Swissmedic Nr.: 58162001
Index: 05.99.00
Pharmacode: 3701281
GTIN/EAN: 7680581620014
Markteintritt: 01.02.2008
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Tamsunax lindert die Beschwerden, die bei der gutartigen Prostatavergrösserung des Mannes (benigne Prostatahyperplasie) auftreten. Der Harnstrahl wird verstärkt, die Blase wird besser entleert und die Reizsymptome der Blase wie Blasendruck, häufiger Harndrang ? besonders auch nachts - werden gebessert.
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. Tamsunax entspannt gezielt diese Muskelzellen, wodurch der Harnabfluss verbessert wird und die Reizerscheinungen der Blase abnehmen.
Tamsunax 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 Tamsunax nicht einnehmen.
Tamsunax sollte nicht in Kombination mit gewissen Pilzmitteln (z.B. Ketoconazol, Itraconazol, Voriconazol) angewandt werden.
In einzelnen Fällen kann der Blutdruck abfallen und evtl. eine Ohnmacht auftreten. Falls Sie Schwindel- und/oder Schwächegefühle bemerken, setzen oder legen Sie sich sofort hin bis die Beschwerden verschwunden sind.
Falls Sie bei der Einnahme eines Arzneimittels aus der gleichen Gruppe (Alpha1-Rezeptorenblocker) mit einem starken Blutdruckabfall reagiert hatten oder wenn Sie eine schwere Nierenerkrankung haben, sprechen Sie vor Beginn der Therapie mit Ihrem Arzt resp. Ihrer Ärztin.
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 Tamsunax einnehmen oder kürzlich eingenommen haben. Der operierende Augenarzt wird daraufhin entsprechende Vorsichtsmassnahmen bezüglich der Medikation und den chirurgischen Techniken einleiten. Falls Sie sich einer Augenoperation wegen trüber Linsen unterziehen müssen, fragen Sie Ihren Arzt oder Ihre Ärztin, ob sie die Einnahme von Tamsunax vorübergehend unterbrechen sollten.
Besonders bei Beginn der Therapie ist beim Autofahren und beim Bedienen von Maschinen Vorsicht geboten, da Tamsunax Schwindelgefühle und Blutdruckabfall auslösen kann. Die gleichzeitige Einnahme von Tamsunax und einem Arzneimittel der gleichen Wirkstoffklasse (Alpha1-Rezeptorenblocker) soll vermieden werden, da eine verstärkte Blutdrucksenkung eintreten kann.
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.
Tamsunax ist ausschliesslich für die Behandlung von Männern bestimmt.
1 Retardkapsel täglich morgens nach dem Frühstück oder nach der ersten Mahlzeit des Tages einnehmen. Eine Einnahme auf nüchternen Magen sollte vermieden werden. Die Retardkapsel soll - im Stehen oder im Sitzen - mit einem Glas Wasser (ca. 150 ml) unzerkaut geschluckt werden.
Die Retardkapsel darf weder zerbissen noch zerkaut werden, da sonst die Wirkstoffaufnahme unerwünscht schnell erfolgt und eventuell zu Nebenwirkungen führen könnte.
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 Tamsunax auftreten:
Schwindel; Ejakulationsstörungen (z.B. Samenerguss in die Harnblase); Kopfschmerzen; Herzklopfen; Blutdrucksenkung und in deren Folge kurzzeitige Ohnmachtsanfällen (Synkope); verstopfte Nase; Magen-Darm-Beschwerden wie Übelkeit, Erbrechen, Durchfall oder Verstopfung; Schwächegefühl.
Überempfindlichkeitsreaktionen wie Hautausschlag, Juckreiz, Nesselsucht und 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.
Sehr selten wurden ausserdem Herzrhythmusstörungen oder Atemnot beobachtet.
Falls Sie sich einer Augenoperation wegen Linsentrübung (Katarakt) unterziehen müssen und Sie Tamsunax 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.
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 lagern.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Retardkapsel enthält: 0.4 mg Tamsulosinhydrochlorid als Wirkstoff, Indigotin (E 132) als Farbstoff und weitere Hilfsstoffe.
58?162 (Swissmedic).
In Apotheken, nur gegen ärztliche Verschreibung.
Packungen zu 10, 30 und 100 Retardkapseln.
Drossapharm AG, 4002 Basel
Diese Packungsbeilage wurde im September 2011 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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