VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED 320/25 mg/mg Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN HYDROCHLOROTHIAZIDE

Available from:

Fair-Med Healthcare GmbH

INN (International Name):

VALSARTAN HYDROCHLOROTHIAZIDE

Dosage:

320/25 mg/mg

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER  

VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED 80 MG/12.5 MG
FILM-COATED TABLETS  
VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED 160 MG/12.5 MG FILM-COATED
TABLETS  
VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED 160 MG/25 MG
FILM-COATED TABLETS  
VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED 320 MG/12.5 MG FILM-COATED
TABLETS  
VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED 320 MG/25 MG
FILM-COATED TABLETS 

Valsartan/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 side effects, talk to your doctor or pharmacist.
This includes any 
possible side effects not listed in this leaflet. 

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

1. WHAT VALSARTAN/HYDROCHLOROTHIAZIDE FAIR-MED IS AND WHAT IT IS USED
FOR  

Valsartan/Hydrochlorothiazide Fair-Med film-coated tablets
contain two active 
substances called valsartan and hydrochlorothiazide. Both of these
substances help to 
control high blood pressure (hypertension).  

•  VALSARTAN  belongs to a class of medicines known as
“angiotensin II receptor 
antagonists”, which help to control high blood pressure. Angiotensin
II is a substance 
in the body that causes vessels to tighten, thus causing your blood
pressure to 
increase. Valsartan works by blocking the effect of angi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydrochlorothiazide Fair-Med 320 mg/25 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 320mg valsartan and 25mg hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Yellow, oval-shaped film coated tablets debossed with ‘L239’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsartan/Hydrochlorothiazide Fair-Med fixed-dose combination is indicated in patients whose blood pressure is not
adequately controlled on valsartan or hydrochlorothiazide monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Valsartan/Hydrochlorothiazide Fair-Med 80/12.5mg or 160/12.5mg or 160/25mg or
320/12.5mg or 320/25mg is one film-coated tablet once daily. Dose titration with the individual components is
recommended. In each case, up-titration of individual components to the next dose should be followed in order to
reduce the risk of hypotension and other adverse events.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients
whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the
recommended dose titration sequence for the individual components is followed.
The clinical response to Valsartan/Hydrochlorothiazide Fair-Med should be evaluated after initiating therapy and if
blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a
maximum dose of Valsartan/Hydrochlorothiazide Fair-Med 320 mg/25 mg.
The antihypertensive effect is substantially present within