus og blodtryk, under

forudsætning af at brugen ikke er kontraindiceret. Intravenøs calciumglyconat kan være

gavnlig til ophævelse af effekten af calciumkanalblokade.

Maveskylning kan være gavnlig i nogle tilfælde. Hos raske forsøgspersoner har brugen af

aktivt kul indtil 2 timer efter administration af 10 mg amlodipin vist sig at reducere den

hastighed, hvormed amlodipin absorberes.

Da amlodipin er stærkt proteinbundet, er det ikke sandsynligt, at dialyse vil have nogen

effekt.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: C 08 CA 01. Selektive calciumantagonister med overvejende vaskulær effekt.

5.1

Farmakodynamiske egenskaber

Amlodipin er en calciumion-influkshæmmer i dihydropyridin-gruppen (langsom

kanalblokker eller calciumantagonist) og hæmmer den transmembrane calciuminfluks i

hjerte- og glat karmuskulatur.

Amlodipins antihypertensive virkning skyldes en direkte afslappende effekt på

karvæggenes glatte muskulatur. Den nøjagtige virkningsmekanisme ved lindring af angina

pectoris er ikke fuldstændigt klarlagt, men amlodipin reducerer den samlede iskæmiske

belastning ved følgende to mekanismer:

Amlodipin dilaterer perifere arterioler og reducerer dermed den samlede perifere

modstand (afterload) mod hjertets arbejde. Da hjertefrekvensen forbliver stabil,

nedsættes det myokardielle energiforbrug og iltbehov.

Amlodipins virkningsmekanisme involverer sandsynligvis også dilatation af de

væsentligste koronararterier og koronararterioler, både i normale og iskæmiske

områder. Denne dilatation øger den myokardielle iltforsyning hos patienter med

spasmer i koronararterierne (Prinzmetals eller variant angina).

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Hos patienter med hypertension reduceres blodtrykket klinisk signifikant i alle døgnets 24

timer både i liggende og i stående stilling ved dosering en gang dagligt. På grund af den

langsomt indsættende virkning er akut hypotension ikke et problem ved behandling med

amlodipin.

Hos patienter med angina pectoris øges den samlede arbejdskapacitet, tiden til angina

pectoris anfald og til 1 mm ST-segment-depression ved dosering af amlodipin en gang

dagligt. Endvidere reduceres hyppigheden af angina pectoris anfald og forbruget af

glyceryltrinitrat-tabletter.

Amlodipin er ikke forbundet med metaboliske bivirkninger eller forandringer i

plasmalipider og kan anvendes til patienter med astma, diabetes og arthritis urica.

Patienter med koronar arteriesygdom (CAD)

Effekten af amlodipin til forebyggelse af kliniske hændelser hos patienter med koronar

arteriesygdom (CAD) er blevet undersøgt i et uafhængigt, multi-center, randomiseret,

dobbelt-blindet placebokontrolleret studie med 1.997 patienter: Comparison of Amlodipine

vs. Enalapril to Limit Occurrences of Thrombosis (CAMELOT). I tillæg til standard-

behandling med statiner, betablokkere, diuretika og acetylsalicylsyre blev 663 patienter

behandlet med amlodipin 5-10 mg, 673 patienter blev behandlet med enalapril 10-20 mg,

og 655 patienter blev behandlet med placebo, i 2 år. De vigtigste virkningsresultater er

anført i tabel 1. Resultaterne indikerer, at amlodipinbehandling var forbundet med færre

hospitalsindlæggelser på grund af angina og revaskulariseringsprocedurer hos patienter

med CAD.

Tabel 1. I Forekomst af signifikante kliniske virkninger for CAMELOT

Forekomst af kardiovaskulære hændelser (%)

Amlopidin vs.

placebo

Virkning

Amlopidin

Placebo

Enalapril

Hazard Ratio

(95 % CI)

P-værdi

Primære endepunkt

Kardiovaskulære

bivirkninger

110 (16,6)

151 (23,1)

136 (20,2)

0,69 (0,54-

0,88)

0,003

De enkelte komponenter

Koronar

revaskularisering

78 (11,8)

103 (15,7)

95 (14,1)

0,73 (0,54-

0,98)

0,03

Indlæggelse pga. angina

51 (7,7)

84 (12,8)

86 (12,8)

0,58 (0,41-

0,82)

0,002

Ikke-letalt MI

14 (2,1)

19 (2,9)

11 (1,6)

0,73 (0,37-

1,46)

0,37

Apopleksi eller TIA

6 (0,9)

12 (1,8)

8 (1,2)

0,50 (0,19-

1,32)

0,15

Kardiovaskulær død

5 (0,8)

2 (0,3)

5 (0,7)

2,46 (0,48-

12,7)

0,27

Indlæggelse pga. CHF

3 (0,5)

5 (0,8)

4 (0,6)

0,59 (0,14-

2,47)

0,46

Genoplivning ved

hjertestop

4 (0,6)

1 (0,1)

0,04

Nye symptomer på

perifer vaskulær lidelse

5 (0,8)

2 (0,3)

8 (1,2)

2,6 (0,50-

13,4)

0,24

Forkortelser: CHF: kongestiv hjerteinsufficiens; CI: konfidensinterval; MI: myokardieinfarkt; TIA:

transitorisk cerebral iskæmi.

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Patienter med hjertesvigt

Hæmodynamiske studier og kliniske studier baseret på arbejdskapaciteten hos patienter i

NYHA klasse II-IV-hjerteinsufficiens viste, at amlodipin ikke førte til en klinisk

forværring målt som arbejdskapacitet, venstre ventrikel-ejektionsfraktion og klinisk

symptomatologi.

Et placebokontrolleret studie (PRAISE), der havde til formål at evaluere patienter med

NYHA-klasse III-IV-hjerteinsufficiens, som fik digoxin, diuretika og ACE-hæmmere,

viste, at amlodipin ikke førte til en stigning i risikoen for mortalitet eller kombineret

mortalitet og morbiditet ved hjerteinsufficiens.

I et opfølgende, placebo-kontrolleret langtidsstudie (PRAISE-2) med amlodipin til

patienter med NYHA III og IV-hjerteinsufficiens - uden kliniske symptomer eller

objektive fund tydende herpå, eller underliggende iskæmisk sygdom – som fik stabile

doser ACE-hæmmere, digitalis og diuretika, havde amlodipin ingen effekt på den totale

kardiovaskulære mortalitet. I den samme population var amlodipin forbundet med en

øgede indberettelser af pulmonært ødem.

Behandling for at forebygge hjerteanfald (ALLHAT-studiet)

Det randomiserede dobbelt-blinde studie, ALLHAT (Antihypertensive and Lipid-Lowering

Treatment to Prevent Heart Attack Trial) er gennemført med henblik på at sammenligne to

nyere behandlinger: amlodipin 2,5-10 mg dagligt (calciumantagonist) eller lisinopril 10-40

mg dagligt (ACE-hæmmer) som førstevalgsbehandling versus chlorthalidon 12,5-25 mg

dagligt (thiaziddiretikum) hos patienter med let til moderat hypertension.

I alt 33.357 hypertensive patienter i alderen 55 år og derover randomiseredes og fulgtes i

gennemsnit 4,9 år. Patienterne havde mindst en yderligere CHD-risikofaktor: Tidligere

myokardieinfarkt eller apopleksi (>6 måneder inden inklusion) eller verificeret anden

aterosklerotisk kardiovaskulær sygdom (totalt 51,5 %), type 2-diabetes (36,1 %), HDL-

kolesterol < 35 mg/dl (11,6%), venstre ventrikel hypertrofi diagnosticeret ved

elektrokardiogram eller ekkokardiografi (20,9 %), aktuel cigaretryger (21,9 %).

Det primære endepunkt var sammensat af letal CHD eller ikke-letalt myokardieinfarkt. Der

var ingen signifikant forskel i det primære endepunkt mellem amlodipingruppen og

chlorthalidongruppen: (RR 0,98; 95 % CI [0,90-1,07]; p = 0,65). I de sekundære

endepunkter, var incidensen af hjerteinsufficiens (komponent i sammensat kardiovaskulært

endepunkt) signifikant højere i amlodipingruppen sammenlignet med chlorthalidongruppen

(10,2 % vs. 7,7 %; RR 1,38; 95 % CI [1,25-1,52]; p < 0,001). Studiet viste dog ingen

forskel i den totale dødelighed uanset årsag mellem amlodipingruppen og chlorthalidon-

gruppen (RR 0,96; 95 % CI [0,89-1,02]; p = 0,20).

Børn (fra 6 år og ældre)

I et studie med 268 børn i alderen 6-17 år med overvejende sekundær hypertension, der

sammenlignede amlodipin 2,5 mg og 5 mg med placebo, reducerede begge amlodipindoser

det systoliske blodtryk signifikant mere end placebo. Forskellen mellem de to doser var

ikke statistisk signifikant.

Amlodipins langtidsvirkninger på vækst, pubertet og generel udvikling er ikke blevet

undersøgt. Langtidsvirkningen af amlodipinbehandling i barndommen på reduktion af

kardiovaskulær morbiditet og mortalitet i voksenlivet er heller ikke klarlagt.

58723_spc.docx

Side 9 af 12

5.2

Farmakokinetiske egenskaber

Absorption/distribution og plasmaproteinbinding:

Efter oral administration af terapeutiske doser absorberes amlodipin godt med maksimal

plasmakoncentration 6-12 timer efter indgift. Den absolutte biotilgængelighed af det

uændrede aktive stof er anslået til mellem 64 og 80 %. Distributionsvolumen er ca. 21 l/kg.

