Solmucol 100

Informazioni principali

  • Nome commerciale:
  • Solmucol 100 granulato
  • Forma farmaceutica:
  • granulato
  • Composizione:
  • acetylcysteinum 100 mg, arom.: saccharinum natricum et alia, excipiens annuncio granulatum, pro charta 1,5 g.
  • 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:
  • Solmucol 100 granulato
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Mucolitico

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47909
  • Data dell'autorizzazione:
  • 24-06-1986
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Solmucol® 100, 200, 600 granulare

IBSA Institut Biochimique SA

Che cos’è Solmucol e quando si usa?

Solmucol contiene come principio attivo l'acetilcisteina. Questo principio attivo fluidifica il muco

denso e viscoso difficile da espettorare e ne favorisce l'espettorazione.

Solmucol è indicato per il trattamento delle malattie delle vie respiratorie con eccessiva produzione

di muco denso e viscoso, come p.es. le malattie da raffreddamento, la bronchite acuta o l'influenza.

Solmucol può anche essere impiegato su prescrizione medica per il trattamento di bronchite cronica,

faringite, laringite, tracheite, sinusite o asma bronchiale o come terapia di sostegno di una malattia

congenita, la mucoviscidosi o fibrosi cistica, che provoca nelle vie respiratorie e digestive un

aumento di produzione di muco particolarmente viscoso.

Di cosa occorre inoltre tener conto durante il trattamento?

L'azione di Solmucol può essere potenziata con un'assunzione abbondante di liquidi.

Il fumo causa una sovrapproduzione di muco nei bronchi. Rinunciando a fumare può contribuire

all'efficacia di Solmucol.

Solmucol può essere somministrato ai diabetici, poiché non contiene alcuna sostanza diabetogena.

Occorre tuttavia tener conto che il contenuto calorico totale di ogni bustina corrisponde a 5kcal/21 kJ

(Solmucol granulare 100), risp. 4,6 kcal/19 kJ (Solmucol granulare 200), risp. 8 kcal/34 kJ (Solmucol

granulare 600).

Quando non si può assumere Solmucol?

Non utilizzare Solmucol in caso di ipersensibilità (allergia) al principio attivo o ad uno o più

eccipienti, se soffre d'ulcera gastrica o intestinale o se allatta.

A causa dell'elevato contenuto di principio attivo, le bustine di Solmucol 600 non devono essere

somministrate ai bambini sotto i 12 anni (in caso di mucoviscidosi sotto i 6 anni).

Inoltre Solmucol non deve essere somministrato in concomitanza a medicamenti sedativi della tosse,

poiché questi sopprimono il riflesso naturale della tosse in modo tale che il muco fluidificato da

Solmucol non può più essere espulso; ciò può causare un congestionamento del muco, con il rischio

di un'infezione delle vie respiratorie e di spasmi bronchiali. Il vostro medico di fiducia sa cosa

occorre fare in questi casi.

Quando è richiesta prudenza nella somministrazione di Solmucol?

Se durante la precedente assunzione di un preparato a base di acetilcisteina (principio attivo di

Solmucol) ha riscontrato delle eruzioni cutanee o delle difficoltà respiratorie, informi assolutamente

il suo medico, farmacista o droghiere prima di prendere questo farmaco.

Se soffre d'asma bronchiale o se è a conoscenza di rischi legati ad emorragie gastrointestinali (p.es.

in caso di ulcera gastrointestinale o di varici dell'esofago) dovrebbe assumere Solmucol solo sotto

controllo medico.

La somministrazione contemporanea di alcuni medicamenti è da evitare, poiché è possibile che

l'effetto di un farmaco influenzi quello dell'altro. Così, se somministrati contemporaneamente a

Solmucol, l'azione di alcuni farmaci contro il restringimento delle vie respiratorie (dilatatori

bronchiali) e di preparati contro i disturbi circolatori alle coronarie (nitroglicerina contro l'angina

pectoris) può essere potenziata.

Nel caso debba (su prescrizione medica) far ricorso ad antibiotici, è necessario che osservi un

intervallo di almeno 2 ore fra l'assunzione di questi e Solmucol. Il suo medico, farmacista o

droghiere le indicheranno per quali antibiotici è necessaria questa precauzione.

In caso di somministrazione concomitante di un antitussivo, vedere «Quando non si può assumere

Solmucol?».

Informi il suo medico, farmacista o droghiere

·se soffre di altre malattie,

·se è allergico o

·se prende o usa altri medicamenti (anche di propria iniziativa!).

Si può somministrare Solmucol durante la gravidanza o l’allattamento?

In base alle esperienze fatte finora, non sono noti rischi per il bambino se il medicamento viene usato

correttamente. Tuttavia, non sono mai state eseguite indagini scientifiche sistematiche.

Per prudenza dovrebbe rinunciare nella misura del possibile ad assumere medicamenti durante la

gravidanza ed il periodo d'allattamento o chiedere consiglio al proprio medico o farmacista.

Informi il suo medico in caso dovesse rimanere incinta durante il trattamento.

Se per ragioni assolutamente necessarie dovesse assumere Solmucol durante il periodo

d'allattamento, per prudenza dovrebbe evitare di allattare il bambino.

Come usare Solmucol?

Salva diversa prescrizione del medico, si consiglia la seguente posologia:

Adulti e bambini con più di 12 anni

3 volte al giorno 1 bustina di granulare Solmucol 200 mg o

1 volta al giorno 1 bustina di granulare Solmucol 600 mg.

Bambini da 2 a 12 anni

3 volte al giorno 1 bustina di granulare Solmucol 100 mg.

Bambini da 1 a 2 anni (solo su prescrizione medica!)

3 volte al giorno ½ bustina di granulare Solmucol 100 mg.

Bambini di meno di 1 anno e lattanti

Solmucol deve essere usato soltanto sotto controllo medico, in ambiente ospedaliero.

Se l'eccessiva secrezione di muco causata dal raffreddore non dovesse diminuire dopo 2 settimane di

trattamento, è il caso di consultare un medico.

Trattamento a lungo termine (solo su prescrizione medica)

400-600 mg al giorno di Solmucol granulare, in 2 o più prese, durata massima di trattamento di 3-6

mesi.

Mucoviscidosi

Posologia come sopra, ma già per bambini da 6 anni: 1 volta al giorno 1 bustina di granulare 600 mg.

Vista la gravità della malattia, il medico può comunque prescrivere una posologia diversa, secondo

lo stato di salute del paziente.

Modo d'uso

Versare il contenuto della bustina in un bicchiere vuoto e scioglierlo in un po' d'acqua.

Eviti di prendere altri medicamenti insieme a Solmucol.

Il farmaco agisce a partire dal secondo o terzo giorno di trattamento.

Il lieve odore di zolfo che si sprigiona al momento dell'apertura della bustina è tipico

dell'acetilcisteina; non indica alcuna alterazione del prodotto e non influenza l'efficacia del

medicamento.

Si attenga alla posologia indicata nel foglietto illustrativo o prescritta dal suo medico. Se ritiene che

l'azione del medicamento sia troppo debole o troppo forte, ne parli al suo medico, farmacista o

droghiere.

Quali effetti collaterali può avere Solmucol?

Con l'assunzione di Solmucol possono manifestarsi i seguenti effetti collaterali:

occasionalmente disturbi gastrointestinali come vomito, diarrea, nausea, dolori addominali o

infiammazioni della mucosa orale come pure reazioni di ipersensibilità, orticaria, mal di testa e

febbre.

Inoltre è possibile che si manifestino casi di polso accelerato, ipotensione e ronzio nelle orecchie,

bruciori di stomaco, emorragie e ritenzione idrica in viso.

In persone predisposte possono comparire reazioni allergiche alla pelle (prurito, eruzioni cutanee) o

agli organi respiratori (difficoltà respiratorie, broncospasmi). In questi casi deve subito interrompere

la somministrazione di Solmucol e avvertire il suo medico al più presto possibile.

L'alito potrebbe assumere temporaneamente un leggero odore sgradevole, probabilmente a causa

della scissione del gruppo sulfidrilico dal principio attivo.

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

droghiere.

Di che altro occorre tener conto?

Solmucol deve essere conservato a temperatura ambiente (15–25 °C) al riparo della luce e fuori della

portata dei bambini.

Il medicamento non deve essere utilizzato oltre la data indicata con «EXP» sulla confezione.

Se possiede dei farmaci scaduti, voglia renderli al suo farmacista o droghiere.

Il medico, farmacista o droghiere, che sono in possesso di documentazione professionale, possono

darle ulteriori informazioni.

Cosa contiene Solmucol?

Principio attivo: bustine da 100, 200 e 600 mg di acetilcisteina.

Eccipienti: xilitolo, saccarina, aroma (arancio) ed altri eccipienti.

Numero dell’omologazione

47909 (Swissmedic).

Dove è ottenibile Solmucol? Quali confezioni sono disponibili?

In farmacia e drogheria, senza ricetta medica.

Solmucol granulare

20 bustine da 100 mg.

20 e 40 bustine da 200 mg.

10 bustine da 600 mg.

Titolare dell’omologazione

IBSA Institut Biochimique SA, 6903 Lugano.

Questo foglietto illustrativo è stato controllato l'ultima volta nel giugno 2009 dall'autorità competente

in materia di medicamenti (Swissmedic).

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Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

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