Demetrin 20

Informazioni principali

  • Nome commerciale:
  • Demetrin 20 Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • prazepamum 20 mg, excipiens pro compresso.
  • 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:
  • Demetrin 20 Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Anxiolyticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 39416
  • Data dell'autorizzazione:
  • 17-06-1977
  • 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 prima di far uso del medicamento.

Questo medicamento le è stato prescritto personalmente e quindi non deve essere consegnato ad altre

persone, anche se i sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Demetrin®, compresse

Che cos’è Demetrin e quando si usa?

Demetrin appartiene alla classe di farmaci delle benzodiazepine e contiene il principio attivo

prazepam che ha un effetto calmante, ansiolitico e rilassante. Demetrin trova impiego nel trattamento

degli stati di ansia e tensione, agitazione e nervosismo, aumentata irritabilità, forti sbalzi di umore e

dei disturbi fisici derivanti dagli stati di tensione nervosa.

Demetrin può essere assunto solo su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

Non tutti gli stati di tensione, agitazione e ansia richiedono un trattamento farmacologico. Spesso

sono espressione di malattie fisiche o psichiche e possono essere influenzati positivamente da altre

misure o dal trattamento della malattia di base.

Quando non si può usare Demetrin?

Demetrin non deve essere assunto in caso di ipersensibilità nota al principio attivo prazepam o a una

delle sostanze ausiliarie (vedere sezione «Cosa contiene Demetrin?») e di dipendenza da altre

sostanze, incluso l’alcol. Demetrin non deve essere usato in caso di forte compromissione della

funzione respiratoria, di insufficienza epatica grave e di debolezza muscolare patologica («miastenia

grave»). Non deve inoltre assumere Demetrin se si sveglia di notte in seguito a difficoltà respiratorie

(cosiddetta «sindrome da apnea del sonno»).

Quando è richiesta prudenza nella somministrazione di Demetrin?

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine! Ciò vale in particolare all’inizio del trattamento e in caso

di posologia elevata. Si raccomanda quindi particolare prudenza nel traffico stradale o nella manovra

di macchine, finché non si conosce la propria reazione individuale a Demetrin e non è stata definita

la posologia più adatta al proprio caso specifico.

Rischio di dipendenza: l’assunzione di Demetrin, come tutti i farmaci contenenti benzodiazepine,

può dare dipendenza. Il fenomeno si sviluppa soprattutto in seguito ad assunzione ininterrotta per un

periodo prolungato (in certi casi già dopo qualche settimana) e dà luogo a sintomi di astinenza in

caso di brusca interruzione della somministrazione. Possono comparire quindi nervosismo, stati

d’ansia, insonnia, difficoltà di concentrazione, mal di testa e accessi di sudorazione. Queste

manifestazioni regrediscono in genere nel giro di due-tre settimane.

Per ridurre al minimo il rischio che si sviluppi dipendenza, si consiglia di seguire le raccomandazioni

seguenti:

– assumere Demetrin solo dietro prescrizione del proprio medico;

– non aumentare in nessun caso la posologia prescritta dal medico;

– informare il medico se si desidera interrompere l’assunzione del farmaco;

– il medico valuterà periodicamente se è necessario proseguire il trattamento;

–l’assunzione per un periodo prolungato (in genere superiore a quattro settimane) deve avvenire

esclusivamente sotto stretto controllo medico.

Informi il suo medico se fa uso contemporaneamente di altri farmaci, specialmente antidolorifici

forti, altri tranquillanti, farmaci contro la depressione, l’epilessia o i disturbi psichici, sonniferi o

farmaci per il rilassamento muscolare. Demetrin può amplificare l'azione di questi farmaci. Per lo

stesso motivo, durante il trattamento con Demetrin dovrebbe astenersi dal consumo di bevande

alcoliche. L’effetto di Demetrin può essere rafforzato o prolungato dall'uso concomitante di

determinati antibiotici, antidepressivi e dai farmaci per il trattamento di infezioni da funghi, ulcere

gastroduodenali, aritmie cardiache o infezione da HIV.

L’assunzione contemporanea di Demetrin e oppiacei può causare una forte depressione di

determinate funzioni cerebrali con gravi disturbi respiratori che possono portare a perdita di

coscienza e morte e deve pertanto essere evitata.

L’assunzione contemporanea di contraccettivi orali (pillola anticoncezionale) può intensificare

l’effetto di Demetrin.

I pazienti affetti dalle rare e congenite affezioni intolleranza al galattosio, deficit di lattasi o

malassorbimento congenito di glucosio - galattosio, non dovrebbero assumere Demetrin compresse.

Informi il suo medico o il suo farmacista nel caso in cui soffra di altre malattie, di allergie o assuma o

applichi (in caso di farmaci per uso esterno) altri medicamenti (anche se acquistati di sua iniziativa)!

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

Se è incinta, prevede una gravidanza oppure allatta, deve assumere Demetrin esclusivamente dietro

esplicita prescrizione del medico. Se si rende necessaria la somministrazione di Demetrin durante

l’allattamento, deve smettere di allattare.

Come usare Demetrin?

Il medico determinerà la posologia adatta al suo caso specifico in base all’intensità della

sintomatologia. Per questo è importante che si attenga scrupolosamente alle prescrizioni riguardo alla

quantità, all’orario di assunzione e alla durata del trattamento. Salvo diversa prescrizione, la

posologia giornaliera per adulti è di 1 compressa di Demetrin 20 o 2 compresse di Demetrin 10. Nei

soggetti anziani sono spesso sufficienti quantità minori. All’occorrenza, il suo medico potrà anche

aumentare la dose. Per i bambini da 3 a 12 anni, la dose sarà definita in base all’età, al peso e

all’altezza. Le compresse vanno deglutite con un po’ di liquido, senza essere masticate. Le

compresse di Demetrin hanno una scanalatura centrale e possono essere spezzate a metà.

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 Demetrin?

In seguito all’assunzione di Demetrin possono manifestarsi i seguenti effetti collaterali: Gli effetti

collaterali più frequenti sono: stanchezza, sonnolenza, rallentamento dei tempi di reazione,

confusione, sogni movimentati, vertigini, stordimento, insicurezza nei movimenti e nell’andatura

(rischio di cadute), mal di testa, tremito, articolazione verbale poco chiara, agitazione, vista

annebbiata, palpitazioni, secchezza della bocca, diversi disturbi gastrointestinali, sudorazione,

eruzioni cutanee passeggere, dolori articolari e senso di debolezza. Sono stati altresì osservati:

prurito, piedi gonfi, diminuzione dell’eccitabilità sessuale, alterazioni delle mestruazioni, lieve

abbassamento della pressione sanguigna e aumento di peso. In casi isolati possono manifestarsi

disturbi della memoria e raramente un aumento temporaneo dei valori epatici. Nei pazienti con

restringimento delle vie respiratorie o con lesioni cerebrali possono comparire disturbi respiratori. In

caso di dosaggio elevato, possono manifestarsi disturbi visivi (es. visione doppia). Sussiste inoltre la

possibilità di reazioni «paradossali» che possono esprimersi con aumentata aggressività, stati di

agitazione acuti o ansia. Qualora dovessero manifestarsi le reazioni descritte, il medico cesserà il

trattamento con Demetrin. In caso di comparsa di questi effetti collaterali deve consultare il medico.

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

Di che altro occorre tener conto?

Conservare le compresse possibilmente nella confezione originale chiusa, a temperatura ambiente

(15-25 °C) e fuori dalla portata dei bambini. Il medicamento non dev'essere utilizzato oltre la data

indicata con «EXP» (= data di scadenza: mese/anno) sulla confezione. Il medico o il farmacista, che

sono in possesso di documentazione professionale dettagliata, possono darle ulteriori informazioni.

Cosa contiene Demetrin?

1 compressa di colore bianco e di forma rotonda di Demetrin 10 con scanalatura centrale per la

divisione contiene come principio attivo 10 mg di prazepam, più le sostanze ausiliarie lattosio,

cellulosa microcristallina, amido di mais, magnesio stearato e biossido di silicio a elevata

dispersione.

1 compressa di colore bianco e di forma rotonda di Demetrin 20 con scanalatura centrale per la

divisione contiene come principio attivo 20 mg di prazepam, più le sostanze ausiliarie lattosio,

cellulosa microcristallina, amido di mais, magnesio stearato e biossido di silicio a elevata

dispersione.

Numero dell’omologazione

39416 (Swissmedic).

Dov’è ottenibile Demetrin? Quali confezioni sono disponibili?

Le compresse di Demetrin sono ottenibili in farmacia, esclusivamente dietro presentazione della

prescrizione medica.

Sono disponibili le seguenti confezioni:

Demetrin 10: 20 o 50 compresse (divisibili).

Demetrin 20: 20 o 50 compresse (divisibili).

Titolare dell’omologazione

Pfizer PFE Switzerland GmbH, Zürich.

Questo foglietto illustrativo è stato controllato l’ultima volta nel novembre 2017 dall’autorità

competente in materia di medicamenti (Swissmedic).

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21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency