Swissmedic Nr.: 37448028
Index: 06.07.10
Pharmacode: 612252
GTIN/EAN: 7680374480283
Markteintritt: 31.08.1972
Kategorie: C Rezeptfreie Abgabe nach Fachberatung, beschränkt auf Apotheken.
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Tardyferon ist ein Eisenpräparat, welches zur Behandlung von Eisenmangel im Blut («Blutarmut») angewendet wird.
Eisenmangelzustände können entstehen:
- bei Blutverlusten (z.B. durch Magen-Darm-Krankheiten, nach Magen-Darm-Operationen oder bei häufigen und starken Regelblutungen) und Infekten;
- in der Schwangerschaft, im Wochenbett und beim Stillen;
- in den Wachstumsphasen bei Kleinkindern und Kindern;
- bei Störungen der Eisenaufnahme aus der Nahrung (z.B. bei verminderter Magensäurebildung, im höheren Lebensalter).
Tardyferon enthält sogenannte «Mucoproteose» als Hilfsstoff. Mucoproteose trägt zu einer gleichmässigen und langsamen Freisetzung des in Tardyferon enthaltenen Eisens bei, wodurch die Verträglichkeit verbessert wird. Durch die verzögerte Freisetzung wird auch die Aufnahme des Eisens im Darm günstig beeinflusst.
Bei leichtem, sogenannt latentem Eisenmangel, das heisst noch vor Ausbildung einer sogenannten Eisenmangelanämie (Blutarmut) werden die normalen Reserven des Körpereisens fast vollständig für die Bildung des roten Blutfarbstoffes (Hämoglobin) verwendet. Die Verarmung an Eisen kann bereits jetzt zu allgemeinen Beschwerden wie vermindertem Appetit und schnellem Ermüden führen. Eine solche Situation kann häufig während der Schwangerschaft auftreten.
Erst bei schwerem Eisenmangel, d.h. wenn das Eisen für die notwendige Bildung des Hämoglobins nicht mehr ausreicht, entsteht der sogenannte manifeste Eisenmangel mit Blutarmut (Anämie).
Bevor Sie mit der Behandlung beginnen, sollte der zu niedrige Gehalt des Blutes an Eisen und Blutfarbstoff (Hämoglobin) vom Arzt oder der Ärztin durch geeignete Untersuchungen bestätigt worden sein, denn wenn die Blutarmut nicht durch Eisenmangel bedingt ist, ist Tardyferon wirkungslos. In solchen Fällen kann eine Verabreichung sogar zu einer Eisenüberladung führen.
Wenn Sie auf einen der Inhaltsstoffe gemäss Zusammensetzung von Tardyferon überempfindlich reagieren. Bei einer selten vorkommenden krankhaften Eisenablagerung in den Geweben (sogenannte Eisenspeicherkrankheit), bei sogenannten Eisenverwertungsstörungen (wenn die «Blutarmut» z.B. auf einer mangelhaften Verwertung des Eisens beruht), bei "Blutarmut", die nicht auf Eisenmangel, sondern z.B. auf einem Mangel an Vitamin B12 beruht, bei begründeter Unverträglichkeit (z.B. bei schweren entzündlichen Veränderungen im Magen und im Darm) sowie bei schweren Leber- und Nierenerkrankungen darf Tardyferon nicht angewendet werden.
Kinder unter 10 Jahren dürfen nicht mit Tardyferon behandelt werden, sondern nur mit einem Arzneimittel, das weniger Eisen enthält.
Bei entzündlichen Magen- oder Darmerkrankungen, bei krankhaft verzögerter Magenentleerung und bei gewissen anderen Krankheiten des Magen-Darm-Kanals sollten Sie Eisenpräparate mit Vorsicht und nur nach Rücksprache mit dem Arzt bzw. der Ärztin einnehmen.
Bestimmte Antibiotika (Tetracycline und Chinolone) sowie Methyldopa, Levodopa und Carbidopa (z.B. Parkinson-mittel) werden bei gleichzeitiger Einnahme mit Tardyferon in ihrer Wirkung beeinträchtigt. Falls eine gleichzeitige Therapie mit diesen Arzneimitteln nicht vermieden werden kann, sollte bei der Einnahme ein zeitlicher Abstand von mindestens 3 Stunden eingehalten werden.
Magnesium, Phosphat-, Calcium- und Goldpräparate behindern die Eisenaufnahme; dies gilt auch für ein bestimmtes Mittel zur Senkung des Blutfettes (Cholestyramin) und für Arzneimittel zur Bindung von Magensäure (Antazida).
Die schleimhautreizende Wirkung von Eisenpräparaten in Magen und Darm kann durch die gleichzeitige Einnahme gewisser entzündungshemmender Arzneimittel, z.B. gegen rheumatische Erkrankungen, verstärkt werden. Deshalb sollte die Einnahme dieser Arzneimittel mindestens 3 bis 4 Stunden auseinander liegen.
Bei der Einnahme von Tardyferon sollte auf gleichzeitigen Konsum von Schwarztee, Kaffee und Eiern verzichtet werden, da die Wirksamkeit des Arzneimittels dadurch eingeschränkt wird.
Chronischer Alkoholmissbrauch kann durch Erhöhung der Eisenaufnahme zu einer Eisenüberladung führen.
Aufgrund der Gefahr von entzündlich bedingten Schleimhautdefekten im Mund sowie Zahnverfärbungen dürfen die Depot-Dragées nicht gelutscht, zerkaut oder länger im Mund gelassen werden, sondern müssen mit einem Glas Wasser sofort als Ganzes geschluckt werden.
