ACICLOVIR Teva Pharma

Information principale

  • Nom commercial:
  • ACICLOVIR Teva Pharma 5 %, crème
  • DCI (Dénomination commune internationale):
  • aciclovir
  • Dosage:
  • 50 mg
  • forme pharmaceutique:
  • crème
  • Composition:
  • composition pour 1 g de crème > aciclovir : 50 mg
  • Mode d'administration:
  • cutanée
  • Unités en paquet:
  • 1 tube(s) aluminium verni de 2 g
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • ACICLOVIR Teva Pharma 5 %, crème
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • ANTIVIRALE A USAGE TOPIQUE
  • Descriptif du produit:
  • 353 908-2 ou 4009 353 908 2 0 - 1 tube(s) aluminium verni de 2 g - Déclaration de commercialisation non communiquée:;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Archivée
  • Numéro d'autorisation:
  • 62842674
  • Date de l'autorisation:
  • 06-03-2000
  • Dernière mise à jour:
  • 09-08-2017

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

NOTICE

ANSM - Mis à jour le : 29/05/2009

Dénomination du médicament

ACICLOVIR TEVA PHARMA 5 %, crème

Encadré

Veuillez lire attentivement cette notice car elle contient des informations importantes pour vous.

Ce médicament est disponible sans ordonnance et vous permet donc de soigner des maladies bénignes sans l'aide d'un

médecin. Néanmoins, vous devez utiliser ACICLOVIR TEVA PHARMA 5 %, crème avec précaution afin d'en obtenir le

meilleur résultat.

Gardez cette notice, vous pourriez avoir besoin de la lire à nouveau.

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

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

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE ACICLOVIR TEVA PHARMA 5 %, crème ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT D'UTILISER ACICLOVIR TEVA PHARMA 5 %, crème ?

3. COMMENT UTILISER ACICLOVIR TEVA PHARMA 5 %, crème ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER ACICLOVIR TEVA PHARMA 5 %, crème ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE ACICLOVIR TEVA PHARMA 5 %, crème ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

ANTIVIRAL A USAGE TOPIQUE

Indications thérapeutiques

Ce médicament est indiqué dans le traitement des poussées d'herpès labial localisé (appelé aussi "boutons de fièvre").

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT D'UTILISER ACICLOVIR TEVA PHARMA 5 %, crème ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

N'utilisez jamais ACICLOVIR TEVA PHARMA 5 %, crème dans les cas suivants:

Antécédents d'allergie à l'aciclovir ou à l'un des constituants de la crème.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec ACICLOVIR TEVA PHARMA 5 %, crème:

Afin d'éviter des irritations locales, éviter d'appliquer la crème sur les muqueuses (buccales, vaginale et oculaire). Eviter le

contact accidentel avec les yeux.

Chez les patients dont les fonctions immunitaires sont diminuées: il est impératif de consulter leur médecin avant d'utiliser ce

médicament.

En absence de cicatrisation au bout de 10 jours de traitement ou d'aggravation de votre bouton de fièvre: arrêtez le

traitement et consulter immédiatement votre médecin.

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments

Veuillez indiquer à votre médecin ou à votre pharmacien si vous prenez ou avez pris récemment un autre médicament,

même s'il s'agit d'un médicament obtenu sans ordonnance.

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

L'administration au long cours de l'aciclovir dans l'herpès récidivant de la femme enceinte n'est pas recommandé.

Demandez conseil à votre médecin ou 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:propylèneglycol.

3. COMMENT UTILISER ACICLOVIR TEVA PHARMA 5 %, crème ?

Instructions pour un bon usage

Sans objet.

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

Posologie

5 applications par jour.

Il est recommandé d'appliquer la crème en débordant largement autour du bouton de fièvre.

Le traitement doit être débuté le plus tôt possible dès les premiers signes de l'infection.

Si vous avez l'impression que l'effet de ACICLOVIR TEVA PHARMA 5 %, crème est trop fort ou trop faible, consultez votre

médecin ou votre pharmacien.

Mode d'administration/Fréquence d'administration/Durée de traitement

Voie cutanée.

Application de la crème 5 fois/jour toutes les 4 heures environ,

Traitement de 5 à 10 jours.

Débutez les applications dès les premières démangeaisons ou brûlures avant même que n'apparaissent les vésicules, le

traitement étant plus efficace s'il est commencé dès les premiers symptômes annonçant une poussée d'herpès labial.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de ACICLOVIR TEVA PHARMA 5 %, crème que vous n'auriez dû:

Consultez immédiatement votre médecin ou votre pharmacien

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

Si vous oubliez de prendre ACICLOVIR TEVA PHARMA 5 %, crème:

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, ACICLOVIR TEVA PHARMA 5 %, crème est susceptible d'avoir des effets indésirables, bien

que tout le monde n'y soit pas sujet.

Des sensations de picotements ou de brûlures passagères peuvent survenir après l'application de la crème.

Chez quelques patients, la crème peut induire un érythème (rougeur), un prurit (démangeaisons), une sécheresse de la peau

ou un eczéma (en raison de la présence de propylèneglycol).

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 ACICLOVIR TEVA PHARMA 5 %, crème ?

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

Date de péremption

Ne pas utiliser ACICLOVIR TEVA PHARMA 5 %, crème après la date de péremption mentionnée sur le tube.

Conditions de conservation

A conserver à une température comprise entre +15°C et +25°C.

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 ACICLOVIR TEVA PHARMA 5 %, crème ?

La substance active est:

Aciclovir ....................................................................................................................................... 50, 00 mg

Pour 1 g de crème.

Les autres composants sont:

Propylèneglycol, vaseline blanche, paraffine liquide, ARLATONE 983S (monostéarate de glycérol, stéarate de

polyoxyéthylène 30), alcool cétylique, diméticone, eau purifiée.

Forme pharmaceutique et contenu

Qu'est-ce que ACICLOVIR TEVA PHARMA 5 %, crème et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de crème. Tube de 2 g.

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

TEVA SANTE

Le Palatin 1

1, cours du Triangle

92936 Paris la Défense Cedex

Exploitant

TEVA CLASSICS

LE PALATIN 1

1, COURS DU TRIANGLE

92936 PARIS LA DEFENSE CEDEX

Fabricant

CHEFARO INTERNATIONAL BV

KEILEWEG 8 - 3029 BS ROTTERDAM

PAYS BAS

SYNTHON BV

MICROWEG 22

6545 NIJMEGEN

PAYS BAS

TEVA SANTE

RUE BELLOCIER

89107 SENS CEDEX

FRANCE

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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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

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

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

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

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

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

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

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

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety