Valsartan/HCTZ Fair-Med 80mg/12,5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, VALSARTAN

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

C09DA03

INN (International Name):

HYDROCHLOROTHIAZIDE 80 mg VALSARTAN 12.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 80 mg VALSARTAN 12.5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2013-03-15

Patient Information leaflet

 
1
PACKAGE LEAFLET: INFORMATION FOR THE USER  

VALSARTAN/HCTZ FAIR-MED 80 MG/12.5 MG FILM-COATED TABLETS 
VALSARTAN/HCTZ FAIR-MED 160 MG/12.5 MG FILM-COATED TABLETS 
VALSARTAN/HCTZ FAIR-MED 160 MG/25 MG FILM-COATED TABLETS 
VALSARTAN/HCTZ FAIR-MED 320 MG/12.5 MG FILM-COATED TABLETS 
VALSARTAN/HCTZ 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. See section 4.  

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

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

Valsartan/HCTZ 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 angiotensin II. As
a result, blood 
vessels relax and blood pressure is lowered.  

• HYDROCHLOROTHIAZIDE belongs to a group of medicines calle

Summary of Product characteristics

 
1
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Valsartan/HCTZ Fair-Med 80mg/12,5mg film-coated Tablets 
Valsartan/HCTZ Fair-Med 160mg/12,5mg film-coated Tablets 
Valsartan/HCTZ Fair-Med 160mg/25mg film-coated Tablets 
Valsartan/HCTZ Fair-Med 320mg/12,5mg film-coated Tablets 
Valsartan/HCTZ Fair-Med 320mg/25mg film-coated Tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Valsartan/HCTZ Fair-Med 80/12.5 mg film-coated tablets:  
Each film-coated tablet contains 80mg valsartan and 12.5mg
hydrochlorothiazide.  
Valsartan/HCTZ Fair-Med 160/12.5 mg film-coated tablets: 

Each film-coated tablet contains 160mg valsartan and 12.5mg
hydrochlorothiazide. 
Valsartan/HCTZ Fair-Med 160/25 mg film-coated tablets:  
Each film-coated tablet contains 160mg valsartan and 25mg
hydrochlorothiazide.   
Valsartan/HCTZ Fair-Med 320/12.5 mg film-coated tablets: 

Each film-coated tablet contains 320mg valsartan and 12.5mg
hydrochlorothiazide. 
Valsartan/HCTZ Fair-Med 320/25 mg film-coated tablets:  
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 

Valsartan/HCTZ Fair-Med 80/12.5 mg 
Light orange, oval-shaped film coated tablets debossed with
‘L235’ on one side and 
plain on other side. 
Valsartan/HCTZ 
Fair-Med 
160/12.5 
mg 

Dark red, oval-shaped film coated tablets debossed with ‘L236’ on
one side and plain 
on other side. 
Valsartan/HCTZ Fair-Med 160/25 mg 

Brown orange, oval-shaped film coated tablets debossed with ‘L237’
on one side and 
plain on other side.   
Valsartan/HCTZ Fair-Med 320/12.5 mg 
Pink, oval-shaped film coated tablets debossed with ‘L238’ on one
side and plain on 
other side. 

Valsartan/HCTZ Fair-Med 320/25 mg  
Yellow, oval-shaped film coated tablets debossed with ‘L239’ on
one side and plain 
on other side.