Swissmedic Nr.: 62181002
Index: 02.05.10
Pharmacode: 5410671
GTIN/EAN: 7680621810023
Markteintritt: 08.05.2012
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Zolmitriptan Actavis gehört zu einer Gruppe von Arzneimitteln, die Serotonin-Agonisten genannt werden und auf Bereiche im Gehirn wirkt, die bei einem Migräneanfall betroffen sind. Zolmitriptan Actavis lindert die migränebedingten Kopfschmerzen innerhalb einer Stunde und bessert andere Symptome wie Übelkeit, Erbrechen, Licht- und Lärmempfindlichkeit. Zolmitriptan Actavis wird zur Behandlung von Migräneanfällen eingesetzt.
Zolmitriptan Actavis darf nur auf Verschreibung und unter ständiger Kontrolle des Arztes oder der Ärztin eingenommen werden.
Zolmitriptan Actavis darf nicht eingenommen werden bei Überempfindlichkeit gegenüber dem Wirkstoff oder gegenüber anderen Hilfsstoffen, bei unbehandeltem Bluthochdruck, nach einem Herzinfarkt oder bei bekannten Durchblutungsstörungen des Herzens (Angina pectoris), des Gehirns und der Gliedmassen.
Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigen!
Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie an Krankheiten leiden wie z.B. Epilepsie, schwere Leber- und/oder Nierenfunktionsstörungen, Bluthochdruck oder Herzkrankheiten einschliesslich Angina pectoris, Herzinfarkt und Wolff-Parkinson-White-Syndrom.
In seltenen Fällen kann ein sogenanntes «Serotonin-Syndrom» auftreten, wenn Triptane wie Zolmitriptan Actavis zusammen mit anderen Arzneimitteln mit serotonerger Wirkung angewendet werden. Dazu gehören bestimmte Arzneimittel gegen Depressionen (z.B. sogenannte selektive Serotonin-Wiederaufnahme-Hemmer oder selektive Serotonin/Noradrenalin-Wiederaufnahme-Hemmer, sog. MAO-Hemmer, L-Tryptophan, Lithium, trizyklische Antidepressiva u.a.). Informieren Sie Ihren Arzt bzw. Ihre Ärztin, wenn Sie mit diesen Arzneimitteln behandelt werden. Das «Serotonin-Syndrom» kann folgende Symptome umfassen: gesteigerte Erregbarkeit der Muskeleigenreflexe, Muskelzuckungen, Zittern, Unruhe, Angst, Halluzinationen, Reizbarkeit bis zum Verwirrtheitszustand und zur Bewusstlosigkeit, schneller Herzschlag, Blutdruckschwankungen, Übelkeit, Erbrechen, Fieber und Durchfall. Informieren Sie Ihren Arzt oder Ihre Ärztin, wenn nach Einnahme von Zolmitriptan Actavis eines dieser Symptome auftritt.
Zolmitriptan Actavis soll bei Kindern nicht angewendet werden, da keine Erfahrungen bei diesen Patienten vorliegen.
Die Wirksamkeit konnte bei Jugendlichen im Alter zwischen 12 und 17 Jahren nicht nachgewiesen werden. Daher soll Zolmitriptan Actavis in dieser Altersgruppe nicht angewendet werden.
Zolmitriptan Actavis soll nicht zur Vorbeugung von Migräne verwendet werden.
Sie sollten nach Einnahme von Zolmitriptan Actavis innerhalb von 24 Stunden keine anderen Migränemedikamente, die ebenfalls zu der Gruppe der Serotonin-Agonisten gehören, anwenden.
Falls Sie ergotaminhaltige Medikamente einnehmen, sollten Sie 24 Stunden warten, bevor Sie Zolmitriptan Actavis einnehmen. Nach Einnahme von Zolmitriptan Actavis sollten Sie innerhalb von 6 Stunden keine ergotaminhaltigen Medikamente einnehmen.
Informieren Sie auch Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbst gekaufte) einnehmen!
Wenn Sie schwanger sind, es werden möchten oder wenn Sie Ihr Kind stillen, sollten Sie Zolmitriptan Actavis nur nach Rücksprache mit Ihrem Arzt oder Ihrer Ärztin anwenden.
Falls Ihr Arzt oder Ihre Ärztin es nicht anders verordnet hat, gelten für Erwachsene folgende Dosierungsrichtlinien:
Bei einem akuten Migräneanfall 1 Filmtablette Zolmitriptan Actavis einnehmen. Zolmitriptan Actavis wirkt unabhängig davon, wann Sie die Tablette während des Anfalls einnehmen. Es ist jedoch ratsam, Zolmitriptan Actavis so früh wie möglich nach dem Auftreten der Migränekopfschmerzen einzunehmen. Falls Sie nach 2 Stunden immer noch starke Migränekopfschmerzen haben oder wenn die Migräne innerhalb von 24 Stunden erneut auftritt, nehmen Sie eine weitere Filmtablette Zolmitriptan Actavis ein.
Haben Sie einmal mehr Zolmitriptan Actavis als vorgeschrieben eingenommen, kontaktieren Sie Ihren Arzt bzw. Ihre Ärztin oder suchen Sie das nächste Krankenhaus auf.
Innerhalb von 24 Stunden sollten nicht mehr als 4 Filmtabletten Zolmitriptan Actavis eingenommen werden.
Zolmitriptan Actavis soll bei Kindern und Jugendlichen unter 18 Jahren nicht angewendet werden, da die Sicherheit und Wirksamkeit bei dieser Patientengruppe nicht nachgewiesen ist.
Gewöhnlich nimmt man eine Filmtablette unzerkaut mit etwas Wasser.
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.
Häufig wurden Kopfschmerzen, Schläfrigkeit, Schwindel, Herzklopfen, Wärmegefühl, Kribbeln in den Fingern und Zehen, gesteigerte Berührungsempfindlichkeit, Schwächegefühl, Muskelschmerzen, Bauchschmerzen, Übelkeit, Erbrechen, trockener Mund, ein Gefühl von Beengung, Schwere, Schmerz oder Druck im Brust-Hals-Bereich oder in den Gliedmassen beobachtet. Gelegentlich wurde über vermehrte und/oder häufigere Harnausscheidung, Herzrasen und vorübergehenden Blutdruckanstieg berichtet.
Selten können allergische Reaktionen (Nesselsucht, Schwellungen der Haut, Schleimhaut und der inneren Organe) auftreten.
Sehr selten wurden vorübergehende Verengungen der Herzgefässe, Herzinfarkt, blutiger Durchfall, häufiger Harndrang, Milzinfarkt und Darminfarkt beobachtet.
Falls Sie eine dieser Nebenwirkungen feststellen, ist es wichtig, dass Sie sich unverzüglich an Ihren Arzt oder Ihre Ärztin wenden. Auch wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Bewahren Sie Zolmitriptan Actavis bei Raumtemperatur (15?25 °C) in der Originalpackung und ausserhalb der Reichweite von Kindern auf.
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. Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Zolmitriptan Actavis Filmtabletten enthalten als Wirkstoff 2,5 mg Zolmitriptan und zusätzliche Hilfsstoffe, die zur Herstellung der Filmtabletten notwendig sind.
62181 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Zolmitriptan Actavis Filmtabletten zu 2,5 mg in Packungen zu 3, 6 und 12 Filmtabletten.
Actavis Switzerland AG, 8105 Regensdorf.
Diese Packungsbeilage wurde im November 2010 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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