Diovan 320 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Valsartan

זמין מ:

Novartis Ireland Limited

קוד ATC:

C09CA; C09CA03

INN (שם בינלאומי):

Valsartan

כמות:

320 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Angiotensin II antagonists, plain; valsartan

מצב אישור:

Marketed

תאריך אישור:

2007-06-01

עלון מידע

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 lowered.
Diovan 40 mg film-coated tablets
CAN BE USED FOR THREE DIFFERENT CONDITIONS:

TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO LESS
THAN 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.

TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK
(myocardial infarction)
.
“Recen

מאפייני מוצר

Health Products Regulatory Authority
30 June 2020
CRN009ML5
Page 1 of 13
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