LOSARTAN/HCTZ

Informació principal

  • Denominació comercial:
  • LOSARTAN/HCTZ BEXAL EFG 100/25 mg 28 compr recub
  • formulario farmacéutico:
  • Comprimidos
  • Vía de administración:
  • Oral
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • LOSARTAN/HCTZ BEXAL EFG 100/25 mg 28 compr recub
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 651332
  • última actualització:
  • 07-06-2018

Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses

LOSARTAN/HCTZ BEXAL EFG 100/25 mg 28

compr recub

losartan+hidroclorotiazida

Indicacions

Medicament que augmenta la quantitat d'orina (DI

TIC) i ajuda a regular la pressi

sangu

(ANTIHIPERTENSIU).

Consideracions

NO prengui aquest medicament si

s al

rgic a SULFAMIDES.

Prengui els comprimits sencers, sense partir ni mastegar, empassant-los amb ajuda d'un got d'aigua.

Pot prendre aquest medicament amb o sense aliments; si t

sties d'est

mac, prengui'l amb

algun aliment.

s aconsellable que prengui aquest medicament al mat

o al migdia, per tal d'evitar haver d'aixecar-se

a la nit a orinar.

S'aconsella que prengui aquest medicament sempre en les mateixes condicions per tal d'augmentar la seva

efic

cia.

Segueixi estrictament la pauta indicada pel seu metge pel que fa a dosi i freq

眉猫

ncia d'administraci

Si fa molt temps que pren aquest medicament, NO deixi de prendre-ho de forma brusca sense consultar-

ho abans amb el seu metge.

Avisi el seu metge si pateix intoler

ncia a alguns sucres o diabetis.

Avisi el seu metge si pateix o ha patit problemes de rony

, problemes de fetge o problemes de cor.

Aquest medicament modifica l'acci

d'altres f

rmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmac

utic.

s possible que el seu metge li recomani una dieta especial, que conv

seguir per augmentar l'efic

cia d'aquest medicament.

Procuri NO fumar, NO abusar de begudes alcoh

liques NI de begudes amb cafe

na (caf

, te,

refrescs de cola) NI prendre salses picants NI menjars irritants i seguir la dieta especial que el seu metge

li recomani, per augmentar l'efic

cia d'aquest medicament.

NO utilitzi substituts de la sal de taula ni suplements de potassi sense coneixement del seu metge.

Amb aquest medicament la seva pell pot tornar-se m

s sensible al sol. Durant el tractament, eviti

l'exposici

perllongada als raigs solars i, si no pot evitar-ho, utilitzi crema protectora.

Aquest medicament pot modificar el resultat d'algunes an

lisis de sang.

Aquest medicament pot donar un resultat positiu en els controls de dopatge.

Informi immediatament el seu metge si est

embarassada o creu que pot estar-ho, aix

com si qued

s embarassada durant el tractament.

Avisi al seu metge si t

algun fill a qui estigui alletant.

Efectes adversos

Interrompi immediatament el tractament i AVISI al seu metge si durant el tractament apareix inflor i

envermelliment dels llavis, la llengua i la cara.

Avisi el seu metge si durant el tractament apareix mareigs.

Aquest medicament pot produir mol

sties gastrointestinals (n

usees, v

mits, etc.), mal de cap,

sensaci

de cansament i visi

de punts negres ("mosques volants").

Si not

s qualsevol altre s

mptoma que creu que pot ser causat per aquest medicament, digui-li-ho al

seu metge.

Posologia

Prengui 1 comprimit a l'esmorzar.

VIA ORAL.

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

9-3-2019

Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity

Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity

Affected products The following products containing Losartan manufactured by Hetero Labs Ltd. Unit 1 are being recalled. Health Canada maintains a complete list of sartan drugs that have been recalled because of nitrosamine impurities on its website.

Health Canada

1-3-2019

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

1-3-2019

FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced

FDA - U.S. Food and Drug Administration

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) 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

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

18-1-2019

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

FDA - U.S. Food and Drug Administration

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

20-12-2018

Health Canada releases test results of certain sartan drugs

Health Canada releases test results of certain sartan drugs

Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.

Health Canada

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

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

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

21-4-2010

Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists

Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists

On 16 April 2010, the Danish Medicines Agency decided on the future reimbursement status of some of the losartan-containing medicines in ATC groups C09C and C09D, making these products eligible for general reimbursement as of 19 April 2010.

Danish Medicines Agency

24-3-2010

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of medicines in ATC groups C09C, C09D and C09X

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of medicines in ATC groups C09C, C09D and C09X

On 8 March 2010, a number of pharmaceutical companies put generic copies of the angiotensin II antagonist losartan on the market at prices comparable to those of the cheapest ACE inhibitors.

Danish Medicines Agency

28-2-2019

EU/3/19/2142 (3R Pharma Consulting GmbH)

EU/3/19/2142 (3R Pharma Consulting GmbH)

EU/3/19/2142 (Active substance: Losartan) - Orphan designation - Commission Decision (2019)1734 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002383

Europe -DG Health and Food Safety