PARACETAMOL Set

Information principale

  • Nom commercial:
  • PARACETAMOL Set 500 mg, comprimé
  • Dosage:
  • 500 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > paracétamol : 500 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC-Aluminium de 16 comprimé(s)
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • PARACETAMOL Set 500 mg, comprimé
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • AUTRES ANALGESIQUES et ANTIPYRETIQUES
  • Descriptif du produit:
  • 377 481-9 ou 4009 377 481 9 3 - plaquette(s) thermoformée(s) PVC-Aluminium de 16 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:
  • Archivée
  • Numéro d'autorisation:
  • 61337014
  • Date de l'autorisation:
  • 25-11-1986
  • Dernière mise à jour:
  • 11-08-2017

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

NOTICE

ANSM - Mis à jour le : 12/10/2006

Dénomination du médicament

PARACETAMOL SET 500 mg, comprimé

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 PARACETAMOL SET 500 mg, comprimé ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE PARACETAMOL SET 500 mg,

comprimé ?

3. COMMENT PRENDRE PARACETAMOL SET 500 mg, comprimé ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER PARACETAMOL SET 500 mg, comprimé ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE PARACETAMOL SET 500 mg, comprimé ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

Ce médicament est un antalgique, antipyrétique.

Indications thérapeutiques

Ce médicament contient du paracétamol. Il est indiqué en cas de douleur et/ou fièvre telles que maux de têtes, états

grippaux, douleurs dentaires, courbatures, règles douloureuses.

Cette présentation est réservée à l'adulte et à l'enfant pesant plus de 27 kg (environ 8 ans).

Lire attentivement Comment prendre PARACETAMOL SET 500 mg, comprimé.

Pour les enfants pesant moins de 27 kg, il existe d'autres présentations de paracétamol: demandez conseil à votre

médecin ou à votre pharmacien.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE PARACETAMOL SET 500 mg,

comprimé ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

Ne prenez jamais PARACETAMOL SET 500 mg, comprimé dans les cas suivants:

Allergie connue au paracétamol ou aux autres constituants du comprimé

Maladie grave du foie.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec PARACETAMOL SET 500 mg, comprimé:

Mises en garde spéciales

En cas de surdosage ou de prise par erreur d'une dose trop élevée prévenir en urgence un médecin.

Ce médicament contient du paracétamol. D'autres médicaments en contiennent.

Ne les associez pas, afin de ne pas dépasser la dose quotidienne recommandée (voir

Comment prendre PARACETAMOL SET 500 mg, comprimé).

La prise de comprimés et de gélules est contre-indiquée chez l'enfant avant 6 ans car il peut avaler de travers et s'étouffer.

Signalez que vous prenez ce médicament si votre médecin vous prescrit un dosage du taux d'acide urique ou de sucre dans

le sang.

Précautions d'emploi

Si la douleur persiste plus de 5 jours, ou la fièvre plus de 3 jours, ou en cas d'efficacité insuffisante ou de survenue de tout

autre signe, ne pas continuer le traitement sans l'avis de votre médecin.

En cas de maladie grave du foie ou des reins, il est nécessaire de consulter votre médecin avant de prendre du paracétamol.

Interactions avec d'autres médicaments

Prise ou utilisation d'autres mé dicaments ou autres formes d'interactions:

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

Le paracétamol, dans les conditions normales d'utilisation, peut être utilisé pendant la grossesse ainsi qu'en cas

d'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

Sans objet.

3. COMMENT PRENDRE PARACETAMOL SET 500 mg, comprimé ?

Instructions pour un bon usage

Sans objet.

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

Cette présentation est réservée à l'adulte et à l'enfant à partir de 27 kg (soit à partir d'environ 8 ans).

Posologie

Chez l'enfant:

La posologie de paracétamol dépend du poids de l'enfant; les âges sont mentionnés à titre d'information.

Si vous ne connaissez pas le poids de l'enfant, il faut le peser afin de lui donner la dose la mieux adaptée.

Le paracétamol existe sous de nombreux dosages, permettant d'adapter le traitement au poids de chaque enfant.

La dose quotidienne de paracétamol recommandée est d'environ 60 mg/kg/jour, à répartir en 4 ou 6 prises, soit environ 15

mg/kg toutes les 6 heures ou 10 mg/kg toutes les 4 heures.

La posologie usuelle est de:

Pour les enfants pesant entre 27 et 40 kg (environ 8 à 13 ans), la posologie est de 1 comprimé à 500 mg par prise, à

renouveler si besoin au bout de 6 heures, sans dépasser 4 comprimés par jour.

Pour les enfants pesant entre 41 et 50 kg (environ 12 à 15 ans), la posologie est de 1 comprimé à 500 mg par prise, à

renouveler si besoin au bout de 4 heures, sans dépasser 6 comprimés par jour.

Pour les adultes et les enfants dont le poids est supérieur à 50 kg (à partir d'environ 15 ans),la posologie usuelle est de

1 à 2 comprimés à 500 mg par prise,selon l'intensité de la douleur, à renouveler en cas de besoin au bout de 4 heures

minimum.

Il n'est généralement pas nécessaire de dépasser 3000 mg de paracétamol par jour, soit 6 comprimés par jour.

Cependant, en cas de douleurs plus intenses et sur conseil de votre médecin, la dose totale peut-être augmentée jusqu'à

4000 mg par jour, soit 8 comprimés par jour.

Cependant:

les doses supérieures à 3 g de paracétamol par jour nécessitent un avis médical,

NE JAMAIS PRENDRE PLUS DE 4 GRAMMES (4000 mg) DE PARACETAMOL PAR JOUR (en tenant compte de tous les

médicaments contenant du paracétamol dans leur formule).

Toujours respecter un intervalle de 4 heures au moins entre les prises.

En cas de maladie grave des reins (insuffisance rénale sévère), les prises doivent être espacées de 8 heures minimum et la

dose totale ne doit pas excéder 6 comprimés par jour (soit 3 g).

De plus, si votre enfant présente une fièvre supérieure à +38,5°C, vous pouvez améliorer l'efficacité du traitement

médicamenteux par les mesures suivantes:

découvrez votre enfant,

faites le boire,

ne laissez pas votre enfant dans un endroit trop chaud.

Mode d'administration

Voie orale.

Les comprimés sont à avaler tels quels avec une boisson (par exemple: eau, lait, jus de fruit).

La prise de comprimés est contre-indiquée chez l'enfant de moins de 6 ans car il peut avaler de travers et s'étouffer. Utiliser

une autre forme.

Fréquence d'administration

Les prises systématiques permettent d'éviter les oscillations de douleur ou de fièvre.

Chez l'enfant, elles doivent être régulièrement espacées, y compris la nuit, de préférence de 6 heures, et d'au moins 4

heures.

Chez l'adulte, elles doivent être espacées de 4 heures minimum.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de PARACETAMOL SET 500 mg, comprimé que vous n'auriez dû:

En cas de surdosage ou de prise par erreur d'une dose trop élevée prévenir en urgence un médecin.

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

Si vous oubliez de prendre PARACETAMOL SET 500 mg, comprimé:

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, PARACETAMOL SET 500 mg, comprimé est susceptible d'avoir des effets indésirables, bien

que tout le monde n'y soit pas sujet.

dans certains cas rares, il est possible que survienne une éruption ou une rougeur cutanée ou une réaction allergique

pouvant se manifester par un brusque gonflement du visage et du cou ou par un malaise brutal avec chute de la pression

artérielle. Il faut immédiatement arrêter le traitement, avertir votre médecin et ne plus jamais reprendre de médicaments

contenant du paracétamol;

Exceptionnellement, des modifications biologiques nécessitant un contrôle du bilan sanguin ont pu être observées: taux

anormalement bas de certains globules blancs ou de certaines cellules du sang comme les plaquettes pouvant se traduire

par des saignements de nez ou des gencives. Dans ce cas, consultez un médecin

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 PARACETAMOL SET 500 mg, comprimé ?

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

Date de péremption

Ne pas utiliser PARACETAMOL SET 500 mg, comprimé 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 PARACETAMOL SET 500 mg, comprimé ?

La substance active est:

Paracétamol .................................................................................................................................... 500 mg

Pour un comprimé.

Les autres composants sont:

Cellulose en poudre microfine, povidone, cellulose en poudre granulée, silice colloïdale anhydre, croscarmellose sodique,

talc, stéarate de magnésium.

Forme pharmaceutique et contenu

Qu'est-ce que PARACETAMOL SET 500 mg, comprimé et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de comprimé. Boîte de 16 comprimés.

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

BIOGARAN

15, boulevard Charles de Gaulle

92707 COLOMBES CEDEX

Fabricant

LABORATOIRES OPODEX INDUSTRIE

34-46, avenue du Vieux Chemin de Saint-Denis

92390 VILLENEUVE-LA-GARENNE

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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BMC USA Corp. recalls Timemachine 01 bicycles

BMC USA Corp. recalls Timemachine 01 bicycles

Variations in tire dimension, tire pressure, head set play and ride load, can result in insufficient space between the front wheel and downtube, posing a fall hazard.

Health Canada

20-7-2018

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Health Canada's inspection program found the recalled product does not meet the labelling and child-resistant packaging requirements for consumer chemical products as set out in the Consumer Chemicals and Containers Regulations, 2001.

Health Canada

18-7-2018

London Drugs Limited recalls Apex Premium LED Lighting Set

London Drugs Limited recalls Apex Premium LED Lighting Set

The battery box of the affected product may melt when the lights are turned on, posing fire and burn hazards.

Health Canada

20-6-2018

Signature of the framework agreement for the ESA Platform: strengthening epidemiological surveillance in animal health

Signature of the framework agreement for the ESA Platform: strengthening epidemiological surveillance in animal health

The signing of the new framework agreement for the Epidemiological Surveillance Platform for Animal Health (ESA Platform) on 20 June 2018 by the Director General for Food in the presence of Roger Genet, Director General of ANSES, and eight other members, signals a new departure for this platform, which has demonstrated its usefulness and effectiveness ever since it was set up in October 2011.  

France - Agence Nationale du Médicament Vétérinaire

28-5-2018

Rona recalls the patio dining set - Marroco

Rona recalls the patio dining set - Marroco

The product could be affected by an assembly defect that could result in broken chair legs, which present a fall hazard for consumers.

Health Canada

23-5-2018

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Health Canada's sampling and evaluation program has determined that the recalled toy does not meet the Canadian safety requirements for toys. The numbered blocks are small parts and the toy may further break apart exposing more small parts, posing a choking hazard for young children.

Health Canada

22-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA - U.S. Food and Drug Administration

22-5-2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

16-1-2018

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules contain the undeclared substance paracetamol.

Therapeutic Goods Administration - Australia

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

20-11-2018

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients.  https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7  pic.twitter.com/IATHeEUgHe

FDA - U.S. Food and Drug Administration

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety