Swissmedic Nr.: 52685028
Index: 10.02.00
Pharmacode: 1599453
GTIN/EAN: 7680526850285
Markteintritt: 18.08.1994
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Roaccutan Gel wird Ihnen von Ihrem Arzt oder Ihrer Ärztin zur Behandlung von Akne und Mitessern durch Auftragen auf die befallenen Stellen verschrieben. Dieses Gel enthält als Wirkstoff Isotretinoin.
Isotretinoin ist eine mit Vitamin A verwandte Substanz; sie bewirkt eine Verdünnung der Hornschicht der Oberhaut und begünstigt damit die Entfernung von Mitessern. Es verhindert auch das Auftreten neuer Pickel dank seiner Wirksamkeit in den tieferen Hautschichten. Roaccutan Gel regt die Erneuerung der Hautzellen an und beugt Aknenarben vor.
Roaccutan Gel dient zur lokalen Behandlung der Akne allein oder in Kombination mit anderen Aknemitteln.
Über eine kombinierte Behandlung entscheidet Ihr Arzt oder Ihre Ärztin.
Roaccutan Gel darf bei einer bekannten Überempfindlichkeit gegenüber einem seiner Bestandteile (Wirksubstanz oder Hilfsstoffe), bei Verletzung der Haut oder im Fall eines akuten Ekzems nicht verwendet werden.
Roaccutan Gel darf nicht mit den Schleimhäuten (Augen, Mund und Nasenöffnungen) in Berührung kommen; es darf nicht auf die geschädigte Haut (Verletzungen, akutes Ekzem) aufgetragen werden. Falls sich versehentlich doch ein Kontakt mit den erwähnten Stellen ergibt, müssen sie mit reichlich Wasser abgespült werden. Es empfiehlt sich, auf die gleichzeitige Verwendung anderer Hautpflegemittel zu verzichten, insbesondere schälender Präparate (Hautpeeling) und hautstraffender Lotionen.
Im Falle einer Kombinationsbehandlung mit Oxidationsmitteln, z.B. Benzoylperoxid, sollte die Anwendung nicht gleichzeitig, sondern zeitlich versetzt erfolgen, da die gleichzeitige Anwendung von Oxidationsmitteln mit Roaccutan Gel die Wirkung von Roaccutan Gel herabsetzen kann.
Während der ganzen Behandlung mit Roaccutan Gel sollte man vermeiden, die behandelte Haut der Sonne (oder ultravioletten Strahlen, zum Beispiel im Solarium) auszusetzen. Die Behandlung kann fortgesetzt werden, wenn die Bestrahlung durch einen geeigneten Schutz auf ein Minimum reduziert wird (beispielsweise durch das Tragen eines Hutes oder die Verwendung einer Sonnenschutzcreme mit hohem Schutzfaktor). Im Falle einer aussergewöhnlichen Sonnenbestrahlung (beispielsweise ein Tag am Meer) darf Roaccutan Gel weder am Vortag noch am betreffenden noch am darauffolgenden Tag verwendet werden. Vor Beginn einer Behandlung mit Roaccutan Gel muss ein Sonnenbrand erst abheilen.
Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Si an anderen Krankheiten leiden, Allergien haben, andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden,
kürzlich auf die zu behandelnde Haut ein anderes Produkt aufgetragen haben.
Über die mögliche Kombination von Roaccutan Gel mit anderen Aknemitteln muss Ihr Arzt oder Ihre Ärztin entscheiden.
Während der Schwangerschaft oder der Stillzeit darf das Arzneimittel nicht angewendet werden.
Tragen Sie das Gel etwa eine Viertelstunde nach der Reinigung der Haut mit den Fingern in einer dünnen Schicht auf die zu behandelnde Oberfläche auf. Waschen Sie sich anschliessend sorgfältig die Hände.
Die Anwendung erfolgt einmal täglich, vorzugsweise an Abend, wegen möglicher erhöhter Sonnenempfindlichkeit der Haut. Die Behandlung sollte über ungefähr drei Monate fortgesetzt werden. 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 Anwendung von Roaccutan Gel auftreten:
Nach dem Auftragen des Gels kann Hitze oder Brennen verspürt werden, und die Haut kann an der Applikationsstelle eine Rötung aufweisen. Es handelt sich dabei um lokale Reizungserscheinungen, die sich besonders bei Menschen mit heller Haut und auf empfindlichen Hautbereichen (beispielsweise am Hals) einstellen. Diese Reaktionen verschwinden im allgemeinen nach einigen Tagen. Sollte die Reizung zu stark sein oder länger anhalten, müssen Sie Ihren Arzt oder Ihre Ärztin informieren, der bzw. die dann beschliesst, ob die Zeitabstände zwischen den Applikationen verlängert werden oder die Behandlung unter Umständen unterbrochen wird.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Nicht einnehmen!
Roaccutan Gel ist ausserhalb der Reichweite von Kindern aufzubewahren.
Nach der Anwendung des Gels die Tube gut verschliessen und die Packung bei einer Temperatur nicht über 25 °C aufbewahren.
Um eine eventuelle Reizwirkung zu vermindern, sollte tagsüber eine feuchthaltende Creme, vor allem im Falle von Sonnenexposition mit hohem Lichtschutzfaktor (mindestens 8), verwendet werden.
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.
1 g Roaccutan Gel enthält als Wirkstoff 0,5 mg Isotretinoin (ein Derivat von Vitamin A).
Hilfsstoffe: Hydroxypropylcellulose (gelbildende Substanz), ein Oxidationshemmer (E 321) und Ethanol.
52685 (Swissmedic).
In Apotheken, nur gegen ärztliche Verschreibung.
Gel 0,05%: Tube zu 30 g.
F. Uhlmann-Eyraud SA, 1217 Meyrin 2 GE.
Diese Packungsbeilage wurde im März 2004 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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