AMLODIPINE Chemical Farma

Information principale

  • Nom commercial:
  • AMLODIPINE Chemical Farma 5 mg, gélule
  • Dosage:
  • 5,00 mg
  • forme pharmaceutique:
  • gélule
  • Composition:
  • composition pour une gélule > amlodipine : 5,00 mg . Sous forme de : bésilate d'amlodipine
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC-Aluminium de 30 gélule(s)
  • Type d'ordonnance:
  • liste I
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • AMLODIPINE Chemical Farma 5 mg, gélule
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • inhibiteur calcique sélectif à principalement effet vasculaire
  • Descriptif du produit:
  • 380 072-9 ou 4009 380 072 9 9 - plaquette(s) thermoformée(s) PVC-Aluminium de 30 gélule(s) - Déclaration de commercialisation non communiquée:;380 073-5 ou 4009 380 073 5 0 - plaquette(s) thermoformée(s) PVC-Aluminium de 100 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:
  • Valide
  • Numéro d'autorisation:
  • 68868206
  • Date de l'autorisation:
  • 30-05-2007
  • Dernière mise à jour:
  • 22-06-2018

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

NOTICE

ANSM - Mis à jour le : 08/07/2013

Dénomination du médicament

AMLODIPINE CHEMICAL FARMA 5 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 AMLODIPINE CHEMICAL FARMA 5 mg, gélule ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE AMLODIPINE CHEMICAL FARMA 5

mg, gélule ?

3. COMMENT PRENDRE AMLODIPINE CHEMICAL FARMA 5 mg, gélule ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER AMLODIPINE CHEMICAL FARMA 5 mg, gélule ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE AMLODIPINE CHEMICAL FARMA 5 mg, gélule ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

AMLODIPINE CHEMICAL FARMA contient la substance active amlodipine qui appartient au groupe de médicaments

appelés inhibiteurs calciques.

Indications thérapeutiques

AMLODIPINE CHEMICAL FARMA est utilisé pour traiter l’augmentation de la pression artérielle (hypertension), ou un

certain type de douleur thoracique dénommé angor, dont une forme rare est l’angor de Prinzmetal.

Chez les patients présentant des valeurs élevées de la pression artérielle, votre médicament agit en relaxant les vaisseaux

sanguins, de telle sorte que le sang les traverse plus facilement. Chez les patients atteints d’angor, AMLODIPINE

CHEMICAL FARMA agit en améliorant l’apport sanguin au muscle cardiaque, qui reçoit ainsi plus d’oxygène, ce qui

prévient l’apparition d’une douleur thoracique. Votre médicament n’apporte pas de soulagement immédiat pour la douleur

thoracique liée à l’angor.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE AMLODIPINE CHEMICAL FARMA 5

mg, gélule ?

Liste des informations nécessaires avant la prise du médicament

Si votre médecin vous a informé(e) d’une intolérance à certains sucres, contactez-le avant de prendre ce médicament.

Contre-indications

Ne prenez jamais AMLODIPINE CHEMICAL FARMA 5 mg, gélule:

si vous êtes allergique (hypersensible) à l’amlodipine ou à l’un des autres composants contenus dans votre médicament

dont la liste est indiquée dans la rubrique 6, ou aux autres inhibiteurs calciques. Cela peut se manifester par des

démangeaisons, des rougeurs de la peau ou des difficultés respiratoires.

Si vous présentez une baisse sévère de la pression artérielle (hypotension).

Si vous présentez un rétrécissement de la valve aortique (sténose aortique) ou un choc cardiogénique (une affection dans

laquelle votre cœur était incapable d’apporter suffisamment de sang à l’organisme).

Si vous souffrez d’une insuffisance cardiaque après une crise cardiaque.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec AMLODIPINE CHEMICAL FARMA 5 mg, gélule:

Vous devez informer votre médecin si vous présentez ou avez présenté l’une des conditions suivantes :

crise cardiaque récente

insuffisance cardiaque

augmentation sévère de la pression artérielle (crise hypertensive)

maladie du foie

vous êtes une personne âgée et votre dose a besoin d’être augmentée

Enfants et adolescents

AMLODIPINE CHEMICAL FARMA n’a pas été étudié chez l’enfant âgé de moins de 6 ans. AMLODIPINE CHEMICAL

FARMA ne doit être utilisé que pour le traitement de l’hypertension chez les enfants et les adolescents âgés de 6 à 17 ans

(voir rubrique 3). Pour des informations complémentaires, veuillez vous adresser à votre médecin.

En raison de la présence d'amidon (source de glucose), ce médicament ne doit pas être pris par les patients présentant une

rare malabsorption du glucose/galactose.

Interactions avec d'autres médicaments

Prise d'autres médicaments

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.

AMLODIPINE CHEMICAL FARMA peut affecter ou être affecté par d’autres médicaments, tel que :

le kétoconazole, l’itraconazole (médicaments antifongiques),

le ritonavir, l’indinavir, le nelfinavir (appelés inhibiteur de protéase utilisé pour traiter l’infection par le VIH)

la rifampicine, l’érythromycine, la clarithromycine (antibiotiques)

Hypericum perforatum (millepertuis)

le vérapamil, le diltiazem (médicaments pour le cœur)

le dantrolène (perfusion pour les augmentations sévères de la température corporelle)

AMLODIPINE CHEMICAL FARMA peut diminuer votre pression artérielle encore davantage si vous prenez déjà d’autres

médicaments destinés à traiter l’augmentation de la pression artérielle.

Interactions avec les aliments et les boissons

Aliments et boissons

Le jus de pamplemousse et le pamplemousse ne doivent pas être consommés par les personnes traitées par AMLODIPINE

CHEMICAL FARMA. Cela est dû au fait que le pamplemousse et le jus de pamplemousse peuvent entraîner une

augmentation des concentrations sanguines de l’ingrédient actif, l’amlodipine, ce qui peut entraîner une augmentation

imprévisible de l’effet hypotenseur de AMLODIPINE CHEMICAL FARMA.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et allaitement

La sécurité de l’amlodipine chez la femme enceinte n’a pas été établie. Si vous pensez être enceinte, ou si vous prévoyez

d’être enceinte, vous devez en parler à votre médecin avant de prendre AMLODIPINE CHEMICAL FARMA.

Il n’a pas été établi si l’amlodipine est excrété dans le lait maternel. Si vous allaitez ou si vous êtes sur le point d’allaiter,

vous devez en parler à votre médecin avant de prendre AMLODIPINE CHEMICAL FARMA.

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

Conduite de véhicules et utilisation de machines

AMLODIPINE CHEMICAL FARMA peut affecter votre capacité à conduire des véhicules et à utiliser des machines. Si les

gélules provoquent des nausées, des vertiges ou une fatigue, ou encore des maux de tête, vous ne devez pas conduire des

véhicules ni utiliser des machines, et vous devez contacter votre médecin immédiatement.

Liste des excipients à effet notoire

Liste des excipients à effet notoire: amidon de maïs.

3. COMMENT PRENDRE AMLODIPINE CHEMICAL FARMA 5 mg, gélule ?

Instructions pour un bon usage

Sans objet.

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

Respectez toujours la posologie indiquée par votre médecin. En cas de doute, consultez votre médecin ou votre

pharmacien.

La posologie initiale habituelle d’AMLODIPINE CHEMICAL FARMA est de 5 mg une fois par jour. Cette dose peut être

augmentée jusqu’à 10 mg d’AMLODIPINE CHEMICAL FARMA une fois par jour.

Votre médicament peut être utilisé avant ou après la consommation d’aliments et de boissons. Il est préférable de prendre

votre médicament à la même heure tous les jours avec un verre d’eau. Ne prenez pas AMLODIPINE CHEMICAL FARMA

avec du jus de pamplemousse.

Utilisation chez les enfants et les adolescents

Pour les enfants et les adolescents (de 6 à 17 ans), la dose initiale habituelle recommandée est de 2,5 mg par jour. La dose

maximale recommandée est de 5 mg par jour. Les gélules d’AMLODIPINE CHEMICAL FARMA à 2,5 mg ne sont

actuellement pas disponibles.

Il est important de continuer à prendre les gélules. N’attendez pas d’avoir pris toutes vos gélules avant de consulter votre

médecin.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de AMLODIPINE CHEMICAL FARMA 5 mg, gélule que vous n’auriez dû :

Prendre trop de gélules peut entraîner une baisse parfois dangereuse de votre pression artérielle. Vous pouvez ressentir des

vertiges, des étourdissements, perdre connaissance ou vous sentir faible. Si la pression artérielle diminue de manière trop

sévère, un choc peut survenir. Votre peau peut devenir froide et moite et vous pouvez perdre conscience. Consultez un

médecin si vous avez pris trop de gélules d’AMLODIPINE CHEMICAL FARMA.

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

Si vous oubliez de prendre AMLODIPINE CHEMICAL FARMA 5 mg, gélule:

Ne vous inquiétez pas. Si vous avez oublié de prendre une gélule, passez complètement la dose. Prenez la dose suivante

selon le rythme normal. Ne prenez pas de dose double pour compenser la dose que vous avez oublié de prendre.

Risque de syndrome de sevrage

Si vous arrêtez de prendre AMLODIPINE CHEMICAL FARMA 5 mg, gélule:

Votre médecin vous indiquera combien de temps vous devez prendre votre médicament. Votre maladie peut récidiver si

vous arrêtez de prendre votre médicament avant que cela ne soit indiqué.

Si vous avez d’autres questions sur l’utilisation de ce médicament, demandez plus d’informations à votre médecin ou à votre

pharmacien..

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, AMLODIPINE CHEMICAL FARMA peut provoquer des effets indésirables, bien que tout le

monde n’y soit pas sujet.

Consultez votre médecin immédiatement si vous présentez l’un des effets indésirables suivants, sévères et très rares après

la prise de ce médicament.

Respiration sifflante soudaine, douleur thoracique, essoufflement ou difficultés respiratoires ;

Gonflement des paupières, du visage ou des lèvres ;

Gonflement de la langue et de la gorge entraînant de grandes difficultés respiratoires ;

Réactions cutanées sévères, notamment éruption cutanée intense, urticaire, rougeur de la peau sur l’ensemble du corps,

démangeaisons sévères, apparition de vésicules, desquamation et gonflement de la peau, inflammation des muqueuses

(syndrome de Stevens-Johnson) ou autres réactions allergiques ;

Crise cardiaque, battements cardiaques anormaux ;

Inflammation du pancréas pouvant entraîner une douleur abdominale et dorsale sévère accompagnée d’un très grand

malaise.

Les effets indésirables fréquents suivants ont été observés. Si l’un de ces effets devient gênant ou s’il dure plus d’une

semaine, vous devez contacter votre médecin.

Effets indésirables fréquents : affectent entre 1 patient sur 10 et 1 patient sur 100 :

Maux de tête, sensations vertigineuses, somnolence (en particulier au début du traitement) ;

Palpitations (conscience de vos battements cardiaques), bouffées vasomotrices ;

Douleur abdominale, nausées ;

Gonflement (œdème) des chevilles, fatigue.

D’autres effets indésirables figurant sur la liste suivante ont été rapportés. Si vous ressentez l’un des effets mentionnés

comme grave ou si vous présentez des effets indésirables non mentionnés dans cette notice, veuillez en informer votre

médecin ou votre pharmacien.

Effets indésirables peu fréquents : affectent entre 1 patient sur 100 et 1 patient sur 1 000 :

Changement de l’humeur, anxiété, dépression, insomnie ;

Tremblements, anomalies du goût, perte de conscience, faiblesse ;

Sensations d’engourdissement ou de fourmillements dans les membres ; perte de la sensation de douleur ;

Troubles visuels, vision double, tintements dans les oreilles ;

Diminution de la pression artérielle ;

Éternuements et écoulement nasal provoqués par une inflammation de la muqueuse du nez (rhinite) ;

Perturbation du transit abdominal, diarrhée, constipation, indigestion, bouche sèche, vomissements (nausées) ;

Chute des cheveux, augmentation de la transpiration, démangeaisons cutanées, plaques rouges sur la peau, changement

de coloration de la peau ;

Difficultés pour uriner, augmentation des envies d’uriner la nuit, augmentation du nombre de mictions ;

Incapacité à obtenir une érection ; gêne ou augmentation des seins chez l’homme ;

Faiblesse, douleur, malaise ;

Douleurs articulaires ou musculaires ; crampes musculaires, douleurs dorsales ;

Augmentation ou diminution du poids.

Effets indésirables rares : affectent entre 1 patient sur 1 000 et 1 patient sur 10 000 :

Confusion.

Effets indésirables très rares : affectent moins d’un patient sur 10 000 :

Diminution du nombre des globules blancs, diminution des plaquettes sanguines pouvant entraîner une formation anormale

d’hématomes ou des saignements fréquents (lésions des globules rouges) ;

Augmentation du sucre dans le sang (hyperglycémie) ;

Trouble des nerfs entraînant une faiblesse, des fourmillements ou un engourdissement ;

Toux, gonflement des gencives ;

Ballonnement abdominal (gastrite) ;

Anomalies de la fonction hépatique, inflammation du foie (hépatite), jaunissement de la peau (ictère), élévation des

enzymes hépatiques pouvant avoir un effet sur certaines analyses médicales ;

Augmentation de la tension musculaire ;

Inflammation des vaisseaux sanguins, souvent accompagnée d’une éruption cutanée ;

Sensibilité à la lumière.

Troubles combinant de la rigidité, des tremblements et/ou trouble du mouvement.

Si vous ressentez l’un des effets mentionnés comme grave ou si vous présentez des effets indésirables non mentionnés

dans cette notice, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER AMLODIPINE CHEMICAL FARMA 5 mg, gélule ?

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

Date de péremption

Ne pas utiliser AMLODIPINE CHEMICAL FARMA 5 mg, gélule après la date de péremption figurant sur la boîte, les

plaquettes.

Conditions de conservation

A conserver à une température ne dépassant pas 30°C.

A conserver dans l'emballage extérieur d'origine.

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 AMLODIPINE CHEMICAL FARMA 5 mg, gélule ?

La substance active est:

Amlodipine .......................................................................................................................................... 5 mg

Sous forme de bésilate d'amlodipine

Pour une gélule.

Les autres composants sont:

Cellulose microcristalline, stéarate de magnésium, amidon de maïs.

Enveloppe de la gélule: gélatine, dioxyde de titane (E171), jaune de quinoléine (E104).

Forme pharmaceutique et contenu

Qu'est-ce que AMLODIPINE CHEMICAL FARMA 5 mg, gélule et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de gélule. Boîte de 30 ou 100.

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

Chemical farma

3 quai louis bleriot

75016 paris

Exploitant

CHEMICAL FARMA

19-23, RUE D'HAUTPOUL

75019 PARIS

Fabricant

SPECIFAR S.A.

1, 28 OCTOVRIOU STR.

12351 AG. VARVARA ATHENES

GRECE

CENTRAFARM SERVICES B.V.

NIEUWE DONK 9

4879 AC ETTEN-LEUR

PAYS BAS

LABORATOIRES BTT

ZI DE KRAFFT

67150 ERSTEIN

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).

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Sans objet.

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Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

24-10-2018

U-Pol Inc. recalls Automotive Repair and Refinish Products

U-Pol Inc. recalls Automotive Repair and Refinish Products

Health Canada has established that these products do not meet the mandatory warning labelling requirements for consumer use, as required under Canadian law. They are correctly labelled for workplace professional users, but the products lack the symbols and warnings required for consumer chemicals.

Health Canada

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

20-9-2018

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Canadians should not buy or use health products that contain 2,4-dinitrophenol, more commonly known as DNP, because it is toxic and can cause death. Products containing DNP are primarily marketed towards bodybuilders and are promoted online as a "fat burner" or "shredder" and for weight loss.

Health Canada

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Food chemical occurrence data: nominations open for stakeholder group

Food chemical occurrence data: nominations open for stakeholder group

Food chemical occurrence data: nominations open for stakeholder group

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

14-8-2018

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

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

20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

J2Labz recalls Sugar Shack Vaping Liquid

Health Canada's sampling and evaluation program has determined that these vaping products do not meet the packaging and labelling requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

19-7-2018

Assessment of the safety of feminine hygiene products

Assessment of the safety of feminine hygiene products

Today ANSES is publishing its health risk assessment on the safety of feminine hygiene products. Chemicals have been identified in these products at very low concentrations not exceeding health thresholds. The expert appraisal did not reveal any risk associated with these substances. Nevertheless, the Agency recommends that manufacturers improve the quality of these products in order to eliminate or minimise the presence of chemicals. ANSES’s expert appraisal also examined the risk of menstrual toxic sho...

France - Agence Nationale du Médicament Vétérinaire

19-7-2018

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-7-2018

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

4-7-2018

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Cases of skin allergies and irritation related to clothing or footwear are regularly reported to the health authorities. Today ANSES is publishing the results of the expert appraisal it conducted to identify the chemicals likely to be found in these articles and possibly responsible for these cases. Further to this expert appraisal, the Agency is issuing recommendations on how to better protect consumers from the risks of skin allergies and irritation caused by the presence of these substances.

France - Agence Nationale du Médicament Vétérinaire

25-6-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

FDA Commissioner Scott Gottlieb, M.D., discusses the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.

FDA - U.S. Food and Drug Administration

28-11-2018

Final decisions amending, or not amending, the current Poisons Standard, November 2018

Final decisions amending, or not amending, the current Poisons Standard, November 2018

Final decisions and reasons for medicines and chemicals referred to the June 2018 scheduling meetings

Therapeutic Goods Administration - Australia

23-8-2018

Final decisions amending, or not amending, the current Poisons Standard, August 2018

Final decisions amending, or not amending, the current Poisons Standard, August 2018

Final decisions for matters referred to the March 2018 ACMS/ACCS meetings & delegate-only decisions on agricultural chemicals & NCEs

Therapeutic Goods Administration - Australia

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.

Europe - EMA - European Medicines Agency

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety