Spasmo-lyt

Primær information

  • Handelsnavn:
  • Spasmo-lyt 20 mg overtrukne tabletter
  • Dosering:
  • 20 mg
  • Lægemiddelform:
  • overtrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Spasmo-lyt 20 mg overtrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 31307
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Information om

Spasmo-lyt

Overtrukne tabletter 20 mg

Læs denne information godt igennem før du begynder at tage medicinen.

• Gem denne information. Du får måske brug for at læse den igen.

• Kontakt læge eller apotek, hvis du har spørgsmål til behandlingen.

• Lægen har ordineret Spasmo-lyt® til dig personligt. Giv derfor ikke medicinen til andre.

Indholdsfortegnelse:

1. Virkning og anvendelse

2. Vigtig information som du skal læse, før du tager Spasmo-lyt®

3. Sådan skal du tage Spasmo-lyt®

4. Bivirkninger

5. Opbevaring

6. Yderligere information

Spasmo-lyt® indeholder:

Det aktive indholdsstof i Spasmo-lyt® er trospiumchlorid 20 mg.

De øvrige indholdsstoffer er: Saccharose, hvedestivelse, mikrokrystallinsk cellulose, talcum,

lactosemonohydrat,

calciumcarbonat

(E170),

titandioxid

(E171),

stearinpalmitinsyre,

croscarmellosenatrium, povidon, macrogol 8000, kolloid vandfri silica, jernhydroxid (E172),

carmellosenatrium, bivoks og carnaubavoks.

Henvisning til diabetikere: 1 overtrukket tablet svarer til 0,06 g kulhydrat svarende til 0,005 BE.

Markedsføring i Danmark

Fremstiller

Repræsentant i Danmark

MADAUS AG

MADAUS AG

Meda AS, Solvang 8, 3450 Allerød

D-51101 Køln

D-51101 Køln

Telefon: 44 52 88 88, Fax: 44 52 88 99

Tyskland

Tyskland

E-mail: info.dk@meda.se

1. Virkning og anvendelse

Spasmo-lyt® 20 mg er en rund gullig sukkerovertrukken tablet.

Spasmo-lyt® tilhører gruppen af krampeløsende midler (spasmolytika) og har en afs-

lappende virkning på urinblæren.

Spasmo-lyt®

anvendes

behandling

unormalt

hyppige

vandladninger,

hyppig

vandladningstrang

hyppig,

ufrivillig

urinafgang

forbindelse

slap

eller

over-

reagerende blæremuskulatur.

Lægen kan have foreskrevet anden anvendelse. Følg altid lægens anvisning.

2. Vigtig information som du skal læse, før du tager Spasmo-lyt®

Tag ikke Spasmo-lyt® ved:

• Tilbageholdelse af urin i blæren i forbindelse med godartede blærehalsskirtelsvulster, grøn

stær med snæver kammervinkel, hurtig og uregelmæssig hjerterytme, udtalt muskelslaphed

(myastenia gravis), svær ulcerøs colitis (blødende tyktarmbetændelse) og svær forstoppelse

med udvidelse af tyktarmen.

Må ikke anvendes af dialysepatienter.

Må ikke anvendes til børn under 12 år.

Særlige forholdsregler

Hos patienter med nedsat nyrefunktion er en nedsættelse af dosis sædvanligvis nødvendig.

Døgndosis bør ikke overskride 20 mg trospiumchlorid svarende til en overtrukken tablet.

Spasmo-lyt® bør anvendes med forsigtighed, hvis du lider af en af følgende sygdomme:

• Blokerende tilstande i mavetarmkanalen såsom forsnævringer af maveporten

• Blokerende urinveje med risiko for ophobning af urin i blæren

• Autonom neuropati (nervelidelse i den del af nervesystemet, der ikke er underlagt viljen)

• Mellemgulvsbrok kombineret med tilbageløb i spiserøret

• Sygdomstilstande ved hvilken en forhøjelse af hjertefrekvensen er uønsket, som f.eks.

forstørret skjoldbruskkirtel, hjertesygdomme med forandringer i koronararterien samt

hjertesvækkelse og dermed følgende kredsløbsforstyrrelse.

• Nedsat leverfunktion

• Nedsat nyrefunktion

Vigtig information om nogle af de øvrige indholdsstoffer i Spasmo-lyt®

Spasmo-lyt®

indeholder

hvedestivelse,

bør

personer,

lider

cøliaki

(svære

fordøjelsesforstyrrelser, som skyldes overfølsomhed overfor gluten i maden) ikke behandles

med Spasmo-lyt® uden lægens anvisning.

Graviditet og amning

Få vejledning hos lægen eller på apoteket før du tager nogen form for medicin.

Graviditet:

Spasmo-lyt®

bør

anvendes

under

graviditet,

hvis

tvingende

nødvendigt.

Rådfør

derfor

lægen

inden

anvendelse

Spasmo-lyt®

under

graviditet.

Amning:

Spasmo-lyt® går over i modermælken i små mængder. Rådfør dig derfor med

lægen før anvendelse under amning.

Trafik- og arbejdssikkerhed

Spasmo-lyt® nedsætter ikke evnen til at betjene maskiner eller køre bil. Da Spasmo-lyt®

imidlertid kan påvirke øjets evne til at stille skarpt på forskellig afstand, kan evnen til at køre

bil eller betjene maskiner principielt påvirkes ved anvendelse af Spasmo-lyt®.

226 911 Spasmolyt Dansk 10.01.2005 16:17 Uhr Seite 1

Brug af anden medicin

Behandlingen med visse andre lægemidler kan påvirkes af Spasmo-lyt®. Således kan

virkningen af følgende lægemidler forstærkes ved samtidig indtagelse af Spasmo-lyt®:

• Amantadin (et lægemiddel, der bl.a. anvendes til behandling af Parkinson sygdom

(rystesyge))

• Visse lægemidler mod depression (såkaldte tricykliske antidepressiva)

• Kinidin (et lægemiddel, der bl.a. anvendes til behandling af hjerterytmeforstyrrelser)

• Antihistaminer (en gruppe lægemidler, der anvendes til behandling af overfølsomheds-

reaktioner)

• Disopyramid (et lægemiddel, der anvendes til behandling af hjerterytmeforstyrrelser)

• Betareceptorstimulerende lægemidler (lægemidler, der bl.a. anvendes til behandling af

astma, til stimulation af hjertet samt til hindring af, at livmoderen trækker sig sammen)

Da Spasmo-lyt® kan påvirke tarmmotorikken og udskillelsen af tarmsaft, kan det ikke

udelukkes, at optagelsen af andre lægemidler vil kunne ændres.

Virkningen af metoclopramid og cisaprid (lægemidler, der bl.a. anvendes til stimulation af

tarmmotorikken) kan nedsættes ved samtidig indtagelse af Spasmo-lyt®.

Da optagelsen af trospiumchlorid kan nedsættes af andre stoffer som guar (et stof der

indtaget i passende mængder kan regulere blodsukkerkoncentrationen), cholestyramin og

cholestipol (lægemidler der sænker fedtindholdet i blodet) bør en samtidig indtagelse

undgås.

Fortæl lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig. Det

gælder også for medicin, som ikke er på recept, naturlægemidler samt stærke vitaminer og

mineraler.

3. Sådan skal du tage Spasmo-lyt®

Dosering

Voksne:

Normaldosis til voksne er 1 tablet 2 gange daglig (svarende til 40 mg trospium-

chlorid daglig).

Børn: Må ikke anvendes til børn under 12 år.

Nedsat nyrefunktion: Ved nedsat nyrefunktion er normaldosis 1 tablet daglig eller hver anden

dag (svarende til 20 mg trospiumchlorid daglig eller hver anden dag). Følg lægens anvisning.

Tabletterne skal synkes hele og indtages med et glas vand før et måltid på tom mave. Med

regelmæssige mellemrum på ca. 3 – 6 måneder vil lægen vurdere, om det er nødvendigt at

fortsætte behandlingen. Følg altid lægens anvisning. Der er forskel på, hvad den enkelte har

brug for. Ændring eller stop i behandlingen bør kun ske i samråd med lægen.

Har du taget for meget Spasmo-lyt®?

Søg straks lægehjælp, hvis du har taget mere af Spasmo-lyt®, end der står i denne infor-

mation, eller mere end lægen har foreskrevet. Symptomer på overdosering er udtalt

mundtørhed, hurtig hjerterytme og vandladningsforstyrrelser. Behandling af overdosering

foretages af hospital/læge med bl.a. skylning af mavesækken og intensiv behandling af

symptomerne.

4. Bivirkninger

Spasmo-lyt® kan som al anden medicin give bivirkninger.

Ikke alvorlige bivirkninger:

Almindeligt forekommende bivirkninger ved normal dosering (forekommer hos mellem 1 og

10 ud af 100 behandlede) er mundtørhed på grund af hæmning af spytsekretionen,

fordøjelsesforstyrrelser, mavesmerter, kvalme eller forstoppelse.

sjældne

tilfælde

(forekommer

mellem

10.000

behandlede)

forekomme

vandladningsforstyrrelser

(f.eks.

ufuldstændig

blæretømning

eller

tilbage-

holdelse af urin), øget hjerterytme, påvirkning af øjets evne til at se skarpt (især hos

langsynede uden tilstrækkelig synskorrektion), diarre, luft i maven, åndenød, hududslæt,

brystsmerter, almen svækkelse. Enkelte tilfælde af uregelmæssig hurtig puls, tilbageholdelse

af urin i blæren, samt hævelse i huden som følge af forstyrrelse i blodkarnervefunktionen er

forekommet.

Fortæl lægen eller apoteket, hvis du får andre bivirkninger end dem, der står her, så

bivirkningerne kan blive indberettet til Lægemiddelstyrelsen, og viden om bivirkninger kan

blive bedre.

Fortæl lægen eller apoteket, hvis du får bivirkninger, der bliver ved og er generende. Nogle

bivirkninger

kræve

behandling.

Patienter

eller

pårørende

også

indberette

bivirkninger direkte til Lægemiddelstyrelsen.

finder

skema

vejledning

under

bivirkninger

Lægemiddelstyrelsens

netsted:

http://www.laegemiddelstyrelsen.dk/.

5. Opbevaring

Opbevar Spasmo-lyt® utilgængeligt for børn.

Anvend ikke Spasmo-lyt® efter den udløbsdato, der er anført på pakningen.

6. Yderligere information

Aflever altid eventuelle medicinrester på apoteket.

Revideret november 2004

Mat.-Nr.: 226 911

12.04

226 911 Spasmolyt Dansk 10.01.2005 16:17 Uhr Seite 2

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