Dieses Arzneimittel enthält Saccharose. Bitte nehmen Sie Tardyferon erst nach Rücksprache mit Ihrem Arzt oder Ihrer Ärztin ein, wenn Ihnen bekannt ist, dass Sie unter einer Unverträglichkeit gegenüber bestimmten Zuckern leiden.
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.
Tardyferon wird auch bei Eisenmangelzuständen in der Schwangerschaft und in der Stillzeit verschrieben. Sie sollten unbedingt mit Ihrem Arzt oder Ihrer Ärztin sprechen, bevor Sie mit der Einnahme von Tardyferon beginnen.
Die Depot-Dragées werden vor den Mahlzeiten mit etwas Flüssigkeit eingenommen und dürfen nicht gelutscht, zerkaut oder länger im Mund gelassen werden, sondern sollen sofort mit einem Glas Wasser als Ganzes geschluckt werden.
? Bei leichter Blutarmut und verstecktem (latentem) Eisenmangel:
Erwachsene: 1 x täglich 1 Depot-Dragée morgens
Kinder und Jugendliche ab 10 Jahren: 1 x täglich 1 Depot-Dragée morgens.
? Bei schwerer Blutarmut:
Erwachsene: 2 x täglich 1 Depot-Dragée morgens und abends
Kinder und Jugendliche ab 10 Jahren: täglich 1 Depot-Dragée morgens bis 2 Depot-Dragées täglich (je 1 Depot-Dragée morgens und abends), falls dies die Maximaldosis für Kinder und Jugendliche von 6 mg(Fe2+)/kg KG/d nicht überschreitet.
Ihr Arzt bzw. Ihre Ärztin kann diese Empfehlung jedoch Ihren Bedürfnissen anpassen.
Die Behandlungsdauer richtet sich nach dem Ausmass des bestehenden Eisenmangels. Die Anwendung sollte etwa 2 bis 3 Monate über das Verschwinden der Eisenmangelsymptome hinaus fortgesetzt werden, um auch die Eisenspeicher aufzufüllen.
Bei versehentlicher Einnahme einer grossen Überdosis können Eisenvergiftungserscheinungen auftreten. Sie beginnen mit Übelkeit, Magenschmerzen, Erbrechen von schwärzlichem Mageninhalt («Kaffeesatz») und Durchfall.
Nach einiger Zeit kann es zu beschleunigtem Puls, Schwindel, Atemnot und Blauwerden der Lippen und des Gesichts, in schweren Fällen zu unregelmässiger Atmung, Krämpfen und Lähmungserscheinungen kommen.
Erzwungenes Erbrechen trägt zur Entfernung einer soeben geschluckten Übermenge an Eisen bei. Als Gegenmittel wird die Einnahme von rohen Eiern und Milch empfohlen. Schnelle ärztliche Behandlung ist in jedem Vergiftungsfall notwendig.
Obwohl das Arzneimittel Tardyferon nicht für Kinder unter 10 Jahren bestimmt ist, sei darauf hingewiesen, dass Kinder auf eine Überdosis Eisen erheblich empfindlicher als Erwachsene reagieren. Bei Kleinkindern kann eine Gesamtdosis von etwa 0,5 g Eisen (= 6 Dragées Tardyferon) bereits zu einem lebensbedrohlichen Zustand führen.
Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt oder der Ärztin 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 Einnahme von Tardyferon auftreten:
Häufig: kommt es zu Übelkeit, Völlegefühl, Magenschmerzen, Durchfall, Verstopfung.
Gelegentlich kommt es zu Dunkelfärbung des Stuhls, Magenschleim-hautentzündung (Gastritis), Oberbauchbeschwerden (Dyspepsie), Erbrechen, Kehlkopfentzündung, Juckreiz, Ausschlag mit Hautrötungen.
Häufigkeit nicht bekannt: Reversible Zahnverfärbungen, entzündlich bedingte Schleimhautdefekte im Mund (bei falscher Anwendung), Überempfindlichkeitsreaktionen und Nesselfieber.
Bei Auftreten solcher Symptome ist unverzüglich der Arzt oder die Ärztin zu informieren.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Da bereits die kleinste Packung mit 30 Depot-Dragées Tardyferon eine Gesamtdosis Eisen enthält, die auf einmal eingenommen vor allem bei Kleinkindern zu einer lebensbedrohlichen Vergiftung führen kann, muss dieses Arzneimittel unbedingt ausserhalb der Reichweite von Kindern aufbewahrt werden.
Bei Raumtemperatur (15-25ºC) aufbewahren.
Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Verfalldatum verwendet werden.
Arzneimittel, die Sie nicht mehr einnehmen oder deren Datum abgelaufen ist, bringen Sie am besten zur Entsorgung in die Apotheke.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Depot-Dragée enthält den Wirkstoff: 80 mg zweiwertiges Eisen in Form von Eisen(II)-sulfat, Hilfsstoffe: Mucoproteose, Saccharose, den Farbstoff Erythrosin (E 127) sowie andere Hilfsstoffe. Der Hilfsstoff Mucoproteose ist tierischer Herkunft.
37448 (Swissmedic)
In Apotheken, ohne ärztliche Verschreibung.Packungen zu 30 und 100 Depot-Dragées.
Pierre Fabre Pharma AG, 4123 Allschwil
Diese Packungsbeilage wurde im August 2014 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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