In vitro studier har vist, at ca. 97,5 % af det cirkulerende amlodipin er bundet til

plasmaproteiner.

Absorptionen af amlodipin er upåvirket af fødeindtagelse.

Biotransformation/elimination

Den terminale plasma-halveringstid er ca. 35-50 timer og er forenelig med dosering 1 gang

dagligt. Amlodipin metaboliseres i vid udstrækning i leveren til inaktive metabolitter. 10 %

uomdannet amlodipin og 60 % af metabolitterne udskilles i urinen.

Nedsat leverfunktion

Der er meget få tilgængelige kliniske data vedrørende amlodipin-administration til

patienter med nedsat leverfunktion. Patienter med nedsat leverfunktion har nedsat

amlodipinclearance, hvilket medfører længere halveringstid og en stigning i AUC på ca.

40-60 %.

Ældre population

Tiden, der går før den maksimale plasmakoncentration af amlodipin er nået, er ens hos

ældre og yngre individer. Amlodipins clearance er tilbøjelig til at falde, hvilket resulterer i

stigning i AUC og eliminationshalveringstid hos ældre patienter. Stigningerne i AUC og

eliminationshalveringstid hos patienter med kongestiv hjerteinsufficiens var som forventet

for den undersøgte aldersgruppe.

Pædiatrisk population

Et populationsfarmakokinetisk studie blev udført med 74 hypertensive børn i alderen 1 -17

år (34 patienter var mellem 6 og 12 år, og 28 patienter var mellem 13 og 17 år), der fik

mellem 1,25 mg og 20 mg amlodipin fordelt på enten 1 eller 2 daglige doser. Hos børn

mellem 6 og 12 år og hos teenagere 13-17 år var oral clearance/absorptionsfraktion (CL/F)

typisk hhv. 22,5 og 27,4 l/time hos mænd og 16,4 og 21,3 l/time hos kvinder. Der blev

observeret en stor individuel variation i eksponering. Der er begrænsede data fra børn

under 6 år.

5.3

Prækliniske sikkerhedsdata

Reproduktionstoksikologi

Reproduktionsstudier på rotter og mus har vist forsinket fødsel, forlænget fødsel og nedsat

overlevelse af afkommet ved doser ca. 50 gange højere end de maksimalt anbefalede doser

til mennesker baseret på mg/kg.

Nedsat fertilitet

Der sås ingen effekt på fertiliteten hos rotter behandlet med amlodipin (hanner i 64 dage og

hunner i 14 dage før parring) ved doser op til 10 mg/kg/dag (8 gange* den maksimalt

anbefalede dosis til mennesker på 10 mg baseret på mg/m

). I et andet rottestudie, hvor

58723_spc.docx

Side 10 af 12

hanrotter blev behandlet med amlodipinbesilat i 30 dage med en dosis sammenlignelig med

doser til mennesker baseret på mg/kg, blev der fundet nedsat follikelstimulerendehormon

og testosteron i plasma samt nedsat spermdensitet, antal modne spermatider og

Sertoliceller.

Karcinogenicitet, mutagenicitet

Rotter og mus, der fik amlodipin i foderet i to år ved koncentrationer beregnet til at give

daglige dosisniveauer på 0,5, 1,25 og 2,5 mg/kg viste ingen tegn på karcinogenicitet. Den

højeste dosis (for mus lig med og for rotter dobbelt* den maksimalt anbefalede kliniske

dosis på 10 mg baseret på mg/m

) var tæt på den maksimalt tolererede dosis for mus, men

ikke for rotter.

Mutagenicitetsstudier viste ingen lægemiddelrelaterede virkninger på hverken gen- eller

kromosomniveau.

*Baseret på en patient på 50 kg

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Mikrokrystallinske cellulose

Natriumstivelsesglycolat

Magnesiumstearat

Disodiumhydrogencitrat

Crospovidon

Natriumcroscarmellose

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

6.5

Emballagetyper og pakningsstørrelser

Blisterpakninger af PVC/PVdC-folie og aluminiumfolie.

Pakningsstørrelser:

5 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 og 100 tabletter.

10 mg: 10, 14,20, 28, 30, 50, 60, 90, 98 og 100 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler ved bortskaffelse.

58723_spc.docx

Side 11 af 12

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Accord Healthcare Limited

Sage House, 319, Pinner Road

North Harrow, Middlesex

HA1 4HF

Storbritannien

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

5 mg:

58723

10 mg:

58724

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

6. juni 2017

10.

DATO FOR ÆNDRING AF TEKSTEN

23. marts 2018

58723_spc.docx

Side 12 af 12

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Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

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

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

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

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