GEM Antitussivum

Informazioni principali

  • Nome commerciale:
  • GEM Antitussivum Sirup
  • Forma farmaceutica:
  • Sirup
  • Composizione:
  • dextromethorphanum 6.25 mg ut dextromethorphani hydrobromidum, arom.: natrii cyclamas, vanillinum et alia, colore.: E-150, tenuto.: E 216, E 218, excipiens annuncio solutionem pro 5 ml.
  • 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:
  • GEM Antitussivum Sirup
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Husten

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 15898
  • Data dell'autorizzazione:
  • 08-11-1950
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Informazione destinata ai pazienti

Legga attentamente il foglietto illustrativo che contiene importanti informazioni.

Questo medicamento le è stato prescritto dal suo medico o le è stato consegnato senza prescrizione

medica in farmacia. Per ottenere il maggior beneficio, usi il medicamento conformemente al foglietto

illustrativo o segua le indicazioni del suo medico o del suo farmacista.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

GEM® Antitussivo, Sciroppo

Che cos’è GEM Antitussivo e quando si usa?

GEM Antitussivo è un tossifugo antitussivo. La sostanza attiva destrometorfano calma lo stimolo

della tosse. Nella dose consigliata, l’azione dura in genere per 6 o più ore.

GEM Antitussivo è indicato per il trattamento della tosse, in particolare di tosse secca e irritativa.

Di che cosa occorre inoltre tener conto durante il trattamento?

Il consumo di tabacco favorisce la tosse («tosse dei fumatori»). Potete sostenere l’azione di GEM

Antitussivo rinunciando al fumo.

GEM Antitussivo è senza zucchero perciò è indicato anche per diabetici. 5 ml GEM Antitussivo

corrispondono a 0.16 unità-pane.

Quando non si può usare GEM Antitussivo?

La somministrazione di GEM Antitussivo deve essere evitata per i soggetti ipersensibilità ad una

delle sostanze contenute, nonché in caso di assunzione di determinati medicamenti contro i disturbi

dell’umore (cosiddetti inibitori MAO) ed all’ assunzione di certi inibitori d’appetito.

Se la vostra tosse o quella del vostro bambino è accompagnata da forte espettorazione (secrezioni

bronchiali), non dovreste prendere, rispettivamente somministrare, medicamenti contro la tosse senza

il parere e la prescrizione del medico.

GEM Antitussivo è edulcorato tra l’altro con sorbitolo che, nel processo di digestione, produce

zucchero di frutta (fruttosio). Pertanto questo preparato non deve essere usato da soggetti che

soffrono di una (rara) alterazione congenita del metabolismo degli zuccheri (intolleranza al fruttosio).

GEM Antitussivo non deve essere somministrato ai bambini di età inferiore ai 2 anni.

Quando è richiesta prudenza nell’uso di GEM Antitussivo?

Se la vostra tosse o la tosse del suo bambino persiste per più di una settimana, consultare un medico

in modo che possa chiarirne le cause e, se necessario, prescrivere un trattamento specifico.

Se soffrite d’asma, di altre affezioni croniche delle vie respiratorie o di malattie del fegato, prendere

GEM Antitussivo solo dietro prescrizione medica. Se dovessero subentrare reazioni di ipersensibilità

(allergie), interrompere immediatamente il trattamento e rivolgersi al medico.

Le reazioni di ipersensibilità si manifestano con eruzioni cutanee, gonfiori del viso, battiti del cuore

accelerati, malessere e/o disturbi respiratori. In singoli casi possono subentrare svenimento e stato di

shock (cosiddetto shock anafilattico).

In determinati soggetti, p.e. in pazienti con affezioni epatiche o renali, nonché in persone con una

predisposizione genetica, la sostanza attiva destrometorfano viene eliminata dall’organismo molto

più lentamente che in altre persone. Ciò può potenziare, già in un periodo di trattamento di 3-4

giorni, non soltanto l’azione antitussiva del preparato, bensì anche gli effetti collaterali. Il suo medico

vi informerà sulle concomitanze.

Questo medicinale può pregiudicare la capacità di reazione, la capacità di guidare utensili o

macchine! Ciò vale in misura maggiore per i trattamenti che superano la durata di 3-4 giorni, nonché

in caso di assunzione contemporanea di bevande alcoliche.

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

- soffre di altre malattie,

- soffre di allergie o

- assume o applica esternamente altri medicamenti (anche se acquistati di sua iniziativa!).

Si può assumere GEM Antitussivo durante la gravidanza o l’allattamento?

Per motivi precauzionali, le donne incinte, che prevedono una gravidanza o che allattano dovrebbero

possibilmente rinunciare ai medicamenti. Per GEM Antitussivo non è accertato che non possa

pregiudicare lo sviluppo o la salute del nascituro. Per tale motivo, nel periodo di gravidanza prendere

questo medicamento solo dietro esplicita prescrizione medica. Assunto verso la fine del periodo di

gravidanza, GEM Antitussivo può provocare difficoltà respiratorie nel nascituro.

La sostanza attiva destrometorfano, contenuta nello sciroppo GEM Antitussivo, viene assorbita in

quantità minime dal latte materno. L’uso di GEM Antitussivo è quindi sconsigliato durante

l’allattamento.

Come usare GEM Antitussivo?

Dossagio per adulti e adolescenti dai 12 anni: 3-4 volte al giorno 20 ml.

Dossagio per bambini

dai 2 a 6 anni: 3-4 volte al giorno 5 ml;

dai 6 a 12 anni: 3-4 volte al giorno 10 ml.

Per il dosaggio, si prega di usare il misurino accluso.

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 o al suo farmacista.

Quali effetti collaterali può avere GEM Antitussivo?

In seguito all’assunzione di GEM Antitussivo possono essere osservati i seguenti effetti collaterali.

Occasionalmente: nausea e vomito, costipazione, stanchezza, capogiri.

Raramente: inappetenza, diarrea, reazioni di ipersensibilità (allergie), agitazione, turbamenti psichici,

spasmi bronchiali con disturbi respiratori, inibizioni respiratorie. Le reazioni di ipersensibilità

(allergie) possono manifestarsi in casi rari. Si esprimono in genere con l’eruzione cutanea/esantema,

transpirazione cutanea, disturbi di respiro, battiti accelerati del cuore e/o malessere. In casi singoli,

possono condurre fino allo svenimento ed allo shock e richiedono subito l’aiuto di un medico.

Gli effetti collaterali possono essere più intensi o più frequenti se il preparato viene somministrato in

dosi più elevate di quelle previste, per un periodo prolungato o in associazione con determinati altri

medicamenti.

In caso di sovradosaggio, ovvero in seguito a somministrazione di dosi più elevate e/o più frequenti

di quelle previste, si intensificano sia gli effetti collaterali qui citati, sia i rischi menzionati al punto

«Quando è richiesta prudenza nell’uso di GEM Antitussivo?». Ulteriori sintomi di un sovradosaggio

possono essere: sudorazione, palpitazioni (battiti accelerati del cuore), vista offuscata, eccitabilità e

svenimenti. Nei bambini, e in particolare nei bambini piccoli, un sovradosaggio può avere gravi

conseguenze.

Se subentrano sintomi di sovradosaggio, interrompere immediatamente la somministrazione di GEM

Antitussivo e contattare il medico.

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

Di che altro occorre tener conto?

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

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

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

darle ulteriori informazioni.

Cosa contiene GEM Antitussivo?

5 ml di sciroppo contengono la sostanza attiva destrometorfano idrobromide 8.5 mg (corr.

destrometorfano 6.25 mg), i dolcificanti sorbitolo, ciclamato ed acesulfame, gli aromatizzanti

vanillina ed altri, i conservanti metil paraidrossibenzoato (E218) e propil paraidrossibenzoato (E216),

il colorante caramello (E 150), nonché ulteriori coadiuvanti.

Numero dell’omologazione

15898 (Swissmedic)

Dove è ottenibile GEM Antitussivo? Quali confezioni sono disponibili?

In farmacia, senza prescrizione medica.

Confezioni da 200 ml.

Titolare dell’omologazione

Iromedica SA, San Gallo

Questo foglietto illustrativo è stato controllato l’ultima volta nel marzo 2008 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

16-5-2018

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

FDA - U.S. Food and Drug Administration

2-3-2018

European top post for Thomas Senderovitz

European top post for Thomas Senderovitz

Director General of the Danish Medicines Agency, Thomas Senderovitz, was Thursday elected Chairperson of the HMA Management Group. HMA is an acronym for Heads of Medicines Agencies and is the network of the heads of the national drug regulatory authorities in Europe.

Danish Medicines Agency

18-1-2019


Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Europe - EMA - European Medicines Agency

18-12-2018


Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

Europe - EMA - European Medicines Agency

17-12-2018


Risk management requirements for elemental impurities in veterinary medicinal products

Risk management requirements for elemental impurities in veterinary medicinal products

Risk management requirements for elemental impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

14-12-2018


Report on the EMA Management Board delegation visit to the future EMA premises

Report on the EMA Management Board delegation visit to the future EMA premises

Report on the EMA Management Board delegation visit to the future EMA premises

Europe - EMA - European Medicines Agency

14-12-2018


EMA Management Board: highlights of December 2018 meeting

EMA Management Board: highlights of December 2018 meeting

EMA Management Board: highlights of December 2018 meeting

Europe - EMA - European Medicines Agency

23-11-2018

Management and communication of medicine shortages and discontinuations in Australia

Management and communication of medicine shortages and discontinuations in Australia

Guidance for sponsors and other stakeholder bodies

Therapeutic Goods Administration - Australia

7-11-2018

AEMS guidance for health professionals

AEMS guidance for health professionals

Adverse Event Management System - instructions on using the new system for health professionals

Therapeutic Goods Administration - Australia

7-11-2018

AEMS guidance for sponsors

AEMS guidance for sponsors

Adverse Event Management System - instructions on using the new system for sponsors

Therapeutic Goods Administration - Australia

17-10-2018

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read:  https://go.usa.gov/xPRNF pic.twitter.com/1VPpgHdbic

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read: https://go.usa.gov/xPRNF pic.twitter.com/1VPpgHdbic

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read: https://go.usa.gov/xPRNF  pic.twitter.com/1VPpgHdbic

FDA - U.S. Food and Drug Administration

12-9-2018

Agenda:  Agenda - Risk management plan information day

Agenda: Agenda - Risk management plan information day

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

5-9-2018

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medical devices on Sept. 9th

FDA - U.S. Food and Drug Administration

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

1-8-2018

Mylotarg (Pfizer Europe MA EEIG)

Mylotarg (Pfizer Europe MA EEIG)

Mylotarg (Active substance: gemtuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5233 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204/T/1

Europe -DG Health and Food Safety

27-7-2018

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Active substance: Gemtuzumab Ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5037 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/00/T/02

Europe -DG Health and Food Safety

22-6-2018

Submissions received and next steps: Management and communication of medicines shortages

Submissions received and next steps: Management and communication of medicines shortages

Submissions received in response to consultation on Management and communication of medicines shortages

Therapeutic Goods Administration - Australia

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

23-4-2018

Mylotarg (Pfizer Limited)

Mylotarg (Pfizer Limited)

Mylotarg (Active substance: gemtuzumab ozogamicin) - New authorisation - Commission Decision (2018)2504 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1993 (IQVIA RDS Ireland Limited)

EU/3/18/1993 (IQVIA RDS Ireland Limited)

EU/3/18/1993 (Active substance: Gemfibrozil) - Orphan designation - Commission Decision (2018)1882 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/218/17

Europe -DG Health and Food Safety