TAMCORE HCT

Información principal

  • Denominación comercial:
  • TAMCORE HCT 160 mg-12,5 mg COMPRIMIDOS RECUBIERTOS
  • Dosis:
  • 160 mg-12,5 mg
  • formulario farmacéutico:
  • COMPRIMIDO
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • SANOFI -AVENTIS DE COLOMBIA, S.A.

Documentos

Localización

  • Disponible en:
  • TAMCORE HCT 160 mg-12,5 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.40.458
  • Fecha de autorización:
  • 22-01-2014
  • última actualización:
  • 03-09-2018

Prospecto

Gobiemo Bolivariano

Ministerio del Poder Popular

Venezuela

para

salud

SISTEMA NACIONAL

REGISTRO SANITARIO DE PRODUCTOS FARMACEUTICOS

RCEF-R-009512014

Caracas, 22 de Enero

2014

Ciudadano(a)

DR. (A). LEONARDO

CADET VARGAS.

Farmaceutico Patrocinante

MEDLEY FARMACEUTICA, S.A.

Presente.-

Vista

solicitud

SREF-11-0521,

categoria

actuando

representaci6n

MEDLEY FARMACEUTICA, S.A., de conformidad

lo establecido en los articulos 1 y

de Medicamentos, publicada en

Gaceta Oficial de

Republica Bolivariana de Venezuela

37.006

del 03 de Agosto de 2.000; siendo favorables los resultados de

evaluaci6n integral,

Institute

Nacional

Higiene

"Rafael

Rangel"

APRUEBA

Producto:

TAMCORE

12,5 mg

COMPRIMIDOS RECUBIERTOS.

Principio(s) Activo(s): VALSARTAN I HIDROCLOROTIAZIDA.

su(s) presentaci6n(es): BLiSTER DE PVC

I

PVDC TRANSPARENTE E INCOLORO

FOIL

ALUMINIO,

ESTUCHE DE CARTON. Venta al Publico: CONTENTIVO

10, 12, 14,

30 y 32 COMPRIMIDOS RECUBIERTOS. Muestra(s) Medica(s): CONTENTIVA

2 y 4

COMPRIMIDOS RECUBIERTOS. Envase Hospitalario: CONTENTIVO

60, 80, 100, 120, 160, 240,

320 y 360 COMPRIMIDOS RECUBIERTOS.

Regimen de venta: CON prescripci6n facultativa.

Propietario: WHINTROP PHARMACEUTICALS

COLOMBIA S.A. I COLOMBIA.

Elaborado por: SANOFI AVENTIS DE COLOMBIA S.A. I COLOMBIA.

Fabricante Envasador: SANOFI AVENTIS

VENEZUELA, S.A. I VENEZUELA.

presente autorizaci6n ha quedado registrada bajo

E.F.40.458114, en

libro EF-2014-01

pag. 49 sometida a todo lo previsto en

Ley de Medicamentos y cualquier otra Normativa Legal que

regule

materia.

~U~~YM.-

Ciudad Universitaria UCV, Los Chaguaramos. Caracas- Republica Bolivariana de Venezuela C6d.

1041

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

E.F.40.458/14

F-PERC-006

Enero 2014

Revision 3

Pagina 1 de 1

Gobiemo Bolivariano

Ministerio

Poder

Popular

Venezuela

para

salud

EF-R-0096/2014

Caracas, 22 de Enero de 2014

Ciudadano(a)

DR. (A). LEONARDO

CADET VARGAS.

Farmaceutico Patrocinante

MEDLEY FARMACEUTICA, S.A.

Presente.-

De conformidad con el Oficio RCEF-R-0095/2014 de fecha 22/01/2014 mediante el cual se le notific6

aprobaci6n

Producto

Farmaceutico

TAMCORE

12,5

COMPRIMIDOS

RECUBIERTOS

Registro

Sanitaria

E.F.40.458/14,

segun

consta

libro

EF-2014-01,

Pag. 49 usted debera cumplir con las siguientes condiciones de comercializaci6n:

COMUNICAR A LOS PRESCRIPTORES SEGUN

ESTABLECIDO

MEDICAMENTOS ARTiCULO

siguiente:

lndicaciones:

Tratamiento

segunda

lfnea

hipertensi6n

arterial

aquellos

pacientes

responden a

monoterapia.

Posologfa:

Adultos: Valsartan: 80 mg - 320 mg

I

Hidroclorotiazida: 12,5 mg - 25 mg, una vez

dfa.

Dosis maxima diaria: 320 mg de Valsartan

I

25mg de Hidroclorotiazida.

Advertencias:

En caso de ser imprescindible su uso por no existir otra alternativa terapeutica, suspendase

lactancia mientras dure el tratamiento.

No se administre en pacientes con insuficiencia hepatica o renal.

No se administre concomitantemente con otros diureticos.

Precauciones:

Pacientes diabeticos que reciben tratamiento con insulina o hipoglicemiantes orales.

Realizar control peri6dico del funcionalismo renal, hepatico, electr61itos sericos

acido urico.

Contraindicaciones:

Hipersensibilidad a los componentes de

formula.

No se administre durante

embarazo o cuando se sospeche su existencia.

Reacciones Adversas:

Piel: erupci6n cutanea.

Gastrointestinal: gastritis, nauseas, v6mitos.

Sistema nervioso central: mareos.

lnteracciones:

Alcohol,

barbituricos

narc6ticos,

hipoglicemiantes

orales,

antihipertensivos,

resina

colestiramina y de colestipol, costicosteroides, ACTH, relajantes musculares no despolarizantes

y litio.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas- Republica Bolivariana de Venezuela C6d.

1041

Telefono: (0058-0212) 219.1622- http://www.inhrr.gob.ve-

RIF:

G-20000101-1

E.F.40.458/14

F-PERC-007

Diciembre

2011

Revisi6n 2

l"''"''

Gobiemo

Bolivariano

I

Ministerio del Poder Popular

Venezuela

para

salud

Se le asigna

producto un perfodo de validez comprobado de dos (02) arias, almacenado bajo

las condiciones climaticas de Venezuela (30

± 2

I

± 5 % HR), en el envase BLISTER

I

PVDC TRANSPARENTE E INCOLORO CON FOIL DE ALUMINIO.

Corregir texto de empaque segun model a anexo y agregar

siguiente:

Via de administraci6n: Oral

lndicaciones y Posologia: A juicio del facultative.

Advertencias:

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

caso de ser imprescindible su usa par

existir otra alternativa terapeutica, suspemdase

lactancia mientras dure el tratamiento.

No exceda

dosis prescrita.

Mantengase fuera del alcance de los nirios.

Antes de administrar este producto, leer el prospecto interne.

Contraindicaciones:

Alergia a los componentes de

formula.

No se administre durante el embarazo o cuando se sospeche su existencia.

caso

requerir variaci6n

las presentaciones aprobadas,

debera

realizar el

tramite

individual correspondiente.

Remitir peri6dicamente, Certificado de Producto Farmaceutico, Certificado de Libre Venta ylo

Certificado de Buenas Practicas de Manufactura, vigentes.

Los textos de empaque, etiqueta, unidad posol6gica y prospecto interne 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 no 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 el producto.

Presentar ante

Institute Nacional de Higiene "Rafael Rangel", cualquier cambia que tenga

producto durante su periodo de Comercializaci6n, relacionado con aspectos de: textos, legales,

farmaceuticos y clinicos, para

cual debera emplear los formularies de solicitud de cambia

post-registro vigentes ylo comunicaciones.

Debe

indicar

Despacho

cuatro

(04)

meses

anticipaci6n,

fecha

probable

comercializaci6n

producto

farmaceutico.

este

lapso

tiempo

procedera

EVALUACION de

metodologfa analftica utilizada en el control de calidad del producto y a

programaci6n respectiva.

10. A los fines del estricto cumplimiento del Articulo 60 del Reglamento de

Ley del Ejercicio de

Farmacia vigente, publicado en Gaceta Oficial

4.582 extraordinario de fecha

de mayo de

1.993, se informa que estan obligados a participar

allnstituto

Nacional

Higiene

"Rafael

Rangel"

fecha en

cual se inicie

comercializaci6n del primer late elaborado, de manera que

los funcionarios acreditados dellnstituto Nacional de Higiene "Rafael Rangel", puedan proceder a

captar las muestras correspondientes en

propio sitio de fabricaci6n, o de distribuci6n

caso de los productos importados.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas- Republica Bolivariana de Venezuela C6d.

1041

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

E.F.40.458/14

F-PERC-007

Diciembre

2011

Revision 2

-~a2de2

('J

Gobiemo

Bolivariano

I

Ministerio del Poder Popular

Venezuela

para

salud

lgualmente

informa que dispone de quince

(15)

dias habiles, para solicitar a esta GERENCIA,

reconsideraci6n

las exigencias serialadas ANTERIORMENTE. Transcurrido dicho lapse queda

usted

obligaci6n de cumplir

las condiciones de uso bajo las cuales fue aprobado

producto.

incumplimiento

alguna

condiciones

comercializaci6n

sera

sancionado

CANCELACION del producto.

~~YM.-

Ciudad Universitaria UCV, Los Chaguaramos. Caracas- Republica Bolivariana de Venezuela C6d.

1041

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

E.F.40.458/14

F-PERC-007

Diciembre

2011

Revision 2

Pagina 3 de 2

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

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

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