Ben-u-ron 500 mg

Informazioni principali

  • Nome commerciale:
  • Ben-u-ron 500 mg Suppositorien für Schulkinder
  • Forma farmaceutica:
  • Suppositorien für Schulkinder
  • Composizione:
  • paracetamolum 500 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 500 mg Suppositorien für Schulkinder
    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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TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

18-5-2018

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

6-9-2012

Danish Pharmacovigilance Update, 16 August 2012

Danish Pharmacovigilance Update, 16 August 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.

Danish Medicines Agency

7-12-2018


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

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

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

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

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

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

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

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

19-1-2018

Pending EC decision:  Panacur AquaSol, fenbendazole, Opinion date: 18-Jan-2018

Pending EC decision: Panacur AquaSol, fenbendazole, Opinion date: 18-Jan-2018

Europe - EMA - European Medicines Agency