FOLIDEX

Informazioni principali

  • Nome commerciale:
  • FOLIDEX
  • Dosaggio:
  • 400mg
  • Forma farmaceutica:
  • COMPRESSE
  • Via di somministrazione:
  • Uso orale
  • Confezione:
  • 28, 120
  • Classe:
  • A
  • Tipo di ricetta:
  • Ricetta ripetibile, validità 6 mesi, ripetibile 10 volte
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

Localizzazione

  • Disponibile in:
  • FOLIDEX
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • acido folico
  • Area terapeutica:
  • Acido folico
  • Indicazioni terapeutiche:
  • Prevenzione primaria dei difetti del tubo neurale del nascituro in donne fertili che stanno pianificando la gravidanza
  • Dettagli prodotto:
  • 036345015 - " 400 MCG COMPRESSE " 28 COMPRESSE - autorizzato; 036345027 - "400 MCG COMPRESSE" 120 COMPRESSE IN BLISTER AL/PVC - autorizzato

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 036345
  • Data dell'autorizzazione:
  • 24-06-2005
  • Ultimo aggiornamento:
  • 24-06-2017

Foglio illustrativo

FOGLIO ILLUSTRATIVO: INFORMAZIONI PER L’UTILIZZATORE

FOLIDEX 400 microgrammi compresse

Acido Folico

Legga attentamente questo foglio prima di prendere questo medicinale perché contiene

importanti informazioni per lei.

-

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

Se ha qualsiasi dubbio, si rivolga al medico o al farmacista o all’infermiere.

Questo medicinale è stato prescritto soltanto per lei. Non lo dia ad altre persone, anche

se i sintomi della malattia sono uguali ai suoi, perché . potrebbe essere pericoloso.-

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

questo foglio, si rivolga al medico o al farmacista o all’infermiere. (Vedere paragrafo 4)

Contenuto di questo foglio:

Che cos'è Folidex e a che cosa serve

Cosa deve sapere prima di prendere Folidex

Come prendere Folidex

Possibili effetti indesiderati

Come conservare Folidex

Contenuto della confezione e altre informazioni

1.

Che cos'è Folidex e a che cosa serve

L’acido folico è una vitamina che serve per il ricambio delle cellule del corpo. Lei necessita di

un regolare apporto di acido folico per mantenersi in salute.

In particolare le donne che pianificano una gravidanza e le donne gravide necessitano di un

adeguato apporto di acido folico per lo sviluppo del bambino.

Folidex è utile nella prevenzione dei difetti del tubo neurale come ad esempio la Spina Bifida

(rara malformazione della parte caudale della colonna vertebrale che può portare ad ernie del

midollo spinale, incontinenza fecale e urinaria e deficit di movimento e sensibilità degli arti

inferiori).

2.

Cosa deve sapere prima di prendere Folidex

Non prenda Folidex

se lei è allergica all’acido folico o ad uno qualsiasi degli eccipienti di Folidex.

se lei ha un tumore

Avvertenze e precauzionise è una donna che ha avuto in precedenza gravidanze (portate

a termine o meno) nelle quali si sono già osservati difetti di sviluppo del tubo neurale;

se è una donna in trattamento con farmaci antiepilettici: carbamazepina o acido valproico;

se è una donna con una storia familiare di difetti dello sviluppo del tubo neurale;

se è una donna in trattamento con antagonisti dell’acido folico (metotressato,

sulfasalazina)

se lei soffre di anemia perniciosa. Infatti, l’acido folico può rendere più difficile la diag-

nosi di anemia perniciosa riducendo le manifestazioni ematologiche di questa malattia,

ma non può contrastare la progressione delle sue complicanze neurologiche

In tutti questi casi potrebbe dover assumere una dose di acido folico superiore a quella

contenuta in una compressa di Folidex.

Documento reso disponibile da AIFA il 10/06/2016

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).

Altri medicinali e Folidex

Informi il suo medico se sta assumendo o ha recentemente assunto uno qualsiasi dei seguenti

medicinali: antiepilettici, antagonisti dell’acido folico (metotressato, sulfasalazina) e

cloramfenicolo

Folidex contiene lattosio

Se il suo medico le ha detto che ha una intolleranza ad alcuni zuccheri, contatti il suo medico

prima di prendere Folidex.

3.

Come prendere Folidex

Prenda sempre Folidex seguendo esattamente le istruzioni del medico o del parmacista . Se ha

dubbi li consulti prima di assumerlo.

La dose abituale è una compressa al giorno da quando viene pianificata la gravidanza fino alla

settimana di gestazione.

La compressa va assunta regolarmente prima dei pasti.

Tale dose non è adeguata nel caso in cui lei abbia avuto in precedenza gravidanze nelle quali

si sono già osservati difetti di sviluppo del tubo neurale.

Se prende più Folidex di quanto deve

Anche dosi molto più elevate di quelle contenute in Folidex non dovrebbero causare danni

alla salute

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

4.

Possibili effetti indesiderati

Come tutti i medicinali, Folidex può causare effetti indesiderati, sebbene non tutte le persone

li manifestino.

Gli effetti indesiderati più comuni, che comunque si manifestano raramente (che compaiono

in più di 1 paziente su 10.000 ma in meno di 1 su 1000, sono reazioni allergiche: eritema,

prurito e orticaria

A dosi più elevate di quelle contenute in Folidex potrebbero manifestarsi disturbi

gastrointestinali (nausea, disturbi addominali, flatulenza) irritabilità ed insonnia.

Segnalazione degli effetti indesiderati

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

rivolga al medico o al farmacista o all’infermiere.

Lei può inoltre segnalare gli effetti

indesiderati

direttamente

tramite

sistema

nazionale

segnalazione

all’indirizzo

www.agenziafarmaco.gov.it/it/responsabili..

Segnalando gli effetti indesiderati lei può contribuire a fornire maggiori informazioni sulla

sicurezza di questo medicinale.

5.

Come conservare Folidex

Non conservare a temperatura superiore a 30°C.

Conservare nel contenitore originale per proteggere il prodotto dall’umidità.

Tenere Folidex fuori dalla vista e dalla portata dei bambini.

Non usi Folidex dopo la data di scadenza che è riportata sulla scatola dopo l’abbreviazione

“Scad.”. La data di scadenza si riferisce all’ultimo giorno del mese.

Non getti alcun medicinalie nell’acqua di scarico e nei rifiuti domestici. Chieda al farmacista

come eliminare i medicinali che non utilizza più. Questo aiuterà a proteggere l’ambiente

6.

Contenuto della confezione e altre informazioni

Documento reso disponibile da AIFA il 10/06/2016

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).

Cosa contiene Folidex

Il principio attivo è acido folico.

Gli eccipienti sono: lattosio monoidrato, cellulosa microcristallina,

carbossimetilamido sodico (tipo A), magnesio stearato

Descrizione dell’aspetto di Folidex e contenuto della confezione

Le compresse hanno una forma biconvessa e sono di colore giallo.

Una confezione contiene 28 compresse in blister o 120 compresse in quattro blister da 30

compresse ognuno.

Titolare dell’autorizzazione all’immissione in commercio e produttore

ITALFARMACO S.p.A. – Viale F. Testi, 330 – 20126 Milano.

Tel. + 39 02 64431

Fax. + 39 02644346

e-mail: info@italfarmaco.com

Questo foglio illustrativo è stato aggiornatoil:

Documento reso disponibile da AIFA il 10/06/2016

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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2-10-2018

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2-10-2018

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2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

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2-10-2018

Zoledronic acid Teva (Teva B.V.)

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1-10-2018

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

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

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24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

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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

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

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

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety