Coop Vitality Domperidon 10 mg

Informazioni principali

  • Nome commerciale:
  • Coop Vitality Domperidon 10 mg Schmelztabletten
  • Forma farmaceutica:
  • Schmelztabletten
  • Composizione:
  • domperidonum 10 mg, saccharinum natricum, aromatica, antiox.: E 320, mantenuto.: Di E 220, 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:
  • Coop Vitality Domperidon 10 mg Schmelztabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Übelkeit und Erbrechen

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 67005
  • Data dell'autorizzazione:
  • 29-01-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Coop Vitality Domperidone

Coop Vitality Health Care GmbH

Che cos’è Coop Vitality Domperidone e quando si usa?

Coop Vitality Domperidone serve per il trattamento sintomatico della nausea e del vomito.

Di che cosa occorre inoltre tener conto durante il trattamento?

In concomitanza con l'assunzione di Domperidon possono presentarsi alcuni rari effetti collaterali,

che rendono necessario interrompere immediatamente il trattamento e rivolgersi subito a un medico.

Le indicazioni dettagliate sono contenute in «Quali effetti collaterali può avere Coop Vitality

Domperidone?».

Quando non si può assumere Coop Vitality Domperidone?

Non si può usare Coop Vitality Domperidone in caso di:

·allergia (ipersensibilità) al principio attivo o ad uno dei costituenti della formulazione

(un'ipersensibilità si presenta ad es. sotto forma di eruzione cutanea, prurito, dispnea o gonfiori al

viso).

·malattia dell'ipofisi, detta prolattinoma.

·malattie gastrointestinali gravi (emorragie, occlusione intestinale meccanica o perforazione

dell'intestino). Affezioni di questo genere possono manifestarsi con forti crampi addominali od

emissione di feci sempre scure.

·malattia epatica in corso o contratta in passato.

·se l'ECG (elettrocardiogramma) indica un problema al cuore denominato «intervallo QT lungo».

·se ha o ha avuto in passato un problema per cui il cuore non è in grado di pompare il sangue nel

corpo come dovrebbe (insufficienza cardiaca).

·se ha un problema per cui i suoi livelli di potassio o magnesio sono ridotti o i livelli di potassio nel

sangue sono aumentati.

·se si assumono contemporaneamente i seguenti farmaci che inibiscono l'enzima epatico CYP3A4,

che rallentano nel corpo il metabolismo di altri farmaci o che possono compromettere il ritmo

cardiaco:

·certi medicamenti (cosiddetti antimicotici azolici) per il trattamento di infezioni fungine, quali

l'itraconazolo, il chetoconazolo, il posaconazolo o il voriconazolo;

·certi antibiotici come l'eritromicina, la claritromicina o la telitromicina, che si usano contro le

infezioni batteriche;

·determinati medicamenti contro le infezioni da virus HIV (inibitori delle proteinasi dell'HIV) come

ritonavir o saquinavir;

·telaprevir, un medicamento contro le infezioni da virus dell'epatite C.

Si sconsiglia di somministrare Coop Vitality Domperidone compresse fondenti ai bambini sotto i 12

anni e agli adulti e adolescenti che pesano meno di 35 kg.

Quando è richiesta prudenza nella somministrazione di Coop Vitality Domperidone?

Se ha oltre 60 anni, prima di prendere Coop Vitality Domperidone chieda consiglio al suo medico.

Se parallelamente si assumono altri medicamenti (compresi preparati a base di piante medicinali), è

assolutamente necessario segnalarli al medico curante o al farmacista, dato che l'assunzione

concomitante di Coop Vitality Domperidone e medicamenti che influenzano l'azione di una

determinata proteina, l'enzima epatico CYP3A4, può portare ad interazioni farmacologiche.

Informare il medico curante o il farmacista se in passato si sono manifestati problemi di cuore o se

attualmente si soffre di cardiopatie, quali insufficienza cardiaca, infarto del miocardio, angina

pectoris o aritmie cardiache (frequenza cardiaca accelerata, rallentata o irregolare).

Se durante il trattamento nota che il ritmo cardiaco è anomalo, interrompa il trattamento con

Domperidon e si rivolga immediatamente al suo medico.

I pazienti ad alto rischio di sviluppare determinate aritmie cardiache (sindrome del QT lungo)

dovrebbero parlarne col medico curante, prima di assumere Coop Vitality Domperidone.

Si sconsiglia di somministrare Coop Vitality Domperidone compresse fondenti a pazienti con

malattie epatiche.

Nei pazienti affetti da nefropatia, il medico considererà la necessità di un aggiustamento del

dosaggio, specie se devono assumere Coop Vitality Domperidone per lungo tempo.

Forme farmaceutiche speciali

Informi il suo medico se assume medicamenti che riducono l'acidità gastrica.

Si sconsiglia di assumere Coop Vitality Domperidone compresse fondenti contemporaneamente a

medicamenti che riducano l'acido gastrico. Si deve prendere Coop Vitality Domperidone compresse

fondenti prima dei pasti e il medicamento contro l'acidità dopo i pasti.

Informi il suo medico se assume anticolinergici (medicamenti per il trattamento delle allergie,

dell'asma, dell'incontinenza, dei crampi gastrointestinali, degli spasmi muscolari, della depressione o

dei disturbi del sonno, come destrometorfano o difenidramina), perché potrebbero influenzare Coop

Vitality Domperidone.

Non guidi veicoli e non utilizzi macchinari se si sente stanco, ha sonno o soffre di capogiri dopo aver

assunto il medicamento.

Informi il medico o il farmacista se:

·assume farmaci per il trattamento di infezioni fungine o batteriche, problemi cardiaci, malaria,

AIDS/HIV, depressione, malattie psichiche, problemi gastrointestinali, tumori maligni, dolori o

dipendenza;

·assume aprepitant, un farmaco per sedare la nausea causata da chemioterapia.

Il suo medico deciderà se questi medicamenti possono essere assunti insieme a Domperidon o se lei

debba essere controllato strettamente in merito alla comparsa di problemi al cuore.

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

assuma altri medicamenti (anche se acquistati di sua iniziativa!).

Si può somministrare Coop Vitality Domperidone durante la gravidanza o l’allattamento?

Gravidanza

Non è noto se l'uso di Coop Vitality Domperidone durante la gravidanza sia dannoso. Se è incinta o

pensa di poterlo essere, si rivolga al medico che deciderà se può prendere Coop Vitality

Domperidone.

Allattamento

Piccole quantità di domperidone sono state rilevate nel latte materno. L'uso durante l'allattamento

non è raccomandato.

Come usare Coop Vitality Domperidone?

Domperidon esplica la sua massima efficacia se lo assume 15-30 minuti prima dei pasti e, se

necessario, prima di coricarsi.

Le dosi sottoelencate sono indicative e possono essere adattate dal medico a seconda delle necessità

individuali.

Adulti ed adolescenti (al di sopra dei 12 anni) con peso corporeo superiore ai 35 kg

Dosaggio di Coop Vitality Domperidone senza prescrizione medica

1 compressa fondente da 10 mg 3 volte al giorno, prima del pasto. La dose massima è di 3 compresse

fondenti da 10 mg al giorno.

Coop Vitality Domperidone non deve essere assunto ininterrottamente per più di una settimana.

Rivolgersi al medico se nausea e vomito persistono per più di una settimana.

Bambini al di sotto dei 12 anni, adulti e adolescenti con un peso corporeo inferiore a 35 kg

Coop Vitality Domperidone non è adatto per i bambini al di sotto dei 12 anni, adulti e adolescenti

con un peso corporeo inferiore a 35 kg. 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 Coop Vitality Domperidone?

Interrompa immediatamente il trattamento con domperidone e si rivolga subito al medico, se si

manifesta uno degli effetti collaterali riportati qui di seguito.

Molto raramente (effetti riscontrati in meno di 1 paziente su 10'000):

·sensazione di capogiro

·crampi

·movimenti involontari del viso o delle braccia e gambe, forte tremore, estrema rigidità muscolare o

spasmi muscolari

·reazione allergica, che può comparire appena dopo la somministrazione e che si manifesta sotto

forma di eruzione cutanea, prurito, respiro breve e/o viso tumefatto

·forte reazione da ipersensibilità che si presenta appena dopo la somministrazione e che si manifesta,

oltre che con altri sintomi, sotto forma di orticaria, prurito, arrossamenti, perdita di conoscenza e

tumefazioni delle mani, dei piedi, del viso o nella zona della laringe, il che può causare disturbi della

deglutizione e problemi respiratori

·aritmia cardiaca

·morte improvvisa a seguito di perdita repentina della funzione cardiaca, in particolare nelle persone

affette precedentemente da una malattia cardiaca.

Con l'assunzione di Coop Vitality Domperidone sono stati riscontrati altri effetti collaterali che

vengono elencati qui sotto:

Frequentemente (effetti riscontrati in almeno 1 paziente su 100, tuttavia in meno di 1 paziente su 10):

·depressione

·stati di angoscia

·perdita d'interesse o diminuzione dell'interesse al sesso

·cefalea

·sonnolenza

·inquietudine

·diarrea

·eruzione

·prurito

·aumento del petto

·dolori al petto o sensibilità alla pressione sul petto

·secrezione lattea dal petto o problemi durante l'allattamento

·ciclo irregolare o interruzione del ciclo nelle donne

·senso di debolezza generale

·bocca secca

Occasionalmente (effetti riscontrati in almeno 1 paziente su 1'000, tuttavia meno di 1 paziente su

100):

·reazione da ipersensibilità

·orticaria

·tumefazione del petto

·secrezione anomala dal petto

Raramente (effetti riscontrati in almeno 1 paziente su 10'000, tuttavia in meno di 1 paziente su

1'000):

·aumento dei livelli di prolattina

Molto raramente (effetti riscontrati in meno di 1 paziente su 10'000):

·stato di agitazione

·nervosismo

·incapacità a urinare

·crampi intestinali passeggeri

·indici di funzionalità epatica anomali

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

Di che altro occorre tener conto?

Tenere fuori dalla portata dei bambini.

Conservare nella confezione originale e a temperatura non superiore ai 30 °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 Coop Vitality Domperidone?

1 compressa fondente di Coop Vitality Domperidone contiene come principio attivo 10 mg di

domperidone; eccipienti: saccarina sodica, aroma, E 220, E320,. altri eccipienti.

Numero dell’omologazione

67005 (Swissmedic).

Dove è ottenibile Coop Vitality Domperidone? Quali confezioni sono disponibili?

In farmacia, senza prescrizione medica:

Coop Vitality Domperidone, compressa fondente: confezione da 30 compresse fondenti.

Titolare dell’omologazione

Coop Vitality Health Care GmbH, 4704 Niederbipp.

Questo foglietto illustrativo è stato controllato l'ultima volta nel febbraio 2015 dall'autorità

competente in materia di medicamenti (Swissmedic).

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Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

23-8-2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

MMDR implementation, SME Assist, GMP reforms, medicinal cannabis and international cooperation

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety