Swissmedic Nr.: 59304002
Index: 04.08.10
Pharmacode: 4947185
GTIN/EAN: 7680593040022
Markteintritt: 30.07.2010
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Resolor gehört zur Gruppe der motilitätssteigernden Arzneimittel (Enterokinetika). Resolor wird für die Behandlung der chronischen Verstopfung bei Erwachsenen verwendet, bei denen die bisherige Therapie mit diätetischen Massnahmen und Laxantien nicht ausreichend wirksam ist. Resolor wirkt auf den Muskel der Darmwand und hilft die normale Funktion des Darmes wiederherzustellen.
Die Behandlung chronischer Verstopfung sollte immer unter ärztlicher Kontrolle durchgeführt werden.
Nehmen Sie Resolor nicht ein, wenn Sie:
auf Prucaloprid oder irgendeinen andern Inhaltsstoff von Resolor allergisch sind;
Dialysepatientin sind;
an einer schweren Lebererkrankung leiden;
eine Perforation oder Obstruktion der Darmwand haben, eine schwere Entzündung des Darmtraktes, eine chronische Entzündung des Dick-oder Enddarms mit Geschwürbildung oder eine akute schwerste Entzündung des Dick- oder Enddarms mit massiver Darmerweiterung.
Verwenden Sie Resolor mit Vorsicht, wenn Sie:
? an einer mässig bis schweren Nierenerkrankung leiden;
? an einer Lebererkrankung leiden;
? zurzeit in medizinischer Behandlung für ein schweres Gesundheitsproblem sind, beispielsweise eine Lungen- oder Herzerkrankung, Krebs oder AIDS.
Wenn Sie sehr starken Durchfall haben, lässt die Wirksamkeit der Empfängnisverhütungspille unter Umständen nach, und es wird empfohlen, eine zusätzliche Empfängnisverhütungsmethode anzuwenden. Beachten Sie hierzu die Packungsbeilage der Empfängnisverhütungspille, die Sie einnehmen.
Resolor enthält Lactose-Monohydrat. Bitte nehmen Sie diese Arzneimittel daher erst nach Rücksprache mit Ihrem Arzt ein, wenn Ihnen bekannt ist, dass Sie unter Unverträglichkeit gegenüber bestimmten Zuckern leiden.
Während der Anwendung von Resolor wurde, vor allem am ersten Tag der Behandlung, über Schwindel und Müdigkeit berichtet, was die Fahrtüchtigkeit und das Bedienen von Maschinen beeinflussen kann.
Informieren Sie Ihren Arzt, Apotheker bzw. Ihre Ärztin, Apothekerin, wenn Sie an andern Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden!
Nehmen Sie Resolor während der Schwangerschaft nur mit ausdrücklichem Einverständnis Ihres Arztes/Ihrer Ärztin ein. Frauen im gebärfähigen Alter sollten während der Behandlung mit Resolor eine wirksame Verhütungsmethode anwenden.
Die Anwendung von Resolor in der Stillzeit wird nicht empfohlen.
Erwachsene: Resolor sollte 1 mal täglich eingenommen werden. Wenn die Einnahme von Resolor nach 4 Wochen nicht wirksam ist, sollte die Therapie abgebrochen werden.
Bei Männern liegen bisher keine ausreichenden Daten zur Beurteilung der Wirksamkeit und Sicherheit von Resolor vor.
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.
Resolor kann morgens oder abends eingenommen werden.
Die Einnahme von Resolor ist unabhängig von Mahlzeiten.
Die Wirksamkeit und Sicherheit bei Kindern und Jugendlichen unter 18 Jahren wurde nicht untersucht. Resolor sollte daher bei ihnen nicht eingesetzt werden.
Die Nebenwirkungen treten meistens anfangs der Behandlung auf und verschwinden gewöhnlich innerhalb einiger Tage bei fortgesetzter Behandlung.
Folgende Nebenwirkungen traten sehr häufig auf (in einem von 10 Patienten): Kopfschmerzen, Übelkeit, Durchfall und Bauchschmerzen.
Folgende Nebenwirkungen traten häufig auf (in weniger als 1 von 10 Patienten): Schwindel, Erbrechen, Verdauungsstörung, Rektalblutung, Blähungen, abnormale Bauchgeräusche, Drang zu häufiger Harnentleerung, Müdigkeit.
Die folgenden Nebenwirkungen traten ebenfalls auf (in weniger als 1 von 100 Patienten): Appetitverlust, Zittern, Herzklopfen, Fieber, vermehrtes Schwitzen und Unwohlsein.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt, Apotheker bzw. Ihre Ärztin, Apothekerin informieren.
Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet werden.
Das Präparat sollte nicht über 30 °C gelagert werden und zum Schutz vor Feuchtigkeit in der Originalblisterverpackung aufbewahrt werden.
Für Kinder unerreichbar aufbewahren.
Arzneimittel sollten nicht ins Abwasser entsorgt werden. Fragen Sie Ihren Apotheker/Ihre Apothekerin, wie Sie nicht mehr verwendete Medikamente entsorgen können.
Weitere Auskünfte erteilt Ihnen Ihr Arzt, Apotheker bzw. Ihre Ärztin, Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Resolor 1 mg: 1 Filmtablette enthält 1 mg Prucaloprid.
Resolor 2 mg: 1 Filmtablette enthält 2 mg Prucaloprid.
Enthält Lactose.
Hilfsstoffe pro Filmtablette.
Resolor 2 mg enthält zusätzlich den Farbstoff Indigotin (E132).
59304 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Resolor 1 und 2 mg ist in Packungen zu 28 Tabletten erhältlich.
Opopharma Vertriebs AG, Riedmattstrasse 9, 8153 Rümlang.
Diese Packungsbeilage wurde im Juni 2010 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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