Surmontil 100 mg

Informazioni principali

  • Nome commerciale:
  • Surmontil 100 mg le compresse sono segnato
  • Forma farmaceutica:
  • le compresse sono segnato
  • Composizione:
  • trimipraminum 100 mg ut trimipramini malea, 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:
  • Surmontil 100 mg le compresse sono segnato
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Antidepressivi

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 28789
  • Data dell'autorizzazione:
  • 10-07-1962
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Surmontil®

Sanofi-Aventis (Suisse) SA

Che cos'è Surmontil e quando si usa?

Surmontil viene usato nel trattamento della depressione. Migliora gli stati di depressione, di ansia, di

tristezza e di agitazione interiore, e agisce beneficamente sui disturbi del sonno di origine psichica.

Surmontil può essere assunto solo su prescrizione medica.

Quando non si può assumere Surmontil?

Surmontil non va assunto in caso d'ipersensibilità al principio attivo, la trimipramina, o a uno dei

suoi eccipienti, in caso di assunzione contemporanea di inibitori della MAO (ad es. per il trattamento

della depressione o del morbo di Parkinson); non va usato inoltre in caso di ingrossamento della

prostata e di disturbi della minzione, in caso di tensione endoculare molto elevata (glaucoma), di

disturbi della conduzione dell'impulso cardiaco e durante la fase di convalescenza dopo un infarto

cardiaco.

Quando è richiesta prudenza nella somministrazione di Surmontil?

I sintomi della depressione, in particolare il comportamento suicida, possono peggiorare durante il

trattamento con Surmontil. In questo caso contatti immediatamente il suo medico.

Nei bambini e negli adolescenti che soffrono di depressione o di altri disturbi psichiatrici, è stata

annunciata un'occorrenza più frequente di disturbi del comportamento, tra cui il rischio aumentato di

idee suicide, di automutilazioni e di suicidio sotto trattamento con degli antidepressivi.

Dei dati di studi clinici condotti presso giovani adulti fino a 25 anni che presentano disturbi

psichiatrici trattati con antidepressivi hanno dimostrato un rischio più elevato di comportamento

suicida.

La sospensione del trattamento non deve essere brusca, la decisione di sospendere il trattamento deve

essere presa in accordo con il suo medico, altrimenti possono comparire dei sintomi di astinenza.

Degli studi hanno evidenziato un aumento del rischio di diabete associato all'uso di antidepressivi

triciclici.

Sindrome serotoninergica: informi il suo medico se assume medicamenti il cui effetto è simile a

quello di Surmontil, come ad esempio i triptani, il tramadol, il litio, gli inibitori selettivi della

ricaptazione della serotonina (SSRI), gli inibitori selettivi della serotonina/norepinefrina (SRNI) e

l'iperico. Tali medicamenti aumentano il rischio di insorgenza di effetti secondari. La sindrome

serotoninergica si manifesta con disturbi della coscienza, rigidità muscolare, tremori e fascicolazioni

muscolari, febbre. In presenza di tali sintomi, contatti immediatamente il suo medico.

È stato dimostrato che, in base alla dose assunta, Surmontil può provocare un prolungamento

dell'intervallo QT (battiti cardiaci lenti e modificazioni dell'ECG).

L'assunzione di Surmontil richiede prudenza in caso di disturbi cardiovascolari (ad es. ipotensione

arteriosa, disturbi del ritmo cardiaco, malattia coronarica), di diabete di tipo 2 (chiamato anche

«diabete mellito» o «diabete non insulino-dipendente») di malattie gravi del fegato o dei reni, di

epilessia, di tensione endoculare elevata o di disturbi della prostata. Particolare prudenza

nell'impiego di Surmontil è richiesta nei pazienti che soffrono di iperfunzione tiroidea, perché gli

antidepressivi possono causare aritmie cardiache. Si richiede prudenza in caso di contemporanea

assunzione di altri medicinali, ad es. per il trattamento dell'asma (analoghi dell'adrenalina), di ulcere

gastriche e duodenali (cimetidina), per la riduzione del peso corporeo (inibitori dell'appetito), contro

la depressione, contro altre malattie psichiche, contro i disturbi del ritmo cardiaco (ad es. chinidina,

amiodarone) e certi medicinali contro l'ipertensione (reserpina, guanetidina, clonidina, metil-DOPA).

Surmontil potenzia l'effetto dell'alcol, di certi sonniferi, di altri farmaci tranquillanti a livello centrale

o che agiscono sulla psiche. Si sconsiglia assolutamente l'assunzione di alcol durante il trattamento.

È necessario informare il suo medico, nel caso debba subire un intervento chirurgico. Surmontil può

causare sonnolenza e disturbi dell'accomodazione, compromettendo la capacità di reazione, la

capacità di condurre un veicolo e la capacità di utilizzare attrezzi o macchine!

Informi il suo medico o il suo farmacista se soffre di altre malattie, offre di allergie o assume o

applica esternamente altri medicamenti (anche se acquistati di sua iniziativa!).

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

Non assuma Surmontil durante la gravidanza se non su esplicita prescrizione del medico, poiché

Surmontil potrebbe danneggiare il bambino nascituro o il neonato.

Il principio attivo di Surmontil passa nel latte materno. Se l'assunzione del prodotto è necessaria,

occorre interrompere l'allattamento. Si rivolga in ogni caso al suo medico.

Come usare Surmontil?

Il dosaggio viene stabilito dal medico, individualmente per ogni paziente. Di regola, s'incomincia con

una dose minore che viene gradualmente aumentata fino ad ottenere l'effetto ricercato; la dose viene

poi ridotta fino alla dose di mantenimento efficace. La dose giornaliera di mantenimento usuale

corrisponde a 50-100 mg di Surmontil (corrispondenti a 2-4 compresse da 25 mg o a ½-1 compressa

da 100 mg). Questa dose giornaliera viene suddivisa in 2-3 dosi singole (durante o dopo i pasti)

oppure viene assunta in una volta la sera 2 ore prima di andare a letto. In certi casi, ad esempio nelle

persone anziane, il medico può ridurre la dose di mantenimento a 25-50 mg di Surmontil al giorno

(corrispondenti a 1-2 compresse da 25 mg). Inghiottire le compresse senza masticarle con un po' di

liquido. In alternativa, il medico può prescrivere Surmontil in gocce (1 goccia corrisp. 1 mg di

trimipramina).

Le gocce di Surmontil vengono assunte con un po' d'acqua durante o dopo i pasti. Mantenere

verticalmente il flaconcino per contare le gocce! Non agitare! Eventualmente, picchiettare

delicatamente sul fondo del flaconcino.

Surmontil non va usato nei pazienti di meno di 18 anni.

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 Surmontil?

In seguito all'assunzione di Surmontil, possono manifestarsi i seguenti effetti collaterali: stanchezza,

vertigini, più raramente stordimento, tremori, agitazione, disturbi del sonno, sonnolenza, mal di testa,

iperglicemia, disturbi cardiaci (anomalie del ritmo cardiaco) disturbi addominali (mal di pancia) e

infiammazioni della mucosa della bocca. In certi casi possono manifestarsi: secchezza della bocca,

disturbi dell'accomodazione (visione offuscata), vampate di calore, sudore, stipsi o difficoltà alla

minzione e ritenzione urinaria. Altre manifestazioni più rare: reazioni allergiche, prurito, sensibilità

alla luce, eruzioni cutanee, gonfiore del viso, ipotensione arteriosa, palpitazioni, disturbi del ritmo

cardiaco, disturbi dell'umore e confusione, soprattutto nelle persone anziane, attacchi epilettici,

disturbi del movimento, disturbi della funzione del fegato, come ostruzione biliare, itterizia, epatite o

innalzamento dei parametri di funzionalità epatica. In casi isolati si è osservato aumento di volume

delle mammelle in pazienti maschi e fuoriuscita di latte dal seno nella donna. È possibile che si

manifesti un'influenza sul comportamento sessuale. Come conseguenza del miglioramento psichico,

può verificarsi un aumento del peso corporeo.

Un aumento della comparsa di disturbi del comportamento, tra cui il rischio aumentato di idee

suicide, di automutilazione e di suicidio, è stato annunciato nei bambini, negli adolescenti e nei

giovani adulti fino a 25 anni che soffrono di depressione o di altri disturbi psichiatrici sotto

trattamento con degli antidepressivi.

Un aumento del rischio di fratture ossee è stato osservato nei pazienti che assumono antidepressivi

triciclici o inibitori selettivi della ricaptazione della serotonina.

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

Di che altro occorre tener conto?

Le gocce di Surmontil contengono 11% in volume di alcol. Si sconsiglia assolutamente l'assunzione

di alcol durante il trattamento. Il preparato è disponibile anche senza alcol (in compresse).

Surmontil va conservato al riparo dalla luce, a temperatura ambiente (15-25 °C) e fuori dalla portata

dei bambini.

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

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

darle ulteriori informazioni.

Cosa contiene Surmontil?

Surmontil contiene il principio attivo trimipramina.

Compresse da 25 e 100 mg di trimipramina (come trimipramina maleato), eccipienti.

Gocce (4%) con 40 mg di trimipramina (come trimipramina mesilato), aromatizzanti (vanillina,

etilvanillina), colorante caramello (E150) e altri eccipienti per 1 ml di soluzione. 1 ml corrisponde a

40 gocce. Contiene 11% in volume di alcol.

Numero dell’omologazione

28789, 29479 (Swissmedic).

Dove è ottenibile Surmontil? Quali confezioni sono disponibili?

In farmacia, solo dietro presentazione della prescrizione medica.

Compresse

Confezione da 50 e confezione multipla da 200 (4× 50) compresse da 25 mg.

Confezioni da 20 e 100 compresse da 100 mg.

Gocce

Flaconcini da 30 ml al 4% (1 goccia corrisp. 1 mg di trimipramina).

Titolare dell’omologazione

sanofi-aventis (svizzera) sa, 1214 Vernier/GE.

Questo foglietto illustrativo è stato controllato l'ultima volta nel dicembre 2014 dall'autorità

competente in materia di medicamenti (Swissmedic).

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22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

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

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