Mydocalm mite

Hauptinformation

  • Handelsname:
  • Mydocalm mite filmtabletten
  • Darreichungsform:
  • filmtabletten
  • Zusammensetzung:
  • tolperisoni hydrochloridum 50 mg, excipiens pro compresso Dunst.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Mydocalm mite filmtabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Myotonolytique

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 32665
  • Berechtigungsdatum:
  • 24-08-1966
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Patienteninformation

Mydocalm®/- mite

Labatec Pharma SA

Was ist Mydocalm/Mydocalm mite und wann wird es angewendet?

Mydocalm/Mydocalm mite enthält den Wirkstoff Tolperison Hydrochlorid, der eine Entspannung

der Muskeln bewirkt.

Es wird auf ärztliche Verschreibung hin verwendet zur Behandlung von Muskelspasmen bei

schmerzhaften Erkrankungen der Skelettmuskulatur, vor allem im Bereich der Wirbelsäule und der

grossen Gelenke.

Es kann ebenfalls bei einer Hypertonie der Skelettmuskulatur im Rahmen einer neurologischen

Erkrankung verschrieben werden.

Wann darf Mydocalm/Mydocalm mite nicht angewendet werden?

Bei Myasthenia gravis (einer seltenen Krankheit, die zu einer Muskelschwäche führt).

Bei einer bestehenden Allergie auf Mydocalm/Mydocalm mite.

Wann ist bei der Einnahme von Mydocalm/Mydocalm mite Vorsicht geboten?

Falls Sie nach Einnahme des Medikamentes abnormale Erscheinungen feststellen (Kribbeln in

Händen oder Füssen, rote Flecken, Schwellungen an Gesicht oder Schleimhäuten,

Atembeschwerden, Unwohlsein, Anzeichen einer möglichen medikamentösen Allergie), dürfen Sie

das Medikament nicht mehr einnehmen und Sie müssen sofort Ihren Arzt verständigen.

Die Risiken für unerwünschte Nebenwirkungen von Medikamenten sind grösser, wenn andere

Erkrankungen oder Allergien bestehen oder wenn gleichzeitig mehrere Medikamente eingenommen

werden.

Informieren Sie Ihren Arzt, Apotheker bzw. Ihre Ärztin, Apothekerin, wenn Sie

·an andern Krankheiten leiden,

·Allergien haben oder

·Andere Arzneimittel (auch selbstgekaufte) einnehmen oder äusserlich anwenden!

Führen von Fahrzeugen und Bedienung von Maschinen: Eine Studie an gesunden Probanden hat

keine Verlängerung der Reaktionszeit infolge Einnahme von Mydocalm/Mydocalm mite aufgezeigt.

Da es jedoch Patienten gegeben hat, die im Verlaufe von Behandlung Schläfrigkeit und

Schwindelgefühle meldeten, ist Vorsicht bei gefährlichen Situationen angezeigt.

Darf Mydocalm/Mydocalm mite während einer Schwangerschaft oder in der Stillzeit eingenommen

werden?

Reproduktionsstudien bei Tieren haben keine Risiken für die Foeten gezeigt, aber man verfügt über

keine entsprechenden kontrollierten Studien beim Menschen.

Von der Einnahme von Mydocalm/Mydocalm mite während der ersten drei Monate einer

Schwangerschaft soll deshalb abgesehen werden; es soll nur bei absoluter Notwendigkeit

verschrieben werden.

Eine stillende Frau soll von der Einnahme von Mydocalm/Mydocalm mite absehen, da das Produkt

möglicherweise in die Muttermilch gelangt.

Wie verwenden Sie Mydocalm/Mydocalm mite?

Bei Erwachsenen beträgt die Dosis im allgemeinen je eine Filmtablette Mydocalm (d.h. eine Dosis

von 150 mg) am Morgen, Mittag und Abend. In gewissen Fällen kann der Arzt eine höhere Dosis

verschreiben (viermal täglich eine Filmtablette zu 150 mg).

Es wurde keine spezifische klinische Studie zur Dosisfindung bei Kindern durchgeführt. Deshalb

wird empfohlen, Mydocalm/mite nur auf ausdrückliche Verordnung des Arztes bzw. der Ärztin an

Kindern unter 15 Jahre zu verabreichen.

Bei Kindern werden die täglichen Dosen an das Körpergewicht angepasst (5 bis 10 mg/kg

Körpergewicht). Dabei wird häufiger Mydocalm mite (Gehalt 50 mg) verwendet.

Bei älteren Personen oder bei Vorliegen bestimmter Krankheiten wird häufig eine niedrigere Dosis

verschrieben.

Die Dosierung wird beibehalten, bis die therapeutische Wirkung erreicht ist. Danach kann eine

Einnahme der einzelnen Dosen in grösseren Zeitabständen verschrieben werden.

Bei einer Verspätung des Zeitpunktes der Einnahme nehmen Sie die normale Dosis zu sich. Falls Sie

einmal ganz vergessen sollten, das Präparat einzunehmen, nehmen Sie keinesfalls das nächste Mal

die doppelte Dosis zu sich.

Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel

wirke zu schwach oder zu stark, so sprechen Sie mit Ihren Arzt oder Apotheker.

Welche Nebenwirkungen kann Mydocalm/Mydocalm mite haben?

Folgende Nebenwirkungen können bei der Einnahme von Mydocalm/mite auftreten:

Gelegentlich treten Nebenwirkungen auf, welche entweder die Verdauung betreffen

(Mundtrockenheit, Magenverstimmung, Durchfall) oder allgemeiner Art sind (Abfall des

Blutdruckes, Müdigkeit, Schläfrigkeit). Informieren Sie Ihren Arzt darüber, denn diese

Nebenwirkungen verschwinden häufig bei einer Reduktion der Dosis. In selteneren Fällen treten

allergische Reaktionen auf. Dabei muss die Behandlung sofort eingestellt und ein Arzt konsultiert

werden (siehe Abschnitt über Vorsichtsmassnahmen).

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

Apotheker informieren.

Was ist ferner zu beachten?

Bewahren Sie Mydocalm/Mydocalm mite in der Originalpackung bei Raumtemperatur (15-25 °C),

geschützt vor Feuchtigkeit und Licht und ausser Reichweite von Kindern aufbewahren.

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

werden.

Falls Sie abgelaufene Filmtabletten besitzen, händigen Sie diese bitte Ihrem Apotheker aus.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker, der über die ausführliche Fachinformation

verfügt.

Was ist in Mydocalm/Mydocalm mite enthalten?

Eine Filmtablette Mydocalm mite enthält 50 mg Tolperison Hydrochlorid sowie Hilfsstoffe.

Bemerkung: «mite» ist ein englisches Wort und bedeutet «niedrige Dosierung».

Eine Filmtablette Mydocalm enthält 150 mg Tolperison Hydrochlorid sowie Hilfsstoffe.

Zulassungsnummer

32665 (Swissmedic).

Wo erhalten Sie Mydocalm/Mydocalm mite ? Welche Packungen sind erhältlich?

In Apotheken, gegen ärztliches Rezept.

Mydocalm mite: Packung zu 30 Filmtabletten.

Mydocalm: Packungen zu 30, 100 und 250 Filmtabletten.

Zulassungsinhaberin

Labatec-Pharma S.A., 1217 Meyrin (Genf).

Diese Packungsbeilage wurde im Oktober 2013 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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Vabomere (Rempex London Limited)

Vabomere (Rempex London Limited)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Authorisation - Commission Decision (2018)7888 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4669/00

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (Active substance: Apraglutide) - Orphan designation - Commission Decision (2018)7812 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Active substance: Lisocabtagene maraleucel) - Orphan designation - Commission Decision (2018)7809 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2095 (United Neuroscience Limited)

EU/3/18/2095 (United Neuroscience Limited)

EU/3/18/2095 (Active substance: Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp) - Orphan designation - Commission Decision (2018)7805 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/08/556 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/556 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/556 (Active substance: N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide) - Transfer of orphan designation - Commission Decision (2018)7814 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/08/T/03

Europe -DG Health and Food Safety

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

9-11-2018

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks.  http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx

FDA - U.S. Food and Drug Administration

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety