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Smpc Tabular CH Template V H. Lundbeck A/S Confidential CH SPC Deanxit 10mg/0.5mg Coated Tablets Approved by 23-Feb-2015, Change: Fertility Update ID-Nr.23022015FI German English Comments Deanxit® Deanxit® Zusammensetzung Composition Wirkstoffe: Melitracen und Flupentixol. Active substances: melitracen and flupentixol. Hilfsstoffe: Laktose, Kartoffelstärke, Gelatine, Talk, Inactive ingredients: lactose, potato starch, Magnesiumstearat, im Überzug: Gelatine, Saccharose, gelatin, talc, magnesium stearate, coating: gebleichtes Wachs, Carnaubawachs, Color: E127 gelatin, saccharose, white wax, carnauba wax, (Erythrosin), E132 (Indigocarmin). coloring agents: E127 (erythrosin), E132 (indigo carmine). Galenische Form und Wirkstoffmenge pro Einheit Galenic form and amount of active substance per unit Dragées zu 10 mg Melitracen (als Coated tablets containing 10 mg melitracen (as Melitracenhydrochlorid) und 0.5 mg Flupentixol (als melitracen hydrochloride) and 0.5 mg flupentixol Flupentixoldihydrochlorid). (as flupentixol dihydrochloride). Aussehen der Dragées: Appearance of the coated tablets: Rund, biconvex, dunkelrosa Round, biconvex, cyclamen Indikationen / Anwendungsmöglichkeiten Indications / Possible Applications Leichte bis mittelschwere Zustände depressiver Mild to moderately severe conditions of Gehemmtheit und Angst. depressive inhibition and anxiety. SmPC Tabular CH Template v. 2.0 Page 1 of 35 H. Lundbeck A/S Confidential CH SPC Deanxit 10mg/0.5mg Coated Tablets Approved by 23-Feb-2015, Change: Fertility Update ID-Nr.23022015FI German English Comments Dosierung / Anwendung Dosage / Application Erwachsene: Adults: In der Regel 2 Dragées täglich: morgens und mittags je As a rule, 2 coated tablets daily: 1 coated tablet 1 Dragée. In schweren Fällen kann morgens die Dosis in the morning and another at noon. In severe auf 2 Dragées erhöht werden. Die tägliche cases, the morning dose can be increased to 2 Maximaldosis beträgt 4 Dragées. coated tablets. The daily maximum dose is 4 coated tablets. Ältere Patienten (über 65 Jahre): Older patients (over 65 years): Morgens 1 Dragée. In schweren Fällen morgens und 1 coated tablet in the morning. In severe cases, mittags je 1 Dragée. one coated tablet in the morning and another at noon. Kinder und Jugendliche (<18 Jahre) Children and adolescents (<18 years) Deanxit wird nicht für die Anwendung bei Kindern und Deanxit is not recommended for use in children Jugendlichen unter 18 Jahren empfohlen, da keine and adolescents due to lack of data on safety and klinischen Daten zur Sicherheit und Wirksamkeit efficacy. vorliegen. Spezielle Dosierungsanweisungen Special dosage instructions Bei herabgesetzter Nieren- sowie Leberfunktion kann Deanxit may be administered in the Deanxit in der empfohlenen Dosierung verabreicht recommended dosage in patients with decreased werden. renal and hepatic function. Hinweis: Bei Auftreten von Schlafstörungen oder Instruction: Should sleep disturbances or severe SmPC Tabular CH Template v. 2.0 Page 2 of 35 H. Lundbeck A/S Confidential CH SPC Deanxit 10mg/0.5mg Coated Tablets Approved by 23-Feb-2015, Change: Fertility Update ID-Nr.23022015FI German English Comments starker Unruhe unter Deanxit ist eine Dosisreduktion zu restlessness arise during treatment with Deanxit, erwägen oder eventuell zusätzlich abends ein leichtes a reduction in the dose should be considered or a Sedativum zu verabreichen. light sedative agent should possibly be prescribed in the evening. Die Dragées werden mit Wasser geschluckt. The coated tablets are swallowed with water. Falls eine Dosis vergessen wurde, soll der Patient In case of a forgotten dose the patient should diese auslassen und die nächste Dosis zur gewohnten skip it and take the the dose at the usual time. Zeit einnehmen. Die Dosis soll nicht verdoppelt The dose should not be doubled. werden. Kontraindikationen Contraindications Überempfindlichkeit gegen Melitracen, Flupentixol oder Hypersensitivity to melitracen, flupentixol or to gegen in Deanxit Dragées enthaltene Hilfsstoffe (siehe inactive ingredients contained in Deanxit tablets Zusammensetzung). (see Composition). Bei Kreislaufkollaps, herabgesetztem Deanxit is contraindicated when there is Bewusstseinszustand (z.B. akute Alkohol-, Barbiturat- circulatory collapse, depression of the CNS (e.g., oder Opiatvergiftungen), komatösem Zustand, acute alcohol, barbiturate or opiate intoxication), Phäochromozytom und Blutdyskrasien ist Deanxit comatose states, pheochromocytoma and blood kontraindiziert. Deanxit ist kontraindiziert nach einem dyscrasias. Deanxit is contraindicated after a kürzlich erfolgten akuten Herzinfarkt, bei Herzblock recently occurred acute myocardial infarction, jeden Grades, bei Erregungsleitungsstörungen sowie with any degree of heart block, with disturbances bei koronarer Insuffizienz. of conduction, and with coronary insufficiency. SmPC Tabular CH Template v. 2.0 Page 3 of 35 H. Lundbeck A/S Confidential CH SPC Deanxit 10mg/0.5mg Coated Tablets Approved by 23-Feb-2015, Change: Fertility Update ID-Nr.23022015FI German English Comments Die gleichzeitige Verabreichung mit MAO-Hemmern ist The simultaneous administration with MAO kontraindiziert (siehe Interaktionen). inhibitors is contraindicated (see Interactions). Bei gleichzeitiger Verabreichung von Melitracen und A serotonin syndrome may appear with einem MAO-Hemmer (nicht-selektive wie auch simultaneous administration of melitracen and a selektive MAO-A-Hemmer [Moclobemid] und MAO-B- MAO inhibitor (both non-selective as well as Hemmer [Selegilin]) kann ein Serotonin-Syndrom selective MAO-A inhibitors [moclobemide] and auftreten. Die Symptomatik äussert sich u.a. in MAO-B inhibitors [selegiline]). Symptoms include Hyperthermie, Myoklonie, Rigidität, Tremor, Agitiertheit, (among others) hyperthermia, myoclonia, rigidity, Verwirrung, Bewusstseinsstörungen, autonomer tremor, agitation, confusion, disturbances in the Dysfunktion (Kreislaufinstabilität). state of consciousness, autonomic dysfunction Wie andere trizyklische Antidepressiva sollte Melitracen (circulatory instability). nicht an Patienten verabreicht werden, die MAO- As with other tricyclic antidepressants, melitracen Hemmer einnehmen. Die Behandlung mit Deanxit darf should not be prescribed for patients who are erst 14 Tage nach Absetzen der Behandlung mit nicht- taking MAO inhibitors. Treatment with Deanxit selektiven MAO-Hemmern sowie Selegilin und may only commence 14 days after discontinuing frühestens einen Tag nach Absetzen der Behandlung therapy with non-selective MAO inhibitors and mit Moclobemid begonnen werden. Nach Beendigung with selegiline, and after one day, at the earliest, einer Deanxit-Therapie soll 14 Tage gewartet werden, after discontinuing moclobemide treatment. When bis eine MAO-Hemmer-Therapie eingeleitet wird. treatment with Deanxit has been discontinued, a 14-day period must be observed before MAO inhibitor treatment is started. SmPC Tabular CH Template v. 2.0 Page 4 of 35 H. Lundbeck A/S Confidential CH SPC Deanxit 10mg/0.5mg Coated Tablets Approved by 23-Feb-2015, Change: Fertility Update ID-Nr.23022015FI German English Comments Warnhinweise und Vorsichtsmassnahmen Warnings and Precautions Deanxit sollte bei Patienten mit organischen Deanxit should be administered with caution in Hirnschäden, Krampfanfällen, Harnverhalt, patients having organic brain damage, seizures, Schilddrüsenüberfunktion, Parkinson-Syndrom, urinary retention, hyperthyroidism, Parkinson’s Myasthenia gravis, fortgeschrittener Lebererkrankung syndrome, myasthenia gravis, advanced hepatic sowie bei Herz-Kreislaufstörungen mit Vorsicht disease as well as in those having cardiovascular angewandt werden. or circulatory problems. Deanxit ist aufgrund seiner aktivierenden Based on its stimulating properties, Deanxit is not Eigenschaften bei leicht erregbaren und hyperaktiven recommended for use in excitable and Patienten nicht zu empfehlen. Falls der Patient hyperactive patients. If the patient has been vorgängig mit sedierenden Arzneimitteln, wie previously treated with sedatives, like Tranquilizern oder Neuroleptika behandelt wurde, tranquillizers or neuroleptics, these must be müssen diese ausschleichend abgesetzt werden. gradually discontinued. Wie bei allen Neuroleptika kann sich ein potentiell The possibility of development of a potentially life lebensbedrohliches malignes neuroleptisches Syndrom threatening neuroleptic malignant syndrome (Hyperthermie, Rigor, Bewusstseinsstörungen, (hyperthermia, muscle rigidity, fluctuating Instabilität des autonomen Nervensystems) entwickeln. consciousness, instability of the autonomous nervous system) exists as with any neuroleptic. Extrapyramidale Störungen können in sehr seltenen In very rare cases, especially at the beginning of Fällen vor allem am Anfang einer Behandlung mit treatment with flupentixol, extrapyramidal SmPC Tabular CH Template v. 2.0 Page 5 of 35 H. Lundbeck A/S Confidential CH SPC Deanxit 10mg/0.5mg Coated Tablets Approved by 23-Feb-2015, Change: Fertility Update ID-Nr.23022015FI German English Comments Flupentixol auftreten. Bei länger dauernder Behandlung disturbances may appear. When neuroleptic mit Neuroleptika wie Flupentixol sind potentiell agents, such as flupentixol, are used for a irreversible Spätdyskinesien möglich. prolonged duration of treatment, potential irreversible tardive dyskinesias are possible. Bei Patienten unter langfristiger Therapie mit For patients undergoing a long-term treatment Flupentixol müssen der psychologische und der with flupentixol, the psychological and the neurologische
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