Fluimucil 100

Informazioni principali

  • Nome commerciale:
  • Fluimucil 100 granulato
  • Forma farmaceutica:
  • granulato
  • Composizione:
  • acetylcysteinum 100 mg, arom.: aspartamum et alia, excipiens annuncio granulatum, pro charta 1 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:
  • Fluimucil 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:
  • 37561
  • Data dell'autorizzazione:
  • 22-11-1972
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Fluimucil

Che cos’è Fluimucil e quando si usa?

Fluimucil contiene il principio attivo acetilcisteina. Questo principio attivo fluidifica e scioglie le

dense secrezioni che ristagnano nelle vie respiratorie e ne favorisce l'espettorazione.

Il muco che ricopre la mucosa delle vie respiratorie svolge un importante ruolo nella protezione

dell'organismo da sostanze nocive presenti nell'aria come batteri, polvere e impurità chimiche.

Queste sostanze irritanti vengono catturate dal muco che le rende inoffensive e poi eliminate con

l’espettorato.

In caso di infezioni batteriche o virali (raffreddore, influenza, bronchite) e di irritazioni croniche

indotte da sostanze nocive, si ha un aumento della produzione di muco. Se il muco diventa più denso

e viscoso, può portare ad un'ostruzione delle vie respiratorie con difficoltà di respirazione e di

espettorazione.

Grazie all’effetto mucolitico, Fluimucil fluidifica le secrezioni dense che possono quindi essere

eliminate meglio con l’espettorato. In questo modo il rischio di un’eventuale infezione diminuisce.

Liberando le vie respiratorie, la tosse si calma e la respirazione diventa più facile.

Fluimucil è indicato per il trattamento di tutte le malattie delle vie respiratorie che provocano

un'eccessiva produzione di muco quali per es. raffreddore o influenza, associati a tosse e catarro,

come pure bronchite acuta e cronica, in caso di sinusite, laringite, faringite, asma bronchiale e (come

terapia complementare) nella mucoviscidosi (fibrosi cistica).

Per via dell’elevato contenuto in principio attivo e della grandezza degli imballaggi di Fluimucil,

questi vanno utilizzati solamente su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

Bere molto può incrementare l’effetto di Fluimucil. Il fumo contribuisce all’eccessiva formazione di

muco bronchiale. Rinunciando al fumo può rafforzare l’effetto di Fluimucil.

Quando non si può usare Fluimucil?

Fluimucil non dev'essere preso in caso di ipersensibilità conosciuta al principio attivo acetilcisteina,

di ulcera gastrica e intestinale o in presenza di una rara malattia congenita del metabolismo proteico

(fenilchetonuria) che richiede l’osservanza di una dieta rigorosa. Il granulare non deve altresì essere

assunto in presenza di un’altra rara malattia congenita del metabolismo glucidico (intolleranza al

fruttosio).

Fluimucil non dovrebbe inoltre essere assunto assieme ad antitussivi in quanto questi sopprimono lo

stimolo della tosse ed il naturale meccanismo di autopulizia delle vie respiratorie impedendo quindi

l’espettorazione del muco fluidificato. Ne può conseguire un ristagno di muco nei bronchi con il

pericolo di causare crampi bronchiali e infezioni delle vie respiratorie.

Per via dell’alto contenuto in principio attivo, le bustine di granulare, le compresse effervescenti e le

compresse da 600 mg non devono essere somministrate a bambini di età inferiore a 12 anni (in caso

di fibrosi cistica: bambini di età inferiore a 6 anni).

Il vostro medico saprà cosa fare in casi del genere.

Fluimucil non è indicato per i bambini di età inferiore ai 2 anni.

Quando è richiesta prudenza nell‘uso di Fluimucil?

L’utilizzo di Fluimucil può, soprattutto all’inizio del trattamento, comportare una fluidificazione

delle secrezioni bronchiali e favorire l’espettorazione. Se il paziente non è in grado di espettorarle in

maniera sufficiente, il medico potrà prendere delle misure di sostegno. Se in passato ha avuto

eruzioni cutanee o disturbi respiratori a seguito dell’assunzione di un medicamento contenente lo

stesso principio attivo di Fluimucil, dovrebbe assolutamente informare il suo medico o il suo

farmacista prima di iniziare la cura.

Se soffre di ipertensione le compresse effervescenti non sono indicate poiché ogni compressa

contiene circa 140 mg di sodio corrisp. a 350 mg di sale da cucina. Il sale che si libera dopo

assunzione orale può aumentare la pressione arteriosa ulteriormente e di conseguenza diminuire

l’effetto dei medicamenti antiipertensivi.

La somministrazione simultanea di altri medicamenti può influenzare reciprocamente l’effetto.

Infatti, l’efficacia di certi medicamenti per il trattamento dell’insufficienza coronarica (ad es. la

nitroglicerina nell’angina pectoris) può essere aumentata.

La somministrazione simultanea di acetilcisteina e di carbamazepina può portare alla riduzione della

concentrazione di carbamazepina.

La somministrazione simultanea di antitussivi può pregiudicare l’effetto di Fluimucil (vedi sopra:

“Quando non si può usare Fluimucil?”). Inoltre gli antibiotici non dovrebbero essere presi

contemporaneamente a Fluimucil ma soltanto dopo un intervallo di almeno 2 ore.

Informi il suo medico o il suo farmacista se soffre di altre malattie, soffre di allergie o assume o

applica altri medicamenti (anche se acquistati di propria iniziativa!).

Si può utilizzare Fluimucil durante la gravidanza o l‘allattamento?

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

correttamente. Tuttavia non sono state compiute indagini scientifiche sistematiche. Per precauzione

dovrebbe rinunciare, nella misura del possibile, ad assumere medicamenti durante la gravidanza o

chiedere consiglio al suo medico o al suo farmacista. Non ci sono informazioni sull’escrezione di

acetilcisteina nel latte materno. Pertanto, Fluimucil dovrebbe essere usato durante l’allattamento

soltanto se il medico curante lo ritiene necessario.

Come usare Fluimucil?

Salvo diversa prescrizione medica, il dosaggio abituale è:

Adolescenti da 12 anni e adulti: 600 mg al giorno, ripartiti su una (1 compressa effervescente, 1

bustina o 1 compressa da 600 mg) o più prese (ad es. 3 volte 200 mg).

Trattamento a lungo termine: 400 – 600 mg al giorno, suddivisi su una o più prese, durata del

trattamento 3–6 mesi al massimo.

Mucoviscidosi: stesso dosaggio, tuttavia già per bambini dai 6 anni, 1 bustina di granulare da 200 mg

3 volte al giorno o 1 bustina di granulare, 1 compressa effervescente o 1 compressa da 600 mg 1

volta al giorno.

Sciogliere la compressa effervescente o il contenuto di una bustina in un bicchiere di acqua fredda o

calda e bere immediatamente. Non sciogliere altri medicamenti insieme a Fluimucil in quanto sia

l’effetto di Fluimucil che quello dell’altro medicamento potrebbe esserne influenzato o annullato.

All'apertura della bustina o del blister si può percepire un leggero odore di zolfo. Questo è tipico del

principio attivo acetilcisteina e non ha alcuna influenza sulla sua efficacia.

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 Fluimucil?

Con l‘assunzione di Fluimucil possono manifestarsi i seguenti effetti collaterali:

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.

Possono anche comparire reazioni allergiche di tipo comune (come ad es. eruzioni cutanee o pruriti).

Qualora le reazioni di ipersensibilità dovessero provocare anche disturbi respiratori e crampi

bronchiali, cosa che può accadere in casi molto rari, dovrebbe interrompere immediatamente il

trattamento con Fluimucil e consultare un medico.

L’alito può temporaneamente avere un odore sgradevole.

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

Di che altro occorre tener conto?

Conservare a temperatura ambiente (15-25 °C), al riparo dalla luce e dall’umidità e fuori dalla

portata dei bambini.

Il medicamento non dev’essere utilizzato oltre la data indicata con "EXP" sulla confezione.

Il medico o il farmacista, che sono in possesso di un’informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Fluimucil?

1 bustina di granulare contiene 200 mg o 600 mg di acetilcisteina; eccipienti: aspartame, sorbitolo e

aromi.

1 compressa effervescente contiene 600 mg di acetilcisteina; eccipienti: aspartame e aromi.

1 compressa contiene 600 mg di acetilcisteina; eccipienti.

Numero dell’omologazione

37561 / 45179 / 57279 (Swissmedic).

Dov’è ottenibile Fluimucil? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Sono disponibili le seguenti confezioni:

90 bustine di granulare da 200 mg.

30 bustine di granulare da 600 mg.

30 e 100 compresse effervescenti da 600 mg.

30 e 60 compresse da 600 mg.

Titolare dell’omologazione

Zambon Svizzera SA

6814 Cadempino

Questo foglietto illustrativo è stato controllato l’ultima volta nel settembre 2016 dall’autorità

competente in materia di medicamenti (Swissmedic).

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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

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