Swissmedic Nr.: 58124001
Index: 02.04.40
Pharmacode: 3660599
GTIN/EAN: 7680581240014
Markteintritt: 29.10.2007
Kategorie: B Charges répétée sur une prescription médicale.
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Betahistin-Mepha ist ein Arzneimittel gegen Schwindel. Seine Wirkung hat eine Erhöhung der Blutzufuhr nach dem Innenohr zur Folge. Betahistin-Mepha wird zur Verminderung der Frequenz und Schwere von Schwindelanfällen verwendet.
Betahistin-Mepha wird auf Verschreibung des Arztes oder der Ärztin verwendet, zur Behandlung von Schwindel, der auf Durchblutungsstörungen des Innenohrs zurückzuführen ist und für die Behandlung des Ménière-Syndroms und ménièreartige Syndrome (Schwindel, Ohrensausen, Gehörverminderung).
Bei Überempfindlichkeit auf einen der Bestandteile des Arzneimittels.
Patienten mit einem Nebennierentumor dürfen nicht mit Betahistin-Mepha behandelt werden.
Betahistin-Mepha ist Ihnen zur Behandlung von Schwindel oder des Ménière-Syndroms verschrieben worden. Beide Krankheiten können Benommenheit und Erbrechen auslösen, und damit Ihre Reaktionsfähigkeit, Ihre Fahrtüchtigkeit und Ihre Fähigkeit, Werkzeuge oder Maschinen zu bedienen, ausgeprägt negativ beeinflussen.
Obwohl Untersuchungen an gesunden Personen ergaben, dass Betahistin keinen Einfluss auf die Fahrtüchtigkeit hat, könnte aufgrund von unerwünschten Arzneimittelwirkungen - besonders am Anfang der Behandlung - die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit Werkzeuge oder Maschinen zu bedienen, beeinträchtigt werden.
Patienten mit Bronchialasthma und Patienten mit Magen- oder Zwölffingerdarmgeschwür in der Vorgeschichte müssen Ihren Arzt bzw. Ihre Ärztin informieren, da Betahistin-Mepha bei diesen Patienten mit Vorsicht verabreicht werden muss.
Bei bestimmungsgemässer Anwendung sind keine besonderen Vorsichtsmassnahmen erforderlich. Asthmatiker sollen Betahistin-Mepha nur unter ärztlicher Überwachung einnehmen.
Betahistin wird bei Kindern und Jugendlichen nicht empfohlen, da ungenügende Daten bezüglich Sicherheit und Wirksamkeit vorliegen.
Informieren Sie Ihren Arzt, Apotheker, bzw. Ihre Ärztin oder Apothekerin, wenn Sie
Während der Schwangerschaft darf Betahistin-Mepha nur auf Verordnung Ihres behandelnden Arztes oder Ihrer Ärztin eingenommen werden.
Eine Anwendung während der Stillzeit wird nicht empfohlen.
Tabletten: 24 mg bis 48 mg pro Tag, aufgeteilt auf 2-3 Gaben; vorzugsweise während den Mahlzeiten einnehmen.
Beim Auftreten von Magenschmerzen sollte das Arzneimittel strikte während den Mahlzeiten eingenommen werden.
| 16 mg Tablette (mit Bruchrille) | 24 mg Tablette (mit Bruchrille) |
| ½-1 Tabl. 3x tägl. | 1 Tabl./2x tägl. |
| oder | |
| 1½ Tabl. 2x tägl. |
Bei einer Tagesdosis von 48 mg, kann jeweils 1 Tablette Betahistin-Mepha 24 mg 2x täglich eingenommen werden.
Eine Besserung kann innerhalb einiger Tage eintreten oder auch nur allmählich, unter Umständen erst nach einigen Behandlungswochen feststellbar sein.
Betahistin wird bei Kindern und Jugendlichen nicht empfohlen, da ungenügende Daten bezüglich Sicherheit und Wirksamkeit vorliegen.
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 Betahistin-Mepha auftreten (Häufigkeit wo bekannt angegeben):
Sehr häufig (?1/10); häufig (?1/100, <1/10); gelegentlich (?1/1000, <1/100); selten (?1/10?000, <1/1000); sehr selten (<1/10?000), einschliesslich Einzelfallmeldungen.
Häufig: Kopfschmerzen, Übelkeit und Verdauungsstörungen.
Selten: Nervosität, Augenbrennen.
Sehr selten: Missempfindungen, Brustbeklemmung.
Unbekannt: Überempfindlichkeitsreaktionen, Kopfdruck, Herzklopfen, Erbrechen, Bauchschmerzen, Brechreiz, Sodbrennen, Magendrücken, Blähungen, Durchfall, Überempfindlichkeitsreaktionen der Haut, wie Juckreiz und Ausschlag, Hitzegefühl.
Kontaktieren Sie sofort einen Arzt bzw. eine Ärztin, wenn Sie plötzlich Schwellungen am Gesicht, an Lippen, Zunge und/oder Rachen (Schluck- oder Atembeschwerden) entwickeln (sog. angioneurotisches Ödem).
Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.
Tablette auf flache Unterlage mit Bruchrille nach oben legen und mit dem flachen Daumen auf die Bruchrille drücken.
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 in der Originalpackung lagern. Für Kinder unerreichbar aufbewahren.
Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.
Betahistin-Mepha 16: 1 Tablette mit Bruchrille enthält 16 mg Betahistini dihydrochloridum sowie Hilfsstoffe.
Betahistin-Mepha 24: 1 Tablette mit Bruchrille enthält 24 mg Betahistini dihydrochloridum sowie Hilfsstoffe.
58'124 (Swissmedic).
In Apotheken nur gegen ärztliche Verschreibung.
Tabletten zu 16 mg: Packungen zu 50 und 100.
Tabletten zu 24 mg: Packungen zu 50 und 100.
Mepha Pharma AG, Basel
Diese Packungsbeilage wurde im März 2013 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.
Interne Versionsnummer: 5.2
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