Swissmedic Nr.: 14770055
Index: 01.01.30
Pharmacode: 5157781
GTIN/EAN: 7680147700556
Markteintritt: k.a.
Kategorie: A Einmalige Abgabe auf eine ärztliche Verschreibung hin.
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Ketalgin enthält den Wirkstoff Methadon. Dieser gehört in die Gruppe der Opiate und hat qualitativ dieselben Effekte wie Morphin.
Ketalgin untersteht der Kontrolle des Betäubungsmittelgesetzes und darf nur von Ihrem Arzt bzw. Ihrer Ärztin an Sie abgegeben oder verschrieben werden. Ketalgin ist ein starkes Schmerzmittel, das im Gegensatz zu schwächeren Präparaten psychische Veränderungen verursachen kann.
Heute wird dieses Präparat bei folgenden Beschwerden eingesetzt:
Auf Verschreibung des Arztes oder der Ärztin.
Dieses Medikament wurde Ihnen von Ihrem Arzt bzw. Ihrer Ärztin zur Behandlung Ihrer Erkrankung ver-schrieben. Wenden Sie es deshalb nie von sich aus für die Behandlung anderer Symptome oder anderer Personen an. Auch bei späteren neuen Erkrankungen dürfen Sie Ketalgin nicht ohne erneute ärztliche Konsultation anwenden. Ketalgin soll ? wie alle Schmerzmittel ? nicht über längere Zeit und in höheren Dosen ohne ärztliche Kontrolle eingenommen werden.
Bei der Behandlung von Opioidabhängigkeit (Methadonprogramm) sollen Sie den gleichzeitigen Konsum anderer Drogen, Alkohol und die Einnahme von anderen, nicht von Ihrem Arzt bzw. Ihrer Ärztin verschriebenen, Medikamenten vermeiden.
Bei Überempfindlichkeit gegenüber Methadon oder einem der Inhaltsstoffe.
Bei schwerer Beeinträchtigung der Atmung.
Bei Bauchschmerzen unklarer Ursache.
Bei Schädel-/Hirn- Verletzung.
Bei schwerer Störung der Leber- oder Nierenfunktion.
Während der Geburt.
Bei Alkoholvergiftung.
Folgen Sie bei der Einnahme/Anwendung von Ketalgin strikt den Anweisungen Ihres Arztes bzw. Ihrer Ärztin. Wenn Sie gleichzeitig noch andere Arzneimittel (z.B. Schlafmittel, Arzneimittel gegen Depressionen, Beruhigungsmittel oder krampflösende Mittel (Antiepileptika) einnehmen, so benachrichtigen Sie unbedingt Ihren Arzt bzw. Ihre Ärztin, da solche Arzneimittel die Wirkung von Ketalgin verändern können.
Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit Werkzeuge oder Maschinen zu bedienen beeinträchtigen!
Verzichten Sie auf die Einnahme von Alkohol während der Therapie mit Ketalgin.
Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie
Während der Schwangerschaft und Stillzeit darf Ketalgin ? wenn überhaupt ? nur in Ausnahmefällen gemäss den Anweisungen Ihres Arzt bzw. Ihrer Ärztin angewendet werden.
Um mögliche Nebenwirkungen zu vermeiden, legt Ihr Arzt bzw. Ihre Ärztin die für Sie geeignete und optimale Dosierung von Ketalgin fest.
Im Allgemeinen liegen die Dosen im folgenden Bereich:
Tabletten 5 mg: ½-3 Tabl., bei Bedarf bis 3 mal täglich.
Zäpfchen 10 mg: 1-2 Zäpfchen, bei Bedarf bis 3 mal täglich.
Maximale Einzeldosis: 20 mg (4 Tabletten oder 2 Zäpfchen).
Maximale Tagesdosis: 60 mg/24 Std. (12 Tabletten oder 6 Zäpfchen).
Regelmässige (tägliche) Einnahme der durch den Arzt bzw. der Ärztin festgesetzten Methadondosis, aufgelöst in Wasser, Orangen- oder Fruchtsaft; Zäpfchen werden in den Darm eingeführt
Brechen Sie die Suchtersatzbehandlung mit Ketalgin irregulär oder vorzeitig ab, ist eine Wiederaufnahme der Behandlung nur nach Rücksprache mit Ihrem behandelnden Arzt bzw. Ihrer behandelnden Ärztin möglich.
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.
Die Anwendung und Sicherheit von Ketalgin bei Kindern und Jugendlichen ist bisher nicht geprüft worden.
Folgende Nebenwirkungen können bei der Einnahme oder Anwendung von Ketalgin auftreten:
Die Nebenwirkungen von Ketalgin sind stark dosis-abhängig. Es können aber bereits bei Anwendung/Einnahme üblicher Mengen an Methadon folgende unerwünschte Wirkungen beobachtet werden:
Übelkeit, Erbrechen, Schwindel, Unruhe, Stimmungsschwankungen (Euphorie, Beruhigung), Beeinträchtigung der Atmung, bei länger dauernder Einnahme zusätzlich Verstopfung sowie Schwierigkeiten beim Wasserlassen.
Im Weiteren ist die Entwicklung einer Abhängigkeit vom Morphin-Typ möglich, insbesondere im Zusammenhang mit höheren Dosen und längerer Anwendungsdauer.
Bei Überdosierung ist der Arzt bzw. die Ärztin oder das nächste Spital unverzüglich aufzusuchen.
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), vor Licht geschützt und für Kinder unerreichbar aufbewahren.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
1 Tablette enthält 5 mg, 20 mg oder 40 mg Methadonhydrochlorid sowie Hilfsstoffe und Färbemittel (20 mg: Chinolingelb (E104), 40 mg: Erythrosin (E127)).
1 Zäpfchen enthält 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 75 mg, 100 mg, 125 mg oder 150 mg Methadonhydrochlorid sowie Hilfsstoffe.
14770, 19932 (Swissmedic).
In Apotheken gegen ärztliche Verschreibung, die nur zum einmaligen Bezug berechtigt.
Ketalgin untersteht dem Bundesgesetz über die Betäubungsmittel und die psychotropen Stoffe.
Nur ermächtigte Ärzte bzw. Ärztinnen dürfen Rezepte dafür ausstellen.
Packungen mit 10 Tabletten (20 mg und 40 mg).
Packungen mit 20 Tabletten (5 mg).
Packungen mit 5 und 25 Zäpfchen (10 mg).
Packungen mit 10 Zäpfchen (5 mg, 20 mg, 30 mg, 40 mg, 50 mg, 75 mg, 100 mg, 125 mg und 150 mg).
Orale Lösungen und weitere Dosisstärken stehen zur Anwendung unter der Aufsicht von Fachpersonen zur Verfügung.
Amino AG, Gebenstorf.
Diese Packungsbeilage wurde im Oktober 2015 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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