Swissmedic Nr.: 53563015
Index: 08.04.30
Pharmacode: 1726288
GTIN/EAN: 7680535630151
Markteintritt: 29.05.1996
Kategorie: A Einmalige Abgabe auf eine ärztliche Verschreibung hin.
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Wellvone ist ein Arzneimittel zur Vorbeugung und Behandlung einer speziellen Art von Lungenentzündung, nämlich der Pneumocystis carinii Pneumonie (PCP), die vor allem bei AIDS-Patienten vorkommt.
Wellvone wird dann angewendet, wenn die üblichen Arzneimittel nicht die gewünschte Wirkung zeigen, oder wenn Unverträglichkeitszeichen, wie z.B. Hautausschlag, Übelkeit und Erbrechen, aufgetreten sind.
Wellvone ist nur auf Verschreibung des Arztes oder der Ärztin hin einzunehmen.
Es ist sehr wichtig, dass Wellvone immer zusammen mit einer vollwertigen Mahlzeit (nicht nur mit einem Yoghurt) eingenommen wird, denn nur so wird das Arzneimittel in einer genügenden Menge ins Blut aufgenommen, um voll wirksam zu sein.
Bei bekannter oder vermuteter Überempfindlichkeit gegenüber dem Wirkstoff Atovaquon oder gegenüber einem anderen Bestandteil des Präparates darf Wellvone nicht eingenommen werden.
Es sind keine speziellen Risiken bekannt, die die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigen könnten, aber aufgrund der Schwere des Krankheitszustandes ist bei der Ausübung dieser Tätigkeiten Vorsicht geboten.
Bei einer sehr schweren Lungenentzündung dürfte die Wirkung von Wellvone ungenügend sein. Auch sollte eine andere Behandlung in Betracht gezogen werden bei Patientinnen und Patienten, die schon vor der Therapie an Erbrechen litten, oder die nur ungenügend Nahrung aufnehmen können.
Die gleichzeitige Einnahme von Wellvone mit Rifampicin oder Rifabutin, Arzneimittel zur Behandlung von Tuberkulose, sollte vermieden werden, da diese Kombinationen zu einer verminderten Wirkung von Wellvone führen können.
Teilen Sie Ihrem Arzt bzw. Ihrer Ärztin mit, falls Sie Arzneimittel zur Behandlung einer HIV-Infektion einnehmen müssen oder wenn Sie Antibiotika (Tetrazykline, Cephalosporine), Arzneimittel gegen Durchfall, Abführmittel, Arzneimittel zur Behandlung von Störungen des Magen-Darm-Traktes (Metoclopramid), Antidepressiva, Schlafmittel oder Arzneimittel zur Behandlung von Angstzuständen (Benzodiazepine) oder Schmerzmittel (Paracetamol, Opiate) einnehmen.
Die Anwendung von Wellvone bei Patientinnen und Patienten über 55 Jahre und bei Patientinnen und Patienten mit Leber- oder Nierenschaden wurde nicht speziell untersucht.
Vor jeder Behandlung sollte der Erreger der Lungenentzündung festgestellt werden, denn Wellvone hilft nicht bei jeder Lungenerkrankung.
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.
Da es noch keine Berichte über die Wirkung von Wellvone während der Schwangerschaft gibt, sollten Sie Wellvone nur nach Rücksprache mit Ihrem Arzt bzw. Ihrer Ärztin einnehmen, wenn Sie schwanger sind oder es werden möchten.
Auch während der Stillzeit sollten Sie Wellvone nicht einnehmen.
1× täglich 1500 mg (entspricht 1× täglich 2 Messlöffel zu 5 ml) Wellvone Suspension zusammen mit einer vollen Mahlzeit.
2× täglich 750 mg (entspricht 2× täglich 1 Messlöffel zu 5 ml) Wellvone Suspension zusammen mit einer vollen Mahlzeit.
Patientinnen und Patienten mit Schluckbeschwerden, denen es nicht möglich ist, zwei volle Mahlzeiten pro Tag einzunehmen, können die gesamte Tagesdosis von 1500 mg (entspricht 2 Messlöffel zu 5 ml) Wellvone Suspension zusammen mit der Mahlzeit einnehmen.
Die Behandlungsdauer beträgt mindestens 21 Tage.
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 Wellvone auftreten:
Da Wellvone vor allem bei HIV-positiven Patientinnen und Patienten, die bereits an Komplikationen ihrer Krankheit leiden, eingesetzt wird, ist es oft schwer zu entscheiden, welche Nebenwirkungen dem Wellvone zuzuordnen sind.
Folgende Nebenwirkungen sind unter Wellvone vermehrt aufgetreten: Hautausschlag, Übelkeit, Durchfall, Kopfschmerzen, Erbrechen, Fieber, Schlaflosigkeit, Überempfindlichkeitsreaktionen (u.a. Ödeme, Engegefühl im Hals), im Blut erhöhte Leberenzymspiegel, reduzierte Natriumspiegel, reduzierte Anzahl weisser (Neutropenie) und roter Blutzellen (Anämie).
Andere mögliche Nebenwirkungen sind: Hautausschlag mit Bläschenbildung, der an kleine Zielscheiben erinnert (dunkler Fleck in der Mitte, umgeben von einem helleren Bereich mit einem dunklen Ring am äusseren Rand, Erythema multiforme); ausgedehnter Hautausschlag mit Bläschenbildung und Schälen der Haut, der insbesondere im Bereich von Mund, Nase, Augen und Genitalien auftritt (Stevens-Johnson-Syndrom).
Wenn solche unerwünschte Wirkungen auftreten, informieren Sie Ihren Arzt bzw. Ihre Ärztin.
Informieren Sie das Fachpersonal bei einer Blutentnahme über die Einnahme von Wellvone, da Wellvone die Blutwerte verändern kann.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin unverzüglich informieren.
Wellvone ist bei Zimmertemperatur (15?25 °C) und ausserhalb der Reichweite von Kindern zu lagern.
Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet werden.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Messlöffel zu 5 ml Wellvone Suspension enthält 750 mg Atovaquon, Saccharin, Vanillin und andere Geschmacksstoffe sowie Benzylalkohol als Konservierungsmittel und weitere Hilfsstoffe.
53563 (Swissmedic).
Wellvone erhalten Sie in Apotheken gegen ärztliche Verschreibung, die nur zum einmaligen Bezug berechtigt.
Wellvone Suspension zu 750 mg/5 ml: 210 ml (inkl. Messlöffel).
GlaxoSmithKline AG, 3053 Münchenbuchsee.
Diese Packungsbeilage wurde im Oktober 2008 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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