Swissmedic Nr.: 44347024
Index: 01.03.10
Pharmacode: 910914
GTIN/EAN: 7680443470245
Markteintritt: 16.04.1982
Kategorie: C Non-prescription de distribution après consultation, limitée aux pharmacies.
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Detensor ist ein Schlafmittel, das zur Behandlung von Schlafstörungen, insbesondere bei Einschlafschwierigkeiten sowie bei vorzeitigem Erwachen in der Nacht angewendet wird.
Detensor sollte nicht eingenommen werden:
? von Asthmatikern (mögliches Eindicken des Bronchialschleimes);
? bei erhöhtem Augeninnendruck («grüner Star»);
? bei Prostataleiden;
? bei Tumoren der Nebenniere (Phäochromozytom);
? bei Störungen der Biosynthese des roten Blutfarbstoffes Häm (Porphyrie);
? bei Kalium ? bzw. Magnesiummangel (Hypokaliämie bzw. Hypomagnesiämie);
? bei Herzrhythmusstörungen;
? bei gleichzeitiger Einnahme von Alkohol oder gewissen Arzneimitteln gegen Depressionen oder Parkinsonkrankheit (MAO-Hemmer);
? bei Schwangerschaft und Stillzeit;
? von Kindern und Jugendlichen unter 16 Jahren;
? bei Überempfindlichkeit (Allergien) auf einen der beiden Wirkstoffe;
? bei Fallsucht (Epilepsie).
Bei Asthma, gleichzeitiger Einnahme von beruhigenden Arzneimitteln oder starken Schmerzmitteln (gleichzeitige Wirkungsverstärkung), eingeschränkter Leberfunktion, Überfunktion der Schilddrüse oder hohem Blutdruck ist Vorsicht geboten.
Unmittelbar nach Einnahme von Detensor dürfen keine Fahrzeuge geführt oder Maschinen bedient werden. Detensor sollte nicht nach Mitternacht eingenommen werden, wenn am nächsten Morgen die Aufmerksamkeit in besonderem Masse beansprucht wird (z.B. Autofahren, Bedienen von Maschinen), da dieses Arzneimittel die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigt. Dies gilt insbesondere nach unzureichender Schlafdauer bzw. im Zusammenwirken mit Alkohol.
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.
Detensor darf während einer Schwangerschaft und in der Stillzeit nicht eingenommen werden.
Sprechen Sie mit Ihrem Arzt bzw. Ärztin, wenn Sie schwanger sind, es werden wollen oder ein Kind stillen.
Falls nicht anders verordnet gelten folgende Dosierungsempfehlungen:
Erwachsene und Jugendliche ab 16 Jahren: 1-1½ Tablette ca. eine halbe Stunde vor dem Schlafengehen mit etwas Wasser einnehmen.
Die Dauer der Behandlung sollte so kurz wie möglich sein. Sie sollte im Allgemeinen nur wenige Tage betragen und zwei Wochen nicht überschreiten. Bei fortbestehenden Schlafstörungen ist ein Arzt zu konsultieren.
Kinder unter 16 Jahren: die Anwendung und Sicherheit von Detensor bei Kindern unter 16 Jahren ist bisher nicht 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. Ihrer Ärztin oder Apothekerin.
Gelegentlich: Benommenheit und Konzentrationsstörungen während des Folgetages, Muskelschwäche.
Selten: Trockenheit im Mund, Übelkeit, Erbrechen, Durchfall, Verstopfung, Sodbrennen, beschleunigter Herzschlag, Schwindel, Kopfschmerzen, Beschwerden beim Wasserlassen.
Sehr selten: Störungen des Gallenabflusses aus der Leber, Überempfindlichkeitsreaktionen, erhöhte Lichtempfindlichkeit der Haut, Mangel an Leukozyten (weisse Blutkörperchen) oder Thrombozyten (Blutplättchen), Unverträglichkeitsreaktionen, paradoxen Reaktionen (Ruhelosigkeit, Nervosität, Erregung, Angstzustände, Zittern, Schlafstörungen), Erhöhung des Augeninnendruckes, und Sehstörungen.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ärztin oder Apothekerin informieren.
Detensor kann bei Allergie-Tests möglicherweise zu falsch-negativen Testergebnissen führen und sollte daher mindestens 3 Tage vorher abgesetzt werden.
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 ausführliche Fachinformation.
1 Tablette mit Teilkerbe enthält:
31 mg Diphenhydraminhydrochlorid, 23 mg 8-Chlortheophyllin sowie Hilfsstoffe.
44347 (Swissmedic)
In Apotheken ohne ärztliche Verschreibung.
Packung zu 20 Tabletten.
Novartis Consumer Health Schweiz AG, Risch.
Diese Packungsbeilage wurde im März 2009 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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