Teglutik 50mg/10ml

Informazioni principali

  • Nome commerciale:
  • Teglutik 50mg/10ml sospensione orale
  • Forma farmaceutica:
  • sospensione orale
  • Composizione:
  • riluzolum 50 mg, arom.: saccharinum natricum, excipiens annuncio suspensionem pro 10 ml.
  • 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:
  • Teglutik 50mg/10ml sospensione orale
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Sclerosi laterale sclerosi laterale amiotrofica (SLA)

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66434
  • Data dell'autorizzazione:
  • 26-04-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Teglutik®

Effik SA

Che cos’è Teglutik e quando si usa?

Il principio attivo contenuto in Teglutik, sospensione orale, è il riluzolo. Teglutik può essere usato

nel trattamento della sclerosi laterale amiotrofica (SLA), una malattia neurologica che può alterare la

capacità di movimento cosciente. Teglutik deve essere utilizzato solo su prescrizione medica.

Dopo averlo agitato delicatamente, il medicamento si presenta come una sospensione orale opaca,

omogenea e leggermente marrone.

Quando non si può assumere Teglutik?

Non assuma Teglutik:

·se in passato ha sviluppato una reazione allergica al principio attivo riluzolo o a uno qualsiasi degli

altri componenti della sospensione orale,

·se soffre di una malattia epatica grave o presenta aumenti dei livelli ematici di alcuni enzimi epatici

(transaminasi),

·se è incinta o sta allattando.

Quando è richiesta prudenza nella somministrazione di Teglutik?

Se dopo aver assunto Teglutik dovesse avere la febbre, questo potrebbe essere dovuto a una

diminuzione dei globuli bianchi che a sua volta potrebbe causare un aumento del rischio di infezioni.

In questo caso, si rivolga immediatamente al suo medico.

Analogamente, se dopo aver assunto Teglutik dovesse sviluppare una tosse secca e/o dovesse avere

difficoltà a respirare, si rivolga immediatamente al suo medico. Questi potrebbero essere sintomi di

un'affezione polmonare (chiamata interstiziopatia o malattia interstiziale polmonare).

Informi il suo medico se soffre di una malattia epatica o renale.

Alcuni dei segnali di problemi al fegato sono: colorazione gialla della cute o della parte bianca

dell'occhio (ittero), prurito in tutto il corpo, nausea e/o vomito.

Se ha meno di 18 anni, tenga presente che l'uso di Teglutik non è raccomandato nei bambini e negli

adolescenti, in quanto non sono disponibili informazioni in merito alla sua sicurezza ed efficacia in

questa popolazione.

Se, dopo aver assunto Teglutik, dovesse avere capogiri o sonnolenza, eviti di mettersi alla guida o di

utilizzare qualsiasi altro macchinario.

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

capacità di utilizzare attrezzi o macchine!

Teglutik contiene sorbitolo (E420). Se le è stata diagnosticata un'intolleranza ad alcuni zuccheri,

contatti il suo medico prima di assumere questo medicamento.

Informi il suo medico o il farmacista se soffre di altre malattie e/o allergie o se assume altri

medicamenti (anche di automedicazione).

Si può assumere Teglutik durante la gravidanza o l'allattamento?

Non prenda Teglutik se è o desidera restare incinta. Non allatti durante il trattamento con Teglutik.

Se rimane incinta, informi immediatamente il suo medico.

Come usare Teglutik?

Se non ha ricevuto indicazioni particolari da parte del suo medico, la dose raccomandata di Teglutik

sospensione orale è di 50 mg di riluzolo (corrispondente a 10 ml di riluzolo ogni 12 ore, ovvero

20 ml (100 mg di riluzolo) al giorno).

Il medicamento va assunto in modo regolare nello stesso momento della giornata (ad esempio il

mattino e la sera), preferibilmente a digiuno (un'ora prima di un pasto principale o due ore dopo).

Qualora ciò non fosse possibile a causa di nausea, la sospensione può essere anche assunta durante i

pasti.

Se ha assunto una dose eccessiva di sospensione, contatti immediatamente il suo medico o si rechi al

pronto soccorso dell'ospedale più vicino.

Se dimentica di prendere una dose, salti la dose dimenticata e assuma la dose successiva al momento

previsto. Non assuma una dose doppia per compensare quella dimenticata.

Non è consigliabile superare la dose di 20 ml (2× 10 ml) al giorno, in quanto potrebbero manifestarsi

ulteriori effetti secondari.

Istruzioni per l'uso:

La sospensione orale va somministrata mediante una siringa graduata. Prima della somministrazione,

la sospensione deve essere agitata manualmente con delicatezza per almeno 30 secondi, facendo

ruotare il flacone di 180°. Verificare quindi visivamente l'omogeneità della sospensione.

Apertura del flacone: premere il tappo e girarlo in senso antiorario (figura 1).

Prendere la siringa, togliere il cappuccio e inserirla nell'apertura dell'adattatore (figura 2).

Capovolgere il flacone (figura 3).

Riempire la siringa con una piccola quantità di sospensione tirando il pistone verso il basso (figura

3A), quindi premerlo verso l'alto per eliminare le eventuali bolle d'aria (figura 3B). Tirare il pistone

verso il basso fino alla linea graduata corrispondente alla quantità in millilitri (ml) prescritta dal

medico (figura 3C).

Girare il flacone all'insù (figura 4A). Estrarre la siringa dall'adattatore (figura 4B).

·Somministrare oralmente l'intero contenuto della siringa. Non è necessario diluire la sospensione in

acqua.

·Chiudere il flacone con il tappo in plastica.

·Lavare la siringa con acqua e, dopo averla asciugata, riapplicarvi il cappuccio (figura 5).

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 Teglutik?

Come tutti i medicamenti, Teglutik può causare effetti indesiderati, sebbene non tutte le persone li

manifestino.

Importante: Si rivolga immediatamente al medico se, durante il trattamento con Teglutik, dovesse

avere febbre, manifestare segnali di una malattia epatica (epatite), sviluppare tosse o avere difficoltà

di respirazione (per maggiori informazioni veda «Quando è richiesta prudenza nella

somministrazione di Teglutik?»).

A seguito dell'assunzione di Teglutik si possono verificare effetti secondari. I più frequenti sono:

stanchezza, nausea e vomito, mal di testa, capogiri, dolori, mal di stomaco, aumento della frequenza

cardiaca e formicolio della bocca.

I valori di alcuni enzimi epatici (transaminasi) possono aumentare. Il suo medico potrà prescriverle

regolarmente esami del sangue per tenere sotto controllo questi parametri durante il trattamento e

apposite terapie in caso di aumento dei valori.

Il suo medico potrà prescriverle un esame del sangue a seguito della comparsa di febbre oppure una

radiografia ai polmoni in presenza di tosse secca e/o di problemi respiratori.

Poiché il riluzolo in sospensione orale viene assorbito più rapidamente rispetto al riluzolo in

compresse, non si può escludere che la sua assunzione provochi stanchezza, capogiri, diarrea e

aumento delle transaminasi con maggiore frequenza rispetto al riluzolo in compresse.

Informi il suo medico se constata un cambiamento del suo stato di salute durante il trattamento con

Teglutik o si manifestano effetti secondari non elencati in questo foglio.

Di che altro occorre tener conto?

Conservare Teglutik a una temperatura inferiore a 30 °C. Tenere fuori dalla portata dei bambini. Non

congelare Teglutik.

Il medicamento non deve essere utilizzato oltre la data indicata con «EXP» sul contenitore.

Dopo l'apertura, utilizzare il contenuto del flacone entro 15 giorni.

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

darle ulteriori informazioni.

Cosa contiene Teglutik?

10 ml di Teglutik sospensione orale contengono 50 mg del principio attivo riluzolo, sorbitolo (E420),

saccarina sodica e altri eccipienti necessari per la produzione di una sospensione orale.

Numero dell'omologazione

66434 (Swissmedic).

Dove è ottenibile Teglutik? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Teglutik sospensione orale 50 mg/10 ml: flacone da 300 ml

Teglutik è venduto in flacone da 300 ml con una siringa graduata in plastica per la somministrazione

orale. Il corpo della siringa è graduato in millilitri fino a 10 ml.

Titolare dell'omologazione

Effik SA, 6900 Lugano

Questo foglietto illustrativo è stato controllato l'ultima volta nell'agosto 2017 dall'autorità competente

in materia di medicamenti (Swissmedic).

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Lartruvo (Eli Lilly Nederland B.V.)

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10-9-2018

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Retacrit (Hospira UK Limited)

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4-9-2018

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BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety