TAMCORE

Información principal

  • Denominación comercial:
  • TAMCORE 80 mg COMPRIMIDOS RECUBIERTOS
  • Dosis:
  • 80 mg
  • formulario farmacéutico:
  • COMPRIMIDO
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • SANOFI AVENTIS FARMACEUTICA LTDA

Documentos

Localización

  • Disponible en:
  • TAMCORE 80 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.40.420
  • Fecha de autorización:
  • 10-01-2014
  • última actualización:
  • 03-09-2018

Prospecto

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

Venezuela

para

Salud

RCEF-R-0016/2014

Ciudadano(a)

DR. (A). LEONARDO

CADET VARGAS.

Farmaceutico Patrocinante

MEDLEY FARMACEUTICA, S.A.

Presente.-

Caracas, 10 de Enero de 2014

De conformidad con

Oficio RCEF-R-0015/2014 de fecha 10/01/2014 mediante

cual

le notific6

aprobaci6n del Producto Farmaceutico TAMCORE 80

COMPRIMIDOS RECUBIERTOS

Registro Sanitaria E.F.40.420/14, segun consta en

libro EF-2014-01, Pag.09 usted debera cumplir

con las siguientes condiciones de comercializaci6n:

COMUNICAR A LOS PRESCRIPTORES SEGUN LO ESTABLECIDO

MEDICAMENTOS ARTiCULO 35,

lo siguiente:

lndicaciones:

Tratamiento de

hipertensi6n arterial.

Tratamiento de

lnsuficiencia Cardiaca 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/dia. Dosis maxima 320 mg.

lnsuficiencia Cardiaca: 40 mg cada 12 horas. Realizar ajustes ascendentes de

dosis hasta 80

y 160 mg cada 12 horas, hasta

dosis mayor, tolerada por

paciente.

Postinfarto del miocardia en pacientes hemodinamicamente estables con disfunci6n

sist61ica

ventricular izquierda: 20 - 160 mg cada

horas.

Advertencias:

caso de ser imprescindible

uso por 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.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas - Republica Bolivariana

Venezuela Cod.

1041

Telefono: (0058-0212)

219.1622-

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

E.F.40.420/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 1 de 4

Gobiemo

Bolivariano

I

Ministerio

Poder Popular

Venezuela

para

Salud

Contraindicaciones:

Hipersensibilidad a los componentes de

formula.

Cirrosis hepatica, colestasis de vias biliares, aldosteronismo primario.

se administre durante

embarazo o cuando se sospeche

existencia.

Reacciones Adversas:

Mareo,

hipotension

ortostatica,

fatiga,

diarrea,

cefalea,

nausea,

insuficiencia

renal,

hiperpotasemia y vertigo.

lnteracciones:

Litio, diureticos ahorradores de potasio.

Se le asigna

producto

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

las condiciones climaticas de Venezuela (30

/70%

HR), en el envase BLISTER

ALUMINIO

(AI)

I

FOIL

ALUMINIO

(AI).

Remitir anexo a

notificacion del inicio de

comercializacion del primer lote del producto,

siguiente:

3.1.

Hoja SR2 incluyendo

numero de galpon corregido, correspondiente a

direccion del

laboratorio Sanofi Aventis de Venezuela S.A (fabricante envasador).

3.2.

Descripcion completa del sistema envase cierre utilizado

el estudio de estabilidad,

serialando sus partes, materiales, colores, opacidad y cualquier otra condicion que los

defina, adem as incluir copia de las hojas de especificaciones emitidas por

proveedor.

3.3.

Certificado

Buenas

Practicas

Manufactura

Laboratorio

Sanofi

Aventis

Venezuela, S.A., original y vigente o

defecto

copia compulsada del mismo.

Remitir

fines

actualizacion

expediente

anexo

proximo

tramite

solicitar,

Certificado de Producto Farmaceutico de Laboratorio Sanofi Aventis Farmaceutica LTDA (Brasil),

original y vigente o

defecto

copia compulsada del mismo.

texto de empaque se considera NO CONFORME, debe contener

siguiente informacion:

Advertencias:

Producto de uso delicado que debe ser administrado bajo estricta vigilancia medica.

caso de ser imprescindible

uso por

existir otra alternativa terapeutica, suspendase

lactancia mientras dure

tratamiento.

No exceda

dosis prescrita.

Mantengase fuera del alcance de los nirios.

Antes de administrar este producto, leer

prospecto interne.

Contraindicaciones:

Alergia a los componentes de

formula.

No se administre durante

embarazo o cuando se sospeche de su existencia.

Corregir

texto

prospecto

interne;

agregando

condiciones

restricciones

contenidas

presente oficio:

lndicaciones:

Tratamiento de

hipertension arterial.

Tratamiento de

insuficiencia cardfaca clase

11-IV.

Para

mejorar

supervivencia

postinfarto

miocardia

pacientes

hemodinamicamente

estables con disfuncion sistolica ventricular izquierda.

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

1041

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

E.F.40.420/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 2 de 4

pJ

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

Venezuela

para

salud

fines del estricto cumplimiento del Articulo 60 del Reglamento de

del Ejercicio de

Farmacia vigente, publicado

Gaceta Oficial

4.582 extraordinario de fecha

mayo de

1.993,

informa

estan

obligados

participar

lnstituto

Nacional

Higiene

"Rafael Rangel"

fecha

cual

inicie

comercializaci6n del primer lote elaborado, de

manera

que los funcionarios

acreditados del

Institute

Nacional

Higiene "Rafael

Rangel",

puedan proceder a captar las muestras correspondientes en

propio sitio de fabricaci6n, o

distribuci6n

caso de los productos importados.

lgualmente

informa que dispone de quince

(15)

dias habiles, para solicitar a esta GERENCIA,

reconsideraci6n

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.

MI/~/GMH.-

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.40.420/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 4 de 4

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