Diovan 3mg/1ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valsartan

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

C09CA03

INN (International Name):

Valsartan

Dosage:

3mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5010678904130

Patient Information leaflet

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
disorders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIOVAN
DO NOT TAKE DIOVAN:

if you are
ALLERGIC
(hypersensitive) to valsartan or any of the other ingredients of this
medicine
(listed in section 6).

if you have
SEVERE LIVER DISEASE.

if you are
MORE

Summary of Product characteristics

OBJECT 1
DIOVAN ORAL SOLUTION
Summary of Product Characteristics Updated 13-Apr-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Diovan
®
3 mg/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 to