Swissmedic Nr.: 51379012
Index: 07.10.40
Pharmacode: 1413885
GTIN/EAN: 7680513790129
Markteintritt: 06.02.1991
Kategorie: C Rezeptfreie Abgabe nach Fachberatung, beschränkt auf Apotheken.
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Traumalix Spray ist ein Arzneimittel zur äusserlichen Anwendung und hat entzündungshemmende und schmerzlindernde Eigenschaften. Der Wirkstoff Etofenamat durchdringt die Haut und erreicht die erkrankten Gewebebezirke.
Beim Auftragen auf die Haut entsteht anfänglich ein leichter Kühleffekt.
Traumalix Spray wird angewendet zur Behandlung von Verstauchungen, Prellungen und Zerrungen (z.B. nach Sportverletzungen).
Als unterstützende Massnahme zur lokalen Behandlung von rheumatischen Beschwerden des Bewegungsapparates.
Traumalix Spray darf nicht auf verletzter oder ekzematös entzündeter Haut angewendet werden. Bei Überempfindlichkeit gegen Etofenamat, Flufenaminsäure oder andere schmerz- und entzündungshemmende Substanzen sowie bei Überempfindlichkeit gegen Propylenglycol darf Traumalix Spray nicht angewendet werden.
Nicht bei Säuglingen und Kleinkindern anwenden.
Traumalix Spray sollte nicht über längere Zeit grossflächig angewendet werden, es sei denn auf ärztliche Verschreibung. Augen und Schleimhäute sollen mit dem Spray nicht in Berührung kommen.
Informieren Sie Ihren Arzt, Apotheker bzw. Ihre Ärztin, Apothekerin, wenn Sie schon ähnliche Produkte (Rheumasalben) verwendet haben und diese zu allergischen Reaktionen führten, wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden!
Traumalix Spray darf während der Schwangerschaft und Stillzeit nicht angewendet werden, ausser auf ausdrückliche ärztliche Verschreibung.
Vorsichtshalber sollten Sie während der Schwangerschaft und Stillzeit möglichst auf Arznei-mittel verzichten oder den Arzt oder den Apotheker bzw. die Ärztin oder die Apothekerin um Rat fragen.
Erwachsene:
Traumalix Spray 4-7-mal täglich auf das erkrankte Gebiet und seine Umgebung aufsprühen, wobei je nach Grösse des betroffenen Bezirkes bis zu neun Sprühstösse appliziert werden können. Dabei empfiehlt es sich, nach jeweils ein bis zwei Sprühstössen die Lösung leicht einzureiben und antrocknen zu lassen.
Informieren Sie Ihren Arzt/Ihre Ärztin, wenn sich die Beschwerden verschlimmern oder nach 2 Wochen nicht gebessert haben.
Kinder:
Die Anwendung und Sicherheit von Traumalix Spray bei Kindern und Jugendlichen ist bisher nicht systematisch geprüft worden.
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 Anwendung von Traumalix Spray auftreten:
In seltenen Fällen können lokale allergische Reaktionen wie z.B. Rötungen, Hautausschlag, Kontaktdermatitis auftreten, die sich nach Absetzen des Präparates normalerweise rasch zurückbilden.
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 dem Behälter mit «EXP» bezeichneten Datum verwendet werden. Bei Raumtemperatur (15?25°C) und ausser Reichweite von Kindern lagern.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführlichen Fachinformationen.
1 ml Traumalix enthält:
Wirkstoff: 100 mg Etofenamat (ein Sprühstoss = 10 mg Etofenamat)
Hilfsstoffe: Macrogol 400, Propylenglykol, Excip. ad solut.
51?379 (Swissmedic)
In Apotheken ohne ärztliche Verschreibung.
Eine Packung Traumalix Spray enthält eine Pumpsprayflasche mit 50 ml Lösung.
Drossapharm AG, 4002 Basel
Diese Packungsbeilage wurde im April 2006 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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