Swissmedic Nr.: 56003006
Index: 02.05.10
Pharmacode: 2912254
GTIN/EAN: 7680560030063
Markteintritt: 03.11.2004
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Zomig gehört zu einer Gruppe von Arzneimittel, die Serotonin-Agonisten genannt wird und auf Bereiche im Gehirn wirkt, die bei einem Migräneanfall oder bei Cluster-Kopfschmerz (starker, kurzer, in Anfällen auftretender einseitiger Kopfschmerz) betroffen sind. Zomig nasal lindert nach 15 Minuten die migränebedingten Kopfschmerzen und bessert andere Symptome wie Übelkeit, Erbrechen, Licht- und Lärmempfindlichkeit. Zomig nasal lindert nach 20-30 Minuten Cluster-Kopfschmerzen und bessert andere Symptome wie wässrige oder gerötete Augen, verstopfte oder laufende Nase auf der Seite, auf welcher der Schmerz während des Cluster-Kopfschmerzes auftritt. Zomig nasal wirkt nur, wenn der Migräneanfall oder der Cluster-Kopfschmerz bereits eingesetzt hat.
Zomig darf nur auf Verschreibung und unter ständiger Kontrolle des Arztes oder der Ärztin angewendet werden.
Zomig nasal darf bei Überempfindlichkeit gegenüber dem Wirkstoff Zolmitriptan oder einem der Hilfsstoffe, bei unbehandeltem Bluthochdruck, nach einem Herzinfarkt oder bei bekannten Durchblutungsstörungen des Herzens (Angina pectoris), des Gehirns und der Gliedmassen nicht angewendet werden.
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 Zomig nasal zusammen mit anderen Arzneimitteln mit serotonerger Wirkung angwendet 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 Anwendung von Zomig nasal eines dieser Symptome auftritt.
Zomig nasal soll bei Kindern und Jugendlichen unter 18 Jahren nicht angewendet werden, da die Sicherheit und Wirksamkeit bei diesen Patienten nicht nachgewiesen ist.
Zomig nasal soll nicht zur Vorbeugung von Migräne oder Cluster-Kopfschmerz verwendet werden.
Sie sollten nach Anwendung von Zomig nasal innerhalb von 24 Stunden keine anderen Migränemedikamente, die ebenfalls zu der Gruppe der Serotonin-Agonisten gehören, anwenden.
Falls Sie ergotaminhaltige Arzneimittel einnehmen, sollten Sie 24 Stunden warten bevor Sie Zomig nasal anwenden. Nach Anwendung von Zomig nasal sollten Sie innerhalb von 6 Stunden keine ergotaminhaltigen Arzneimittel anwenden.
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!
Wenn Sie schwanger sind, es werden möchten oder wenn Sie Ihr Kind stillen, sollten Sie Zomig nasal nur nach Rücksprache mit Ihrem Arzt oder Ihrer Ärztin anwenden.
Zomig nasal ist ausschliesslich zur Anwendung in der Nase geeignet.
Falls Ihr Arzt oder Ihre Ärztin es nicht anders verordnet hat, gelten für Erwachsene folgende Dosierungsrichtlinien:
Bei einem akuten Migräneanfall wird eine Einzeldosis Zomig nasal à 2,5 mg oder 5 mg empfohlen. Es spielt keine Rolle, in welchem Nasenloch Sie den Nasalspray anwenden. Beim Migräneanfall wirkt Zomig nasal unabhängig vom Zeitpunkt der Anwendung während des Anfalles. Es ist jedoch ratsam, Zomig nasal so früh wie möglich nach dem Auftreten der Migränekopfschmerzen einzusetzen. Falls Sie nach 2 Stunden immer noch starke Migränekopfschmerzen haben, oder wenn die Migränekopfschmerzen innerhalb von 24 Stunden erneut auftreten, wenden Sie eine weitere Einzeldosis Zomig nasal an.
Bei einem akuten Cluster-Kopfschmerz wird eine Dosis à 5 mg (=1 Einzeldosis à 5 mg oder 2 Einzeldosen à 2,5 mg) oder 10 mg (=2 Einzeldosen à 5 mg) empfohlen. Sie sollten Zomig nasal sofort nach Auftreten des Cluster-Kopfschmerzes anwenden. Bei Cluster-Kopfschmerz kann möglicherweise die Nase auf der Seite verstopft sein, auf welcher Sie Schmerzen haben. Wenn dies der Fall ist, wenden Sie den Nasalspray im anderen Nasenloch an.
Haben Sie einmal mehr Zomig nasal als vorgeschrieben angewendet, kontaktieren Sie Ihren Arzt bzw. Ihre Ärztin oder suchen Sie das nächste Krankenhaus auf.
Innerhalb von 24 Stunden dürfen nicht mehr als 10 mg (=maximal 2 Einzeldosen Zomig nasal 5 mg) angewendet werden.
Zomig nasal soll bei Kindern und Jugendlichen unter 18 Jahren nicht angewendet werden, da die Sicherheit und Wirksamkeit bei dieser Patientengruppe nicht nachgewiesen ist.
Wichtig: Zomig nasal enthält eine Einzeldosis und wird nur ein einziges Mal benutzt. Drücken Sie den Stöpsel (A) erst dann, wenn Sie Zomig nasal in eines Ihrer Nasenlöcher eingeführt haben.
1. Reinigen Sie Ihre Nase sanft. Entfernen Sie die graue Schutzkappe (B).
2. Nehmen Sie den Nasalspray locker in die Hand.
3. Führen Sie den Nasalspray so weit wie komfortabel in ein Nasenloch ein. Halten Sie den Kopf gerade. Drücken Sie den Stöpsel (A) (Sie hören ein Klicken). Atmen Sie normal weiter.
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.
Sehr häufig können Störungen der Geschmacksempfindung auftreten. Häufig wurden ein unangenehmes Gefühl in der Nasenhöhle, Nasenbluten, Kopfschmerzen, Schläfrigkeit, Schwindel, Herzklopfen, Wärmegefühl, Kribbeln in den Fingern und Zehen, gesteigerte Berührungsempfindlichkeit, Schwächegefühl, Muskelschmerzen, Bauchschmerzen, Übelkeit, Erbrechen, trockener Mund, Schluckstörungen, ein Gefühl von Beengung, Schwere, Schmerz oder Druck im Brust-Halsbereich 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, Schleimhäute 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.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Bewahren Sie Zomig nasal in der Originalverpackung, bei Raumtemperatur (15-25 °C) 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. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Zomig nasal enthält als Wirkstoff 2,5 mg oder 5 mg Zolmitriptan und zusätzliche Hilfsstoffe, die zur Herstellung des Nasalsprays notwendig sind.
56003 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Zomig nasal 2,5 mg: Packungen zu 2 Einzeldosen Nasalspray.
Zomig nasal 5 mg: Packungen zu 2 oder 6 Einzeldosen Nasalspray.
AstraZeneca AG, 6301 Zug.
Diese Packungsbeilage wurde im Oktober 2012 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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