CO-DIOVAN 160 PLUS TABLET

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

Novartis South Africa (Pty) Ltd

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS HYDROCHLOROTHIAZIDE 25,0 mg VALSARTAN 160,0 mg

Estado de Autorización:

Canceled

Fecha de autorización:

2007-01-11

Información para el usuario

Applicant
Novartis South Africa (Pty) Ltd
Product Name
DIOVAN 40, 80, 160 and 320
Strength and dosage form
Each film-coated tablet contains 40, 80, 160 or 320 mg valsartan
1.3.2 APPROVED PATIENT INFORMATION LEAFLET
17 February 2022
Page 1 of 14
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
DIOVAN 40 MG, 80 MG, 160 MG, 320 MG FILM-COATED TABLETS
VALSARTAN
SUGAR FREE
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 belongs to a class of medicines known as angiotensin-II
receptor antagonists, which help to
control high blood pressure.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DIOVAN
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
DIOVAN has been prescribed for you personally and you should not share
your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
Applicant
Novartis South Africa (Pty) Ltd
Product Name
DIOVAN 40, 80, 160 and 320
Strength and dosage form
Each film-coated tablet contains 40, 80, 160 or 320 mg valsartan
1.3.2 APPROVED PATIENT INFORMATION LEAFLET
17 February 2022
Page 2 of 14
DIOVAN is used to treat high blood pressure. Due to narrowed arteries
high blood pressure increases
your heart’s workload. If it continues for a long time, 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.
DIOVAN is used to treat adult heart failure patients. Heart failure is
associated with shortness of breath,
and swelling of the feet and legs due to fluid build-up. Heart failure
means that the hea

Ficha técnica

Applicant
Novartis South Africa (Pty) Ltd
Product Name
Diovan 40, 80, 160 and 320
Dosage form and strength
Each film-coated tablet contains 40, 80, 160 or 320 mg valsartan
1.31.1 APPROVED PROFESSIONAL INFORMATION
17 February 2022
Page 1 of 29
SCHEDULING STATUS: S3 1. NAME OF THE MEDICINE
DIOVAN
® 40
(Film-coated tablet)
DIOVAN
® 80 TABLETS
(Film-coated tablet)
DIOVAN
® 160 TABLETS
(Film-coated tablet)
DIOVAN
® 320 TABLETS
(Film-coated tablet)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 40 mg, 80 mg, 160 mg or 320 mg valsartan.
For the full list of excipients, see SECTION 6.1
3. PHARMACEUTICAL FORM
Film Coated tablets (FCT)
_DIOVAN_
_®_
_ 40 Tablet: _
Applicant
Novartis South Africa (Pty) Ltd
Product Name
Diovan 40, 80, 160 and 320
Dosage form and strength
Each film-coated tablet contains 40, 80, 160 or 320 mg valsartan
1.31.1 APPROVED PROFESSIONAL INFORMATION
17 February 2022
Page 2 of 29
Yellow, ovaloid with bevelled edges, scored on one side with debossing
“DO” on the scored side
and “NVR” on the other side.
Length: approximately 9,1 mm
Width: approximately 3,5 mm
The score line on one side of DIOVAN 40 mg film-coated tablet is to
divide the tablet into equal
doses.
_DIOVAN_
_®_
_ 80 Tablet: _
Pale red, round film-coated tablet with bevelled edges, imprinted
“D/V” on the one side and “NVR”
on the other side.
Diameter: approximately 8,2 mm
_DIOVAN_
_®_
_ 160 Tablet: _
Grey-orange, ovaloid film-coated tablet, imprinted “DX” on the one
side and “NVR” on the other
side.
Length: approximately 14,2 mm
Width: approximately 5,7 mm
Applicant
Novartis South Africa (Pty) Ltd
Product Name
Diovan 40, 80, 160 and 320
Dosage form and strength
Each film-coated tablet contains 40, 80, 160 or 320 mg valsartan
1.31.1 APPROVED PROFESSIONAL INFORMATION
17 February 2022
Page 3 of 29
_DIOVAN_
_®_
_ 320 Tablet: _
Dark grey-violet, ovaloid film-coated tablet with bevelled edges,
imprinted “DXL” on the one side
and “NVR” on the other side.
Length: approximately 17,6 mm
Width: a