Swissmedic Nr.: 55835026
Index: 01.06.00
Pharmacode: 3991600
GTIN/EAN: 7680558350265
Markteintritt: 22.04.2004
Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.
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Trimipramin Sandoz wird zur Behandlung von Depressionen eingesetzt. Es hellt die Stimmung auf, mildert Angstzustände, beseitigt Traurigkeit und innere Unruhe und wirkt bei Schlaflosigkeit psychischen Ursprungs. Trimipramin Sandoz darf nur auf Verschreibung des Arztes oder der Ärztin angewendet werden.
Sie dürfen Trimipramin Sandoz nicht einnehmen bei Überempfindlichkeit auf den Wirkstoff Trimipramin oder einen Hilfsstoff von Trimipramin Sandoz, bei gleichzeitiger Einnahme eines MAO-Hemmers, (z.B. zur Behandlung von Depressionen oder von Parkinson-Krankheit), ferner bei vergrösserter Prostata mit Beschwerden beim Wasserlösen, bei massiv erhöhtem Augeninnendruck (Glaukom), bei schweren Reizleitungsstörungen des Herzes sowie während der Erholungsphase nach einem frischen Herzinfarkt.
Unter der Behandlung mit Trimipramin Sandoz können sich die Symptome der Depression, insbesondere suizidalen Verhaltens, verschlechtern. In diesem Fall sollten Sie umgehend Ihren Arzt bzw. Ihre Ärztin kontaktieren.
Bei Kindern und Jugendlichen mit Depressionen oder anderen psychiatrischen Diagnosen wurde unter der Behandlung mit Antidepressiva über ein vermehrtes Auftreten von Verhaltensstörungen, inkl. erhöhtem Risiko von Suizidgedanken, Selbstverletzungen und vollendetem Suizid berichtet.
Daten aus klinischen Studien mit jungen Erwachsenen bis 25 Jahren mit psychiatrischen Störungen, die mit Antidepressiva behandelt wurden, haben ein erhöhtes Risiko für suizidales Verhalten gezeigt.
Ein Abbruch der Behandlung darf nicht plötzlich erfolgen und nur in Absprache mit Ihrem Arzt bzw. mit Ihrer Ärztin erfolgen, da es sonst zu Entzugssymptomen kommen kann.
Studien haben ein erhöhtes Diabetesrisiko in Verbindung mit trizyklischen Antidepressiva gezeigt.
Serotoninsyndrom: Informieren Sie Ihren Arzt, wenn Sie Medikamente mit Trimipramin Sandoz-ähnlicher Wirkung einnehmen.
Zu diesen Medikamenten zählen etwa Triptane, Tramadol, Lithium, Selektive Serotonin-Wiederaufnahmehemmer (SSRI), Selektive Serotonin-/Noradrenalin-Wiederaufnahmehemmer (SSNRI) und Johanniskraut.
Diese Medikamente erhöhen das Risiko von Nebenwirkungen. Beim Serotoninsyndrom treten Bewusstseinsstörungen, Muskelsteifheit (Rigor), Zittern (Tremor), unwillkürliche Muskelzuckungen und Fieber auf.
Informieren Sie unverzüglich Ihren Arzt, wenn solche Symptome auftreten.
Trimipramin Sandoz kann dosisabhängig das QT-Intervall verlängern (den Herzschlag verlangsamen und das EKG verändern).
Falls Sie an Herz-/Kreislaufstörungen (z.B. tiefer Blutdruck, Herzrhythmusstörungen, koronare Herzkrankheit), nicht insulinabhängiger Zuckerkrankheit (Typ-II-Diabetes), schweren Leber- oder Nierenerkrankungen, Epilepsie, erhöhtem Augeninnendruck, oder Prostatabeschwerden leiden, sollten Sie mit der Einnahme von Trimipramin Sandoz vorsichtig sein. Bei Patienten mit Schilddrüsenüberfunktion ist Trimipramin Sandoz mit besonderer Vorsicht anzuwenden, weil Antidepressiva zu Herzrhythmusstörungen führen können. Vorsicht ist geboten bei gleichzeitiger Verwendung von anderen Arzneimitteln z.B. zur Behandlung von Asthma (Adrenalin-Analoge), von Magen- oder Zwölffingerdarmgeschwüren (Cimetidin), zur Gewichtsreduktion (Appetitzügler), gegen Depression, gegen andere psychische Störungen, gegen Herzrhythmusstörungen (z.B. Chinidin, Amiodaron) und gewissen Arzneimitteln gegen Bluthochdruck (Reserpin, Guanethidin, Clonidin, Methyldopa).
Trimipramin Sandoz verstärkt die Wirkung von Alkohol, gewissen Schlafmitteln, anderen zentral beruhigenden oder auf die Psyche wirkenden Arzneimitteln. Von Alkoholkonsum während der Behandlung wird grundsätzlich abgeraten. Falls ein chirurgischer Eingriff bevorsteht, sollten Sie Ihren Arzt bzw. Ihre Ärztin informieren. Trimipramin Sandoz kann Schläfrigkeit und verschwommenes Sehen verursachen und dadurch die Reaktionsfähigkeit, die Fahrtüchtigkeit und Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigen.
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.
Nehmen Sie Trimipramin Sandoz während der Schwangerschaft nur auf ausdrückliche Verordnung des Arztes oder der Ärztin ein, denn Trimipramin Sandoz könnte dem ungeborenen oder gestillten Kind schaden.
Der Wirkstoff von Trimipramin Sandoz geht in die Muttermilch über. Es muss abgestillt werden, wenn Sie das Medikament einnehmen müssen. Nehmen Sie in jedem Fall Kontakt mit Ihrem Arzt oder mit Ihrer Ärztin auf.
Die Dosierung wird vom Arzt bzw. von der Ärztin für jeden Patienten bzw. jede Patientin individuell festgelegt. In der Regel beginnt man mit einer niedrigen Dosierung, die langsam gesteigert und nach Eintreten der Wirkung auf die notwendige Erhaltungsdosis reduziert wird. Die übliche tägliche Erhaltungsdosis beträgt 50?100 mg Trimipramin Sandoz (entspricht 2?4 Tabletten zu 25 mg, ½?1 Tablette zu 100 mg). Diese Tagesdosis wird entweder auf 2?3 Einzeldosen verteilt (während oder nach den Mahlzeiten), oder in einer Einmaldosis am Abend, 2 Stunden vor dem Schlafengehen, eingenommen. In gewissen Fällen, z.B. bei älteren Patienten bzw. Patientinnen, kann der Arzt bzw. die Ärztin die Erhaltungsdosis auf 25?50 mg Trimipramin Sandoz pro Tag (entspricht 1?2 Tabletten zu 25 mg) reduzieren. Schlucken Sie die Tabletten unzerkaut mit etwas Flüssigkeit. Als Alternative kann der Arzt bzw. die Ärztin auch Tropfen verschreiben (1 Tropfen entspr. 1 mg Trimipramin).
Trimipramin Sandoz Tropfen werden mit etwas Wasser während oder nach den Mahlzeiten eingenommen, Flasche beim Tropfen senkrecht halten! Nicht schütteln! Zum Antropfen evtl. leicht auf den Flaschenboden klopfen.
Trimipramin Sandoz darf bei Patienten bzw. Patientinnen unter 18 Jahren nicht angewendet 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 Trimipramin Sandoz auftreten:
Müdigkeit und Schwindel, gelegentlich auch Benommenheit, Zittern, Unruhe, Schlafstörungen, Schläfrigkeit, Kopfschmerzen, hoher Blutzuckerspiegel, Herzfunktionsstörungen (Herzrhythmusstörungen), Bauchbeschwerden und Entzündung der Mundschleimhaut. In gewissen Fällen kann Mundtrockenheit, verschwommenes Sehen, Wallungen, Schweissausbruch, Verstopfung und Schwierigkeiten beim Wasserlösen sowie Harnverhaltung vorkommen. Seltener kommt es zu allergischen Reaktionen, Juckreiz, Lichtempfindlichkeit, Hautausschlag, Schwellung im Gesicht, Blutdruckabfall, Herzklopfen, Herzrhythmusstörungen, Launenhaftigkeit und Verwirrtheit v.a. bei älteren Patienten bzw. Patientinnen, epileptischen Anfällen, Bewegungsstörungen, Beeinträchtigung der Leberfunktion, wie Gallenstauung, Gelbsucht, Leberentzündung oder erhöhte Leberfunktionswerte. In Einzelfällen wurde eine Brustvergrösserung beim Mann und Milchfluss aus der weiblichen Brust beobachtet. Eine Beeinflussung des gewohnten Sexualverhaltens ist möglich. Gewichtszunahme aufgrund der psychischen Besserung kann vorkommen.
Eine Zunahme des Auftretens von Verhaltensstörungen, einschliesslich verstärkten Risikos suizidaler Gedanken, Selbstverletzung und Suizid, wurde bei Kindern, Jugendlichen und jungen Erwachsenen bis 25 Jahre mit Depression oder anderer psychiatrischer Störungen während der Behandlung mit Antidepressiva berichtet.
Bei Patienten welche trizyklische Antidepressiva oder selektive Serotonin-Wiederaufnahmehemmer einnahmen, wurde ein erhöhtes Risiko von Knochenbrüchen beobachtet.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Trimipramin Sandoz Tropfen enthalten 12% Vol. Alkohol. Von Alkoholkonsum während der Behandlung wird grundsätzlich abgeraten. Nach dem erstmaligen Öffnen sind die Tropfen 12 Monate haltbar. Das Präparat ist auch alkoholfrei (als Tabletten) erhältlich.
Das Arzneimittel in der Originalpackung, bei Raumtemperatur (15-25 °C), vor Licht geschützt und ausser Reichweite von Kindern aufbewahren.
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.
Trimipramin Sandoz enthält den Wirkstoff Trimipramin.
Tabletten mit 25 mg resp. 100 mg Trimipramin (als Trimipraminmaleat), Hilfsstoffe.
Tropfen (4%) mit 40 mg/ml Trimipramin (als Trimipraminmesilat), Aromatika, weitere Hilfsstoffe. 1 ml entspricht 40 Tropfen. Enthält 12% Vol. Alkohol.
55835, 58449 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Packung mit 50 und Bündelpackung mit 200 (4× 50) Tabletten zu 25 mg (teilbar).
Packungen mit 20 und 100 Tabletten zu 100 mg (teilbar).
Flaschen zu 30 ml zu 4% (1 Tropfen entspr. 1 mg Trimipramin).
Sandoz Pharmaceuticals AG, Risch; Domizil: Rotkreuz.
Diese Packungsbeilage wurde im Dezember 2014 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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