Swissmedic Nr.: 52471060
Index: 01.04.10
Pharmacode: 4186958
GTIN/EAN: 7680524710604
Markteintritt: 27.01.1994
Kategorie: C Rezeptfreie Abgabe nach Fachberatung, beschränkt auf Apotheken.
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Remotiv 500 enthält den quantifizierten Trockenextrakt, Ze 117, aus den zur Blütezeit geernteten oberirdischen Teilen des Johanniskrautes (Hypericum perforatum L.). Durch die Standardisierung des Herstellungsverfahrens wird eine gleichbleibende Qualität dieses pflanzlichen Arzneimittels garantiert.
Remotiv 500 zeigt eine beruhigende und ausgleichende Wirkung bei: gedrückter Stimmung, Stimmungslabilität, innerer Unruhe, Ängstlichkeit, Spannungszuständen und damit einhergehenden Ein- und Durchschlafstörungen.
Falls Ihre Beschwerden länger als einen Monat andauern, sollten Sie ärztliche Hilfe beanspruchen.
Das Präparat ist für DiabetikerInnen geeignet.
Bei bekannter Überempfindlichkeit gegen Johanniskraut-Extrakte oder weitere Bestandteile des Arzneimittels (siehe «Was ist in Remotiv 500 enthalten?») bzw. bei bekannter Lichtüberempfindlichkeit darf Remotiv 500 nicht angewendet werden.
Johanniskraut-Präparate dürfen bei Kindern ab 6 Jahren nur nach ausdrücklicher Anweisung eines Arztes angewendet werden.
Johanniskraut-Präparate können die Wirkung anderer Medikamente abschwächen! Remotiv 500 darf deshalb nicht mit folgenden Arzneimitteln angewendet werden:
Gewisse Arzneimittel zur Hemmung des Immunsystems (z.B. mit dem Wirkstoff Ciclosporin, Tacrolimus oder Sirolimus), wie sie namentlich nach Organtransplantationen gegeben werden.
Anti-retrovirale Arzneimittel in der HIV-Behandlung aus der Gruppe der nichtnukleosidalen Reverse-Transkriptase Hemmer (z.B. Nevirapin) und HIV Proteinase Hemmer (z.B. Indinavir).
Gewisse Arzneimittel gegen Krebs (Zytostatika z.B. Imatinib, Irinotecan).
Arzneimittel zur Hemmung der Blutgerinnung (sogenannte orale Antikoagulantien z.B. mit den Wirkstoffen Acenocoumarol, Phenprocoumon oder Warfarin).
Auch sollte Remotiv 500 mit folgenden verschreibungspflichtigen Arzneimitteln nur unter ärztlicher Überwachung eingenommen werden:
Digoxin (sog. Herzglycoside gegen Herzinsuffizienz); der Antibabypille oder anderen hormonalen Verhütungsmitteln (z.B. injizierte Depot-Präparate, unter der Haut angebrachte Implantate, auf die Haut angebrachte Hormon-Pflaster, vaginal angewendete Produkte mit Hormonfreisetzung u.a.) aufgrund von Zwischenblutungen sowie der Gefahr einer ungewollten Schwangerschaft; Methadon; bestimmte Antidepressiva (Arzneimittel gegen Depressionen) oder andere serotoninerge Wirkstoffe (z.B. Amitriptylin, Fluoxetin oder Buspiron u.a.); gewisse Arzneimittel gegen erhöhte Blutfette wie Simvastatin (Komedikation mit Pravastatin scheint jedoch möglich); Midazolam (starkes Schlafmittel bzw. Sedativum aus der Gruppe der Benzodiazepine) oder Steroidhormone wie Cortison und Prednison, die eingenommen werden müssen oder mittels Infusion gegeben werden.
Vor allfälligen Operationen ist Remotiv 500 mindestens 5 Tage vorher abzusetzen und sollte erst nach Rücksprache mit einem Arzt bzw. einer Ärztin wieder eingenommen werden.
In sehr seltenen Fällen und vor allem bei hellhäutigen Personen kann es nach Einnahme von Johanniskraut-Präparaten und nachfolgender Sonnenlichtbestrahlung zu Hautreaktionen, wie z.B. sonnenbrandähnlichen Hautrötungen, kommen. Lichtempfindliche Personen sollten daher in der Zeit der Anwendung Haut und Augen vor länger dauernder direkter Sonneneinstrahlung schützen und auf den Besuch von Solarien verzichten.
Wenn Sie neben Remotiv 500 noch andere, insbesondere vom Arzt bzw. von der Ärztin verschriebene Arzneimittel einnehmen, besprechen Sie dies bitte mit Ihrem Arzt bzw. Ihrer Ärztin.
Informieren Sie ferner 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!
Aufgrund der bisherigen Erfahrungen ist bei bestimmungsgemässer Anwendung kein Risiko für das Kind bekannt. Systematische wissenschaftliche Untersuchungen wurden aber nie durchgeführt. Vorsichtshalber sollten Sie während der Schwangerschaft und Stillzeit auf dieses Arzneimittel verzichten oder den Arzt oder den Apotheker bzw. die Ärztin oder die Apothekerin um Rat fragen.
Erwachsene nehmen 1 mal täglich 1 Filmtablette (morgens oder abends), am besten mit oder nach dem Essen mit etwas Flüssigkeit ein. Das Präparat sollte höchstens 1 Monat lang und ohne Unterbrechung eingenommen werden. Eine darüber hinausgehende Behandlungsdauer sollte ausschliesslich unter ärztlicher Aufsicht erfolgen.
Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt 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 Remotiv 500 auftreten:
Häufig: Magen-Darm Störungen, Kopfschmerzen und Schwitzen.
Gelegentlich: Schwindel.
Im Falle von auftretenden Hautrötungen sind die Filmtabletten nicht weiter einzunehmen und die Hautsymptome von einem Arzt bzw. einer Ärztin abklären zu lassen.
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 Originalverpackung aufbewahren.
Das Arzneimittel ist ausserhalb der Reichweite von Kindern aufzubewahren.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Remotiv 500 enthält pro Filmtablette 500 mg des quantifizierten Trockenextraktes (Ze 117) aus den zur Blütezeit geernteten oberirdischen Teilen des Johanniskrautes (entsprechend 0,5 - 1,5 mg Gesamthypericine und maximal 0,2% Hyperforin, Extraktionsmittel Ethanol 50% (m/m), Droge-Extrakt-Verhältnis 4?7:1). Dieses Präparat enthält zusätzlich Hilfsstoffe.
52471 (Swissmedic).
In Apotheken ohne ärztliche Verschreibung.
In Blisterpackungen zu 30 und 60 Filmtabletten.
Max Zeller Söhne AG, 8590 Romanshorn.
Diese Packungsbeilage wurde im April 2011 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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