Swissmedic Nr.: 53222064
Index: 01.01.30
Pharmacode: 2797770
GTIN/EAN: 7680532220645
Markteintritt: 12.03.1996
Kategorie: A Einmalige Abgabe auf eine ärztliche Verschreibung hin.
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Palladon ist ein Schmerzmittel zur Behandlung mittelstarker bis starker akuter (Palladon) und andauernder (Palladon/Palladon Retard) Schmerzen. Es enthält den Wirkstoff Hydromorphon.
Für die Schmerztherapie stehen Kapseln mit einer normalen Wirkstoff-Freisetzung (Palladon) sowie Kapseln mit verzögerter Wirkstoff-Freisetzung (Palladon Retard) zur Verfügung. Palladon Kapseln wirken 3?4 Stunden. Nach der Einnahme von Palladon Retard wird das Hydromorphon im Magen-Darm-Trakt langsam herausgelöst und in den Körper aufgenommen. Die schmerzhemmende Wirkung von Palladon Retard hält deshalb über etwa 9?12 Stunden an. Palladon darf nur auf Verschreibung und unter regelmässiger Kontrolle des Arztes oder der Ärztin verwendet werden.
Wenn Sie überempfindlich (allergisch) gegen den Wirkstoff Hydromorphon oder einen der Hilfsstoffe sind,
wenn Sie schwere Atembeschwerden haben,
bei akuten Bauchschmerzen, bestehender Lähmung der Darmtätigkeit (paralytischer Ileus), akuter Lebererkrankung, verzögerter Magenentleerung,
bei Bewusstlosigkeit, schweren Kopfverletzungen (bei erhöhtem Hirndruck), Anfallsleiden oder erhöhter Krampfbereitschaft, Alkoholdelirium (Delirium tremens),
wenn Sie gleichzeitig ein Arzneimittel aus der Gruppe der Monoaminoxidase-Inhibitoren einnehmen (gewisse Arzneimittel gegen Depressionen oder Parkinsonkrankheit) oder während der letzten 2 Wochen eingenommen haben (konsultieren Sie Ihren Arzt oder Ihre Ärztin!).
Bei bekannter Opioidabhängigkeit,
bei Kopfverletzungen,
bei Alkoholabhängigkeit,
bei psychischen Störungen, die mit einem (teilweisen) Realitätsverlust einhergehen (Psychosen) und durch Alkohol oder Vergiftungszustände mit anderen Substanzen bedingt sind (Intoxikationspsychosen),
bei niedrigem Blutdruck verbunden mit geringer zirkulierender Blutmenge,
bei Bewusstseinsstörungen,
bei Gallenwegserkrankungen, Gallen- oder Nierenkolik,
bei Entzündung der Bauchspeicheldrüse (Pankreatitis),
bei mit Verengungen einhergehenden (obstruktiven) oder entzündlichen Darmerkrankungen,
bei krankhaft vergrösserter Prostata (Prostatahypertrophie),
bei Nebennierenrinden-Funktionsschwäche (Addisonscher Krankheit),
bei Unterfunktion der Schilddrüse,
bei Atembeschwerden,
bei Kindern unter 12 Jahren,
bei älteren oder geschwächten Patienten.
Bei längerfristiger Anwendung von Palladon kann es zur Entwicklung einer Toleranz kommen. Das bedeutet, dass Sie höhere Dosen zum Erzielen des erwünschten schmerzlindernden Effekts benötigen könnten.
Bei missbräuchlicher Anwendung von Palladon besteht, wie auch bei anderen Opioiden, das Risiko einer Abhängigkeit. Ganz selten kann das auch bei vorschriftsgemässer Einnahme vorkommen. Es ist deshalb wichtig, dass Sie Palladon nur auf Verschreibung Ihres Arztes bzw. Ihrer Ärztin und genau nach seinen/ihren Anweisungen einnehmen. Bei Absetzen der Therapie sind die Anweisungen des Arztes bzw. der Ärztin sorgfältig zu beachten (z.B. stufenweises Absetzen).
Wenn Sie eine Operation vor sich haben, sagen Sie dem Spitalarzt/der Spitalärztin, dass Sie Palladon nehmen.
Palladon kann die Wirkung anderer Arzneimittel wie Narkose-, Schlaf- und Beruhigungsmittel, gewisse Arzneimittel gegen Depressionen (Antidepressiva) und Alkohol verstärken.
Auf Alkohol-Einnahme ist während der Behandlung mit Palladon zu verzichten.
Palladon Kapseln enthalten Lactose. Bitte nehmen Sie Palladon Kapseln daher erst nach Rücksprache mit Ihrem Arzt oder Ihrer Ärztin ein, wenn Ihnen bekannt ist, dass Sie unter einer Unverträglichkeit gegenüber bestimmten Zuckern leiden.
Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigen!
Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden!
Palladon soll während einer Schwangerschaft nicht eingenommen werden. Ihr Arzt/Ihre Ärztin kann allerdings Ausnahmen machen. Während der Behandlung mit Palladon dürfen Sie nicht stillen.
Nehmen Sie Palladon/Palladon Retard immer genau nach Anweisung des Arztes bzw. der Ärztin ein. Bitte fragen Sie bei lhrem Arzt/Ihrer Ärztin bzw. Ihrem Apotheker/Ihrer Apothekerin nach, wenn Sie nicht ganz sicher sind. Die Dosierung hängt von der Stärke Ihrer Schmerzen und Ihrer individuellen Empfindlichkeit ab.
