Mydocalm mite

Informazioni principali

  • Nome commerciale:
  • Mydocalm mite compresse rivestite con film
  • Forma farmaceutica:
  • compresse rivestite con film
  • Composizione:
  • tolperisoni hydrochloridum 50 mg, excipiens pro compresso obducto.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Mydocalm mite compresse rivestite con film
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Myotonolytique

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 32665
  • Data dell'autorizzazione:
  • 24-08-1966
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Mydocalm®/- mite

Labatec Pharma SA

Che cos'è Mydocalm/Mydocalm mite e quando si usa?

Mydocalm/Mydocalm mite contiene il principio attivo tolperisone cloridrato che è un

decontratturante muscolare.

Lo si usa su prescrizione medica nella terapia degli spasmi muscolari, in caso di affezioni dolorose di

origine muscolo-scheletrica, in particolare della colonna vertebrale e delle grandi articolazioni.

Lo si può pure prescrivere nell'ipertonia della muscolatura scheletrica associata a una malattia

neurologica.

Quando non si può usare Mydocalm/Mydocalm mite?

Miastenia grave (malattia rara che provoca debolezza muscolare).

Precedente allergia al Mydocalm/Mydocalm mite.

Quando è richiesta prudenza nella somministrazione di Mydocalm/Mydocalm mite?

Se dopo aver preso il medicamento constata delle manifestazioni anormali (formicolìi alle mani, ai

piedi, comparsa di placche rosse, tumefazione del viso o delle mucose, disturbi respiratori,

malessere, sintomi che possono far pensare ad un'allergia medicamentosa) bisogna smettere di

prendere Mydocalm/Mydocalm mite e avvertire immediatamente il medico.

I rischi di effetti collaterali indesiderati dei medicamenti aumentano in presenza di altre malattie o di

allergie e in caso di assunzione concomitante di diversi farmaci.

Informi il suo medico, il suo farmacista nel caso in cui

·soffre di altre malattie,

·soffre di allergie o

·assume o applica altri medicamenti (anche acquistati di sua iniziativa)

Guida di veicoli e uso di macchine: uno studio effettuato su persone sane non ha evidenziato un

prolungamento dei tempi di reazione dovuto al Mydocalm/Mydocalm mite. Tuttavia, dato che certi

pazienti curati con questo farmaco hanno riferito sonnolenza e vertigini, le attività pericolose

richiedono prudenza.

Si può somministrare Mydocalm/Mydocalm mite durante la gravidanza o l'allattamento?

Gli studi di riproduzione effettuati sugli animali non hanno dimostrato rischi per il feto, ma non si

dispone di studi in materia effettuati sulla donna incinta.

Si eviti quindi di prendere Mydocalm/Mydocalm mite durante i primi tre mesi di gravidanza; il

medicamento sarà prescritto solo se è assolutamente necessario.

Le donne che allattano evitino di prendere Mydocalm/Mydocalm mite perché è possibile che il

farmaco passi nel latte materno.

Come usare Mydocalm/Mydocalm mite?

Per gli adulti, in generale la dose è di una compressa rivestita di Mydocalm (cioè una dose di 150

mg) al mattino, a mezzogiorno e alla sera. In certi casi il medico può prescrivere una dose più elevata

(una compressa rivestita da 150 mg quattro volte al giorno).

Non è stato fatto nessuno studio clinico specifico di dose-finding nel bambino. Si consiglia dunque di

somministrare Mydocalm/mite ai bambini di meno di 15 anni solo nel caso in cui il medico l'abbia

espressamente prescritto.

Per i bambini la dose giornaliera è adeguata al peso corporeo (da 5 a 10 mg/kg di peso). In questo

caso si usa con maggior frequenza Mydocalm mite (contenente 50 mg di principio attivo).

Per le persone anziane, o in presenza di certe malattie concomitanti, spesso la dose prescritta è più

bassa.

Si mantiene la dose giornaliera finché si ottiene il risultato terapeutico. In seguito la prescrizione

medica può prevedere un intervallo più lungo tra le singole somministrazioni.

In caso di semplice ritardo nell'assumere il farmaco prenda la dose prevista. Se ha dimenticato del

tutto di prendere una dose non raddoppi quella successiva.

Non modifichi di propria iniziativa la posolagia prescritta. Se ritiene che l'azione del medicamento

sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Mydocalm/Mydocalm mite?

Con l'assunzione o l'applicazione di Mydocalm/Mydocalm mite possono manifestarsi i seguenti

effetti collaterali:

Occasionalmente si manifestano degli effetti collaterali, che possono essere a livello del tubo

digerente (secchezza della bocca, intolleranza gastrica, diarrea) o di carattere generale (calo della

pressione arteriosa, stanchezza, sonnolenza). Ne informi il medico, perché spesso essi diminuiscono

dopo aver ridotto la dose. Le manifestazioni allergiche sono più rare, ma in questo caso bisogna

cessare immediatamente la terapia e consultare un medico (vedi il capitolo riguardante le situazioni

che richiedono prudenza).

Se osserva effetti collaterali qui non descritti dovrebbe informare il suo medico, il suo farmacista.

Di che altro occorre tener conto?

Conservare Mydocalm/Mydocalm mite nella confezione originale a temperatura ambiente (15-

25 °C), al riparo dall'umidità e dalla luce, e fuori dalla portata dei bambini.

Il medicamento non dev'essere utilizzato oltre la data indicate con «EXP» sulla confezione.

Se ha dei compresse rivestite la cui data di scadenza è trascorsa li riporti in farmacia.

Il medico o il farmacista, che sono in possesso di documentazione specializzata e dettagliata,

possono darle ulteriori informazioni.

Che cosa contiene Mydocalm/Mydocalm mite?

Una compressa rivestita di Mydocalm mite contiene 50 mg di tolperisone cloridrato e sostanze

ausiliarie. «Mite» significa a bassa dose.

Una compressa rivestita di Mydocalm contiene 150 mg di tolperisone cloridrato e sostanze ausiliarie.

Numero dell'omologazione

32665 (Swissmedic).

Dov'è ottenibile Mydocalm/Mydocalm mite? Quali confezioni sono disponibili?

In farmacia, con ricetta medica.

Mydocalm mite: 30 compresse rivestite.

Mydocalm: 30, 100 e 250 compresse rivestite.

Titolare dell’omologazione

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

Questo foglietto illustrativo è stato controllato l’ultima volta nel ottobre 2013 dall’autorità

competente in materia di medicamenti (Swissmedic).

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Europe -DG Health and Food Safety

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

22-11-2018

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Renewal - Commission Decision (2018)7895 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/R/18

Europe -DG Health and Food Safety

22-11-2018

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