Swissmedic Nr.: 33153015
Index: 08.02.10
Pharmacode: 315436
GTIN/EAN: 7680331530150
Markteintritt: k.a.
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Myambutol ist ein Arzneimittel gegen Tuberkulose und wird über eine längere Zeit in Kombination mit anderen Arzneimitteln eingesetzt.
Myambutol hemmt die Vermehrung der für die Krankheit verantwortlichen Bakterien. Das Arzneimittel verteilt sich in den meisten Körperteilen, einschliesslich der Lunge.
Myambutol darf nur auf Verschreibung des Arztes oder der Ärztin eingenommen werden.
Dieses Arzneimittel wurde Ihnen von Ihrem Arzt oder Ihrer Ärztin zur Behandlung Ihrer gegenwärtigen Erkrankung verschrieben.
Das Antibiotikum in Myambutol ist nicht gegen alle Mikroorganismen, welche Infektionskrankheiten verursachen, wirksam. Die Anwendung eines falsch gewählten oder nicht richtig dosierten Antibiotikums kann Komplikationen verursachen. Wenden Sie es deshalb nie von sich aus für die Behandlung anderer Erkrankungen oder anderer Personen an.
Myambutol darf nicht eingenommen werden
bei vorgeschädigtem Sehnerv und bestehenden Augenerkrankungen;
wenn Sie auf einen Inhaltsstoff (Wirkstoff oder Hilfsstoff) überempfindlich (allergisch) sind.
Eine Überempfindlichkeit äussert sich z.B. durch Asthma, Atemnot, Kreislaufbeschwerden, Schwellungen der Haut (z.B. Nesselfieber) und der Schleimhäute oder Hautausschläge.
Um ein mögliches Auftreten von Sehstörungen frühzeitig zu erfassen, wird der behandelnde Arzt oder die behandelnde Ärztin (oder der oder die über die Einnahme von Myambutol informierte Augenarzt oder Augenärztin) in 4-wöchigen Abständen, Augenkontrollen bezüglich Farbsehen/Gesichtsfeld und Sehschärfe durchführen.
Bei Patientinnen und Patienten mit eingeschränkter Nierenfunktion sind Augenkontrollen in wöchentlichen Abständen durchzuführen.
Durch diese Vorsichtsmassnahme können mögliche Sehstörungen frühzeitig im noch reversiblen Stadium erfasst werden. Der behandelnde Arzt oder die behandelnde Ärztin wird dann das Arzneimittel absetzen, damit sich die Sehstörung wieder zurückbilden kann.
In wenigen Fällen, wo die Entdeckung der Sehstörung sich um ein Jahr verzögerte, wurde von irreversiblen Schädigungen berichtet.
Es liegen nur beschränkte Erfahrungen bei Kindern unter 13 Jahren vor. Besonders bei Kleinkindern, bei denen objektivierbare Augenkontrollen schwer durchführbar sind, muss gesichert sein, dass diese regelmässig stattfinden.
Wie bei anderen stark wirkenden Medikamenten sollten vor und während der Behandlung die Nierenfunktion, die Leberwerte und das Blutbild überwacht werden.
Durch eine verminderte Ausscheidung von Uraten wie z.B. Harnsäure kann unter Umständen ein akuter Gichtanfall ausgelöst werden.
Durch Arzneimittel gegen Magenübersäuerung wird Myambutol in seiner Wirkung abgeschwächt. Deshalb sollte Myambutol mindestens 1 Stunde vor einem Präparat gegen Magenübersäuerung eingenommen werden.
Wenn Sie ein empfängnisverhütendes Mittel («Pille») nehmen, beachten Sie, dass seine Wirksamkeit während der Behandlung mit Myambutol herabgesetzt werden kann. Deshalb kann Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin weitere Massnahmen zur Empfängnisverhütung empfehlen.
Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie gleichzeitig neurotoxische Arzneimittel e (z.B. Disulfiram) einnehmen.
Myambutol kann die Sehkraft und das Farbensehen vermindern, dadurch kann die Fahrtüchtigkeit oder die Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigt werden.
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 (Externa)!
Das Präparat soll von schwangeren Frauen oder stillenden Müttern nicht eingenommen werden.
Myambutol darf nur in Kombination mit anderen Arzneimitteln zur Behandlung der tuberkulose (Tuberkulostatika) eingesenkt werden.
Myambutol wird als einmalige morgendliche Tagesdosis eingenommen. Es kann zum Frühstück eingenommen werden. Es ist wichtig, dass Sie Myambutol täglich, ohne Unterbruch einnehmen, da sonst die Wirksamkeit nicht gewährleistet ist oder vermehrt unerwünschte Wirkungen auftreten können.
Die Dosierung bestimmt Ihr Arzt oder Ihre Ärztin nach Beurteilung des Krankheitsstadiums und sie beläuft sich im Normalfall nicht über 25 mg Ethambutol pro Kilogramm Körpergewicht.
Bei ungenügender Nierenfunktion wird Ihr Arzt oder Ihre Ärztin die Dosierung entsprechend anpassen.
Bei Kindern unter 13 Jahren wird die Anwendung im Allgemeinen nicht empfohlen.
Eine begonnene Antibiotika-Therapie sollte so lange wie vom Arzt oder von der Ärztin verordnet durchgeführt werden. Die Krankheitssymptome verschwinden oft, bevor die Infektion vollständig ausgeheilt ist. Deshalb sollte die Behandlung über das Verschwinden der Krankheitszeichen hinaus fortgesetzt werden. Eine ungenügende Anwendungsdauer oder ein zu frühes Beenden der Behandlung kann ein erneutes Aufflammen der Erkrankung zur Folge haben.
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. Ihre Ärztin oder Apothekerin.
Folgende Nebenwirkungen können bei der Einnahme von Myambutol auftreten:
Als wichtigste Nebenwirkung des Wirkstoffs Ethambutol wurden Sehstörungen (Abnahme der Sehkraft, Erkrankungen der Sehnerven, Entzündungen der Sehnerven, Gesichtsfeldeinschränkung, Farbenblindheit und Blindheit) beobachtet, welche bei frühzeitiger Entdeckung reversibel sind (siehe «Wann ist bei der Einnahme/Anwendung von Myambutol Vorsicht geboten?»). Ferner wurde über, Rötungen, Hautausschläge, Juckreiz, Gelenkschmerzen, Fieber, Übelkeit, Erbrechen, Appetitlosigkeit, Bauchschmerzen, Schwindel, Verwirrtheit, Orientierungsstörungen, Halluzinationen, allergische Reaktionen, akute Gichtsymptome, Blutbildstörungen, Leberschädigungen mit z.T. tödlichen Ausgang und «Kribbeln» sowie Taubheit in den Extremitäten berichtet.
Wenn Sie eine der genannten oder weitere Nebenwirkungen, die hier nicht beschrieben sind, bemerken, sollten Sie unverzüglich Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Durch die Einnahme von Myambutol kann es zu Alkoholunverträglichkeiten kommen.
Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet werden.
Bei Raumtemperatur (15?25 °C) und Arzneimittel sorgfältig und ausserhalb der Reichweite von Kindern lagern.
Nach Beendigung der Behandlung sollte das Arzneimittel mit dem restlichen Inhalt an Ihre Abgabestelle (Arzt/Ärztin, Apotheker/Apothekerin) zur fachgerechten Entsorgung gebracht werden.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Filmtablette Myambutol enthält:
Wirkstoff: Ethambutoldihydrochlorid 100 mg respektive 400 mg; Hilfsstoffe.
33153 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Myambutol 100 mg/400 mg*: Packungen zu 100 Filmtabletten (*teilbar).
Labatec-Pharma SA, 1217 Meyrin (Genf).
Diese Packungsbeilage wurde im Oktober 2003 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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