Die Einnahme von Palladon Kapseln erfolgt normalerweise alle 4 Stunden. Die übliche Dosierung bei Behandlungsbeginn ist 1 Palladon 1,3 mg oder 2,6 mg Kapsel alle 4 Stunden. Bei Bedarf wird der Arzt/die Ärztin die Dosierung schrittweise erhöhen.
Die Einnahme von Palladon Retard erfolgt normalerweise alle 12 Stunden. Die übliche Dosierung bei Behandlungsbeginn ist 2× täglich 1 Palladon Retard 4 mg Kapsel. Bei Bedarf wird der Arzt/die Ärztin die Dosierung schrittweise erhöhen und/oder die Einnahmehäufigkeit auf 3× täglich festsetzen. Falls Ihnen der Arzt/die Ärztin Palladon Retard 3× täglich verordnet, erfolgt die Einnahme in Abständen von 8 Stunden.
Palladon und Palladon Retard Kapseln sind mit einem Getränk ganz zu schlucken. Bei Schluckschwierigkeiten können die Kapseln geöffnet werden und deren Inhalt auf weiche Nahrung (z.B. Joghurt, Eiscreme, Brei) gestreut eingenommen werden. Es ist darauf zu achten, dass der ganze Kapselinhalt (z.B. auf einen Löffel mit weicher Nahrung gestreut) ohne zu kauen oder zu zerbeissen sofort eingenommen wird.
Halten Sie sich genau an den vom Arzt/von der Ärztin vorgeschriebenen Einnahmerhythmus. Um vor den Schmerzen oder ihrem Wiederauftreten optimal geschützt zu sein, ist es wichtig, dass die Kapseln in den vom Arzt/von der Ärztin bestimmten Abständen eingenommen werden. Warten Sie nicht mit der Einnahme, bis Sie wieder Schmerzen verspüren.
Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer Ärztin oder Apothekerin.
Wenn Sie mehr Palladon bzw. Palladon Retard als verordnet eingenommen haben, sollten Sie sofort Ihren Arzt bzw. Ihre Ärztin informieren.
Folgende Nebenwirkungen können bei der Einnahme von Palladon auftreten:
Häufige Nebenwirkungen sind Appetitabnahme, Angst, Verwirrtheit, Schlaflosigkeit, Schwindel, Schläfrigkeit, Blutdruckabfall, Bauchschmerzen, Verstopfung, Übelkeit und Erbrechen, Mundtrockenheit, Juckreiz, Schwitzen, Harnverhalten sowie verstärkter Harndrang, Schwächezustände.
Gelegentlich treten auf: Depression, Missstimmung, Euphorie, Halluzinationen, Albträume, Kopfschmerzen, Zittern oder unwillkürliche Muskelzuckungen, Missempfindungen, Verengung der Pupillen, verschwommenes Sehen, Herzrasen, Atemnot, Verdauungsstörungen, Durchfall, Geschmacksstörungen, vermindertes sexuelles Verlangen, Erektionsstörungen, Hautausschlag, juckender Ausschlag (Nesselsucht), Gewöhnung bei längerfristiger Anwendung.
Selten: Unruhe, Krampfanfälle, Müdigkeit bis Benommenheit, Verlangsamung der Herzfrequenz, Herzklopfen, erschwertes Atmen, Gallenkoliken, Rötung des Gesichtes.
Sehr selten: Überempfindlichkeit, gesteigerte Schmerzempfindlichkeit, Darmverschluss, Wassereinlagerung in den Gliedern (Ödeme).
Bei vermuteter Überdosierung ist sofort der Arzt/die Ärztin zu benachrichtigen, der/die entsprechende Gegenmassnahmen einleiten wird. Zeichen einer Überdosierung sind verengte Pupillen, extreme Verlangsamung der Atmung, tiefer Blutdruck, narkoseartige Zustände.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Arzneimittel. Nicht in Reichweite von Kindern aufbewahren.
Vor Feuchtigkeit schützen, bei Raumtemperatur (15?25 °C) und in der Originalpackung (Blister) lagern.
Nach Beendigung der Behandlung das Arzneimittel mit dem restlichen Inhalt Ihrer Abgabestelle (Arztpraxis, Apotheke) zur fachgerechten Entsorgung zurückbringen.
Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet werden.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Wirkstoff: Hydromorphonhydrochlorid.
1 Kapsel enthält 1,3 mg bzw. 2,6 mg Hydromorphonhydrochlorid.
Hilfsstoffe: Lactose, Farbstoff Erythrosin (E 127) sowie weitere Hilfsstoffe.
1 Kapsel enthält 4 mg, 8 mg, 16 mg bzw. 24 mg Hydromorphonhydrochlorid.
Palladon Retard 4 mg: Farbstoffe Erythrosin (E 127), Indigocarmin (E 132) sowie weitere Hilfsstoffe.
Palladon Retard 8 mg: Farbstoff Erythrosin (E 127) sowie weitere Hilfsstoffe.
Palladon Retard 16 mg: Hilfsstoffe zur Herstellung.
Palladon Retard 24 mg: Farbstoff Indigocarmin (E 132) sowie weitere Hilfsstoffe.
53222, 53223 (Swissmedic).
In Apotheken gegen ärztliche Verschreibung, die nur zum einmaligen Bezug berechtigt.
Untersteht dem Bundesgesetz über die Betäubungsmittel und die psychotropen Stoffe.
Packungen zu je 30 und 60 Kapseln.
Mundipharma Medical Company, Hamilton/Bermuda, Zweigniederlassung Basel.
Diese Packungsbeilage wurde im Juni 2011 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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