Myambutol 100 mg

Informazioni principali

  • Nome commerciale:
  • Myambutol 100 mg compresse filmate
  • Forma farmaceutica:
  • compresse filmate
  • Composizione:
  • ethambutoli hydrochloridum 100 mg, colore.: E 104, 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:
  • Myambutol 100 mg compresse filmate
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Tubercolare

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 33153
  • Data dell'autorizzazione:
  • 24-07-1967
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Myambutol® compresse rivestite

Labatec Pharma SA

Che cos'è Myambutol e quando si usa?

Myambutol è un medicamento contro la tubercolosi che si usa per periodi lunghi in associazione ad

altri farmaci.

Myambutol inibisce la moltiplicazione dei batteri responsabili della malattia. II medicamento si

diffonde in quasi tutto l'organismo, compresi i polmoni. Myambutol si può prendere solamente su

prescrizione del medico.

Di che cosa occorre inoltre tener conto durante il trattamento?

Questo medicamento le è stato prescritto dal suo medico per curare la malattia di cui soffre

attualmente.

L'antibiotico contenuto in Myambutol non è efficace contro tutti i microorganismi che causano

malattie infettive. L'uso di un antibiotico scelto in modo inappropriato oppure a dosi sbagliate può

provocare delle complicazioni. Perciò non lo adoperi mai di sua iniziativa per curare altre malattie o

altre persone.

Quando non si può assumere Myambutol?

Non si può prendere Myambutol

·in presenza di lesioni del nervo ottico o di malattie preesistenti degli occhi;

·in caso di ipersensibilità (allergia) a un componente del medicamento (principio attivo o sostanze

ausiliarie). Una ipersensibilità può manifestarsi p. es. con asma, difficoltà respiratorie, disturbi

circolatori, gonfiore della pelle (p. es. orticaria) e delle mucose, o eruzioni cutanee.

Quando è richiesta prudenza nella somministrazione di Myambutol?

Per individuare precocemente la possibile comparsa di disturbi della vista, il medico curante (o

l'oculista informato del fatto che Lei prende Myambutol) effettuerà dei controlli oftalmologici a

intervalli di 4 settimane, riguardanti la visione deil colori, il campo visivo e l'acuità visiva.

Nei pazienti con funzionalità renale ridotta i controlli oftalmologici vanno fatti tutte le settimane.

Questa misura precauzionale permette di individuare precocemente eventuali disturbi della vista,

quando sono ancora allo stadio reversibile. Se sarà il caso, il medico curante le farà sospendere il

medicamento affinché il disturbo della vista possa regredire e scomparire.

In pochi casi in cui il disturbo della vista è stato scoperto con un anno di ritardo sono state riportate

lesioni irreversibili. L'esperienza in bambini al disotto di 13 anni è limitata. La realisazione di

controlli oftalmologici regolari dev'essere garantita, specialmente nei bambini piccoli con i quali è

difficile effettuare controlli oftalmologici obiettivabili.

Come nei altri medicamenti con azione potente la funzione renale, i valori del fegato e il quadro

ematologico devono essere controllati prima e durante il trattamento. Una eliminazione ridotta degli

urati come p. es. acido urico può eventualmente condurre a una crisa acuta di gotte.

I medicamenti contro l'iperacidità di stomaco (antiacidi) riducono l'effetto di Myambutol. Perciò

Myambutol va preso almeno 1 ora prima di un antiacido.

Se prende un contraccettivo orale («pillola») tenga presente che la sua efficacia durante la terapia con

Myambutol può diminuire. II medico o il farmacista potranno consigliarle altri metodi contraccettivi.

Informi il medico o il farmacista se sta prendendo medicamento neurotossici (per es. disulfiram).

Myambutol può diminuire l'acuità visiva e la visione dei colori. Perciò può alterare la capacità di

guidare o di utilizzare attrezzi o macchine.

Informi il suo medico o il suo farmacista

·nel caso in cui soffre di altre malattie,

·soffre di allergie

·assume altri medicamenti (anche se acquistati di sua iniziativa)!

Si può somministrare Myambutol durante la gravidanza o l'allattamento?

Le gestanti e le donne che allattano non devono prendere questo medicamento.

Come usare Myambutol?

Myambutol deve essere utilizzato solo in combinazione con altri medicamenti per il trattamento della

tubercolosi (tubercolostatici).

Myambutol si prende in un'unica dose quotidiana al mattino. Lo si può prendere a colazione. È

importante prendere Myambutol tutti i giorni senza interruzione, perché altrimenti la sua efficacia

non sarebbe garantita oppure potrebbero manifestarsi in maggior misura degli effetti indesiderati.

La posologia è stabilita dal medico dopo aver valutato lo stadio della malattia: di norma non è

superiore a 25 mg di etambutolo per chilo di peso corporeo.

In caso di funzionalità renale insufficiente il medico adatterà opportunamente la posologia.

In generale, l'uso non è racommandato nei bambini al disotto di 13 anni.

Quando si è iniziata una terapia con antibiotici bisogna continuarla per tutta la durata prescritta dal

medico. Spesso i sintomi della malattia scompaiono prima che l'infezione sia completamente guarita.

Perciò il trattamento va continuato anche dopo la scomparsa dei sintomi. Se la terapia ha una durata

insufficiente o se la si smette troppo presto la malattia può manifestarsi nuovamente.

Non modifichi di propria iniziativa la posologia 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 Myambutol?

In seguito all'assunzione di Myambutol possono manifestarsi i seguenti effetti collaterali:

Gli effetti collaterali più importanti del principio attivo etambutolo sono dei disturbi della vista

(diminuzione della vista, malattie dei nervi ottici, infiammazioni dei nervi ottici, limitazione del

campo visivo, cecità dei colori e cecità) che, se scoperti in tempo, sono reversibili (vedi «Quando è

richiesta prudenza nella somministrazione di Myambutol?»). Inoltre è stato riferito di arrossamenti,

eruzioni cutanee, prurito, dolori alle articolazioni, febbre, nausea, vomito, mancanza d'appetito,

dolori addominali, vertigini, stato confusionale, disturbi dell'orientamento, allucinazioni, reazioni

allergiche, sintomi acuti di gotta, disturbi del quadro ematologico, lesioni del fegato, in diversi casi

con fine mortale nonchè «formicolli» e intorpidimento delle estremità.

Se osserva effetti collaterali citali oppure altri qui non descritti, consulti senza indugio il medico o il

farmacista.

Di che altro occorre tener conto?

Quando si prende Myambutol può manifestarsi un'intolleranza all'alcool.

II medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sul contenitore.

Conservare il medicamento a temperatura ambiente (15-25 °C) e fuori della portata dei bambini.

A cura terminata porti il resto del medicamento a chi glieto aveva dispensato (medico, farmacista)

affinché sia eliminato conformemente alle esigenze.

II medico o il farmacista, che sono in possesso di documentazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Myambutol?

1 compressa rivestita di Myambutol contiene:

Principio attivo: 100 mg o 400 mg di dicloridrato etambutolo; sostanze ausiliarie.

Numero dell'omologazione

33153 (Swissmedic).

Dov'è ottenibile Myambutol? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Myambutol 100 mg/400 mg*: Confezioni da 100 compresse rivestite (* divisibili).

Titolare dell’omologazione

Labatec-Pharma SA, 1217 Meyrin (Genève).

Questo foglietto illustrativo è stato controllato l'ultima volta nel dicembre 2015 dall'autorità

competente in materia di medicamenti (Swissmedic).

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3-8-2018

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15-6-2018

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12-6-2018

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FDA - U.S. Food and Drug Administration

28-2-2018

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3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

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

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety