Tegretol 100

Informazioni principali

  • Nome commerciale:
  • Tegretol 100 Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • carbamazepinum 100 mg, carmellosum natricum, 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:
  • Tegretol 100 Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Antiepilepticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 29789
  • Data dell'autorizzazione:
  • 05-06-1963
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Informazioni 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 rileggerlo all’occorrenza.

Tegretol®

Che cos’è Tegretol e quando si usa?

Tegretol, a base del principio attivo carbamazepina, è un antiepilettico e lo si usa su prescrizione del

medico per il trattamento delle crisi convulsive (epilessia) negli adulti e nei bambini. Inoltre lo si

utilizza anche nella terapia di alcune malattie dei nervi, per es. La nevralgia del trigemino,

determinate malattie psichiche (manie, sindrome maniaco-depressiva), come pure per trattare i

disturbi che si verificano durante il trattamento delle dipendenze da alcool.

Quando non si può usare Tegretol?

Non si può prendere Tegretol in caso di reazioni di ipersensibilità (allergia) al principio attivo

carbamazepina o a principi attivi analoghi come ad esempio oxcarbazepina (Trileptal) o altri

medicamenti, anch'essi messi in correlazione con reazioni di ipersensibilità, quali gli antidepressivi

triciclici (p. es. amitriptilina, imipramina).

Parimenti non si deve prendere Tegretol assieme a determinati medicamenti, i cosiddetti inibitori

delle monoaminossidasi (IMAO) per il trattamento degli stati depressivi.

In presenza di determinate malattie concomitanti Tegretol non va preso, oppure lo si può prendere

solo dopo una visita medica approfondita. Perciò informi il medico se soffre o ha sofferto in

precedenza delle seguenti malattie:

·disturbi della funzione cardiaca,

·disturbi della formazione del sangue,

·malattie del fegato o dei reni,

·forme miste di attacchi epilettici,

·aumento della pressione intraoculare (glaucoma),

·stati confusionali o agitazione e irrequietezza,

·reazioni di ipersensibilità alla oxcarbazepina o ad altri farmaci,

·porfiria,

·Sospensione orale: reazioni allergiche ai conservanti (parabeni) o intolleranza al fruttosio

(sorbitolo).

Quando è richiesta prudenza nella somministrazione/nell’uso di Tegretol?

Prenda subito contatto col medico o si assicuri che qualcun altro possa farlo per lei se si manifesta

uno qualsiasi dei seguenti effetti collaterali (occasionali o rari). Questi potrebbero essere dei segni

premonitori di una grave alterazione del sangue, del fegato, dei reni o di altri organi e richiedere

urgentemente un trattamento medico:

·febbre, mal di gola, eruzioni cutanee, ulcerazioni della bocca, linfonodi ingrossati,

·colorazione scura dell’urina,

·segni di forti reazioni della pelle, come per es. desquamazione, eruzioni,

·qualsiasi colorazione gialla della pelle o del bianco dell’occhio,

·gonfiore delle caviglie, dei piedi o delle gambe,

·battito cardiaco irregolare, difficoltà di respirazione, dolore al petto, perdita di conoscenza,

·aumento delle crisi convulsive,

·aumento dei lividi per cause banali,

·nel caso in cui, a causa dell’assunzione di Tegretol, si verifichino vertigini, sonnolenza, diminuzione

della pressione arteriosa o confusione, cosa che può portare a cadute.

Durante il trattamento con Tegretol (in particolare durante i primi mesi dopo l'inizio della terapia)

raramente si manifestano reazioni cutanee/di ipersensibilità gravi e meno gravi. Questo rischio può

essere valutato con maggiore precisione prima di iniziare il trattamento grazie a un determinato

esame del sangue, in particolare nei pazienti europei ma anche nei pazienti di origine asiatica.

Pertanto, prima di iniziare il trattamento, si consiglia di consultare il proprio medico curante e di

eseguire il relativo test sul sangue. È importante tener presente che, nonostante un risultato normale

del test sul sangue, si possono presentare reazioni cutanee indesiderate e che, viceversa, anche in

presenza di un risultato patologico del test sul sangue non necessariamente si verificano reazioni

indesiderate.

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

capacità di utilizzare attrezzi o macchine.

Informi il medico se deve sottoporsi a un intervento chirurgico (anche di poco conto).

Siccome Tegretol, come altri medicamenti psicoattivi, può provocare una diminuzione della

tolleranza all’alcool, durante la terapia è consigliabile rinunciare al consumo di alcool.

Non mangi pompelmo, né beva succo di pompelmo: gli effetti di Tegretol potrebbero risultare

rafforzati. Altri succhi di frutta non hanno effetti. Nelle donne che assumono preparati contraccettivi

(pillola anticoncezionale) contemporaneamente a Tegretol, possono manifestarsi dei sanguinamenti

intermestruali. La pillola può, quindi, diventare inefficace. Perciò, oltre alla pillola, occorre far uso

anche di metodi anticoncezionali non ormonali.

Informi il suo medico o il suo farmacista nel caso in cui:

·soffre di altre malattie,

·soffre di allergie,

·ha una malattia dei reni o assume medicamenti per ridurre il livello di sodio nel sangue, o

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

Un esiguo numero di pazienti, trattati con antiepilettici del tipo del Tegretol, sviluppavano pensieri di

autolesionismo o di suicidio. Qualora, in qualsiasi momento durante l'assunzione di Tegretol,

dovesse avere pensieri di questo tipo, si metta immediatamente in contatto con un medico.

Si può somministrare Tegretol durante la gravidanza o l’allattamento?

Le donne in età fertile devono utilizzare un metodo contraccettivo affidabile durante il trattamento

con Tegretol e fino a 2 settimane dopo l’ultima dose. Se è incinta, prevede una gravidanza o allatta,

deve assolutamente informarne il medico. Tegretol non si può prendere o utilizzare durante la

gravidanza o l’allattamento se il medico non lo prescrive espressamente.

Come usare Tegretol?

Tegretol va preso soltanto su prescrizione medica. Si attenga sempre scrupolosamente alle istruzioni

del medico nell’assumere il medicamento. In caso di dubbi, consulti il medico o il farmacista. La

posologia è stabilita dal medico e varia a seconda del campo d’applicazione, dell’età e dell’intensità

dei disturbi.

Tegretol sospensione orale: per un dosaggio corretto, deve essere usato il misurino in dotazione: 1

misurino (5 ml) contiene 100 mg del principio attivo di Tegretol. Agitare il flacone prima dell’uso.

Tegretol va preso durante o dopo i pasti, con del liquido.

Le compresse Tegretol CR Divitabs (compressa intera o mezza compressa, a seconda della

prescrizione) devono essere ingerite senza masticare, con un po’ di liquido.

Per ottenere il miglior effetto e diminuire la probabilità di effetti collaterali, è molto importante che

Tegretol venga preso regolarmente. Se una volta dimentica di prendere o utilizzare il medicamento,

recuperi la dose tralasciata il più presto possibile. Se però è già il momento di prendere o utilizzare la

dose successiva, non prenda né utilizzi la dose dimenticata, ma passi direttamente alla successiva.

In caso di dimenticanza di più di una dose, consulti il medico.

Nel trattamento della nevralgia del trigemino, la dose massima giornaliera è di 1200 mg.

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 Tegretol?

Con l’assunzione di Tegretol possono manifestarsi i seguenti effetti collaterali:

Soprattutto all’inizio della terapia possono manifestarsi crisi di vertigini, disturbi della coordinazione

dei movimenti, disturbi della vista e dell’udito, mal di testa, dolori articolari o muscolari, stanchezza,

disturbi gastrointestinali (per es. nausea, vomito, inappetenza, bocca secca), infiammazioni

intestinali, eruzioni cutanee allergiche, prurito, ipersensibilità della pelle e degli occhi alla luce

solare, caduta dei capelli. Inoltre possono verificarsi movimenti involontari, irrequietezza,

comportamento aggressivo, allucinazioni, diarrea o stipsi, aumento o diminuzione della pressione

arteriosa, intorpidimento delle mani e dei piedi, frequente bisogno di urinare, diminuzione

improvvisa della quantità di urina e disturbi della funzione sessuale.

Effetti collaterali la cui frequenza è sconosciuta: ricomparsa di un’infezione da virus dell’herpes,

perdita delle unghie, fratture ossee, diminuzione della densità ossea, disturbi della memoria, cadute

conseguenti a vertigini, sonnolenza, diminuzione della pressione arteriosa o confusione.

Se si manifestano irregolarità del battito cardiaco, ittero, difficoltà ad urinare, diarrea, dolore

addominale, aumento di peso, peggioramento di manifestazioni cutanee e fenomeni febbrili simili

all’influenza, oppure se i disturbi sopra elencati persistono per lungo tempo, consulti il medico.

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

Di che altro occorre tener conto?

Durante l’assunzione di Tegretol, si protegga dai raggi solari intensi.

Conservare i medicamenti fuori dalla portata dei bambini.

Tegretol compresse va conservato al riparo dall’umidità e non al disopra di 25°C.

Tegretol sospensione orale va conservato al riparo dalla luce e non al di sopra dei 30°C. Dopo la

prima apertura, la sospensione deve essere consumata entro 3 mesi.

Tegretol CR Divitabs va conservato al riparo dall’umidità e non al di sopra dei 30°C.

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 Tegretol?

Tegretol contiene come principio attivo la carbamazepina.

1 compressa con linea di frattura parziale contiene: 200 mg o 400 mg di carbamazepina, sodio

carbossimetil cellulosa (prodotta da cotone geneticamente modificato) e ulteriori sostanze ausiliarie.

1 CR Divitabs divisibile contiene: 200 mg o 400 mg di carbamazepina e sostanze ausiliarie.

5 ml (= 1 misurino) di sospensione orale contengono: 100 mg di carbamazepina; i conservanti metile

p-idrossibenzoato, propile p-idrossibenzoato (E218/216) e acido sorbico (E200), vanillina e altri

aromatizzanti, saccarina e altre sostanze ausiliarie.

Numero dell’omologazione

36896, 29789, 47443 (Swissmedic)

Dove è ottenibile Tegretol? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Compresse da 200 mg: 50.

Compresse da 400 mg: 30 e 200.

CR Divitabs da 200 mg (divisibili): 50 e 200.

CR Divitabs da 400 mg (divisibili): 30 e 200.

Sospensione orale al 2 % con misurino da 5 ml (= 100 mg): 250 ml.

Titolare dell’omologazione

Novartis Pharma Schweiz AG, Risch; Domicilio: 6343 Rotkreuz

Questo foglietto illustrativo è stato controllato l’ultima volta nel maggio 2018 dall’autorità

competente in materia di medicamenti (Swissmedic).

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Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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