Swissmedic Nr.: 57637002
Index: 05.99.00
Pharmacode: 3124441
GTIN/EAN: 7680576370023
Markteintritt: 13.01.2006
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Diese Beschwerden sind nicht nur bedingt durch die im Alter häufige Vergrösserung der Vorsteherdrüse, sondern auch durch eine «Verkrampfung» der glatten Muskelzellen in der Prostata, des Blasenausgangs und der Harnröhre.
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Omix Ocas erhalten Sie auf Verschreibung Ihres Arztes bzw. Ihrer Ärztin.
Bei Überempfindlichkeit gegenüber Tamsulosin (Wirkstoff) oder den anderen Bestandteilen des Präparates.
Überempfindlichkeiten erkennen Sie zum Beispiel an Hautausschlag und/oder Juckreiz sowie an Schwellungen im Bereich von Gesicht, Hals oder Zunge.
Auch erschwerte Atmung/Atemnot deutet auf eine Überempfindlichkeitsreaktion hin.
Bei schweren Leberfunktionsstörungen.
Patienten, die unter tiefem Blutdruck mit Schwindelgefühl beim Aufstehen oder Stehen leiden (orthostatische Hypotonie) dürfen Omix Ocas nicht einnehmen.
Omix Ocas sollte nicht in Kombination mit gewissen Pilzmitteln (z.B. Ketoconazol, Itraconazol, Voriconazol) angewandt werden.
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Informieren Sie ebenfalls Ihren Arzt oder Ihre Ärztin wenn Sie an einer Herzkrankheit leiden oder wenn Sie Arzneimittel gegen arteriellen Bluthochdruck einnehmen.
Wenn Sie sich aufgrund einer Trübung der Linsen (Katarakt) einer Augenoperation unterziehen müssen, sollten Sie bitte den Augenarzt informieren, dass Sie Omix Ocas einnehmen oder kürzlich eingenommen haben. Der operierende Augenarzt wird daraufhin entsprechende Vorsichtsmassnahmen bezüglich der Medikation und den chirurgischen Techniken einleiten.
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Besonders bei Beginn der Therapie ist beim Autofahren und beim Bedienen von Maschinen Vorsicht geboten, da Omix Ocas Schwindelgefühle und Blutdruckabfall auslösen kann.
Die gleichzeitige Einnahme von Omix Ocas und einem Arzneimittel der gleichen Wirkstoffklasse (Alpha1-Rezeptorenblocker) soll vermieden werden, da eine verstärkte Blutdrucksenkung eintreten kann.
Es ist möglich, dass Tablettenrückstände im Stuhl auftauchen.
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! Dies gilt besonders für blutdrucksenkende Arzneimittel und Herzmittel aller Art.
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1 Retardtablette täglich schlucken. Die Retardtablette darf weder zerkaut noch anderweitig zerkleinert werden, da sonst die Wirkstoffaufnahme unerwünscht schnell erfolgt und eventuell zu Nebenwirkungen führen könnte.
Am Anfang der Therapie, oder wenn Sie ein erhöhtes Risiko für rasch abfallenden Blutdruck haben, sollten Sie Omix Ocas auf leeren Magen einnehmen. Bei guter Verträglichkeit kann die weitere Einnahme unabhängig von den Mahlzeiten erfolgen.
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.
Folgende Nebenwirkungen können bei der Einnahme von Omix Ocas auftreten:
Schwindel; Ejakulationsstörungen (z.B. Samenerguss in die Harnblase); Kopfschmerzen; Herzklopfen; Blutdrucksenkung und in deren Folge kurzzeitige Ohnmachtsanfälle (Synkope); verstopfte Nase; Magen-Darm-Beschwerden wie Übelkeit, Erbrechen, Durchfall oder Verstopfung; Schwächegefühl.
Überempfindlichkeitsreaktionen wie Hautausschlag, Juckreiz, Nesselsucht, Gewebsschwellungen (z.B. an Gesicht, Rachen oder Zunge) und Schwierigkeiten beim Atmen wurden beobachtet.
In Einzelfällen kann es zu einer langdauernden, schmerzhaften Erektion ohne sexuelle Stimulation kommen (sog. «Priapismus»). In einem solchen Fall ist der Arzt oder die Ärztin unverzüglich aufzusuchen. Sehr selten wurde Stevens-Johnson-Syndrom (einer arzneimittelallergisch bedingten Hauterkrankung mit schweren Störungen des Allgemeinbefindens, hohen Temperaturen, Hautausschlag, Entzündung und Blasenbildung der Haut und/oder Schleimhaut der Lippen, Augen, Mund, Nase oder Genitalien) beobachtet.
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Falls Sie sich einer Augenoperation wegen Linsentrübung (Katarakt) unterziehen müssen und Sie Omix Ocas einnehmen oder kürzlich eingenommen haben, kann sich die Pupille nur schlecht ausdehnen und die Iris (farbiger kreisförmiger Teil des Auges) kann während des Eingriffs schlotterig werden. Dadurch kann die Operation erschwert werden.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Omix Ocas darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet werden.
Bei Raumtemperatur (15?25 °C) lagern.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Retardtablette enthält: 400 Mikrogramm Tamsulosinhydrochlorid als Wirkstoff, das Antioxidans E 321 (Butylhydroxytoluol) und weitere Hilfsstoffe.
57637 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Packung zu 10, 30 und 100 Retardtabletten.
Astellas Pharma AG, 8304 Wallisellen.
Diese Packungsbeilage wurde im September 2011 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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