VITIS VINIFERA YES PHARMA

Informazioni principali

  • Nome commerciale:
  • VITIS VINIFERA YES PHARMA
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

Localizzazione

  • Disponibile in:
  • VITIS VINIFERA YES PHARMA
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Dettagli prodotto:
  • 044519015 - "GRANULATO PER SOLUZIONE ORALE" 30 BUSTINE IN CARTA/AL DA 360 MG - autorizzato

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 044519
  • Ultimo aggiornamento:
  • 26-03-2018

Foglio illustrativo

FOGLIO ILLUSTRATIVO

Foglio illustrativo: informazioni per l’utilizzatore

Vitis vinifera YES Pharma granulato per soluzione orale

Estratto secco di foglie di vite

Legga attentamente questo foglio prima di prendere questo medicinale perché contiene

importanti informazioni per lei.

Prenda questo medicinale sempre come esattamente descritto in questo foglio o come il medico o il

farmacista le hanno detto di fare.

Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo.

Se desidera maggiori informazioni o consigli, si rivolga al farmacista.

Se si manifesta uno qualsiasi degli effetti indesiderati, tra cui effetti non elencati in questo

foglio, si rivolga al medico o al farmacista. Vedere paragrafo 4.

Si rivolga al medico se non nota miglioramenti o se nota un peggioramento dei sintomi dopo 2

settimane.

Contenuto di questo foglio

Cos’è Vitis vinifera YES Pharma e a cosa serve

Cosa deve sapere prima di prendere Vitis vinifera YES Pharma

Come prendere Vitis vinifera YES Pharma

Possibili effetti indesiderati

Come conservare Vitis vinifera YES Pharma

Contenuto della confezione e altre informazioni

1.

Cos’è Vitis vinifera YES Pharma e a cosa serve

Vitis vinifera YES Pharma è un medicinale di origine vegetale per il trattamento dei sintomi

dell’insufficienza venosa cronica negli adulti, come gambe gonfie, sensazione di pesantezza, dolore,

stanchezza, prurito, tensione e crampi ai polpacci.

2.

Cosa deve sapere prima di prendere Vitis vinifera YES Pharma

Non prenda Vitis vinifera YES Pharma:

se è allergico al principio attivo o ad uno qualsiasi degli altri componenti di questo medicinale

(elencati al paragrafo 6).

Avvertenze e precauzioni

Si rivolga al medico o al farmacista prima di prendere Vitis vinifera YES Pharma.

Consulti immediatamente il medico in caso di

infiammazione cutanea o ulcere

infiammazione delle vene (tromboflebite)

indurimento del tessuto sotto la pelle (indurimento sottocutaneo)

dolore intenso

gonfiore improvviso di una o di entrambe le gambe

problemi al cuore o al rene

In caso di risposta inadeguata o insoddisfacente entro 2 settimane, consultare il medico, poiché

l’edema potrebbe dipendere da altre cause.

Attenersi rigorosamente alle ulteriori misure non invasive prescritte dal medico, come ad es. usare

fasciature, indossare calze elastiche o bagnare le gambe con un getto di acqua fredda.

Pazienti con funzionalità renale e/o epatica compromessa

Se soffre di insufficienza renale o di funzionalità epatica compromessa, si rivolga al medico o al

farmacista prima di prendere Vitis vinifera YES Pharma. Non sono disponibili dati che consentano di

fornire un dosaggio raccomandato per questi pazienti.

Bambini e adolescenti

In assenza di dati sufficienti sulla sicurezza, l’uso nei bambini e negli adolescenti al di sotto dei 18

anni di età non è raccomandato.

Altri medicinali e Vitis vinifera YES Pharma

Documento reso disponibile da AIFA il 09/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere

qualsiasi altro medicinale.

Non sono stati effettuati studi d’interazione.

Gravidanza, allattamento e fertilità

Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza o se sta allattando con

latte materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.

Gravidanza

In assenza di dati sufficienti sulla sicurezza, l’uso di Vitis vinifera YES Pharma in gravidanza non è

raccomandato.

Allattamento

In assenza di dati sulla sicurezza sufficienti, l’uso di Vitis vinifera YES Pharma durante

l’allattamento non è raccomandato.

Fertilità

Non sono disponibili dati sulla fertilità.

Guida di veicoli e utilizzo di macchinari

Non sono stati condotti studi sugli effetti sulla capacità di guidare veicoli e sull’uso di macchinari.

3.

Come prendere Vitis vinifera YES Pharma

Prenda questo medicinale seguendo sempre esattamente quanto riportato in questo foglio o le

istruzioni del medico o del farmacista. Se ha dubbi consulti il medico o il farmacista.

Adulti e anziani

La dose raccomandata è di 1-2 bustine al giorno.

Modo di somministrazione

Prendere Vitis vinifera YES Pharma prima di colazione. Sciogliere l’intero contenuto di una bustina

in un bicchiere d’acqua, agitando bene per facilitarne lo scioglimento. La soluzione così ottenuta

deve essere ingerita immediatamente dopo la ricostituzione e può essere presa indipendentemente dai

pasti.

Durata del trattamento

La durata di trattamento raccomandata con Vitis vinifera YES Pharma è di 12 settimane.

Possono essere necessarie da 2 a 3 settimane di trattamento prima di osservare benefici.

Il trattamento a lungo termine è possibile dopo avere consultato il medico.

Uso nei bambini e negli adolescenti

In assenza di dati sufficienti sulla sicurezza, l’uso nei bambini e negli adolescenti al di sotto dei 18

anni di età non è raccomandato.

Uso nei pazienti con funzionalità epatica e/o renale compromessa

Se soffre di funzionalità epatica e/o renale compromessa, deve rivolgersi al medico prima di prendere

Vitis vinifera YES Pharma. Non sono disponibili dati che consentano di fornire un dosaggio

raccomandato per questi pazienti.

Se prende più Vitis vinifera YES Pharma di quanto deve

Non sono stati segnalati casi di sovradosaggio. Se prende più Vitis vinifera YES Pharma di quanto

deve, si rivolga al medico, che deciderà le misure necessarie.

Se dimentica di prendere Vitis vinifera YES Pharma

Non prenda una dose doppia per compensare la dimenticanza della dose, ma continui a prendere la

dose consueta alla solita ora.

Se ha qualsiasi dubbio sull’uso di questo medicinale, si rivolga al medico o al farmacista.

4.

Possibili effetti indesiderati

Come tutti i medicinali, questo medicinale può causare effetti indesiderati sebbene non tutte le

persone li manifestino.

La frequenza dei possibili effetti indesiderati riportati qui di seguito non è nota:

mal di testa, dolori allo stomaco, nausea e altri disturbi gastrointestinali, reazioni di ipersensibilità

cutanea, quali prurito, arrossamento della pelle, orticaria.

Se nota uno degli effetti indesiderati di cui sopra, smetta di prendere Vitis vinifera YES Pharma e

consulti il medico, che stabilirà la gravità degli effetti indesiderati e deciderà le misure necessarie.

Documento reso disponibile da AIFA il 09/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Segnalazione degli effetti indesiderati

Se manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si

rivolga al medico o al farmacista. Lei può inoltre segnalare gli effetti indesiderati direttamente

tramite il sistema nazionale di segnalazione all’indirizzo www.aifa.gov.it/content/segnalazioni-

reazioni-avverse

Segnalando gli effetti indesiderati può contribuire a fornire maggiori informazioni sulla sicurezza di

questo medicinale.

5.

Come conservare Vitis vinifera YES Pharma

Conservi questo medicinale fuori dalla vista e dalla portata dei bambini.

Non usi questo medicinale dopo la data di scadenza che è riportata sulla scatola e sulle bustine dopo

SCAD. La data di scadenza si riferisce all’ultimo giorno di quel mese.

Questo medicinale non richiede alcuna condizione particolare di conservazione.

6.

Contenuto della confezione e altre informazioni

Cosa contiene Vitis vinifera YES Pharma

Una bustina contiene 360 mg di estratto (sotto forma di estratto secco) di Vitis vinifera L. folium

(foglie di vite) (DER 4-6:1), solvente di estrazione: acqua.

Gli altri componenti sono:

Maltodestrina

Acido tartarico

Silice colloidale anidra

Sucralosio

Descrizione dell’aspetto di Vitis vinifera YES Pharma e contenuto della confezione

Vitis vinifera YES Pharma è un granulato di colore da brunastro a rosso-violaceo confezionato in

bustine in alluminio laminato.

Ciascuna confezione contiene 30 bustine da 808 mg.

Titolare dell’autorizzazione all’immissione in commercio e produttore

YES Pharmaceutical Development Services GmbH

Bahnstraße 42-46

61381 Friedrichsdorf

Germania

Questo medicinale è autorizzato negli Stati membri dello Spazio Economico Europeo (EEA) con

le seguenti denominazioni:

Belgio:

Venvit granulaat voor drank/granulés pour solution buvable/Granulat zur

Herstellung einer Lösung zum Einnehmen

Germania:

Venvit 360 mg Granulat zur Herstellung einer Lösung zum Einnehmen

Francia:

VIGNE ROUGE YES PHARMA 360 mg Granulés pour solution buvable

Grecia:

Vitis vinifera extract/YES Pharma 360 mg Κοκκία σε φακελίσκο για παρασκευή

πόσιμου διαλύματος

Italia:

Vitis vinifera YES Pharma

Lussemburgo:

Venvit granulés pour solution buvable/Granulat zur Herstellung einer Lösung

zum Einnehmen

Austria:

Venvit 360 mg Granulat zur Herstellung einer Lösung zum Einnehmen

Portogallo:

Venvit 360 mg Granulado para solução oral

Spagna:

Venvit granulado para solución oral

Cipro:

Venvit 360 mg Κοκκία σε φακελίσκο για παρασκευή πόσιμου διαλύματος

Questo foglio illustrativo è stato aggiornato il {MM/AAAA}.

Documento reso disponibile da AIFA il 09/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

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22-8-2018

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Protopic (Leo Pharma A/S)

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EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

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

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

22-8-2018

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevice pic.twitter.com/SQYFz30oFy

FDA - U.S. Food and Drug Administration

22-8-2018

Do you need to improve your contact lens wear and care habits? Here are some simple tips to help keep your eyes safe! #OnePairTakeCarepic.twitter.com/Gnez9sxXgE

Do you need to improve your contact lens wear and care habits? Here are some simple tips to help keep your eyes safe! #OnePairTakeCarepic.twitter.com/Gnez9sxXgE

Do you need to improve your contact lens wear and care habits? Here are some simple tips to help keep your eyes safe! #OnePairTakeCare pic.twitter.com/Gnez9sxXgE

FDA - U.S. Food and Drug Administration

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety