Swissmedic Nr.: 60020004
Index: 02.03.00
Pharmacode: 5637759
GTIN/EAN: 7680600200043
Markteintritt: 18.02.2010
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Nebivolol Spirig HC enthält den Wirkstoff Nebivolol, der zur Gruppe der Betarezeptorenblocker gehört. Nebivolol Spirig HC wird eingesetzt in der Behandlung von Bluthochdruck (Hypertonie) und chronischer Herzschwäche (Herzinsuffizienz).
Das Arzneimittel darf nur auf Verschreibung des Arztes oder der Ärztin angewandt werden.
Nebivolol Spirig HC darf nicht eingenommen werden bei Überempfindlichkeit gegenüber Nebivolol oder einem der Hilfsstoffe, bei Leberfunktionsstörungen, vom Herzen ausgehenden (kardiogenen) Schockzuständen, unbehandelter akuter Herzschwäche (Herzinsuffizienz) oder bei Schwangerschaft und in der Stillzeit.
Wie andere Betarezeptorenblocker darf Nebivolol Spirig HC nicht angewendet werden bei: der Herzrhythmusstörung Sinusknoten-Syndrom (Sick-Sinus-Syndrom), einer Herzrhythmusstörung, bestimmten Erregungsleitungsstörungen am Herzen (SA-Block, AV-Block 2. und 3. Grades), Bronchialverkrampfung und Asthma in der Vorgeschichte, bestimmten unbehandelten Tumoren der Nebenniere (Phäochromozytom), Übersäuerung des Blutes (metabolische Azidose), einer Herzfrequenz in Ruhe unter 50 Schlägen pro Minute (Bradykardie), krankhaft niedrigem Blutdruck (Hypotonie) sowie schweren Durchblutungsstörungen in den Gliedmassen.
Die folgenden Vorsichtsmassnahmen gelten allgemein für Betarezeptorenblocker wie Nebivolol Spirig HC. Unter den folgend aufgeführten Bedingungen soll Nebivolol Spirig HC nur mit Vorsicht angewendet werden.
Informieren Sie deshalb Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie eine oder mehrere der untenstehenden Bedingungen aufweisen oder im Laufe der Therapie mit Nebivolol Spirig HC entwickeln.
Ungewöhnlich niedriger Puls (Bradykardie): Ruhepuls unter 50?55 Schlägen pro Minute und/oder Zeichen wie Schwindel, Schwäche und Gangunsicherheit.
Herzerkrankungen (z.B. Angina pectoris, ischämische Herzkrankheiten, Reizleitungsstörungen). Durchblutungsstörungen in den Armen und Beinen. Anhaltende Atembeschwerden, insbesondere chronische, die Atmung behindernde Erkrankungen.
Diabetes: Nebivolol Spirig HC hat keinen Einfluss auf den Blutzucker, aber es kann die Anzeichen eines zu tiefen Blutzuckers (Nervosität, Zittern, hoher Puls) verdecken.
Schilddrüsenüberfunktion: ein erhöhter Puls, der ein Krankheitszeichen ist, kann durch Nebivolol Spirig HC verdeckt werden. Beim abrupten Absetzen des Arzneimittels besteht die Gefahr einer erhöhten Herzschlagfrequenz (Tachykardie).
Allergien: Nebivolol Spirig HC kann die Reaktion auf Pollen oder andere Substanzen verstärken.
Schuppenflechte (Psoriasis): Patienten mit bestehender oder aus der Vorgeschichte bekannter Schuppenflechte sollten Nebivolol Spirig HC nur nach sorgfältiger Abwägung einnehmen.
Bestimmte Arzneimittel zur Behandlung von Herzerkrankungen (Calciumantagonisten, Antiarrhythmika, Clonidin und Digitalis), Narkosemittel, Mittel zur Behandlung von Magengeschwüren, bestimmte sympathomimetisch wirkende Substanzen und Arzneimittel, die bei Depressionen und Schlaflosigkeit eingesetzt werden, beeinflussen die Wirkung von Nebivolol Spirig HC bzw. werden in ihrer Wirkung durch Nebivolol Spirig HC beeinflusst. Bitte teilen Sie Ihrem Arzt bzw. Ihrer Ärztin mit, wenn Sie solche Arzneimittel einnehmen, da eine Dosisanpassung notwendig sein kann.
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!
Über die Sicherheit von Nebivolol Spirig HC in der Schwangerschaft beim Menschen liegen nur unzureichende Daten vor. Es ist jedoch bekannt, dass Betablocker die Durchblutung der Plazenta reduzieren, was zum Tod des Fetus während der Schwangerschaft oder einer frühzeitigen Geburt führen könnte und zudem besteht die Möglichkeit von Nebenwirkungen beim Fetus und beim Neugeborenen. Deshalb soll Nebivolol Spirig HC in der Schwangerschaft nicht verwendet werden.
Da die Möglichkeit besteht, dass Nebivolol in die Muttermilch ausgeschieden wird, darf das Arzneimittel auch in der Stillzeit nicht eingenommen werden.
Die folgenden Angaben gelten, soweit Ihnen Ihr Arzt bzw. Ihre Ärztin Nebivolol Spirig HC nicht anders verordnet hat.
Im Allgemeinen beträgt die Dosierung für Erwachsene eine Tablette zu 5 mg täglich. Bis zur optimalen blutdrucksenkenden Wirkung dauert es ca. 1?2 Wochen, gelegentlich bis zu 4 Wochen.
Bei Patienten mit eingeschränkter Nierenfunktion und bei Patienten über 65 Jahren beträgt die empfohlene Anfangsdosis eine halbe Tablette täglich und kann wenn erforderlich auf 1 Tablette erhöht werden.
Die Behandlung der stabilen chronischen Herzinsuffizienz wird mit einer tiefen Dosis begonnen, gefolgt von einer schrittweisen, wöchentlichen Erhöhung der Dosis, bis die optimale Erhaltungsdosis erreicht ist. Die Anfangsdosis ist üblicherweise eine viertel Tablette (= 1,25 mg) pro Tag und wird je nach Bedarf bis auf 2 Tabletten (= 10 mg) täglich erhöht.
Nach der ersten Dosis sowie nach jeder weiteren Dosisänderung werden Sie vom Arzt überwacht um sicherzustellen, dass Ihr Zustand stabil bleibt.
Nebivolol Spirig HC wird zusätzlich zu einer Standardtherapie eingesetzt.
Die Tabletten können mit einer Mahlzeit, vorzugsweise immer zur selben Tageszeit, eingenommen werden.
Legen Sie die Tablette mit der Kreuzbruchrille nach oben auf eine ebene und harte Unterlage. Brechen Sie nun die Tablette entlang der Bruchrille, indem Sie sie mit beiden Zeigefingern auf die Unterlage drücken. Um eine viertel Tablette zu erhalten, wiederholen Sie bitte die Teilung mit einer halben Tablette wie bereits beschrieben.
Die Dauer der Behandlung mit Nebivolol Spirig HC wird vom Arzt festgelegt und ist abhängig von der Erkrankung.
Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, sprechen Sie mit Ihrem Arzt oder Apotheker bzw. Ihrer Ärztin oder Apothekerin.
Folgende Nebenwirkungen können bei der Einnahme von Nebivolol Spirig HC auftreten:
Bei der Therapie der chronischen Herzschwäche treten sehr häufig (über 10 %) Schwindel (vor allem in der Phase der Dosiseinstellung) und verlangsamter Herzschlag (Bradykardie) auf. Weitere häufig auftretende Nebenwirkungen sind: Kopfschmerzen, Müdigkeit/Kraftlosigkeit, Hautkribbeln, Durchfall, Verstopfung, Übelkeit, Atemnot und Schwellungen (Ödeme) sowie zusätzlich vor allem in der Phase der Dosiseinstellung in der Behandlung der chronischen Herzschwäche: Verschlechterung der Herzschwäche, Herzblock (Anzeichen sind unregelmässiger Herzschlag, Müdigkeit und Schwindel bei zu raschem Aufstehen), tiefer Blutdruck und Blutdruckabfall beim Aufstehen, Arzneimittelunverträglichkeit.
Gelegentlich sind die folgenden Nebenwirkungen bei der Behandlung von Bluthochdruck beobachtet worden: verlangsamter Pulsschlag, bestimmte Herzfunktionsstörungen, zu niedriger Blutdruck, Herzschwäche (inklusive Verschlechterung einer bestehenden), Auftreten oder Verstärkung von zeitweiligem Hinken, Sehstörungen, Impotenz, Depressionen, Alpträume, Verdauungsstörungen, Blähungen, Erbrechen, krampfhafte Verengungen der Bronchien und Hautreaktionen wie Juckreiz und Ausschläge.
Sehr selten aufgetreten sind anfallsartige, kurzdauernde Ohnmacht und Verschlimmerung einer Schuppenflechte.
In Einzelfällen wurden Überempfindlichkeitsreaktionen und Schwellung von Haut oder Schleimhäuten durch Flüssigkeitsansammlung im Gewebe (angioneurotisches Ödem) beobachtet.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP.» bezeichneten Datum verwendet werden.
Bei Raumtemperatur (15-25 °C), in der Originalpackung und für Kinder unerreichbar aufbewahren.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Tablette enthält 5 mg Nebivolol (als Hydrochlorid) und Hilfsstoffe zur Herstellung einer Tablette. Die Tablette hat eine Kreuzbruchrille und kann in zwei oder vier Teile geteilt werden.
60020 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Es sind Packungen zu 28, 56 und 98 Tabletten erhältlich.
Spirig HealthCare AG, 4622 Egerkingen/Schweiz.
Diese Packungsbeilage wurde im Februar 2010 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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