MEHTYLINE

Information principale

  • Nom commercial:
  • MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame potassique
  • Dosage:
  • 1000 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > acide ascorbique : 1000 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • tube(s) polypropylène de 10 comprimé(s)
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame potassique
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • VITAMINE C.
  • Descriptif du produit:
  • 353 847-3 ou 4009 353 847 3 7 - tube(s) polypropylène de 10 comprimé(s) - Déclaration de commercialisation non communiquée:;354 125-1 ou 4009 354 125 1 5 - tube(s) polypropylène de 15 comprimé(s) - Déclaration de commercialisation non communiquée:;353 849-6 ou 4009 353 849 6 6 - tube(s) polypropylène de 20 comprimé(s) - Déclaration de commercialisation non communiquée:;353 850-4 ou 4009 353 850 4 8 - tube(s) aluminium de 10 comprimé(s) - Déclaration de commercialisation non communiquée:;354 126-8 ou 4009 354 126 8 3 - tube(s) aluminium de 15 comprimé(s) - Déclaration de commercialisation non communiquée:;353 851-0 ou 4009 353 851 0 9 - tube(s) aluminium de 20 comprimé(s) - Déclaration de commercialisation non communiquée:;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Abrogée
  • Numéro d'autorisation:
  • 61318398
  • Date de l'autorisation:
  • 28-03-2000
  • Dernière mise à jour:
  • 11-08-2017

Notice: composition, indications thérapeutiques, interactions, posologie, effets indésirable, grossesse, allaitement

NOTICE

ANSM - Mis à jour le : 01/06/2005

Dénomination du médicament

MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame potassique

Encadré

Veuillez lire attentivement cette notice avant de prendre ce médicament. Elle contient des informations importantes

pour votre traitement.

Si vous avez d'autres questions, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Gardez cette notice, vous pourriez avoir besoin de la relire.

Si vous avez besoin de plus d'informations et de conseils, adressez-vous à votre pharmacien.

Si les symptômes s'aggravent ou persistent, consultez votre médecin.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si vous ressentez un des effets mentionnés

comme étant grave, veuillez en informer votre médecin ou votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame

potassique ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE MEHTYLINE 1 g SANS SUCRE,

comprimé effervescent édulcoré à l'aspartam et à l'acésulfame potassique ?

3. COMMENT PRENDRE MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame

potassique ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à

l'acésulfame potassique ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame

potassique ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

Sans objet.

Indications thérapeutiques

Ce médicament est indiqué dans les états de fatigue passagers de l'adulte (à partir de 15 ans).

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE MEHTYLINE 1 g SANS SUCRE,

comprimé effervescent édulcoré à l'aspartam et à l'acésulfame potassique ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

Ne prenez jamais MEHTYLINE 1 g SANS SUCRE, comprimé effervescent dans les cas suivants:

Allergie connue à l'un des composants,

Lithiases rénales oxalo-calciques pour des doses supérieures à 1g/jour,

En cas de phénylcétonurie (maladie héréditaire dépistée à la naissance), en raison de la présence d'aspartam.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec MEHTYLINE 1 g SANS SUCRE, comprimé effervescent :

La prise de ce médicament ne dispense pas de respecter les principales règles d'hygiène telles que: activité physique

régulière, alimentation équilibrée (notamment éviter la prise d'alcool, de tabac, et /ou d'excitants), heures régulières de

sommeil, repos.

Les besoins physiologiques en vitamines sont normalement assurés par un apport alimentaire varié.

En raison de la présence de sorbitol, ce médicament ne doit pas être utilisé en cas d'intolérance au fructose (maladie

métabolique héréditaire).

Ce médicament contient 194 mg de sodium par comprimé : en tenir compte chez les personnes suivant un régime pauvre en

sel strict.

Ce médicament contient 2,91 mg de potassium par comprimé : en tenir compte dans la ration journalière.

Prévenez votre médecin en cas d'insuffisance rénale.

En raison d'un effet légèrement stimulant, il est souhaitable de ne pas prendre la vitamine C en fin de journée.

Chez les diabétiques, la vitamine C peut modifier les résultats des analyses sanguines ou urinaires.

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments :

Ce médicament contient de la Vitamine C. D'autres médicaments en contiennent. Ne les

associez pas, afin de ne pas dépasser les doses maximales conseillées (voir mode d'emploi

et posologie).

Si vous prenez ou avez pris récemment un autre médicament, y compris un médicament obtenu sans ordonnance, parlez-en

à votre médecin ou à votre pharmacien.

Interactions avec les aliments et les boissons

Sans objet.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et allaitement

Ce médicament ne sera utilisé pendant la grossesse que sur les conseils de votre médecin.

L'utilisation de la vitamine C est à éviter pendant l'allaitement.

Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout médicament.

Sportifs

Sans objet.

Effets sur l'aptitude à conduire des véhicules ou à utiliser des machines

Sans objet.

Liste des excipients à effet notoire

Liste des excipients à effet notoire: sorbitol, aspartam (source de phénylalanine) (E951), sodium,potassium.

3. COMMENT PRENDRE MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à l'acésulfame

potassique ?

Instructions pour un bon usage

Sans objet.

Posologie, Mode et/ou voie(s) d'administration, Fréquence d'administration et Durée du traitement

Posologie

RESERVE A L'ADULTE (à partir de 15 ans).

1 comprimé par jour à dissoudre dans un verre d'eau de préférence le matin.

Durée de traitement

La durée d'utilisation est limitée à 1 mois.

Si vous avez l'impression que l'effet de MEHTYLINE 1 g SANS SUCRE, comprimé effervescent n'agit pas comme vous

l'attendiez, consultez votre médecin ou votre pharmacien.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de MEHTYLINE 1 g SANS SUCRE, comprimé effervescent que vous n'auriez dû : consultez

votre médecin ou votre pharmacien.

Instructions en cas d'omission d'une ou de plusieurs doses

Si vous oubliez de prendre MEHTYLINE 1 g SANS SUCRE, comprimé effervescent : ne prenez pas de dose double

pour compenser la dose que vous avez oublié de prendre.

Risque de syndrome de sevrage

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, MEHTYLINE 1g SANS SUCRE, comprimé effervescent est susceptible d'avoir des effets

indésirables, bien que tout le monde n'y soit pas sujet. Possibilité de troubles digestifs et de diarrhées.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si certains effets indésirables deviennent

graves, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER MEHTYLINE 1 g SANS SUCRE, comprimé effervescent édulcoré à l'aspartam et à

l'acésulfame potassique ?

Tenir hors de la portée et de la vue des enfants.

Date de péremption

Ne pas utiliser MEHTYLINE 1 g SANS SUCRE, comprimé effervescent après la date de péremption mentionnée sur la boîte.

Conditions de conservation

Pas de précautions particulières de conservation.

Si nécessaire, mises en garde contre certains signes visibles de détérioration

Les médicaments ne doivent pas être jetés au tout à l'égout ou avec les ordures ménagères. Demandez à votre pharmacien

ce qu'il faut faire des médicaments inutilisés. Ces mesures permettront de protéger l'environnement.

6. INFORMATIONS SUPPLEMENTAIRES

Liste complète des substances actives et des excipients

Que contient MEHTYLINE 1 g SANS SUCRE, comprimé effervescent ?

La substance active est:

Acide ascorbique ....................................................................................................................... 1000,00 mg

Pour un comprimé effervescent.

Les autres composants sont:

Bicarbonate de sodium, carbonate de sodium anhydre, acide citrique anhydre, sorbitol, aspartam, acésulfame potassique,

chlorure de sodium, arôme orange, arôme citron, huile végétale adsorbante, phosphate sodique de riboflavine.

Forme pharmaceutique et contenu

Qu'est-ce que MEHTYLINE 1 g SANS SUCRE, comprimé effervescent et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de comprimés effervescents. Boîte de 10, 15 ou 20.

Nom et adresse du titulaire de l'autorisation de mise sur le marché et du titulaire de l'autorisation de fabrication responsable

de la libération des lots, si différent

Titulaire

BAYER SANTE FAMILIALE

33, rue de l'Industrie

74240 Gaillard

Exploitant

Laboratoires ROCHE NICHOLAS S.A.

33, rue de l'Industrie

74240 GAILLARD

Fabricant

Laboratoires ROCHE NICHOLAS S.A.

33, rue de l'Industrie

74240 GAILLARD

Noms du médicament dans les Etats membres de l'Espace Economique Européen

Sans objet.

Date d’approbation de la notice

La dernière date à laquelle cette notice a été approuvée est le {date}.

AMM sous circonstances exceptionnelles

Sans objet.

Informations Internet

Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Afssaps (France).

Informations réservées aux professionnels de santé

Sans objet.

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Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Méthode d’analyse des acides haloacétiques dans les eaux - Consultation

Méthode d’analyse des acides haloacétiques dans les eaux - Consultation

France - Agence Nationale du Médicament Vétérinaire

10-9-2018

Kangaroo Manufacturing Inc. rappelle la glu «Super Cool Slime »

Kangaroo Manufacturing Inc. rappelle la glu «Super Cool Slime »

Le programme de contrôle et d'évaluation de Santé Canada a déterminé que les produits« Super Cool Slime » ne respectent pas les exigences canadiennes en matière de sécurité des jouets en ce qui a trait à la teneur en acide borique.

Canadiens en santé

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

14-8-2018

Rappel des préparations à glu de Genius Premium Craft Boxes

Rappel des préparations à glu de Genius Premium Craft Boxes

Le programme de contrôle et d'évaluation de Santé Canada a établi que ces glus à préparer soi-même ne respectent pas les exigences canadiennes en matière de sécurité des jouets relativement à la teneur en acide borique.

Canadiens en santé

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

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

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

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

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety