Swissmedic Nr.: 56036003
Index: 01.03.10
Pharmacode: 2991259
GTIN/EAN: 7680560360030
Markteintritt: 06.11.2003
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
(0/5 , 772)Um Zoldorm® (10 mg) kaufen zu können, benötigst Du zunächst ein Rezept.
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Wir organisieren mit einer unserer Partner-Apotheken eine Sendung Deines Zoldorm® (10 mg)'s gegen Unterschrift (24h)
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Zoldorm ist ein Schlafmittel zur Behandlung verschiedener Formen von schwerer Schlaflosigkeit, vor allem von Ein- und Durchschlafstörungen und von frühem Aufwachen am Morgen.
Obwohl Zoldorm zu einer anderen chemischen Familie gehört, beruht seine Wirkung auf einem ähnlichen Mechanismus wie dem der Benzodiazepine.
Zoldorm ist nur auf ärztliche Verschreibung erhältlich.
Zoldorm darf nur bei ausgeprägten Schlafstörungen verwendet werden und während einer kurzen Zeit, im Allgemeinen 7 bis 10 Tagen. Die Behandlung soll 4 Wochen nicht überschreiten. Falls der Arzt bzw. die Ärztin ausnahmsweise eine länger dauernde Therapie vorsehen sollte, wird er Sie über die Fortsetzung der Behandlung informieren, da eine solche Fortsetzung regelmässige ärztliche Kontrolle benötigt.
Zusätzlich sind folgende Regeln zur Schlafhygiene zu beachten:
Zoldorm darf in folgenden Fällen nicht eingenommen werden:
Schlaf-Apnoe-Syndrom (Störungen der Atmungsregulierung mit nächtlichen Atemstillständen), schwere Ateminsuffizienz, ausgeprägte Muskelmüdigkeit (Myasthenia gravis), schwere Leberfunktionsstörung, Allergie auf eine in Zoldorm enthaltene Substanz, Laktose-Intoleranz.
Obwohl keine chemische Verwandtschaft mit Benzodiazepinen besteht, ist der Wirkungsmechanismus von Zoldorm dem dieser Substanzen sehr ähnlich. Deshalb sei verwiesen auf das Folgende:
Die Einnahme von Zoldorm kann, wie bei allen Schlafmitteln zur Abhängigkeit führen. Diese tritt vor allem bei fortgesetzter Einnahme auf (in gewissen Fällen bereits nach wenigen Wochen), sowie bei Personen, welche schon an psychiatrischen Störungen, Alkoholabhängigkeit oder Toxikomanie gelitten haben. Beim abrupten Absetzen der Arzneimitteleinnahme können Entzugssymptome auftreten, z.B. Unruhe, Angstzustände, Schlaflosigkeit, Konzentrationsstörungen, Kopfschmerzen und Schweissausbruch. Diese Zeichen verschwinden im Allgemeinen nach zwei bis drei Wochen.
Um das Abhängigkeitsrisiko möglichst klein zu halten, sind folgende Empfehlungen zu beachten:
Die Behandlung älterer Personen mit Zoldorm erfordert deren engmaschige Überwachung durch den Arzt bzw. die Ärztin.
Bestimmte Krankheiten (Atem-, Leber-, Niereninsuffizienz) verlangen eine Anpassung der Dosis. Solche Krankheiten können die Wirkung und auch die Nebenwirkungen dieses Arzneimittels verstärken.
Kinder und Jugendliche: Das Präparat ist nicht an Kinder unter 18 Jahren abzugeben, da für diese Altersgruppe nur beschränkte klinische Erfahrungen vorliegen.
Fahrzeuglenker und Führer von Maschinen sind auf das eventuelle Risiko von Schläfrigkeit aufmerksam zu machen. Um dieses Risiko zu vermeiden wird eine ganze Nacht an Schlaf (7?8 Stunden) empfohlen.
Tritt im Laufe der Behandlung eine unerwünschte Wirkung ein, ist sie dem behandelnden Arzt bzw. der behandelnden Ärztin mitzuteilen.
Zoldorm darf nicht zusammen mit Alkohol eingenommen werden, weil Alkohol die Arzneimittelwirkung verstärken kann.
Andere Beruhigungsmittel wie Antidepressiva, Sedativa, andere Schlafmittel, Arzneimittel gegen Epilepsie und Schmerzmittel (z.B. Opiate) können die Wirkung von Zoldorm deutlich verstärken. Wenn Sie an Depression oder an einer anderen Verhaltensstörung leiden, dürfen Sie Zoldorm nicht ohne das eindrückliche Einverständnis Ihres Arztes bzw. Ihrer Ärztin einnehmen.
Es wurden Fälle berichtet, in denen Personen nach der Einnahme von Zoldorm oder einem ähnlichen Medikament während des Schlafs oder in nicht völlig wachem Zustand Handlungen ausführten (Somnambulismus) und sich später nicht daran erinnerten. Die beobachteten Verhaltensweisen umfassten Somnambulismus beim Autofahren, bei der Essenszubereitung, beim Essen, beim Telefonieren oder während des Geschlechtsverkehrs sowie in Einzelfällen selbstschädigendes Verhalten. Die Einnahme von Alkohol und anderen Medikamenten, die auf das zentrale Nervensystem wirken, scheinen in Verbindung mit Zoldorm das Risiko für solches Verhalten zu erhöhen. Wenn Sie bei sich ein solches Verhalten feststellen, das Sie selbst oder andere gefährden könnte, brechen Sie die Behandlung ab und benachrichtigen Sie Ihren Arzt bzw. Ihre Ärztin.
Die Einnahme von Zoldorm kann zu Schläfrigkeit und Bewusstseinsverminderung führen, dies kann Stürze und daraus resultierende schwere Verletzungen nach sich ziehen.
Beim Führen von Fahrzeugen und der Bedienung von Maschinen kann Zoldorm die Leistungsfähigkeit und die Aufmerksamkeit beeinträchtigen. Es kann auch Schläfrigkeit oder verschwommenes Sehen zur Folge haben. Die unerwünschten Wirkungen können durch die Einnahme von Alkohol verstärkt werden.
Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie
Schwangerschaft: Wenn Sie schwanger sind oder es werden möchten, dürfen Sie Zoldorm nicht einnehmen.
Stillzeit: Nehmen Sie Zoldorm nicht ein, wenn Sie stillen, da geringe Mengen von Zolpidem in die Muttermilch übergehen.
Befolgen Sie die Anweisung Ihres Arztes bzw. Ihrer Ärztin.
Die übliche Dosis beträgt eine Filmtablette zu 10 mg abends unmittelbar vor dem Zubettgehen oder wenn man sich bereits im Bett befindet. Nehmen Sie nie mehr als eine Filmtablette pro Nacht ein.
Als Regel sollten Sie immer die kleinste wirksame Dosis einnehmen und das so kurz wie möglich.
Sind Sie über 65 Jahre alt, wird Ihnen der Arzt bzw. die Ärztin im Allgemeinen am Anfang eine halbe Filmtablette verschreiben. Überschreiten Sie die Dosis von 10 mg pro Tag nicht. Das Arzneimittel ist unmittelbar vor dem Zubettgehen einzunehmen.
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.
Die Nebenwirkungen sind von der eingenommenen Dosis und der individuellen Empfindlichkeit abhängig, speziell bei älteren Personen.
Die Nebenwirkungen treten am häufigsten in der Stunde nach der Einnahme auf, wenn Sie nicht abliegen und nicht sofort einschlafen (siehe «Wie verwenden Sie Zoldorm?»). Sie können aber ebenfalls am nächsten Morgen beim Erwachen auftreten.
Folgende Nebenwirkungen können bei der Einnahme oder Anwendung von Zoldorm auftreten:
Am häufigsten werden Halluzinationen, Unruhe, Alpträume, tägliche Schläfrigkeit, Müdigkeit, Kopfschmerzen, Schwindelgefühle, Verschlechterung der Schlafstörung, Gedächtnisstörungen, Durchfall, Übelkeit, Erbrechen, Bauchschmerz und Rückenschmerzen beobachtet.
Es wurden ebenfalls häufig Fälle von Infektionen der oberen und unteren Atemwege beobachtet.
Gedächtnisstörungen treten am häufigsten auf, wenn Sie wach sind, aber das Arzneimittel noch immer wirksam ist. Möglicherweise können Sie sich in der Folge nicht mehr an die Ereignisse erinnern, die während dieser Wachphase aufgetreten sind.
Gelegentlich können auch Nebenwirkungen wie Verwirrung, Reizbarkeit und doppeltes Sehen auftreten.
Seltene Fälle von Leberfunktionsstörungen, Gelbsucht oder Leberentzündungen wurden beobachtet.
Es wurde über Einzelfälle von Stürzen berichtet, vor allem bei älteren Menschen oder Patienten, welche die empfohlene Dosierung nicht eingehalten haben.
Falls eines dieser Symptome auftritt, informieren Sie sofort Ihren Arzt bzw. Ihre Ärztin.
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.
In der Originalpackung, bei Raumtemperatur (15-25 °C) und ausser Reichweite von Kindern lagern.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Eine teilbare Filmtablette Zoldorm enthält als Wirkstoff 10 mg Zolpidemtartrat sowie die Hilfsstoffe Lactose, Cellulose, Natrium-Stärkeglykolat, Siliciumdioxid, Bernsteinsäure, Magnesiumstearat, Hydroxypropylmethylcellulose, Titandioxid und Macrogol 4000.
56036 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Filmtabletten zu 10 mg: Packungen zu 10 und 30 teilbaren Filmtabletten.
Sandoz Pharmaceuticals AG, Risch; Domizil: Rotkreuz.
Diese Packungsbeilage wurde im März 2015 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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