CADIVAST 10/20 amlodipine (as besilate) and atorvastatin (as calcium) 10 mg/20 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate,atorvastatin calcium trihydrate

Available from:

Alphapharm Pty Ltd

INN (International Name):

amlodipine besilate,atorvastatin calcium trihydrate

Authorization status:

Registered

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CADIVAST
®
_Amlodipine (as besilate) and atorvastatin (as calcium trihydrate)
tablets _
1
NAME OF THE MEDICINE
Amlodipine (as besilate) and atorvastatin (as calcium trihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients in Cadivast are amlodipine besilate and
atorvastatin calcium trihydrate.
Excipients with known effect: Soya bean products
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CADIVAST 5/10 TABLETS
:
A white to off-white, film-coated, oval, biconvex tablet debossed with
“AA
4” on one side of the tablet and “M” on the other side.
CADIVAST 5/20 TABLETS
:
A white to off-white, film-coated, round, biconvex tablet debossed
with “AA
5” on one side of the tablet and “M” on the other side.
CADIVAST 5/40 TABLETS
:
A white to off-white, film-coated, capsule shaped, biconvex tablet
debossed
with “AA 6” on one side of the tablet and “M” on the other
side.
CADIVAST 5/80 TABLETS
:
A white to off-white, film-coated, oval, biconvex tablet debossed with
“AA
7” on one side of the tablet and “M” on the other side
CADIVAST 10/10 TABLETS
:
A blue, film-coated, barrel shaped, biconvex tablet debossed with
“AA 8” on
one side of the tablet and “M” on the other side.
CADIVAST 10/20 TABLETS
:
A blue, film-coated, oval, biconvex tablet debossed with “AA 9” on
one side
of the tablet and “M” on the other side.
CADIVAST 10/40 TABLETS
:
A blue, film-coated, round, biconvex tablet debossed with “AA 10”
on one
side of the tablet and “M” on the other side.
CADIVAST 10/80 TABLETS
:
A blue, film-coated, capsule shaped, biconvex tablet debossed with
“AA 11”
on one side of the tablet and “M” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amlodipine besilate and atorvastatin calcium trihydrate tablet is
indicated for patients in whom treatment
with amlodipine and atorvastatin is appropriate at the doses
presented.
THE INDICATIONS FOR AMLODIPINE ARE:
1.
Hyperte