TAMCORE

Información principal

  • Denominación comercial:
  • TAMCORE 160 mg COMPRIMIDOS RECUBIERTOS
  • Dosis:
  • 160 mg
  • formulario farmacéutico:
  • COMPRIMIDO RECUBIERTO
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • SANOFI - AVENTIS DE VENEZUELA, S.A.

Documentos

Localización

  • Disponible en:
  • TAMCORE 160 mg COMPRIMIDOS RECUBIERTOS
    Venezuela
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • Instituto Nacional de Higiene - República Bolivariana de Venezuela
  • Estado de Autorización:
  • VIGENTE
  • Número de autorización:
  • E.F.40.576
  • Fecha de autorización:
  • 17-03-2014
  • última actualización:
  • 03-09-2018

Prospecto

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

Venezuela

para

saJud

RCEF-R-0350/2014

Caracas, 17 de Marzo de 2014

Ciudadano(a)

DR. (A). LEONARDO RAFAEL CADET VARGAS.

Farmaceutico Patrocinante

MEDLEY FARMACEUTICA, S.A.

Presente.-

conformidad con

Oficio RCEF-R-0349/2014 de fecha 17/03/2014 mediante

cual se

notific6

aprobaci6n del Producto Farmaceutico TAMCORE 160

COMPRIMIDOS RECUBIERTOS

W

Registro Sanitaria E.F.40.576/14,

segun consta

libra EF-2014-01,

Pag.

176 usted

debera

cumplir

las siguientes condiciones de comercializaci6n:

COMUNICAR

PRESCRIPTORES

SEGUN

ESTABLECIDO

MEDICAMENTOS ARTiCULO

lo siguiente:

lndicaci6n:

Tratamiento de

hipertensi6n arterial.

Tratamiento de

insuficiencia cardfaca clase

11-IV.

Para

mejorar

supervivencia

postinfarto

miocardia en

pacientes

hemodinamicamente

estables con disfunci6n sist61ica ventricular izquierda.

Posologia:

Hipertensi6n Arterial: Adultos: 80 mg-160 mg/dfa. Dosis maxima 320 mg.

lnsuficiencia Cardiaca: 40 mg cada

horas. Realizar ajustes ascendentes de

dosis hasta 80

y 160 mg cada 12 horas, hasta

dosis mayor tolerada par el paciente.

Postinfarto del miocardia

pacientes hemodinamicamente estables con disfunci6n

sist61ica

ventricular izquierda:

160 mg cada

horas.

Advertencias:

caso de ser imprescindible

usa par no existir otra alternativa terapeutica, suspendase

lactancia mientras dure

tratamiento.

Precauciones:

Pacientes con insuficiencia hepatica moderada a grave.

pacientes con desequilibrio hidroelectrolitico, debe corregirse dicha alteraci6n antes de

administraci6n de este producto.

Realizar control frecuente de electrolitos sericos,

especialmente del potasio,

caso de

administraci6n concomitante de suplementos de potasio, sustitutos de sal que contienen potasio

u otras drogas que puedan ocasionar hiperpotasemia.

Contraindicaciones:

Hipersensibilidad a los componentes de

formula.

Cirrosis hepatica, colestasis de vias biliares, aldosteronismo primario.

se administre durante

embarazo o cuando se sospeche su existencia.

Reacciones

Adversas:

Mareo,

hipotensi6n

ortostatica,

fatiga,

diarrea,

cefalea,

nausea,

insuficiencia

renal,

hiperpotasemia y vertigo.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas - Republica Bolivariana de Venezuela Cod.

1041

Teh§fono:

(0058-0212) 219.1622- http://www.inhrr.gob.ve- RIF: G-20000101-1

E.F.40.576/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 1

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

Venezuela

para

salud

le asigna

producto

perlodo de validez comprobado de dos (02) alios, almacenado bajo

las condiciones climaticas de Venezuela (30

170%

HR),

envase BLiSTER

POLIAMIDA ORIENTADA

(OPA)-

ALUMINIO

(AL)-

POLIVINILCLORURO (PVC)

I

FOIL

ALUMINIO.

Remitir:

3.1.

Certificado de Buenas Practicas de Manufactura de Sanofi-Aventis de Venezuela,

S.A.,

original y vigente o

su defecto

copia compulsada del mismo, una vez que

mismo se

encuentre disponible.

3.2.

Anexo a

notificaci6n del inicio de

comercializaci6n del primer lote del producto,

Certificado

Libre

Venta

Buenas

Practicas

Manufactura

Sanofi-Aventis

Farmaceutica LTDA. BRASIL, original y vigente o

su defecto

copia compulsada del

mismo.

Corregir

texto de empaque indicando

siguiente:

4.1. Nombre del producto: Tamcore 160

Comprimidos Recubiertos.

4.2. Fabricante envasador (Cuando aplique): Sanofi- Aventis de Venezuela S.A. Venezuela.

Corregir

texto de empaque segun

modelo anexo, agregando lo siguiente:

Advertencias:

Producto de uso delicado que debe administrarse bajo vigilancia medica.

caso de ser imprescindible

uso por

existir otra alternativa terapeutica, suspendase

lactancia mientras dure el tratamiento.

Antes de administrar este producto, leer

prospecto interno.

Contraindicaciones:

se administre durante

embarazo o cuando se sospeche su existencia.

Alergia a los componentes de

formula.

Con Prescripci6n Facultativa.

Corregir

texto

prospecto

interno

segun

modelo

anexo,

agregando

condiciones

restricciones de uso contenidas

presente oficio.

caso

de requerir variaci6n

presentaciones aprobadas,

debera

realizar

tramite

individual correspondiente.

Remitir peri6dicamente Certificado de Producto Farmaceutico, Certificado de Libre Venta y/o

Certificado de Buenas Practicas de Manufactura vigente.

textos de empaque, etiqueta, unidad posol6gica y prospecto interno deben adecuarse, segun

caso,

establecido

Oficio

Aprobaci6n,

Oficio

Condiciones

Comercializaci6n, las Normas y Boletines de

Junta Revisora de Productos Farmaceuticos.

Comunicar

Institute Nacional de Higiene "Rafael Rangel", a traves del Centro Nacional de

Farmacovigilancia (CENAVIF), cualquier efecto

descrito durante

proceso de evaluaci6n del

Registro Sanitaria que derive de

actividad farmacol6gica del

mismo o de alguno de sus

ingredientes y del cual se tenga conocimiento despues de aprobado

producto.

Presentar ante el Institute Nacional de Higiene "Rafael Rangel", cualquier cambio que tenga

producto durante

periodo de Comercializaci6n, relacionado con aspectos de: textos, legales,

farmaceuticos y cllnicos, para

cual debera emplear los formularies de solicitud de cambio

post - registro vigentes y/o comunicaciones.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas - Republica Bolivariana de Venezuela Cod.

1041

Teh§fono: (0058-0212)

219.1622-

http://www.inhrr.gob.ve- RIF: G-20000101-1

E.F.40.576/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 2 de 3

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

de

Venezuela

para

salud

Debe

indicar

Despacho

cuatro

(04)

meses

anticipaci6n,

fecha

probable

comercializaci6n

producto

farmaceutico.

este

lapso

tiempo

procedera

EVALUACION

metodologfa analftica utilizada

control

calidad del producto y a

programaci6n respectiva.

A los fines del estricto cumplimiento del Articulo

del Reglamento de

del Ejercicio

Farmacia vigente, publicado

Gaceta Oficial

W

4.582 extraordinario

fecha

Mayo

1993,

informa

estan

obligados

participar

Institute

Nacional

de

Higiene

"Rafael Rangel"

fecha

cual

inicie

comercializaci6n del primer lote elaborado,

manera

funcionarios acreditados

Institute Nacional

Higiene "Rafael

Rangel",

puedan proceder a captar las muestras correspondientes

propio sitio de fabricaci6n, o

distribuci6n

caso de los productos importados.

lgualmente

informa que dispone

quince

(15)

dfas habiles, para solicitar a esta

GERENCIA,

reconsideraci6n de las exigencias selialadas

ANTERIORMENTE.

Transcurrido dicho lapso

queda

usted

obligaci6n de cumplir

las condiciones de uso

bajo

las cuales fue aprobado

producto.

incumplimiento

alguna

condiciones

comercializaci6n

sera

sancionado

CANCELACION

del producto.

~1/&tl/MNQ.-

Presidenta del Institute

Nacio~Tgiene'

Gaceta Oficial

40.2Cl--2

de Fecha 08/

Resoluci6n

del 08/07/201

Ciudad Universitaria UCV, Los Chaguaramos.

Caracas-

Republica Bolivariana de Venezuela Cod.

1041

Teh§fono: (0058-0212)

219.1622-

http://www.inhrr.gob.ve- RIF: G-20000101-1

E.F.40.576/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 3 de 3

21-9-2018

Valsartan: EMA revisión de impurezas extendidas a otros medicamentos sartanes

EMA , 20 de septiembre de 2018 La Agencia Europea de Medicamentos (EMA) está ampliando su informe de impurezas en valsartán tras la detección de niveles muy bajos de N-nitrosodietilamina (NDEA) en otra sustancia activa, losartán, hecho por Hetero Labs en India. Como resultado de la detección de esta impureza por parte de las autoridades alemanas, la revisión ahora incluirá medicamentos que contienen otros cuatro "sartanes", a saber, candesartán, irbesartán, losartán y olmesartán.

REDCIMLAC - Red de Centros de Información de Medicamentos de Latinoamérica y el Caribe

13-9-2018

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

13-9-2018

Health Canada advises of a second impurity linked to recalled valsartan drugs

Health Canada advises of a second impurity linked to recalled valsartan drugs

OTTAWA - Health Canada is advising Canadians that a second impurity, called N-nitrosodiethylamine (NDEA) has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China.

Health Canada

10-9-2018

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine (NDMA). Health Canada scientists have assessed the available data to determine the potential increased risk of developing cancer, to help put the risk into context for Canadians.

Health Canada

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

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

16-7-2018

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

13-7-2018

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA - U.S. Food and Drug Administration

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Health Canada

5-7-2018

Recall of valsartan blood pressure medicine

Recall of valsartan blood pressure medicine

Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible to be switched to another type of medicine.

Danish Medicines Agency

8-3-2012

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

Danish 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

3-5-2018

Entresto (Novartis Europharm Limited)

Entresto (Novartis Europharm Limited)

Entresto (Active substance: sacubitril / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2779 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4062/T/18

Europe -DG Health and Food Safety