Swissmedic Nr.: 55341002
Index: 11.06.20
Pharmacode: 2200401
GTIN/EAN: 7680553410025
Markteintritt: 05.05.2000
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Zaditen Ophtha Augentropfen ist ein Arzneimittel zur Behandlung von Allergien im Augenbereich. Es lindert die typischen Zeichen von Bindehautentzündungen allergischer Art wie Juckreiz und Rötung. Die Wirkung tritt rasch ein und hält 8-12 Stunden an.
Zaditen Ophtha Augentropfen dürfen nur auf Verschreibung des Arztes bzw. der Ärztin angewendet werden.
Dieses Arzneimittel wurde Ihnen zur Behandlung Ihrer gegenwärtigen Augenbeschwerden von Ihrem Arzt bzw. Ihrer Ärztin verordnet. Verwenden Sie es nicht für die Behandlung anderer Erkrankungen oder von Drittpersonen.
Hinweis für Kontaktlinsenträger: Grundsätzlich sollten bei geröteten und/oder entzündeten Augen keine Kontaktlinsen getragen werden.
Wegen des Konservierungsmittels Benzalkoniumchlorid, das Reizungen der Augen verursachen kann, sollen weiche, hydrophile Kontaktlinsen während einer Behandlung mit Zaditen Ophtha Augentropfen im Fläschchen keinesfalls getragen werden. Die Linsen müssen vor der Anwendung von Zaditen Ophtha Augentropfen herausgenommen werden und dürfen frühestens nach 15 Minuten wieder eingesetzt werden. Dies gilt nicht für die Einzeldosen, welche kein Konservierungsmittel enthalten.
Bei bekannter Überempfindlichkeit gegen einen der Inhaltsstoffe dürfen Zaditen Ophtha Augentropfen nicht angewendet werden. Das Präparat soll bei Kleinkindern unter 3 Jahren nicht angewendet werden.
Bei Verabreichung von mehreren Arzneimitteln am Auge sollte ein Zeitintervall von mindestens 5 Minuten zwischen den einzelnen Anwendungen eingehalten werden.
Zaditen Ophtha/Zaditen Ophtha SDU Augentropfen kann die Reaktionsfähigkeit beeinträchtigen. Unmittelbar nach der Anwendung der Augentropfen kann verschwommenes Sehen auftreten. Sie sollten nicht am Strassenverkehr teilnehmen oder Maschinen bedienen, bis diese Beeinträchtigung abgeklungen ist.
Zaditen Ophtha Augentropfen im Fläschchen enthalten Benzalkoniumchlorid als Konservierungsmittel, welches Reizungen der Augen verursachen kann -und, bei häufiger und langfristiger Anwendung, eine Entzündung oder Ulzeration der Hornhaut. Deshalb ist bei häufiger oder langfristiger Anwendung bei Patienten mit trockenen Augen oder vorgeschädigter Hornhaut eine engmaschige Überwachung angezeigt.
Informieren Sie Ihren Arzt oder Apotheker, bzw. Ihre Ärztin oder Apothekerin wenn Sie an andern Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbstgekaufte) einnehmen oder am Auge anwenden.
Zaditen Ophtha Augentropfen dürfen während der Schwangerschaft und der Stillzeit nur nach Rücksprache mit Ihrem Arzt oder Apotheker bzw. Ihrer Ärztin oder Apothekerin angewendet werden.
Wenn vom Arzt bzw. von der Ärztin nicht anders verordnet, werden Zaditen Ophtha Augentropfen wie folgt angewendet:
Erwachsene und Kinder ab 3 Jahren: 2× täglich 1 Tropfen in den Bindehautsack beider Augen.
Die Behandlungsdauer sollte 6 Wochen nicht überschreiten.
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.
Folgende Nebenwirkungen können bei der Anwendung von Zaditen Ophtha auftreten:
In den Augen gelegentlich: Brennen und Stechen, punktierte Hornhautentzündung, Verschwommensehen nach Applikation der Augentropfen, trockene Augen, Probleme mit den Augenlidern, Bindehautentzündung, Schmerzen in den Augen, Lichtempfindlichkeit, Blutungen unter der Bindehaut.
Gelegentlich: Kopfschmerzen, Schläfrigkeit, Hautausschlag, Entzündungen der Haut einschliesslich Ekzeme, Nesselsucht, Mundtrockenheit und allergische Reaktionen.
Es wurde auch über aufgeschwollene Augen, Ausschläge am Augenlied und Anschwellen des Gesichts sowie über Verschlimmerung bereits bestehender allergischer Reaktionen wie Asthma und Ekzeme sowie über Gefühl von Benommenheit berichtet.
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 der Packung mit «EXP» bezeichneten Datum verwendet werden. Zaditen Ophtha sollte in der verschlossenen Originalpackung bei Raumtemperatur (15-25 °C) und ausser Reichweite von Kindern aufbewahrt werden. Ein eventuell verbleibender Rest ist Ihrer Abgabestelle zur fachgerechten Entsorgung zurückbringen.
Fläschchen: nach Gebrauch sofort schliessen. Angebrochene Packung nicht länger als 1 Monat verwenden. Um die Sterilität der Augentropfen zu erhalten, Tropferspitze weder mit den Händen noch mit dem Auge berühren.
Einzeldosen: enthalten kein Konservierungsmittel, eventuelle Reste sind unmittelbar nach der Anwendung fortzuwerfen. Geöffneten Blister mit den Einzeldosenbehälter-Streifen in die Schachtel zurücklegen und nicht länger als 3 Monate aufbewahren.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Fläschchen: 1 ml der Augentropfen enthält 0.25 mg Ketotifen als Wirkstoff (als Ketotifenhydrogenfumarat) und Benzalkoniumchlorid als Konservierungsmittel sowie weitere Hilfsstoffe.
Einzeldosen (SDU) zu 0.4 ml: 1 ml enthält 0.25 mg Ketotifen als Wirkstoff (als Ketotifenhydrogenfumarat) sowie weitere Hilfsstoffe.
55341, 55342 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Fläschchen zu 5 ml.
Einzeldosen: 20 (4 Streifen mit 5 Einzeldosen). SDU = Single Dose Unit = Einzeldosen.
Novartis Pharma Schweiz AG, Risch; Domizil: 6343 Rotkreuz.
Diese Packungsbeilage wurde im Februar 2015 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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