Atedurex mite

Hauptinformation

  • Handelsname:
  • Atedurex mite Filmtabletten
  • Darreichungsform:
  • Filmtabletten
  • Zusammensetzung:
  • atenololum 50 mg, chlortalidonum 12.5 mg, excipiens pro compresso Dunst.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Atedurex mite Filmtabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Hypertonie

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 54076
  • Berechtigungsdatum:
  • 25-06-1998
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Atedurex®/- mite, Filmtabletten

Sandoz Pharmaceuticals AG

Was ist Atedurex/- mite und wann wird es angewendet?

Atedurex/- mite vereint in einer Filmtablette zwei Substanzen, die sich in ihrer blutdrucksenkenden

Wirkung sinnvoll ergänzen.

Atedurex/- mite enthält die Wirkstoffe Atenolol und Chlortalidon. Atenolol senkt den Blutdruck und

dämpft die Herztätigkeit ohne die Muskulatur der Atemwege zu beeinflussen, was eine unerwünschte

Wirkung anderer, dem Atenolol verwandter Stoffe ist. Somit können auch Patienten mit

Erkrankungen der Atemwege (Atemnot, Asthma) Atedurex/- mite mit entsprechender Vorsicht

einnehmen.

Chlortalidon senkt den Blutdruck, indem es die Ausscheidung von Wasser und Salz durch die Nieren

erhöht.

Atedurex/- mite darf nur auf Verschreibung und unter ständiger Kontrolle des Arztes oder der Ärztin

verwendet werden.

Wann darf Atedurex/- mite nicht angewendet werden?

Falls Sie an einer Herzkrankheit mit verlangsamtem Puls (unter 50 Schläge pro Minute), an

Herzschwäche oder Herzblock leiden, dürfen Sie Atedurex/- mite nicht einnehmen. Bei Patienten mit

Herzschwäche ist eine spezielle Behandlung, eventuell die Kombination mit einem anderen

Herzmittel, notwendig. Auf jeden Fall müssen Sie Ihren Arzt resp. Ihre Ärztin informieren, falls Sie

bereits früher einmal eine allergische Reaktion auf Atedurex/- mite bzw. Atenolol oder Chlortalidon

gezeigt haben oder falls Sie jemals einen sehr langsamen oder unregelmässigen Puls, einen sehr

tiefen Blutdruck oder eine sehr schlechte Durchblutung hatten. Auch wenn man bei Ihnen ein

Phäochromozytom festgestellt hat oder nach längerem Fasten dürfen Sie Atedurex/- mite nicht

anwenden. Atedurex/- mite ist für die Behandlung von Kindern nicht geeignet.

Wann ist bei der Einnahme von Atedurex/- mite Vorsicht geboten?

Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge

oder Maschinen zu bedienen, beeinträchtigen.

Wie bei anderen Diuretika kann auch das in Atedurex/- mite enthaltene Chlortalidon eine

Zuckerkrankheit oder Gicht verschlechtern. Informieren Sie deshalb Ihren Arzt bzw. Ihre Ärztin,

falls Sie an einer Zuckerkrankheit leiden, schon einmal einen Gichtanfall hatten oder Disopyramide

resp. Amiodarone gegen unregelmässigen Herzschlag einnehmen.

Wenn Sie an Allergien, Asthma, Atembeschwerden oder Durchblutungsstörungen leiden oder

Probleme mit dem Herz, den Nieren resp. der Schilddrüse haben, sollte Atedurex/- mite mit Vorsicht

angewendet werden. Vorsicht ist auch angebracht, wenn Sie gleichzeitig andere Arzneimittel

anwenden wie z.B. Lithium, Schmerzmittel, abschwellende Nasensprays oder Mittel gegen

Erkältungen, unregelmässigen Puls und Herzinsuffizienz.

Falls Sie Clonidin gegen Bluthochdruck oder Migräne anwenden, sollten Sie weder Clonidin noch

Atedurex/- mite von sich aus absetzen, ohne mit Ihrem Arzt bzw. mit Ihrer Ärztin darüber

gesprochen zu haben.

Ebenso müssen vor einem chirurgischen Eingriff dem Narkosearzt resp. der Narkoseärztin alle

Arzneimittel, die Sie einnehmen, bekannt sein.

Suchen Sie unverzüglich Ihren Arzt bzw. Ihre Ärztin auf, falls Ihr Ruhepuls im Verlauf der

Behandlung unter 50 Schläge pro Minute sinkt, oder falls Ihr Blutdruck zu niedrig ist. Anzeichen

hierfür sind Müdigkeit und Schwindel bei zu raschem Aufstehen.

Bei Zuckerkranken kann Atedurex/- mite die Wirkung von Insulin oder von anderen

blutzuckersenkenden Mitteln herabsetzen. Ebenso können die sonst bei tiefem Blutzucker

einsetzenden Körperreaktionen, wie erhöhter Puls, verändert sein.

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!

Darf Atedurex/- mite während einer Schwangerschaft oder in der Stillzeit eingenommen werden?

Während einer Schwangerschaft oder in der Stillzeit sollten Sie, wenn möglich, keine Arzneimittel

einnehmen. Dies gilt insbesondere auch für Atedurex/- mite.

Informieren Sie unbedingt Ihren Arzt bzw. Ihre Ärztin, falls Sie schwanger sind, eine

Schwangerschaft planen oder ein Kind stillen.

Wie verwenden Sie Atedurex/- mite?

Nehmen Sie Atedurex/- mite genau nach Anweisung Ihres Arztes bzw. Ihrer Ärztin ein. Im

Allgemeinen beträgt die Dosis für Erwachsene 1× täglich eine Filmtablette Atedurex, in leichteren

Fällen 1× täglich 1 Filmtablette Atedurex mite. Bei Patienten, die an einer Nierenkrankheit mit

Ausscheidungsstörungen leiden, wird der Arzt bzw. die Ärztin die Dosis entsprechend anpassen.

Nehmen Sie die Filmtablette unzerkaut, am besten immer zur gleichen Tageszeit, mit etwas Wasser

oder Fruchtsaft ein. Wenn Sie einmal eine Filmtablette vergessen haben, nehmen Sie diese ein,

sobald Sie sich daran erinnern. Es sollten jedoch nicht zwei Filmtabletten gleichzeitig eingenommen

werden.

Ohne Rücksprache mit Ihrem Arzt bzw. Ihrer Ärztin sollten Sie die Dosis nicht verändern oder das

Arzneimittel absetzen. Ein unkontrollierter hoher Blutdruck kann gefährliche Folgen haben.

Ein allfälliges Absetzen sollte über 1 bis 2 Wochen langsam ausschleichend erfolgen.

Die Anwendung und Sicherheit von Atedurex/- mite, Filmtabletten bei Kindern und Jugendlichen ist

bisher nicht geprüft worden.

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. Ihrer Ärztin

oder Apothekerin.

Welche Nebenwirkungen kann Atedurex/- mite haben?

Folgende Nebenwirkungen können bei der Einnahme von Atedurex/- mite auftreten:

Häufig können Müdigkeit, Übelkeit, Erbrechen, Durchfall, verlangsamter Pulsschlag sowie kalte

Hände und Füsse auftreten. Gelegentlich wurden Schlafstörungen beobachtet. Selten ist von

Verwirrtheit, Schwindel, Kopfschmerzen, Stimmungsschwankungen, Alpträumen, Halluzinationen,

Kribbeln in den Händen und Füssen, Sehstörungen, trockenen Augen, tiefem Blutdruck mit

Schwindel bei zu raschem Aufstehen, Atembeschwerden bei Asthmatikern, Mundtrockenheit,

Verstärkung einer Schuppenflechte, Hautausschlägen, Haarausfall und Impotenz berichtet worden.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

In der Originalverpackung, bei Raumtemperatur (15–25 °C), vor Licht und Feuchtigkeit geschützt

und ausser Reichweite von Kindern lagern.

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet

werden. Wenn die Haltbarkeit abgelaufen ist, bringen Sie die Packung in die Apotheke zur

Entsorgung zurück.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Atedurex/- mite enthalten?

Atedurex/- mite enthält die Wirkstoffe Atenolol und Chlortalidon und ist als weisse Filmtablette

erhältlich.

Atedurex

Filmtabletten zu 100 mg Atenolol und 25 mg Chlortalidon und Hilfsstoffe.

Atedurex mite

Filmtabletten zu 50 mg Atenolol und 12,5 mg Chlortalidon und Hilfsstoffe.

Zulassungsnummer

54076 (Swissmedic)

Wo erhalten Sie Atedurex/- mite? Welche Packungen sind erhältlich?

Atedurex/- mite erhalten Sie in Apotheken nur gegen ärztliche Verschreibung.

Atedurex: Packungen zu 10 und 100 Filmtabletten.

Atedurex mite: Packungen zu 30 und 100 Filmtabletten.

Zulassungsinhaberin

Sandoz Pharmaceuticals AG, Risch; Domizil: Rotkreuz.

Diese Packungsbeilage wurde im November 2013 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Mitem® 20 mg

Rote - Liste

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

29-8-2018

Varuby (TESARO U.K. Limited)

Varuby (TESARO U.K. Limited)

Varuby (Active substance: rolapitant) - Centralised - Yearly update - Commission Decision (2018)5765 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (Active substance: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells) - Orphan designation - Commission Decision (2018)5733 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/088/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - PSUSA - Modification - Commission Decision (2018)5710 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10455/201711

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Active substance: anagrelide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5682 of Sat, 25 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/480/T/82

Europe -DG Health and Food Safety

24-8-2018

Progynova® 21 mite

Rote - Liste

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety