Swissmedic Nr.: 53259022
Index: 04.99.00
Pharmacode: 2029686
GTIN/EAN: 7680532590229
Markteintritt: 28.09.1998
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Budesonid, der Wirkstoff von Budenofalk 3 mg, ist ein Glukokortikoid mit lokaler Wirkung. Budenofalk 3 mg eignet sich zur Behandlung von entzündlichen Darmerkrankungen wie Morbus Crohn und der chronischen entzündlichen Dickdarmerkrankung «kollagene Colitis».
Budenofalk 3 mg darf nur auf Verschreibung des Arztes bzw. der Ärztin eingenommen werden:
zur Behandlung von leichten bis mittelschweren Schüben des Morbus Crohn, insbesondere wenn der letzte Abschnitt des Dünndarms und/oder der obere Teil des Dickdarms betroffen sind;
zur Behandlung einer kollagenen Colitis, die u.a. mit chronisch wässrigen Durchfällen einhergeht.
Budenofalk 3 mg darf nicht eingenommen werden bei bekannter Überempfindlichkeit gegen Budesonid oder einen anderen Bestandteil des Präparates, bei schweren Leberfunktionsstörungen und bei Infektionen durch Bakterien, Pilze oder Viren.
Budenofalk 3 mg darf nicht von Kindern eingenommen werden.
Vorsicht ist geboten, wenn Sie unter Tuberkulose, Bluthochdruck, Zuckerkrankheit (Diabetes mellitus), Knochenschwund (Osteoporose), Magen- und Darmgeschwüren oder grünem (Glaukom) oder grauem (Katarakt) Star leiden und wenn Diabetes und Glaukom bei Ihren Familienangehörigen vorkommt.
Patienten ohne Windpocken in der Vorgeschichte sollen jeden Kontakt zu Patienten mit Windpocken oder Herpes zoster meiden resp. nach einem Kontakt unverzüglich den Arzt oder die Ärztin konsultieren. Bei Operationen oder anderen Stressfaktoren ist es empfehlenswert, zusätzliche systemische Kortikosteroide zu verabreichen. Während der Behandlung mit Budenofalk 3 mg sollten Sie sich nicht impfen lassen. Ihr Arzt bzw. Ihre Ärztin weiss, was in diesem Falle zu tun ist.
Kortikosteroide können Zeichen von Infektionen verschleiern und neue Infektionen können unter einer solchen Therapie auftreten. Die körpereigene Abwehr kann vermindert und die Lokalisation der Infektion manchmal nicht möglich sein. Informieren Sie Ihren Arzt resp. Ihre Ärztin auch, wenn Infektionskrankheiten während der Behandlung mit Budenofalk 3 mg auftreten.
Andere Arznei- oder Lebensmittel beeinflussen die Wirkung von Budenofalk 3 mg oder werden selbst in ihrer Wirkung durch Budenofalk 3 mg beeinflusst. Dazu zählen Herzglykoside (Mittel zur Verbesserung der Herztätigkeit), harntreibende Mittel, Blutzucker senkende Mittel, bestimmte blutgerinnungshemmende Mittel, Mittel gegen Entzündungen und Rheuma, Phenytoin und Mittel gegen Pilzinfektionen, Antibiotika, Ciclosporin (Mittel gegen die körpereigene Abwehr) und die Pille. Beachten Sie bitte, dass diese Angaben auch für vor kurzem angewandte Arzneimittel gelten können.
Vorsichtshalber sollten sie auch keinen Grapefruitsaft zusammen mit Budenofalk einnehmen.
Theoretisch mögliche Wechselwirkungen mit Kunstharzen, wie Colestyramin (Mittel gegen Fettstoffwechselstörung) und Antazida (säurebindende Magenmittel) sind nicht auszuschliessen. Bei gleichzeitiger Einnahme von Budenofalk 3 mg kann es zu einer Abschwächung der Wirkung von Budenofalk 3 mg kommen. Daher sollten diese Präparate um mindestens zwei Stunden zeitversetzt eingenommen 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.
Budenofalk 3 mg darf in der Schwangerschaft nur auf ausdrückliche Anweisung des Arztes bzw. der Ärztin eingenommen werden. Frauen im gebärfähigen Alter müssen vor der Behandlung mit Budenofalk 3 mg eine mögliche Schwangerschaft ausschliessen und während der Behandlung geeignete Massnahmen zur Schwangerschaftsverhütung treffen. Während einer Behandlung mit Budenofalk 3 mg soll nicht gestillt werden. Sprechen Sie mit Ihrem Arzt bzw. Ihrer Ärztin, wenn Sie schwanger sind, es werden möchten oder stillen.
Erwachsene: Soweit vom Arzt bzw. der Ärztin nicht anders verordnet, nehmen Sie 1-mal täglich 3 Kapseln morgens oder 3-mal täglich (morgens, mittags, abends) 1 Kapsel ca. ½ Stunde vor den Mahlzeiten unzerkaut mit reichlich Flüssigkeit (z.B. einem Glas Wasser) ein.
Erwachsene: Die empfohlene Tagesdosis ist 3 Kapseln. Die ganze Tagesdosis wird 1-mal täglich morgens ca. ½ Std. vor dem Frühstück eingenommen.
Die Dauer der Anwendung wird vom Arzt bzw. der Ärztin bestimmt und richtet sich nach dem Krankheitsverlauf. Budenofalk 3 mg soll nicht abrupt, sondern allmählich abgesetzt werden.
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 Einnahme von Budenofalk 3 mg auftreten:
Gelegentlich: Abschwächung der körpereigenen Abwehr (Erhöhung des Infektionsrisikos).
Gelegentlich: Fettverteilungsstörung (wie Vollmondgesicht, Stammfettsucht), Blutzuckeranstieg, Zuckerkrankheit, Wasseransammlung im Gewebe, Gewichtszunahme, vermehrte Kaliumausscheidung, Unterfunktion resp. Schwund der Nebennierenrinde, Wachstumsverzögerung bei Kindern, Ausbleiben der Regelblutung, männlicher Behaarungstyp bei Frauen, Potenzstörungen.
Gelegentlich: Depressionen, Gereiztheit, Euphorie.
Gelegentlich: Erhöhung des Augeninnendrucks, Linsentrübung.
Gelegentlich: Bluthochdruck, Erhöhung des Thromboserisikos, Blutgefässerkrankungen.
Gelegentlich: Magenbeschwerden, Magen- und Darmgeschwür, Entzündung der Bauchspeicheldrüse.
Gelegentlich: Hautausschlag aufgrund von Überempfindlichkeitsreaktionen, Streifenbildungen und Blutungen in der Haut, Akne, verzögerte Wundheilung, Ekzem.
Gelegentlich: Muskelschwäche, Knochenbrüchigkeit, Knochen- und Knorpelschwund.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Medikamente vor Kinderhänden schützen! Das Medikament darf nur bis zu dem auf dem Behälter mit «Exp.» bezeichneten Datum verwendet werden. Bei Raumtemperatur (15?25 °C) lagern.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Ihre Ärztin, resp. Ihr Apotheker oder Ihre Apothekerin. Diese Personen verfügen über ausführliche Fachinformation.
1 Kapsel mit magensaftresistenten Pellets enthält 3 mg Budesonid, den Farbstoff E 127, sowie weitere Hilfsstoffe.
53259 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Packungen zu 50 und 100 Kapseln mit magensaftresistenten Pellets erhältlich.
Vifor SA, 1752 Villars-sur-Glâne.
Diese Packungsbeilage wurde im Juni 2015 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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