6. Pharmaceutical particulars
6.1 List of excipients
Co-Diovan 80/12.5 mg Tablets:

Core:

Microcrystalline cellulose

Silica, colloidal anhydrous

Crospovidone

Magnesium stearate

Coating:

Hypromellose

Macrogol 8000

Talc

Red iron oxide (E172)

Yellow iron oxide (E172)

Titanium dioxide (E171).

Co-Diovan 160/12.5 mg Tablets:

Core:

Microcrystalline cellulose

Silica, colloidal anhydrous

Crospovidone

Magnesium stearate

Coating:

Hypromellose,

Macrogol 8000

Talc

Titanium dioxide (E171)

Red iron oxide (E172)

Co-Diovan 160/25 mg Tablets:

Core:

Microcrystalline cellulose

Silica, colloidal anhydrous

Crospovidone

Magnesium stearate

Coating:

Hypromellose

Macrogol 8000

Talc

Titanium dioxide (E171)

Red iron oxide (E172)

Yellow iron oxide (E172)

Black iron oxide (E172)

6.2 Incompatibilities
Not applicable.

6.3 Shelf life

Co-Diovan 80/12.5 mg Tablets:
 3 years
 
Co-Diovan 160/12.5 mg Tablets:
 3 years
 
Co-Diovan 160/25 mg Tablets:
 3 years
 

6.4 Special precautions for storage
Do not store above 30°C.

Store in the original package.

6.5 Nature and contents of container
PVC/PE/PVDC, PVC/PVDC aluminium blister packs containing 28, 56 and 98 tablets per pack.

6.6 Special precautions for disposal and other handling
No specific instructions for use / handling.

7. Marketing authorisation holder
Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

8. Marketing authorisation number(s)
Co-Diovan 80/12.5 mg Tablets: PL 00101/0480

Co-Diovan 160/12.5 mg Tablets: PL 00101/0650

Co-Diovan 160/25 mg Tablets: PL 00101/0651

9. Date of first authorisation/renewal of the authorisation
Co-Diovan 80/12.5 mg Tablets:
 29 January 2003 / 03 November 2010
 
Co-Diovan 160/12.5 mg Tablets:
 23 June 2004 / 03 November 2010
 
Co-Diovan 160/25 mg Tablets:
 23 June 2004 / 03 November 2010

10. Date of revision of the text
24 June 2014