DIOVAN 3 Mg/Ml Oral Solution

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:

3 Mg/Ml

Forma farmaceutica:

Oral Solution

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:

2010-05-28

Foglio illustrativo

 
1

PACKAGE LEAFLET: INFORMATION FOR THE USER 

DIOVAN 3 MG/ML ORAL SOLUTION 
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 lowered. 

Diovan 3 mg/ml oral solution CAN BE USED TO TREAT HIGH BLOOD
PRESSURE IN CHILDREN AND ADOLESCENTS 
6 TO 18 YEARS OF AGE. High blood pressure increases the workload
on the heart and arteries. If not 
treated it can damage the blood vessels of the brain, heart, and
kidneys, and may result in a stroke, 
heart failure, or kidney failure. High blood pressure
increases the risk of heart attacks. Lowering your 
blood pressure to normal reduces the risk of developing these

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diovan 3mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 3 mg of valsartan.
Excipients:
Each ml solution contains 0.3 g sucrose, 1.22 mg methyl
parahydroxybenzoate (E218) and 5 mg poloxamer (188)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension in children and adolescents 6 to 18 years of
age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Children and adolescents 6 to 18 years of age
For children and adolescents who are unable to swallow tablets, the
use of the Diovan oral solution is recommended.
The systemic exposure and peak plasma concentration of valsartan is
about 1.7-fold and 2.2-fold higher with the
solution compared to the tablets.
The initial dose for the Diovan oral solution is 20 mg (corresponding
to 7 ml of the solution) once daily for children
and adolescents below 35 kg of weight and 40 mg (corresponding to 13
ml of the solution) once daily for those
weighing 35 kg or more. The dose should be adjusted based on blood
pressure response up to a maximum dose of
40 mg valsartan once daily (corresponding to 13 ml of the solution)
for children and adolescents with body weight
below 35 kg and 80 mg valsartan (corresponding to 27 ml of the
solution) for children and adolescents with body
weight of 35 kg or more.
Switching between Diovan tablets and Diovan Oral Solution
It is not recommended to switch between Diovan tablets and Diovan oral
solution unless clinically required
If switching from Diovan tablets to Diovan oral solution is considered
essential on clinical grounds, the valsartan dose
should be adjusted as described in the table below and blood pressure
should be carefully monitored. The dose should
be titrated based on blood pressure response and tolerability.
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