Swissmedic Nr.: 53863019
Index: 03.01.10
Pharmacode: 1800406
GTIN/EAN: 7680538630196
Markteintritt: 18.07.1996
Kategorie: C Rezeptfreie Abgabe nach Fachberatung, beschränkt auf Apotheken.
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Calmesin-Mepha Sirup ist ein Hustenmittel, das den Wirkstoff Dextromethorphan enthält. Dextromethorphan lindert übermässigen Hustenreiz. Calmesin-Mepha Sirup wird zur Behandlung des Hustens, insbesondere des trockenen Reizhustens angewendet.
Tabakkonsum begünstigt den Husten («Raucherhusten»). Sie können die Wirkung von Calmesin-Mepha Sirup unterstützen, indem Sie auf das Rauchen verzichten.
Diabetikerhinweis: 5 ml Sirup = 0,16 Obstwerte = 0,16 BE.
Bei Überempfindlichkeit gegen einen der Inhaltsstoffe sowie während einer Behandlung mit gewissen Arzneimitteln gegen Gemütsstörungen (sogenannte MAO-Hemmer).
Calmesin-Mepha Sirup ist mit dem sogenannten Azofarbstoff E 124 gefärbt und enthält die Konservierungsmittel E 216 und E 218. Bei Überempfindlichkeit (Allergie) auf einen dieser Hilfsstoffe oder auf gewisse Fieber-, Schmerz- oder Rheumamittel (Acetylsalicylsäure, wie z.B. Aspirin oder Alcacyl, oder sogenannte Prostaglandinhemmer; siehe «Welche Nebenwirkungen kann Calmesin-Mepha Sirup haben?») dürfen Sie dieses Präparat nicht anwenden.
Calmesin-Mepha Sirup ist mit Rohrzucker (Saccharose) gesüsst, aus welchem bei der Verdauung Fruchtzucker (Fruktose) entsteht. Deshalb dürfen Sie dieses Präparat nicht anwenden, wenn Sie oder Ihr Kind an einer (seltenen) angeborenen Störung des Zuckerstoffwechsels (sogenannte Fruktose-Intoleranz) leiden.
Bei Atemwegserkrankungen mit übermässig starker Schleimbildung, bei Atemschwäche oder bei schweren Herz- Kreislauf Krankheiten dürfen Sie Calmesin-Mepha Sirup nicht einnehmen.
Calmesin-Mepha Sirup darf nicht an Kinder unter 1 Jahr verabreicht werden.
Husten ist ein Abwehrmechanismus des Körpers, der bestimmte Ursachen hat. Wenn Ihr Husten oder der Husten Ihres Kindes mehr als eine Woche anhält, sollten Sie einen Arzt bzw. eine Ärztin aufsuchen, damit dieser die Ursache abklärt und eine schwerere Krankheit ausschliesst und, falls nötig, eine spezifische Behandlung einleitet.
Wenn Sie an chronischen Erkrankungen der Atemwege oder an einer Lebererkrankung leiden, sollten Sie Calmesin-Mepha Sirup nur auf ärztliche Verordnung verwenden.
Wenn Sie an Asthma oder Nesselfieber (sogenannte chronische Urtikaria) leiden oder wenn Sie zu Überempfindlichkeitsreaktionen neigen, sollten Sie Calmesin-Mepha Sirup nur mit Vorsicht anwenden, weil dann das Risiko, dass solche Reaktionen auftreten können, erhöht ist.
Bei Auftreten von Überempfindlichkeitsreaktionen (Allergie) müssen Sie die Behandlung sofort abbrechen und einen Arzt aufsuchen. Überempfindlichkeitsreaktionen machen sich mit Hautausschlägen, Gesichtsschwellungen, beschleunigtem Herzschlag, Unwohlsein und/oder Atembeschwerden bemerkbar. In Einzelfällen können sie bis zur Ohnmacht und zum Schock (sogenannter Kreislaufschock) gehen.
Bei gewissen Personen, z.B. bei Patienten mit einer Leber- oder Nierenerkrankung, sowie bei Personen mit einer erblichen (genetischen) Veranlagung, wird der Wirkstoff Dextromethorphan nach Einnahme wesentlich langsamer abgebaut als bei anderen Personen. Dadurch können nicht nur die hustenstillende Wirkung, sondern vor allem die Nebenwirkungen schon nach einer Behandlungsdauer von 3?4 Tagen zunehmen. Ihr Arzt bzw. Ihre Ärztin wird Sie über die Zusammenhänge aufklären.
Es ist zu beachten, dass Calmesin-Mepha Sirup auch bei bestimmungsgemässem Gebrauch das Reaktionsvermögen soweit verändern kann, dass die Fähigkeit zur aktiven Teilnahme am Strassenverkehr oder zum Bedienen von Maschinen beeinträchtigt werden kann. Dies gilt in verstärktem Masse bei einer Behandlungsdauer, die 3?4 Tage überschreitet, sowie bei gleichzeitigem Genuss von alkoholischen Getränken.
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!
Wenn Sie schwanger sind oder es werden möchten, oder wenn Sie stillen, sollten Sie vorsichtshalber möglichst auf Arzneimittel verzichten. Für Calmesin-Mepha Sirup ist nicht sicher, ob es die Entwicklung und Gesundheit des ungeborenen Kindes beeinträchtigen kann. Deshalb sollten Sie dieses Arzneimittel während der Schwangerschaft nur einnehmen, wenn Ihr Arzt dies ausdrücklich verordnet hat. Wenn Sie Calmesin-Mepha Sirup kurz vor dem Ende der Schwangerschaft einnehmen, kann dies zu Atemschwierigkeiten beim Neugeborenen führen.
Der Wirkstoff von Calmesin-Mepha Sirup tritt in geringen Mengen in die Muttermilch über. Von einer Anwendung während der Stillzeit wird deshalb abgeraten.
Flasche vor Gebrauch schütteln.
Kleinkinder (1?2 Jahre, nur auf ärztliche Verschreibung): morgens und abends ½ Messlöffel.
Kinder (2?8 Jahre): morgens und abends 1 Messlöffel.
Kinder (8?12 Jahre): morgens und abends 2 Messlöffel.
Jugendliche und Erwachsene: morgens und abends 2?3 Messlöffel.
1 Messlöffel entspricht 5 ml.
Die Therapiedauer soll in der Regel nicht länger als 3?4 Tage betragen.
Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt bzw. von 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 Einnahme von Calmesin-Mepha Sirup auftreten:
Calmesin-Mepha Sirup kann gelegentlich Übelkeit und Erbrechen, Verstopfung, Müdigkeit und Schwindel verursachen.
In seltenen Fällen können auftreten: Appetitlosigkeit, Durchfall, Unruhe, Verwirrtheit, Bronchialverengungen mit Atembeschwerden, Atemhemmung und Überempfindlichkeitsreaktionen (Allergie). Letztere äussern sich im Allgemeinen mit Hautausschlag (Urtikaria), Schweissausbrüchen, Atembeschwerden, beschleunigtem Herzschlag und/oder Unwohlsein, doch in Einzelfällen können sie bis zur Ohnmacht und zum Schock gehen und sofortige ärztliche Hilfe erfordern (siehe «Wann ist bei der Einnahme von Calmesin-Mepha Sirup Vorsicht geboten?»).
Die Nebenwirkungen können stärker sein oder häufiger auftreten, wenn das Präparat in höheren Dosen über längere Zeit oder zusammen mit gewissen anderen Arzneimitteln eingenommen wird.
Bei einer Überdosierung, d.h. bei Einnahme von höheren als den empfohlenen Dosen und/oder bei Einnahme in kürzeren als den empfohlenen Zeitabständen verstärken sich die oben aufgeführten Nebenwirkungen und die Risiken, die im Abschnitt «Wann ist bei der Einnahme von Calmesin-Mepha Sirup Vorsicht geboten?» beschrieben sind.
Zusätzliche Zeichen einer Überdosierung können sein: Schwitzen, Herzklopfen, verschwommenes Sehen, Erregbarkeit und Bewusstseinsverlust. Bei Kindern und insbesondere bei Kleinkindern kann eine Überdosierung schwerwiegende Folgen haben.
Sollten Zeichen einer Überdosierung auftreten, müssen Sie unverzüglich mit der Einnahme resp. Verabreichung von Calmesin-Mepha Sirup aufhören und einen Arzt bzw. eine Ärztin verständigen.
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Nicht in Reichweite von Kindern aufbewahren!
Calmesin-Mepha Sirup in der Originalpackung bei Raumtemperatur (15?25 °C) vor Licht und Feuchtigkeit geschützt aufbewahren.
Die Sirupflasche nach jedem Gebrauch gut verschliessen.
Angebrochene Flasche nicht länger als ein halbes Jahr aufbewahren. Bei längerem Stehen dickt der Sirup nach. Dies ist völlig normal. Durch kräftiges Schütteln vor der Verabreichung verflüssigt sich der Sirup wieder soweit, dass eine genaue Dosierung möglich ist.
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.
5 ml (1 Messlöffel) Calmesin-Mepha Sirup enthalten: den Wirkstoff 11,5 mg Dextromethorphan, gebunden an Ionenaustauscher, entspr. 15 mg Dextromethorphanhydrobromid, Aromastoffe: Vanillin und Kirsche, Konservierungsstoffe: Parahydroxybenzoesäuremethylester/propylester E 218/E 216; 1,6 g Zucker (= 6,4 kcal = 27,2 kJ); Farbstoff: Ponceau 4 R (E 124) und andere Hilfsstoffe.
53863 (Swissmedic).
In Apotheken ohne ärztliche Verschreibung.
Packungen zu 90 ml Sirup.
Mepha Pharma AG, Aesch/BL.
Diese Packungsbeilage wurde im Februar 2007 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
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