CIPROFIBRATE Ref

Information principale

  • Nom commercial:
  • CIPROFIBRATE Ref 100 mg, gélule
  • Dosage:
  • 100 mg
  • forme pharmaceutique:
  • gélule
  • Composition:
  • composition pour une gélule > ciprofibrate : 100 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC PVDC aluminium de 20 gélule(s)
  • Type d'ordonnance:
  • liste II
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • CIPROFIBRATE Ref 100 mg, gélule
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • HYPOCHOLESTEROLEMIANTS ET HYPOTRIGLYCERIDEMIANTS/FIBRATES
  • Descriptif du produit:
  • 379 733-5 ou 4009 379 733 5 9 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 20 gélule(s) - Déclaration de commercialisation non communiquée:;379 734-1 ou 4009 379 734 1 0 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 28 gélule(s) - Déclaration de commercialisation non communiquée:;379 735-8 ou 4009 379 735 8 8 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 30 gélule(s) - Déclaration de commercialisation non communiquée:;379 736-4 ou 4009 379 736 4 9 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 90 gélule(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:
  • Archivée
  • Numéro d'autorisation:
  • 67025110
  • Date de l'autorisation:
  • 30-05-2007
  • Dernière mise à jour:
  • 10-08-2017

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

NOTICE

ANSM - Mis à jour le : 07/12/2010

Dénomination du médicament

CIPROFIBRATE REF 100 mg, gélule

Encadré

Veuillez lire attentivement l'intégralité de cette notice avant de prendre ce médicament.

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

Si vous avez toute autre question, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Ce médicament vous a été personnellement prescrit. Ne le donnez jamais à quelqu'un d'autre, même en cas de symptômes

identiques, cela pourrait lui être nocif.

Si l'un des effets indésirables devient grave ou si vous remarquez un effet indésirable non mentionné dans cette notice,

parlez-en à votre médecin ou à votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE CIPROFIBRATE REF 100 mg, gélule ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE CIPROFIBRATE REF 100 mg, gélule ?

3. COMMENT PRENDRE CIPROFIBRATE REF 100 mg, gélule ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER CIPROFIBRATE REF 100 mg, gélule ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE CIPROFIBRATE REF 100 mg, gélule ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

Sans objet.

Indications thérapeutiques

Ce médicament est indiqué dans les hypercholestérolémies (taux anormalement élevé de cholestérol dans le sang) et/ou les

hypertriglycéridémies (taux anormalement élevé de triglycérides-graisses dans le sang) de l'adulte, lorsqu'un régime adapté

et assidu s'est avéré insuffisant.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE CIPROFIBRATE REF 100 mg, gélule ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

Ne prenez jamais CIPROFIBRATE REF 100 mg, gélule dans les cas suivants:

Allergie au ciprofibrate ou à l'un des autres constituants de ce médicament (voir Que contient CIPROFIBRATE REF 100

mg, gélule ?),

insuffisance hépatique (foie),

insuffisance rénale,

en association avec un autre médicament pour le cholestérol de la même classe (un fibrate),

Précautions d'emploi ; mises en garde spéciales

Faites attention avec CIPROFIBRATE REF 100mg, gélule:

Mises en garde spéciales

En cas de douleurs musculaires, prévenir immédiatement votre médecin traitant (voir Quels sont les effets indésirables

éventuels ?).

Prévenir votre médecin si vous êtes atteint d'une maladie de la thyroïde.

Un bilan hépatique sera pratiqué avant traitement et régulièrement pendant la première année de traitement,

En raison de la présence de lactose, ce médicament ne doit pas être utilisé en cas de galactosémie, de syndrome de

malabsorption du glucose et du galactose ou de déficit en lactase (maladies métaboliques rares).

Précautions d'emploi

La prise de ce médicament ne dispense pas du régime et sa poursuite régulière est toujours indispensable. Un bilan

sanguin régulier est nécessaire.

L'utilisation chez l'enfant nécessite une surveillance médicale particulière.

NE JAMAIS LAISSER A LA PORTEE DES ENFANTS.

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,

notamment si vous prenez un médicament anticoagulant, ou une statine (autre médicament destiné à diminuer le taux de

cholestérol dans le sang), 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

Grossesse

La prise de ce médicament est déconseillée en cas de grossesse. En cas de découverte fortuite d'une grossesse alors que

vous preniez ce médicament, il convient d'interrompre ce dernier. Contactez alors votre médecin traitant.

Allaitement

Par manque de données concernant le passage dans le lait, et dans le cas où ce traitement apparaît réellement nécessaire

après l'accouchement, l'allaitement est déconseillé.

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: lactose.

3. COMMENT PRENDRE CIPROFIBRATE REF 100 mg, gélule ?

Instructions pour un bon usage

Sans objet.

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

Posologie

La posologie est de 1 gélule par jour. Cette posologie ne doit pas être dépassée.

Dans tous les cas, se conformer strictement à l'ordonnance de votre médecin.

Si vous avez l'impression que l'effet de CIPROFIBRATE REF 100 mg, gélule est trop fort ou trop faible, consultez votre

médecin ou votre pharmacien.

Mode d'administration

Voie orale.

Se conformer strictement à l'ordonnance de votre médecin.

En association avec le régime, ce médicament constitue un traitement symptomatique devant être prolongé et régulièrement

surveillé.

Pour une bonne utilisation, il est indispensable de vous soumettre à une surveillance médicale régulière, qui comporte des

dosages sanguins réguliers des enzymes du foie (transaminases) la première année de traitement.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de CIPROFIBRATE REF 100 mg, gélule que vous n'auriez dû: ne pas hésiter à demander l'avis

de votre médecin.

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

Si vous oubliez de prendre CIPROFIBRATE REF 100 mg, gélule: ne prenez pas de dose double pour compenser la dose

que vous avez oublié de prendre.

Ne pas hésiter à demander l'avis de votre médecin.

Risque de syndrome de sevrage

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, CIPROFIBRATE REF 100 mg, gélule est susceptible d'avoir des effets indésirables, bien

que tout le monde n'y soit pas sujet .

Ces effets sont peu fréquents et bénins:

troubles digestifs, gastriques ou intestinaux à type de digestion difficile, nausées, vomissements, diarrhées,

maux de tête, vertiges, rares cas de somnolence,

réactions cutanées: démangeaisons, boutons, exceptionnellement réaction cutanée lors d'une exposition au soleil ou aux

U.V., alopécie (perte de cheveux),

élévation transitoire des transaminases (enzymes du foie),

quelques cas d'impuissance,

quelques cas isolés de maladies du poumon,

des douleurs musculaires (avec parfois augmentation des enzymes musculaires).

Si vous ressentez des douleurs musculaires, une sensibilité musculaire douloureuse ou une

faiblesse musculaire, contactez immédiatement votre médecin, car les problèmes musculaires

peuvent être graves dans de rares cas.

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 CIPROFIBRATE REF 100 mg, gélule ?

Tenir hors de la portée et de la vue des enfants

Date de péremption

Ne pas utiliser CIPROFIBRATE REF 100 mg, gélule 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 CIPROFIBRATE REF 100 mg, gélule ?

La substance active est:

Ciprofibrate ...................................................................................................................................... 100 mg

Pour une gélule.

Les autres composants sont:

Lactose monohydraté, amidon prégélatinisé, silice colloïdale anhydre, stéarate de magnésium.

Enveloppe de la gélule: gélatine, dioxyde de titane (E171), oxyde de fer jaune (E172), oxyde de fer rouge (E172), oxyde de

fer noir (E172).

Forme pharmaceutique et contenu

Qu'est-ce que CIPROFIBRATE REF 100 mg, gélule et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de gélule. Boîte de 20, 28, 30 ou 90.

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

BIOGARAN

15, BOULEVARD CHARLES DE GAULLE

92700 COLOMBES

Exploitant

LABORATOIRES BIOGARAN

15 BOULEVARD CHARLES DE GAULLE

92707 COLOMBES CEDEX

Fabricant

ROTTENDORF PHARMA GMBH

OSTENFELDER STRASSE 51-61

59320 ENNIGERLOH

ALLEMAGNE

ROTTENDORF PHARMA

ZONE INDUSTRIELLE N°2 DE PROUVY - ROUVIGNIES

59121 PROUVY

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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