Diovan 40 mg film-coated tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Valsartan

Disponibbli minn:

Novartis Ireland Limited

Kodiċi ATC:

C09CA; C09CA03

INN (Isem Internazzjonali):

Valsartan

Dożaġġ:

40 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Angiotensin II antagonists, plain; valsartan

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2005-07-29

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

Health Products Regulatory Authority
30 June 2020
CRN009ML5
Page 1 of 14
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 less than
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
hypot