Betaserc 24 mg

Informazioni principali

  • Nome commerciale:
  • Betaserc 24 mg Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • betahistini dihydrochloridum 24 mg, excipiens pro compresso.
  • 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:
  • Betaserc 24 mg Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Schwindel

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 36119
  • Data dell'autorizzazione:
  • 20-12-1971
  • 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. Questo medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Betaserc®

Che cos’è Betaserc e quando si usa?

Betaserc è un medicamento contro le vertigini. La sua azione provoca un aumento dell'apporto di

sangue all'orecchio interno. Betaserc viene impiegato per ridurre la frequenza e la gravità degli

attacchi di vertigine.

Betaserc viene usato su prescrizione medica per il trattamento di vertigini dovute a disturbi

circolatori dell'orecchio interno e per la terapia della sindrome di Ménière e di sindromi analoghe

(vertigini, ronzii auricolari, abbassamento dell'udito).

Quando non si può usare Betaserc?

In caso di ipersensibilità nota al principio attivo o a una delle componenti del medicamento.

Non devono essere trattati con Betaserc i pazienti affetti da tumore surrenalico.

Quando è richiesta prudenza nella somministrazione di Betaserc?

I pazienti che presentano nella storia clinica precedenti affezioni da asma bronchiale o da ulcera

gastrica o duodenale devono informare il proprio medico in quanto la somministrazione di Betaserc

in tali pazienti necessita di particolare cautela.

Gli asmatici devono prendere Betaserc solo sotto sorveglianza medica.

Per quanto riguarda le gocce (Betaserc gocce), si raccomanda prudenza nelle persone affette da

disturbi cronici alle vie respiratorie, che potrebbero correre un rischio d'aspirazione assumendo il

preparato. Se il paziente inspira durante l’assunzione delle gocce, possono comparire in teoria spasmi

nei bronchi nonché un eventuale abbassamento della pressione sanguigna.

Betaserc può causare reazioni allergiche (in alcuni casi ritardate).

Bambini e adolescenti

Betaserc non è raccomandato nei bambini e negli adolescenti perché i dati sulla sicurezza e

l’efficacia sono insufficienti.

Assunzione di Betaserc con altri medicamenti

Informi il Suo medico se assume i cosiddetti MAO-inibitori (compresi medicamenti contenenti il

principio attivo selegilina contro il Parkinson) o antistaminici (sostanze contro le allergie o contro la

gastrite o le ulcere gastriche).

Capacità di condurre un veicolo e di utilizzare macchine

Betaserc le è stato prescritto per il trattamento delle vertigini o della sindrome di Ménière. Entrambe

le affezioni possono provocare stordimento e vomito e compromettere pertanto gravemente la sua

capacità di reazione, di guidare veicoli e di utilizzare attrezzi o macchine.

Anche se le indagini sulle persone in buona salute hanno dimostrato che la betaistina non ha

influenza sulla capacità di guida, gli effetti collaterali potrebbero, specialmente all’inizio del

trattamento, influire negativamente sulla capacità di condurre un veicolo o di utilizzare attrezzi o

macchine.

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 somministrare Betaserc durante la gravidanza o l’allattamento?

Informi il suo medico se è in gravidanza, sta pianificando una gravidanza o sta allattando.

Betaserc non deve essere assunto durante la gravidanza o l’allattamento, a meno che il medico non

glielo abbia prescritto esplicitamente.

Come usare Betaserc?

Adulti

Compresse: Da 24 mg a 48 mg al giorno, suddivisi in 2 o 3 porzioni da prendere preferibilmente

durante i pasti.

Appena si manifestano dolori allo stomaco, il farmaco deve rigorosamente essere preso durante i

pasti.

Dosaggio Giornaliero Compressa da 8 mg

Compressa da 16 mg

(secabile)

Compressa da 24 mg

(secabile)

24 mg

1 cpr. 3x / giorno

½ cpr. 3x / giorno

48 mg

2 cpr. 3x / giorno

1 cpr. 3x / giorno

3 cpr. 2x / giorno

1½ cpr. 2x / giorno

1 cpr. 2x / giorno

Le compresse da 16 mg presentano una scanalatura e possono essere divise in due dosi uguali da

8 mg. Posare la compressa secabile su una base piana con la scanalatura in alto e premere col pollice

sulla scanalatura per rompere la compressa.

Le compresse di Betaserc da 24 mg presentano una linea di frattura decorativa. Esse possono essere

dimezzate per facilitarne l’assunzione, ma non per somministrare la metà della dose. Le compresse di

Betaserc da 24 mg sono indicate solo per una dose giornaliera da 48 mg (1 compressa di Betaserc da

24 mg 2x al giorno).

Gocce: La dose abituale è di 1 - 2 ml (24 – 48 mg) 3x / giorno o 3 ml (48 mg) 2x / giorno. Le gocce

possono essere prese diluite in un bicchiere d'acqua o, in alternativa, anche non diluite.

L’imballaggio contiene una pipetta graduata di 1, 2 e 3 ml che permette un dosaggio esatto.

Un miglioramento può manifestarsi nel giro di pochi giorni o anche solo in modo graduale; in certi

casi è osservabile soltanto dopo alcune settimane di trattamento.

Bambini e adolescenti

Betaserc non è raccomandato nei bambini e negli adolescenti perché i dati sulla sicurezza e

l’efficacia sono insufficienti.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l’azione del medicamento

sia troppo debole o troppe forte ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Betaserc?

In seguito all’assunzione di Betaserc possono manifestarsi i seguenti effetti collaterali.

Frequente: cefalea, nausea e disturbi gastro-intestinali.

Raro: nervosismo, bruciore agli occhi.

Molto raro: alterazioni della sensibilità, costrizione al petto.

Possono manifestarsi anche i seguenti effetti collaterali: reazioni di ipersensibilità, sensazione di

pressione nella testa, palpitazioni, vomito, dolori addominali, senso di vomito, bruciore di stomaco,

peso allo stomaco, flatulenza, diarrea, reazioni di ipersensibilità della pelle come prurito ed eruzione

cutanea, sensazione di calore.

Consultare immediatamente un medico se si manifestano improvvisamente gonfiori al viso, alle

labbra, alla lingua e/o a livello delle faringi (difficoltà nell’inghiottire o disturbi respiratori)

(cosiddetto edema angioneurotico).

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» sul contenitore.

Compresse: non conservare a temperatura superiore ai 30°C. Conservare le compresse nella scatola

(proteggere dalla luce).

Gocce: conservare a temperatura ambiente (15 – 25 °C).

Custodire il preparato fuori della portata dei bambini.

Il medico o il farmacista, che sono in possesso di un’informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene il Betaserc?

Betaserc 8 mg, compresse: 1 compressa contiene 8 mg di betahistini dihydrochloridum come

principio attivo e sostanze ausiliarie per la preparazione delle compresse.

Betaserc 16 mg, compresse: 1 compressa (con scanalatura, secabile) contiene 16 mg di betahistini

dihydrochloridum come principio attivo e sostanze ausiliarie per la preparazione delle compresse.

Betaserc 24 mg, compresse: 1 compressa (con linea di frattura decorativa) contiene 24 mg di

betahistini dihydrochloridum come principio attivo e sostanze ausiliarie per la preparazione delle

compresse.

Betaserc gocce:

1 ml contiene 8 mg di betahistini dihydrochloridum come principio attivo nonché le seguenti

sostanze ausiliarie: aromatica (vanillina), saccarina sodica, conservanti: E 216 (propile

p-idrossibenzoato), E 218 (metile p-idrossibenzoato), etanolo 5 Vol. % (0,05 ml per ml).

Numero dell’omologazione

36119, 52403 (Swissmedic)

Dove è ottenibile Betaserc? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Compresse da 8 mg: confezioni da 50 e 100 compresse

Compresse da 16 mg: confezioni da 50 e 100 compresse

Compresse da 24 mg: confezioni da 50 e 100 compresse

Gocce da 8 mg/ml: confezione da 120 ml

Titolare dell’omologazione

BGP Products GmbH, 6341 Baar

Questo foglietto illustrativo è stato controllato l’ultima volta nel febbraio 2017 dall’autorità

competente in materia di medicamenti (Swissmedic).

[Version 204 I]

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Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

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Orphan designation: bertilimumab, Treatment of bullous pemphigoid, 24/11/2018, Positive

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Europe - EMA - European Medicines Agency

19-12-2018


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Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

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Europe - EMA - European Medicines Agency

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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

Renvela (Genzyme Europe B.V.)

Renvela (Genzyme Europe B.V.)

Renvela (Active substance: sevelamer (carbonate)) - Centralised - Variation - Commission Decision (2018)6225 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/993/X/39

Europe -DG Health and Food Safety

24-9-2018

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Active substance: Deferiprone) - Centralised - Authorisation - Commission Decision (2018)6233 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4710

Europe -DG Health and Food Safety

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Active substance: Sevelamer carbonate) - Centralised - Variation - Commission Decision (2018)6214 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3971/X/11

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

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

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

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

Mektovi (Pierre Fabre MEdicament)

Mektovi (Pierre Fabre MEdicament)

Mektovi (Active substance: binimetinib) - Centralised - Authorisation - Commission Decision (2018)6217 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004579/0000

Europe -DG Health and Food Safety

24-9-2018

Cyramza (Eli Lilly Nederland B.V.)

Cyramza (Eli Lilly Nederland B.V.)

Cyramza (Active substance: ramucirumab) - Centralised - Yearly update - Commission Decision (2018)6246 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Braftovi (Pierre Fabre MEdicament)

Braftovi (Pierre Fabre MEdicament)

Braftovi (Active substance: encorafenib) - Centralised - Authorisation - Commission Decision (2018)6216 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004580/0000

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Diacomit (Biocodex)

Diacomit (Biocodex)

Diacomit (Active substance: Stiripentol) - Centralised - Renewal - Commission Decision (2018)6254 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/664/R/21

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Active substance: Insulin degludec/insulin aspart) - Centralised - Yearly update - Commission Decision (2018)6242 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

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

24-9-2018

Tresiba (Novo Nordisk A/S)

Tresiba (Novo Nordisk A/S)

Tresiba (Active substance: Insulin degludec) - Centralised - Yearly update - Commission Decision (2018)6244 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Neofordex (Laboratoires CTRS)

Neofordex (Laboratoires CTRS)

Neofordex (Active substance: dexamethasone) - Centralised - Yearly update - Commission Decision (2018)6239 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Lumark (IDB Holland B.V.)

Lumark (IDB Holland B.V.)

Lumark (Active substance: lutetium, isotope of mass 177) - PSUSA - Modification - Commission Decision (2018)6212 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010391/201712

Europe -DG Health and Food Safety

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