Chemmart Amlodipine/Atorvastatin 10/80 amlodipine (as besilate) + atorvastatin (as ca propylene glycol solvate) 10mg/80mg film-c
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
18-11-2014
Summary of Product characteristics
(SPC)
14-11-2014
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
amlodipine besilate,Atorvastatin calcium propylene glycol solvate
Available from:
Apotex Pty Ltd
INN (International Name):
amlodipine besilate,Atorvastatin calcium propylene glycol solvate
Patient Information leaflet
CHEMMART AMLODIPINE /
ATORVASTATIN
_5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 & 10/80 TABLETS_
_Contains the active ingredients amlodipine (as besylate) and
atorvastatin (as calcium propylene glycol_
_solvate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about amlodipine and
atorvastatin combination tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Amlodipine/Atorvastatin,
Tablets. It contains the active
ingredients amlodipine besylate and
atorvastatin calcium propylene glycol
solvate.
It is used to:
•
treat high blood pressure
•
treat high cholesterol
•
treat angina (type of chest pain)
•
reduce the risk of heart attack or
stroke in patients with high blood
pressure who have coronary heart
disease (CHD) or multiple risk
factors for CHD.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
This medicine co
Read the complete document
Summary of Product characteristics
Product Information – Australia
Chemmart AMLODIPINE/ATORVASTATIN Tablets
Page 1
CHEMMART AMLODIPINE/ATORVASTATIN 5/10, 5/20, 5/40, 5/80, 10/10, 10/20,
10/40 & 10/80
TABLETS
NAME OF THE MEDICINE
Amlodipine (as besylate) and Atorvastatin (as calcium propylene glycol
solvate)
ACTIVE INGREDIENT #1
Amlodipine besylate
Chemical Name:
(3-ethyl 5-methyl (4_RS_)-2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-
methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate)
Structural Formula:
Molecular Formula:
C
20
H
25
CIN
2
O·C
6
H
5
SO
3
H.
Molecular Weight:
567.05.
CAS Registry Number:
111470-99-6.
ACTIVE INGREDIENT #2
Atorvastatin (as calcium propylene glycol solvate)
Chemical Name:
calcium
bis((3_R_,5_R_)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-
phenyl-1_H_-pyrrol-1-yl]-3,5-dihydroxyheptanoate)propylene glycol
solvate
Structural Formula:
Molecular Formula:
C
66
H
68
CaF
2
N
4
O
10
* C
3
H
8
O
2
.
Molecular Weight:
1231.46.
CAS Registry Number:
134523-03-8 (Atorvastatin calcium)
Product Information – Australia
Chemmart AMLODIPINE/ATORVASTATIN Tablets
Page 2
DESCRIPTION
Amlodipine besylate is a white or almost white powder that is slightly
soluble in water and sparingly
soluble in ethanol. Atorvastatin calcium propylene glycol solvate is a
white to off-white crystalline
powder that is sparingly soluble in methanol, practically insoluble in
ethanol and very slightly soluble in
acetonitrile.
Amlodipine and atorvastatin combination tablets contains the following
amount of amlodipine (as
besylate)
and
atorvastatin
(as
calcium
propylene
glycol
solvate)
respectively:
5/10mg,
5/20mg,
5/40mg, 5/80mg, 10/10mg, 10/20mg, 10/40mg and 10/80mg.
In addition, each tablet contains croscarmellose sodium,
microcrystalline cellulose, iron oxide yellow,
magnesium stearate, colloidal anhydrous silica, calcium acetate,
OPADRY II complete film coating
system 85F10919 Blue (ARTG #10379) (10mg/10mg, 10mg/20mg, 10mg/40mg
and 10mg/80mg
strengths only) and OPADRY II complete film coating system White
85F180001 (ARTG #108944)
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