Xenalon 100 mg

Informazioni principali

  • Nome commerciale:
  • Xenalon 100 mg Lactabs
  • Forma farmaceutica:
  • Lactabs
  • Composizione:
  • spironolactonum 100 mg, excipiens pro compresso obducto.
  • 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:
  • Xenalon 100 mg Lactabs
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Diureticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 42725
  • Data dell'autorizzazione:
  • 18-01-1980
  • 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 prima di far uso del medicamento.

Questo medicamento le è stato prescritto personalmente e quindi non deve essere consegnato ad altre

persone, anche se i sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Xenalon 50/100 Lactab®

Che cos’è Xenalon e quando si usa?

Lo Xenalon è un medicamento che stimola l’escrezione urinaria aumentando l'eliminazione di acqua

e sali presenti in eccesso nell’organismo. È però importante che l’organismo trattenga elementi vitali

come il potassio ed il magnesio. Lo Xenalon causa pure abbassamento di una pressione arteriosa

troppo elevata.

In generale l'effetto dello Xenalon si manifesta fra il 3º e il 6º giorno di trattamento e può perdurare

ancora per 72 ore dopo la cessazione della terapia. Lo Xenalon si usa in caso di accumulo d’acqua

nei tessuti, in malattie del cuore, del fegato o dei reni.

Lo Xenalon si usa pure per il trattamento di una pressione sanguigna troppo elevata, preferibilmente

assieme ad un altro medicamento antiipertensivo.

Lo Xenalon va preso su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

È raccomandabile una dieta a contenuto ridotto di sale.

Quando non si può usare Xenalon?

Lo Xenalon non si può prendere in caso di gravi disfunzioni dei reni, di determinati disturbi degli

elettroliti (p.es. tassi troppo elevati del potassio o tassi troppo bassi del sodio), di assunzione

concomitante di eplerenone come pure di ipersensibilità conosciuta allo spironolattone o ad una delle

sostanze ausiliarie indicate nella composizione.

Quando è richiesta prudenza nella somministrazione/nell uso di Xenalon?

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine!

Nei pazienti con funzionalità renale ridotta, gravi disturbi della funzionalità del fegato o grave

insufficienza cardiaca l’uso dello Xenalon richiede particolare prudenza. Il medico ordinerà degli

esami di laboratorio e all’occorenza modificherà o ridurrà la posologia dello Xenalon. Altri

medicamenti possono influire sull’effetto dello Xenalon e viceversa.

Se si somministrano contemporaneamente medicamenti a base di potassio , una dieta ricca di

potassio, prodotti sostitutivi del sale da cucina contenenti potassio, medicamenti che aumentano il

tasso di potassio (p.es. antibiotici contenenti trimetoprim), di certi medicamenti anticoagulanti

(eparina o eparine a basso peso molecolare) e di certi farmaci antiipertensivi (inibitori dell'ACE,

inibitori dell’angiotensina II) o medicamenti antinfiammatori come pure di farmaci che contrastano

l’azione dell’ormone aldosterone (antagonisti dei recettori dell’aldosterone), sussiste il rischio che la

concentrazione di potassio nel sangue raggiunga livelli pericolosamente elevati, soprattutto in caso di

contemporaneo blocco renale.

Lo Xenalon può potenziare l’effetto di altri medicamenti che stimolano l’escrezione urinaria

(diuretici) e prolungare la metabolizzazione di farmaci contenenti digossina. Perciò il medico

adatterà la posologia. In caso di associazione a determinati analgesici (p.es. l’Aspirina) può

verificarsi un aumento dei tassi sanguigni del potassio. Informi il medico se contemporaneamente

prende degli analgesici.

Durante il trattamento con lo Xenalon si deve rinunciare completamente a consumare alcolici.

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

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

Si può assumere/usare Xenalon durante la gravidanza o l’allattamento?

Durante la gravidanza lo Xenalon non si deve prendere, a meno che il suo medico gielo prescriva

espressamente in caso di malattia che mette la vita in pericolo. Le donne che allattano non devono

prendere lo Xenalon. Se il medico ha prescritto espressamente lo Xenalon bisogna prima smettere di

allattare.

Come usare Xenalon?

La dose e la durata del trattamento sono stabilite dal suo medico. La dose media all’inizio del

trattamento va da 100 a 200 mg al giorno. Successivamente si può ridurla.

Prenda i Lactab preferibilmente a colazione o a pranzo, con un po' d'acqua. Soprattutto all’inizio del

trattamento è sconsigliabile prendere il medicamento la sera perché l'aumento dell'escrezione urinaria

inizia più tardi nel corso della notte.

Non modifichi di propria iniziativa la posologia prescritta. 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 Xenalon?

In seguito all’assunzione dello Xenalon possono manifestarsi i seguenti effetti collaterali:

disturbi nel tratto gastrointestinale (diarrea, crampi), sonnolenza, mal di testa, vertigini o eruzioni

sulla pelle (anche gravi, ad esempio con formazione di bolle o distacco della pelle), svogliatezza,

confusione, disturbi nei movimenti, modificazioni del quadro ematologico, prurito, orticaria, caduta

dei capelli, aumento della pelosità, malessere, febbre, variazione dei tassi sanguigni degli elettroliti

con conseguenti disturbi di cuore, disturbi del ritmo cardiaco, modificazione del desiderio sessuale.

Raramente si verificano emorragie/ulcere/infiammazioni dello stomaco, ittero, funzionalità anormale

del fegato, modificazioni benigne del seno, crampi alle gambe, disturbi ai reni.

Nell'uomo possono occasionalmente manifestarsi gonfiore delle ghiandole mammarie, disturbi della

potenza sessuale, diminuzione del numero degli spermatozoi.

Irregolarità della mestruazione o assenza della stessa; emorragie nella postmenopausa, dolori al seno.

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

Di che altro occorre tener conto?

Il medicamento non dev’essere utilizzato oltre la data indicata con «EXP» sulla confezione.

Conservare nella confezione originale, in luogo asciutto e a temperatura non superiore ai 25 °C).

Tenere fuori dalla portata dei bambini.

Il medico o il farmacista, che sono in possesso di documentazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Xenalon?

Principio attivo:

Xenalon 50 mg: 1 Lactab contiene 50 mg di spironolattone.

Xenalon 100 mg: 1 Lactab contiene 100 mg di spironolattone.

Sostanze ausiliarie:

Sodio laurilsolfato e altre sostanze ausiliarie.

Numero dell’omologazione

42725 (Swissmedic).

Dove è ottenibile Xenalon? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Xenalon-50 Lactab: 20 e 50 Lactab.

Xenalon-100 Lactab: 20 e 50 Lactab.

Titolare dell’omologazione

Mepha Pharma AG, Basel.

Questo foglietto illustrativo è stato controllato l’ultima volta nel gennaio 2015 dall’autorità

competente in materia di medicamenti (Swissmedic).

Numero interno della versione: 6.1

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The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety