DIOVAN 320 Milligram Film Coated Tablet

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

VALSARTAN

Доступно од:

Novartis Pharmaceuticals UK Ltd

АТЦ код:

C09CA03

INN (Међународно име):

VALSARTAN

Дозирање:

320 Milligram

Фармацеутски облик:

Film Coated Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Angiotensin II antagonists, plain

Статус ауторизације:

Authorised

Датум одобрења:

2007-06-01

Информативни летак

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

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diovan 320 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 320 mg valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Dark grey-violet, ovaloid film-coated tablet with bevelled edges,
slightly convex, scored on one side with debossing
“DC” on one side of the score and “DC” on the other side of
the score and “NVR” on the reverse side of the tablet. 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
Hypertension
Treatment of essential hypertension in adults, and hypertension in
children and adolescents 6 to 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Hypertension
The recommended starting dose of Diovan is 80 mg once daily. The
antihypertensive effect is substantially present
within 2 weeks, and maximal effects are attained within 4 weeks. In
some patients whose blood pressure is not
adequately controlled, the dose can be increased to 160 mg and to a
maximum of 320 mg.
Diovan may also be administered with other antihypertensive agents
(see sections 4.3, 4.4, 4.5 and 5.1). The addition of
a diuretic such as hydrochlorothiazide will decrease blood pressure
even further in these patients.
_Additional information on special populations_
Older people
No dose adjustment is required in elderly patients.
Patients with Renal impairment
No dose adjustment is required for adult patients with a creatinine
clearance >10 ml/min (see sections 4.4 and 5.2).
Patients with Hepatic impairment
Diovan is contraindicated in patients with severe hepatic impairment,
biliary cirrhosis and in patients with cholestasis
(see sections 4.3, 4.4 and 5.2). In patients with mild to moderate
hepatic impairment without cholestasis, the dose of
valsartan should not exceed 80 mg.
_Paediatric population_
Paediatric hypertension
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