DIOVAN 40 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

VALSARTAN

Commercializzato da:

Novartis Pharmaceuticals UK Ltd

Codice ATC:

C09CA03

INN (Nome Internazionale):

VALSARTAN

Dosaggio:

40 Milligram

Forma farmaceutica:

Film Coated Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Angiotensin II antagonists, plain

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2005-07-29

Foglio illustrativo

Live Text:
 
Yes /   
 
No /   
 
Both Production Site:
Barbera
WO:
1392047
CTM:
Jimenez Lopez, Eva
Comp. Description:
LFT_DIOVAN_ALL DOSAGES_FCT_IE Printing Colours:
Black
Comp. No. New:
1125159-A15-IE
Comp. No. Old:
1125159-A14-IE
Format/Dimension:
190 x (2 x 297) mm
Tech. Drawing No.:
N/A
Technical Colours:
Cutting
Min. Font Size Text:
11 pt
Font Type:
News Gothic
Version No.: 2
Date: 05 Jun 2015
J.N.: 253435
Braille: 
N/A
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PACKAGE LEAFLET:  
INFORMATION FOR THE USER
DIOVAN 40 MG FILM-COATED 
TABLETS
DIOVAN 80 MG FILM-COATED 
TABLETS
DIOVAN 160 MG FILM-COATED 
TABLETS
DIOVAN 320 MG FILM-COATED 
TABLETS
Valsartan
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 Diovan is and what it is used for
2.   What you need to know before you take Diovan
3.   How to take Diovan
4.   Possible side effects
5.   How to store Diovan
6.   Contents of the pack and other information
1.   WHAT DIOVAN IS AND WHAT IT IS USED FOR
Diovan contains the active substance valsartan 
and 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. Diovan works by blocking the effect of 
angiotensin II. As a result, blood vessels relax and 
blood pressure is

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diovan 40 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, ovaloid film-coated tablet with bevelled edges, slightly
convex, scored on one side with debossing “D” on one
side of the score and “O” on the other side of the score
and “NVR” on the reverse side of the tablet. The tablet can be
divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension in children and adolescents 6 to 18 years of
age.
Recent myocardial infarction
Treatment of clinically stable adult patients with symptomatic heart
failure or asymptomatic left ventricular systolic
dysfunction after a recent (12 hours
-
10 days) myocardial infarction (see sections 4.4 and 5.1).
Heart failure
Treatment of adult patients with symptomatic heart failure when
Angiotensin Converting Enzyme (ACE) inhibitors are
not tolerated or in beta-blocker intolerant patients as add-on therapy
to ACE inhibitors when mineralocorticoid receptor
antagonists cannot be used (see sections 4.2, 4.4, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Recent myocardial infarction
In clinically stable patients, therapy may be initiated as early as 12
hours after a myocardial infarction. After an initial
dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80
mg, and 160 mg twice daily over the next few
weeks. The starting dose is provided by the 40 mg divisible tablet.
The target maximum dose is 160 mg twice daily. In general, it is
recommended that patients achieve a dose level of 80
mg twice daily by two weeks after treatment initiation and that the
target maximum dose, 160 mg twice daily, be
achieved by three months, based on the patient's tolerability. If
symptomatic hypotension or renal dysfunction occur,
consideration should be given to a dose reductio