Prazine 100 mg

Informazioni principali

  • Nome commerciale:
  • Prazine 100 mg Confetti
  • Forma farmaceutica:
  • Confetti
  • Composizione:
  • promazini hydrochloridum 100 mg, colore.: E 127, 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:
  • Prazine 100 mg Confetti
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Neurolepticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 23527
  • Data dell'autorizzazione:
  • 22-08-1957
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

diverse

Informazioni per i 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.

Prazine®

Che cos'è il Prazine e quando si usa?

Il Prazine è un farmaco per il trattamento di gravi disturbi dell'umore e di altri stati d'animo che

inconsapevolmente sono molto limitanti. Inoltre il Prazine può venir prescritto per alleviare forme

gravi di nausea e vomito. Il Prazine va impiegato solamente su prescrizione medica.

Quando non si può usare il Prazine?

Il Prazine non deve essere usato in caso di ipersensibilità (allergia) a una delle sue componenti o a

medicamenti della stessa classe chimica, le cosiddette fenotiazine. Inoltre non va assunto né in caso

di perdita di coscienza provocata da sostanze ad azione sedativa sul sistema nervoso centrale (alcool,

barbiturici, oppiacei), né in caso di glaucoma ad angolo chiuso. Il Prazine non va somministrato a

bambini di età inferiore ai 12 anni.

Quando è richiesta prudenza nella somministrazione del Prazine?

Questo medicamento può ridurre la capacità di reazione, la capacità di utilizzare attrezzi o macchine

e la capacità di condurre un veicolo!

Specialmente nelle prime settimane di assunzione il Prazine può causare sonnolenza, vertigini e

disturbi della vista. Finché questi effetti non saranno scomparsi è sconsigliabile guidare veicoli,

manovrare macchine pericolose o effettuare lavori che richiedono concentrazione e una vista

perfetta. Anche malattie di fondo come le psicosi o le turbe comportamentali possono pregiudicare la

capacità di utilizzare attrezzi o macchine e la capacità di guidare.

I pazienti allergici ai coloranti azoici, all'acido acetilsalicilico, o a medicamenti antireumatici e

antidolorifici (inibitori delle prostaglandine) non devono assumere i confetti di Prazine 50 mg.

Se ha sofferto in passato o soffre attualmente di una delle seguenti malattie, usi il Prazine solo con la

massima prudenza:

cardiopatie, disturbi dell‘irrorazione cerebrale, estrema ipotensione arteriosa, malattie epatiche,

epilessia, asma grave, difficoltà respiratorie a causa di infezioni polmonari acute.

La comparsa improvvisa di sintomi d'infezione, come p.es. infiammazione della gola - generalmente

tra la 4a e la 10a settimana di trattamento - dev'essere immediatamente comunicata al medico, che

dovrà verificare che non si tratti di agranulocitosi, ovvero una diminuzione dei granulociti, un

sottogruppo dei leucociti.

Raramente, durante il trattamento con il Prazine, può verificarsi la cosiddetta "sindrome neurolettica

maligna". Se ha febbre alta con forte tensione muscolare e disturbi nervosi, deve rivolgersi

immediatamente al medico.

Poiché il Prazine inibisce la sudorazione e di conseguenza la regolazione termica del corpo, le

persone esposte ad estremo calore o che praticano uno sport devono fare attenzione a non

surriscaldarsi. Anche in sauna può manifestarsi un senso di debolezza.

Durante il trattamento con il Prazine bisogna astenersi dal consumo di alcool, poiché ciò

comporterebbe il rischio di un abbassamento indesiderato della pressione arteriosa.

L‘associazione con altre sostanze che provocano una sedazione a livello centrale, come p.e. alcool,

calmanti, sonniferi, medicamenti contro allergie o raffreddori (antistaminici), andrebbe evitata a

causa di un possibile potenziamento degli effetti.

Il Prazine può aumentare la fotosensibilità della pelle, quindi si dovrebbe rinunciare a un'esposizione

prolungata al sole.

Tra l'assunzione del Prazine e di farmaci contro l'iperacidità gastrica (antiacidi) o contro la diarrea, è

necessario rispettare un intervallo di 2 ore affinché il Prazine possa esercitare completamente il suo

effetto.

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

medicamenti (anche acquistati di propria iniziativa).

Si può usare il Prazine durante la gravidanza o l'allattamento?

Il Prazine non va assunto durante la gravidanza, a meno che il medico curante non lo ritenga

assolutamente necessario.

Con l'uso del Prazine durante l'ultimo trimestre di gravidanza, possono verificarsi nel neonato

tremore, rigidità muscolare, debolezza, sonnolenza, eccitazione, difficoltà respiratoria o problemi

nell'alimentazione.

Se è incinta, lo comunichi immediatamente al Suo medico, che le indicherà come procedere. In ogni

caso il trattamento non dev'essere sospeso a propria discrezione. La sospensione improvvisa del

trattamento può avere conseguenze gravi.

Informi immediatamente anche il Suo ginecologo o la Sua ostetrica in caso di assunzione del Prazine

durante la gravidanza, in particolare se dopo la nascita il Suo bambino presenta i problemi sopra

descritti.

Siccome molti medicamenti passano nel latte materno, è sconsigliato usare il Prazine durante il

periodo di allattamento.

Come usare il Prazine?

Il Suo medico fisserà individualmente la dose e la frequenza di somministrazione, a seconda della

gravità del disturbo da curare e della risposta terapeutica.

Le seguenti dosi vengono quindi riportate solamente a titolo orientativo; esse possono naturalmente

differire dalla Sua posologia personale: disturbi dell'umore: 25 mg - 200 mg, ogni 4 - 6 ore. Forte

nausea e vomito: 25 mg - 50 mg, ogni 4 - 6 ore. Giovani di oltre 12 anni con episodi acuti di disturbi

psicotici cronici: 25 mg, ogni 4 - 6 ore.

Il Prazine può essere assunto con un bicchiere d'acqua o di latte durante i pasti.

Non modifichi di Sua iniziativa la posologia del medicamento che le è stata prescritta. Se ritiene che

il farmaco agisca troppo poco o troppo ne parli al medico o al farmacista.

Quali effetti collaterali può avere il Prazine?

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

In certi casi può comparire sonnolenza, che però spesso è desiderata durante il trattamento. Di solito

sparisce spontaneamente con il proseguimento della cura o diminuisce riducendo la dose.

Prazine 50 mg, confetti: il colorante giallo arancio S (E110) nei confetti di Prazine 50 mg può

causare reazioni allergiche della pelle o delle vie respiratorie, in particolare in pazienti con asma,

orticaria cronica, o ipersensibilità all'acido acetilsalicilico e altri antireumatici o antidolorifici.

Informi il medico nel caso in cui si dovessero manifestare i seguenti effetti collaterali:

disturbi motori, portamento fisico anomalo, tensione muscolare al viso, alla nuca e al dorso, tremore

delle mani o delle dita, incapacità a restare seduti tranquillamente. Se i disturbi motori sono forti, se

compromettono in modo notevole la qualità della vita o se durano a lungo, ne parli al Suo medico.

Disturbi della vista, disturbi della parola.

Reazioni cutanee come eruzioni cutanee, pelle secca o desquamazione della pelle e ipersensibilità

alla luce. Secchezza della bocca, stitichezza. Difficoltà ad urinare, disturbi del ciclo mestruale,

secrezione di latte nella donna e aumento di volume delle mammelle o impotenza nell’uomo.

Nel caso in cui si dovessero manifestare i seguenti effetti collaterali, interrompa il trattamento con il

Prazine e consulti subito il medico:

palpitazioni, polso troppo frequente o irregolare, abbassamento della pressione arteriosa che causa

debolezza, capogiri, o addirittura breve perdita di conoscenza. Difficoltà di respirazione, febbre con

disturbi del sistema nervoso, forte rigidità muscolare. Improvvisa comparsa di sintomi di infezione,

p.e. infiammazione della gola.

Colorazione giallognola della pelle o degli occhi (ittero).

Molto raramente con l'uso di Prazine nell'ultimo trimestre di gravidanza possono verificarsi nel

neonato tremore, rigidità muscolare, debolezza, sonnolenza, eccitazione, difficoltà respiratoria o

problemi nell'alimentazione.

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

Di che altro occorre tener conto?

Conservazione:

Il Prazine va tenuto 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.

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

possono darle ulteriori informazioni.

Cosa contiene il Prazine?

1 confetto di Prazine 25 mg contiene: 25 mg di promazina cloridrato e sostanze ausiliarie.

1 confetto di Prazine 50 mg contiene: 50 mg di promazina cloridrato; colorante: giallo arancio S (E

110) e sostanze ausiliarie.

1 confetto di Prazine 100 mg contiene: 100 mg di promazina cloridrato; colorante: eritrosina (E 127)

e sostanze ausiliarie.

Numero dell’omologazione

23527 (Swissmedic)

Dov'è ottenibile il Prazine? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Prazine confetti da 25 mg, 50 mg o 100 mg: 50 confetti

Titolare dell’omologazione

Tentan AG, 4452 Itingen

Questo foglietto illustrativo è stato controllato l'ultima volta nel novembre 2013 dall'autorità

competente in materia di medicamenti (Swissmedic).

PI_Prazine/05.14

17-1-2019

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Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

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13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

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First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

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9-11-2018

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20-9-2018

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7-9-2018

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1-9-2018

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29-8-2018

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28-8-2018

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14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

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3-8-2018

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Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

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Therapeutic Goods Administration - Australia

15-6-2018

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