Ben-u-ron 250 mg

Informazioni principali

  • Nome commerciale:
  • Ben-u-ron 250 mg Suppositorien für Kleinkinder
  • Forma farmaceutica:
  • Suppositorien für Kleinkinder
  • Composizione:
  • paracetamolum 250 mg, excipiens pro suppositorio.
  • 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:
  • Ben-u-ron 250 mg Suppositorien für Kleinkinder
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Analgetikum, Antipyretikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 29152
  • Data dell'autorizzazione:
  • 13-11-1964
  • 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 che contiene informazioni importanti.

Questo medicamento le è stato prescritto dal suo medico o le è stato consegnato senza prescrizione

medica in farmacia o in drogheria. Faccia uso corretto del medicamento conformemente al foglietto

illustrativo o segua le indicazioni del medico, del farmacista o del droghiere, al fine di ottenere il

maggior beneficio.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

ben-u-ron supposte

Che cos’è ben-u-ron e quando si usa?

ben-u-ron contiene il principio attivo paracetamolo, che ha un effetto analgesico e antipiretico.

Lo si usa per il trattamento immediato di mal di testa, mal di denti, dolori a livello delle articolazioni

e dei legamenti, mal di schiena, dolori mestruali, dolori causati da traumi (p. es. di tipo sportivo),

dolori in caso di malattie da raffreddamento e febbre.

Di che cosa occorre inoltre tener conto durante il trattamento?

Come tutti gli antipiretici e analgesici, anche il ben-u-ron non va assunto senza prescrizione medica

per più di 5 giorni dagli adulti e bambini dai 12 anni o per più di 3 giorni dai bambini fino ai 12 anni.

In caso di febbre ben-u-ron non va assunto per più di 3 giorni senza prescrizione medica.

Gli analgesici non vanno assunti regolarmente per un lungo periodo senza il controllo del medico. I

dolori persistenti necessitano di un accertamento medico.

In caso di febbre alta, sintomi di infezione secondaria o sintomi persistenti per più di tre giorni si

raccomanda di consultare il medico.

Non si deve superare la posologia indicata o prescritta dal medico.

Per prevenire il rischio di sovradosaggio è necessario assicurarsi che i medicamenti assunti

contemporaneamente (p.es. altri analgesici, antipiretici o medicamenti contro il raffreddore) non

contengano paracetamolo. Un sovradosaggio di paracetamolo può causare un grave danno epatico.

Occorre inoltre considerare che l’assunzione protratta nel tempo di antidolorifici può contribuire alla

persistenza del mal di testa.

L’uso prolungato di analgesici, specialmente in caso di associazione di diversi principi attivi

antidolorifici, può provocare delle lesioni permanenti ai reni con rischio di insufficienza renale.

Quando non si possono usare le supposte ben-u-ron?

ben-u-ron non va assunto nei seguenti casi:

-ipersensibilità al principio attivo paracetamolo e ad altre sostanze analoghe (p.es. proparacetamolo)

o a una delle sostanze ausiliarie (vedi “Cosa contengono le supposte ben-u-ron?”). Un’ipersensibilità

di questo genere si manifesta per esempio sotto forma di asma, difficoltà di respirazione, disturbi

circolatori, gonfiori a livello della pelle e delle mucose o eruzioni sulla pelle (orticaria).

-gravi malattie epatiche (p.es. epatite acuta, cirrosi epatica, ascite ovvero accumulo di liquido nella

cavità peritoneale).

-abuso di alcool.

-disfunzione ereditaria del fegato (cosiddetta malattia di Meulengracht).

Quando è richiesta prudenza nell’utilizzo delle supposte ben-u-ron?

È necessario consultare il medico prima dell’assunzione:

-in presenza di lesioni ai reni o al fegato;

-in presenza di una rara malattia ereditaria dei globuli rossi, la cosiddetta “carenza di glucosio-6-

fosfatodeidrogenasi”;

-in caso di uso concomitante di medicamenti che influiscono sul fegato, in particolare certi farmaci

contro la tubercolosi e l’epilessia o medicamenti col principio attivo zidovudina utilizzati in caso di

immunodeficienza (AIDS);

-in caso di assunzione dei seguenti medicamenti:

·medicamenti anticoagulanti (p.es. Marcoumar);

·Cholestyramin (medicamento che riduce i grassi nel sangue);

·Chloramphenicol (medicamento contro le infezioni);

·Metoclopramid (medicamento contro nausea e vomito);

·Phenytoin, Phenobarbital, Carbamazepin (medicamento contro epilessia (convulsioni));

·Rifampicin, Isoniazid (medicamento contro la tubercolosi);

·Probenecid (medicamento contro la gotta);

·Zidovudin (medicamento contro l’infezione HIV (AIDS)).

-in caso di infezione grave (p.es. sepsi);

-in caso di sottopeso o denutrizione;

-in caso di consumo regolare di alcol.

Si sconsiglia l’uso concomitante di paracetamolo e bevande alcoliche. Il rischio di danni epatici

aumenta soprattutto se non si assumono degli alimenti insieme al medicamento.

Le persone ipersensibili agli analgesici o agli antireumatici possono avere una reazione di

ipersensibilità anche al paracetamolo (vedi “Quali effetti collaterali possono provocare le supposte

ben-u-ron?”).

In casi molto rari il paracetamolo può causare reazioni cutanee gravi. In caso di insorgenza di

reazioni cutanee, interrompere l’assunzione delle supposte ben-u-ron e consultare il medico (vedi

“Quali effetti collaterali possono provocare le supposte ben-u-ron?”).

Le supposte ben-u-ron non agiscono sulla capacità di guidare o di utilizzare macchinari.

Tuttavia, l’assunzione di un analgesico richiede sempre attenzione.

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

assuma o applichi esternamente (anche se acquistati di sua iniziativa).

Le supposte ben-u-ron possono essere utilizzate durante la gravidanza o l’allattamento?

Per precauzione, durante la gravidanza o l’allattamento bisogna evitare il più possibile di utilizzare

medicamenti o chiedere consiglio al medico, al farmacista o al droghiere.

In base alle esperienze fatte finora non sono noti rischi per il bambino in caso di uso, per un breve

periodo, del principio attivo paracetamolo nella posologia indicata.

Anche se passa in minime quantità nel latte materno, il paracetamolo si può usare anche durante

l’allattamento.

Come usare le supposte ben-u-ron?

Non deve essere superata la dose massima giornaliera. Le singole dosi non devono essere assunte a

intervalli più frequenti di 4–8 ore.

Le supposte vanno introdotte nel retto.

Lattanti da 3 a 5 kg (0–3 mesi): 1 supposta da 75 mg fino a 3 volte al giorno.

Lattanti da 5 a 7 kg (3–6 mesi): 1 supposta da 75 mg fino a 4 volte al giorno.

Lattanti da 7 a 10 kg (6–12 mesi): 1 supposta da 125 mg fino a 4 volte al giorno.

Bambini da 10 a 15 kg (1–3 anni): 1 supposta da 250 mg fino a 3 volte al giorno.

Bambini da 15 a 22 kg (3–6 anni: 1 supposta da 250 mg fino a 4 volte al giorno.

Bambini da 22 a 30 kg (6–9 anni): 1 supposta da 500 mg fino a 3 volte al giorno.

Bambini da 30 a 40 kg (9–12 anni): 1 supposta da 500 mg fino a 4 volte al giorno.

Adolescenti e adulti (oltre i 40 kg): 1 supposta da 1000 mg fino a 4 volte al giorno.

Si attenga alla posologia indicata nel foglietto illustrativo o prescritta dal medico. Se ritiene che

l’azione del medicamento sia troppo debole o troppo forte ne parli al suo medico, al suo farmacista o

al suo droghiere.

In caso di assunzione incontrollata (sovradosaggio) consultare immediatamente il medico, anche in

assenza di disturbi. A causa del rischio di un grave danno epatico, vanno intraprese immediate

misure mediche. Nausea, vomito, mal di pancia, inappetenza o un quadro patologico generale

possono essere indicativi di un sovradosaggio, ma si manifestano solo diverse ore (fino a un giorno)

dopo l‘assunzione.

Quali effetti collaterali possono avere le supposte ben-u-ron?

Con l’utilizzo delle supposte ben-u-ron possono insorgere i seguenti effetti collaterali: raramente

reazioni di ipersensibilità come prurito, gonfiori della pelle e delle mucose o eruzioni cutanee anche

gravi (molto rare), nausea, affanno o asma. Se si manifestano dei sintomi di ipersensibilità o

emorragie/ematomi bisogna interrompere l’utilizzo del medicamento e consultare il medico. Sono

state inoltre osservate alterazioni del quadro ematologico, come un numero ridotto di piastrine

(trombocitopenia) o una forte riduzione di determinati globuli bianchi (agranulocitosi).

In caso di effetti collaterali qui non descritti è necessario informare il suo medico, farmacista o

droghiere.

Di che altro occorre tener conto?

Conservare a temperatura inferiore a 25°C e fuori della portata dei bambini.

Il paracetamolo può alterare la misurazione della glicemia mediante il metodo della glucosio

ossidasi. I medicamenti con il principio attivo paracetamolo non devono essere somministrati ai

bambini che abbiano assunto inavvertitamente alcol.

Il medico, il farmacista o il droghiere, che sono in possesso di documentazione specializzata e

dettagliata, possono fornire ulteriori informazioni.

Cosa contengono le supposte ben-u-ron?

1 supposta contiene 75 mg / 125 mg / 250 mg / 500 mg / 1000 mg di paracetamolo come principio

attivo, nonché sostanze ausiliarie.

Numero dell’omologazione

29152 (Swissmedic)

Dove sono ottenibili le supposte ben-u-ron? Quali confezioni sono disponibili?

Nelle farmacie e drogherie, senza prescrizione medica:

10 supposte da 75 mg.

10 supposte da 125 mg.

10 supposte da 250 mg.

10 supposte da 500 mg.

Nelle farmacie, con prescrizione medica:

10 supposte da 1000 mg.

Titolare dell’omologazione

Nutrimedis SA, 1630 Bulle / FR

Questo foglietto illustrativo è stato controllato l’ultima volta nell’agosto 2016 dall’autorità

competente in materia di medicamenti (Swissmedic).

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Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

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Europe -DG Health and Food Safety

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

19-7-2018

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Active substance: N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide) - Transfer of orphan designation - Commission Decision (2018)4810 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/138/16/T/02

Europe -DG Health and Food Safety

3-7-2018

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Active substance: tolvaptan) - Centralised - 2-Monthly update - Commission Decision (2018) 4250 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/II/31

Europe -DG Health and Food Safety

6-6-2018

Stocrin (Merck Sharp and Dohme B.V.)

Stocrin (Merck Sharp and Dohme B.V.)

Stocrin (Active substance: efavirenz) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3689 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/250/T/113

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

21-5-2018

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Active substance: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)) - Transfer of orphan designation - Commission Decision (2018)3136 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/089/07/T/01

Europe -DG Health and Food Safety

23-4-2018

Mylotarg (Pfizer Limited)

Mylotarg (Pfizer Limited)

Mylotarg (Active substance: gemtuzumab ozogamicin) - New authorisation - Commission Decision (2018)2504 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204

Europe -DG Health and Food Safety