Swissmedic Nr.: 58039001
Index: 05.99.00
Pharmacode: 3685180
GTIN/EAN: 7680580390017
Markteintritt: 17.10.2007
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Finasterax ist ein Arzneimittel zur Behandlung der gutartigen Prostatavergrösserung (Benigne Prostatahyperplasie/Prostata = Vorsteherdrüse des Mannes).
Finasterax darf nur auf Verschreibung des Arztes oder der Ärztin eingenommen werden.
Gutartige Prostatavergrösserung ist eine verbreitete, mit zunehmendem Alter häufiger werdende Krankheit, die sich über viele Jahre langsam entwickelt. Bei fortgeschrittener Vergrösserung der Prostata können Beschwerden beim Wasserlösen und im Bereich der Blase auftreten. Typisch dafür sind: Verzögerung zu Beginn der Blasenentleerung, Nachtröpfeln nach dem Wasserlösen, verminderte Stärke des Harnstrahls, ein- bis mehrfache Unterbrechungen im Harnfluss während des Wasserlösens, Gefühl der unvollständig entleerten Blase, Schmerzen und Brennen während des Wasserlösens, notwendiges Pressen zur Ingangsetzung des Harnflusses, nasse Kleider, dringendes Bedürfnis Wasser zu lösen, häufiges Wasserlösen bei Tag und bei Nacht. Bekannte Komplikationen einer unbehandelten gutartigen Prostatavergrösserung sind: wiederholt auftretende Harnwegsinfektionen, Nierenversagen, akute Harnverhaltung und dadurch bedingte chirurgische Eingriffe.
Finasterax beeinflusst die Ursache des krankhaften Prostatawachstums. Es vermag die vergrösserte Prostata zu verkleinern und damit die oben erwähnten Beschwerden zu verbessern. Eine gutartige Prostatavergrösserung entwickelt sich über eine längere Zeit, deshalb erfordert die Rückbildung der vergrösserten Prostata in der Regel eine lange Therapie mit Finasterax, obwohl in manchen Fällen eine rasche Besserung der Symptome beobachtet werden konnte.
Unabhängig davon, ob Sie eine Verbesserung oder Änderung Ihrer Symptome beobachten, kann die Therapie mit Finasterax das Risiko für eine plötzliche Harnverhaltung oder für einen operativen Eingriff senken.
Befolgen Sie die Anweisungen Ihres Arztes bzw. Ihrer Ärztin. Beim Absetzen von Finasterax kann sich die Prostata wieder vergrössern und die Symptome der benignen Prostatahyperplasie können wieder auftreten. Suchen Sie Ihren Arzt bzw. Ihre Ärztin für regelmässige Kontrolluntersuchungen auf.
Finasterax kann die Resultate einer Blutuntersuchung, den sogenannten PSA-Test beeinflussen. Wenn bei Ihnen ein PSA-Test durchgeführt wird, weisen Sie Ihren Arzt bzw. Ihre Ärztin darauf hin, dass Sie Finasterax einnehmen.
Nehmen Sie Finasterax nicht ein, wenn Sie auf irgendeinen der Inhaltsstoffe überempfindlich (allergisch) reagieren.
Finasterax darf nicht von Frauen und Kindern eingenommen werden.
Berichten Sie Ihrem Arzt bzw. Ihrer Ärztin über alle medizinischen Probleme, die Sie haben oder früher gehabt haben, sowie über Ihnen bekannte Allergien.
Wenn Sie Veränderungen in Ihrem Brustgewebe feststellen, wie z.B. Knoten, Schmerzen, Vergrösserung der Brust oder Ausfluss aus den Brustwarzen, sollten Sie sich umgehend an Ihren Arzt bzw. Ihre Ärztin wenden. Diese Anzeichen weisen möglicherweise auf eine ernsthafte Erkrankung wie Brustkrebs hin.
Über männliche Infertilität und/oder schlechte Samenqualität wurde bei einigen Männern unter Einnahme von Finasterax berichtet. Über eine Verbesserung der Samenqualität nach Absetzen des Arzneimittels wurde berichtet.
Frauen im gebährfähigen Alter sollten den Kontakt mit Finasterax durch Anfassen von zerbrochenen Filmtabletten vermeiden, da wegen der möglichen Aufnahme des Wirkstoffs während einer Schwangerschaft die normale Entwicklung der äusseren Geschlechtsorgane eines männlichen Kindes beeinträchtigt werden kann. Finasterax Filmtabletten sind beschichtet, bei normaler Handhabung ist kein Kontakt mit dem Wirkstoff möglich, ausser die Filmtabletten sind zerdrückt oder zerbrochen.
Finasterax geht normalerweise keine Wechselwirkungen mit anderen Arzneimitteln ein. Informieren Sie jedoch Ihren Arzt bzw. Ihre Ärztin immer über alle Arzneimittel, die Sie gerade einnehmen oder einzunehmen gedenken, auch über solche, die Sie ohne Rezept erhalten.
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!
Finasterax darf nicht von Frauen eingenommen werden.
Die übliche Dosierung beträgt eine Filmtablette Finasterax täglich, unabhängig von den Mahlzeiten.
Nehmen Sie Finasterax einmal täglich wie vorgeschrieben ein. Sollten Sie trotzdem einmal eine Dosis vergessen, so nehmen Sie keine Extradosis ein. Nehmen Sie einfach Ihren üblichen Einnahmeplan von einer Filmtablette pro Tag wieder auf.
Sollten Sie zu viele Filmtabletten aufs Mal eingenommen haben, so setzen Sie sich sofort mit Ihrem Arzt bzw. Ihrer Ärztin in Verbindung.
Ändern Sie nicht von sich aus die verschriebene Dosierung des Arzneimittels. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. Ihrer Ärztin oder Apothekerin (siehe auch Kapitel «Was ist ferner zu beachten?»).
Folgende Nebenwirkungen können bei der Einnahme von Finasterax auftreten:
Gelegentlich beobachtete unerwünschte Wirkungen, deren Ursache als möglicherweise, wahrscheinlich oder sicher mit dem Präparat in Verbindung gebracht wurde, waren: Impotenz, abnehmende Libido (Geschlechtstrieb) und Änderungen oder Probleme mit der Ejakulation wie vermindertes Ejakulat-Volumen.
Nach längerer Einnahme von Finasterax verschwanden diese unerwünschten Wirkungen in einigen Fällen, wenn die Symptome andauerten, waren sie beim Absetzen gewöhnlich reversibel.
Selten wurde über Druckempfindlichkeit und/oder Vergrösserung der Brust berichtet.
Einige Männer berichteten auch über Folgendes:
?Allergische Reaktionen wie Hautausschlag, Juckreiz, Nesselsucht, Schwellung der Lippen, der Zunge, des Rachens und des Gesichts
?Hodenschmerzen
?Eine auch nach Absetzen des Arzneimittels fortbestehende Unfähigkeit zur Erektion
?Ejakulationsprobleme, nach Absetzen des Arzneimittels fortbestehend
?Depression
?Abnahme der Libido (Geschlechtstrieb), nach Absetzen des Arzneimittels fortbestehend
?In sehr seltenen Fällen Brustkrebs
Wenn Sie Veränderungen in Ihrem Brustgewebe feststellen, wie z.B. Knoten, Schmerzen oder Ausfluss aus den Brustwarzen, sollten Sie sich umgehend an Ihren Arzt bzw. Ihre Ärztin wenden.
Auch wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Das Arzneimittel soll für Kinderhand unerreichbar aufbewahrt werden.
Das Arzneimittel soll in der Originalverpackung und bei Raumtemperatur (15-25 °C) aufbewahrt werden.
Das Arzneimittel darf nur bis zu dem auf der Packung 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.
Eine Tablette Finasterax enthält als Wirkstoff 5 mg Finasteride, sowie weitere Hilfsstoffe.
58'039 (Swissmedic)
In Apotheken nur gegen ärztliche Verschreibung
Das Arzneimittel ist in Kalenderpackungen zu 28 oder 98 Filmtabletten erhältlich.
Drossapharm AG, 4002 Basel
Diese Packungsbeilage wurde im März 2014 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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