CADATIN 10/40
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
17-08-2017
Summary of Product characteristics
(SPC)
16-08-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
amlodipine besilate,Atorvastatin calcium
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
amlodipine besilate,Atorvastatin calcium
Patient Information leaflet
CADATIN™
_5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 AND 10/80_
_Amlodipine Besilate and Atorvastatin Calcium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cadatin.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cadatin
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CADATIN IS USED
FOR
Cadatin is used to treat high blood
pressure and high cholesterol (fat in
the blood). Cadatin can also be used
for angina (a certain type of chest
pain). Cadatin can be used in people
who have high blood pressure and
coronary heart disease (CHD) or who
are at risk of CHD (for example, if
they have diabetes, a history of
stroke, or small blood vessel
disease). In these people, Cadatin is
used to help reduce the risk of having
a heart attack or stroke.
_WHAT IS HIGH BLOOD_
_PRESSURE?_
There are usually no symptoms of
high blood pressure (hypertension).
The only way of knowing that you
have hypertension is to have your
blood pressure checked on a regular
basis. If high blood pressure is not
treated it can lead to serious health
problems.
_WHAT IS CHOLESTEROL?_
Everyone has cholesterol in their
blood. It is a type of blood fat needed
by the body for things such as
building cell lining, making bile
acids (which help to digest food) and
some hormones. However, too much
cholesterol can be a problem.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body makes too much
cholesterol or you take too much
cholesterol in your diet, then your
level becomes too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
There are different types of
cholesterol. LDL, or lo
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Summary of Product characteristics
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Page 1 of 34
PRODUCT INFORMATION
CADATIN
5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 AND 10/80
(AMLODIPINE BESILATE AND ATORVASTATIN CALCIUM)
NAME OF THE MEDICINE
CADATIN amlodipine (as besilate) and atorvastatin (as calcium) 5 mg/
10mg, 5 mg/20 mg,
5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10
mg/80 mg tablets.
CADATIN contains the active ingredients amlodipine besilate and
atorvastatin calcium.
AMLODIPINE BESILATE
Amlodipine besilate is a dihydropyridine derivative and has the
following structural formula
and enantiomer:
Chemical name:
3-ethyl, 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-
chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
benzene sulphonate
Molecular formula:
C
20
H
25
ClN
2
O
5.
C
6
H
6
O
3
S
Molecular weight:
567.1 (free base 408.9)
CAS registry number:
111470-99-6.
ATORVASTATIN CALCIUM
Atorvastatin calcium has the following structural formula:
NHC
N
O
CH
CH
3
CH
3
CH
2
CH
2
CH
2
CH
2
CH
CH
C
O
O
-
F
2
•Ca
•3H O
2
2+
OH
OH
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Page 2 of 34
Chemical name:
[R-(R*,R*)]-2-(4-fluorophenyl)-ß,
-dihydroxy-5-(1-methylethy
l)- 3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole -1-heptanoic
acid, calcium salt (2:1)
Molecular formula:
(C
33
H
34
FN
2
O
5
)
2
Ca.3H
2
O
Molecular weight:
1209.42
CAS registry number:
134523-03-8.
DESCRIPTION
Amlodipine besilate and atorvastatin calcium are white to off white
crystalline powders.
Amlodipine besilate is slightly soluble in water and sparingly soluble
in ethanol. Atorvastatin
calcium is practically insoluble in aqueous solutions of pH 4 and
below. Atorvastatin calcium
is very slightly soluble in distilled water, pH 7.4 phosphate buffer
and acetonitrile, slightly
soluble in ethanol, and freely soluble in methanol.
In addition to the active ingredients amlodipine besilate and
atorvastatin calcium, each
CADATIN
tablet
contains
the
following
inactive
ingredients:
calcium
carbonate,
croscarmellose sodium, microcrystalline
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