LOSARTAN /HYDROCHLOROTHIAZIDE BLUEFISH 100/25 Milligram Film Coated Tablet

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE

Saatavilla:

Bluefish Pharmaceuticals AB

ATC-koodi:

C09DA01

INN (Kansainvälinen yleisnimi):

LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE

Annos:

100/25 Milligram

Lääkemuoto:

Film Coated Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Angiotensin II antagonists and diuretics

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-02-25

Pakkausseloste

PACKAGE LEAFLET : INFORMATION FOR THE USER 

LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH 50 MG/12.5
MG AND 100 MG/25 MG FILM-COATED 
TABLETS 

(LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE) 

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  TAKING  THIS  MEDICINE  BECAUSE  IT  CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
-  Keep this leaflet. You may need to read it again. 
-  If you have any further questions, ask your doctor
or pharmacist. 
-  This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, 
even if their signs of illness are the same as yours. 
-  If  you get any of the side effects, talk to your doctor or pharmacist.

This includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET:  
1.  What Losartan/Hydrochlorothiazide Bluefish is and what it is
used for 
2.  What you need to know
before you take Losartan/Hydrochlorothiazide Bluefish  
3.  How to take Losartan/Hydrochlorothiazide Bluefish  
4.  Possible side effects. 
5.  How to store Losartan/Hydrochlorothiazide Bluefish  
6.  Contents of the pack and other information 

1.  WHAT LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH IS AND WHAT IT IS
USED FOR 

Losartan/Hydrochlorothiazide  Bluefish  is  a  combination  of  an  angiotensin  II  receptor  antagonist 
(losartan) and a diuretic (hydrochlorothiazide). 

Losartan/Hydrochlorothiazide  Bluefish  is  indicated  for  the  treatment  of  essential  hypertension 
(high blood pressure). 

2.  WHAT YOU NEED TO
KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH   

DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH  


  if you are allergic to losartan, hydrochlorothiazide or to
any of the other 
ingredients of  this medicine (listed in section 6). 

  if  you

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide Bluefish 100 mg/25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Losartan/Hydrochlorothiazide Bluefish 100 mg/25 mg film-coated tablet
contains: 100 mg of losartan potassium and 25
mg of hydrochlorothiazide.
Excipient:
Losartan/Hydrochlorothiazide Bluefish 100 mg/25 mg film-coated tablet
contains 310.00 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Losartan/Hydrochlorothiazide Bluefish 100 mg/25 mg film-coated tablets
are yellow and round with a score line.
The score-line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan/Hydrochlorothiazide Bluefish is indicated for treatment of
essential hypertension in patients whose blood
pressure is not adequately controlled on losartan or
hydrochlorothiazide alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is available in 2 strengths: 50 mg/12.5 mg and
100 mg/25 mg
Posology
Hypertension
Losartan and hydrochlorothiazide is not for use as initial therapy,
but in patients whose blood pressure is not adequately
controlled by losartan potassium or hydrochlorothiazide alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered in patients
whose blood pressure is not adequately controlled.
The usual
maintenance dose of Losartan/Hydrochlorothiazide Bluefish is one
tablet
of Losartan/Hydrochlorothiazide
Bluefish 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg)
once daily.
For patients who do not respond
adequately to Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg,
the dosage may be increased to one tablet
of
Losartan/Hydrochlorothiazide Bluefish 100 mg/25 mg (losartan 100
mg/Hydrochlorothiazide25 mg) once daily.
The
maximum d