Diovan Tablet 40mg
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
06-06-2014
Summary of Product characteristics
(SPC)
16-01-2019
Active ingredient:
Valsartan
Available from:
NOVARTIS (SINGAPORE) PTE LTD
ATC code:
C09CA03
Dosage:
40.00 mg
Pharmaceutical form:
TABLET, FILM COATED
Composition:
Valsartan 40.00 mg
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
Novartis Pharma Stein AG
Authorization status:
ACTIVE
Authorization date:
2005-05-20
Patient Information leaflet
DIOVAN
Angiotensin II antagonist
DESCRIPTION AND
COMPOSITION
PHARMACEUTICAL FORMS
Film-coated tablet.
Diovan 40 mg: Yellow, ovaloid with bevelled edges, scored on one side; with debossing
“DO” on the scored side and “NVR” on the other side
Diovan 80 mg: Pale red, round with bevelled edges, scored on one side; with debossing
“D/V” on the scored side and “NVR” on the other side
Diovan 160 mg: Grey-orange, ovaloid, scored on one side; with debossing “DX/DX” on the
scored side and “NVR” on the other side
Diovan 320 mg: Dark grey-violet, ovaloid with bevelled edges with debossing “DXL” on one
side and “NVR” on the other side.
Appearance of tablets may differ between countries. Certain dosage strengths may not be
available in all countries.
ACTIVE SUBSTANCE
Active substance: (_S_)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-valine (INN
= valsartan).
One tablet contains 40 mg, 80 mg, 160 mg or 320 mg valsartan.
EXCIPIENTS
Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate,
hypromellose, titanium dioxide (E171), Macrogol 8000, red iron oxide (E172), yellow iron
oxide (E172), black iron oxide (E172; 40 mg, 160 mg and 320 mg tablets only), brown iron
oxide (mixture of red iron oxide and black iron oxide
(320 mg tablets only).
Pharmaceutical formulations may vary between countries.
INDICATIONS
HYPERTENSION
Treatment of hypertension.
Novartis
Page 2
Country Specific Package Leaflet
31 Oct 2013
Diovan film-coated tablets
HEART FAILURE
Treatment of heart failure (NYHA class II-IV) in patients receiving standard therapy such as
diuretics, digitalis and either angio
Read the complete document
Summary of Product characteristics
TRADE NAME
Diovan® 40 mg, 80 mg and 160 mg film coated tablets
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
One tablet contains 40 mg, 80 mg or 160 mg of valsartan
.
PHARMACEUTICAL FORMS
Film-coated tablet (FCT)
Diovan 40 mg: Yellow, ovaloid with bevelled edges, scored on one side;
with debossing
“DO” on the scored side and “NVR” on the other side. The score
line on one side of Diovan
40mg FCT is to divide the tablet into equal doses.
Diovan 80 mg: Pale red, round with bevelled edges, scored on one side;
with debossing
“D/V” on the scored side and “NVR” on the other side
Diovan 160 mg: Grey-orange, ovaloid, scored on one side; with
debossing “DX/DX” on the
scored side and “NVR” on the other side
Appearance of tablets may differ between countries. Certain dosage
strengths may not be
available in all countries.
The score line on one side of Diovan 80mg or 160mg FCT is only to
facilitate breaking for
ease of swallowing and not to divide into equal doses.
EXCIPIENTS
Microcrystalline
cellulose,
crospovidone,
colloidal
anhydrous
silica,
magnesium
stearate,
hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide
(E172), yellow iron
oxide (E172), black iron oxide (E172; 40 mg or 160 mg tablets only),
Pharmaceutical formulations may vary between countries.
INDICATIONS
HYPERTENSION
Treatment of hypertension.
HEART FAILURE
Treatment of heart failure (NYHA class II-IV) in patients receiving
standard therapy such as
diuretics,
digitalis
and
either
angiotensin-converting
enzyme
(ACE)
inhibitors
or
beta-
blockers but not both; presence of all these standard therapies is not
mandatory.
Diovan improves morbidity in these patients, primarily via reduction
in hospitalization for
heart failure. Diovan also slows the progression of heart failure,
improves NYHA functional
Novartis
Country Specific Package Leaflet
10 Sep 2018
Page
2
Diovan film-coated
tablets
class, ejection fraction and signs and symptoms of heart failure and
improves quality of life
versus placebo (see section CLINICAL PHARMACOLO
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