CADUET TABLETS 5MG20MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

AMLODIPINE BESYLATE EQV AMLODIPINE (EXTRA-GRANULAR INGREDIENTS); ATORVASTATIN CALCIUM EQV ATORVASTATIN (ATORVASTATIN GRANULATION)

Διαθέσιμο από:

VIATRIS PRIVATE LIMITED

Φαρμακολογική κατηγορία (ATC):

C10BX03

Δοσολογία:

5 MG

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

AMLODIPINE BESYLATE EQV AMLODIPINE (EXTRA-GRANULAR INGREDIENTS) 5 MG; ATORVASTATIN CALCIUM EQV ATORVASTATIN (ATORVASTATIN GRANULATION) 20 MG

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Pfizer Manufacturing Deutschland GmbH

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2005-03-10

Φύλλο οδηγιών χρήσης

CADUET

 TABLETS 

1.  TRADE NAME(S) OF THE MEDICINAL PRODUCT 

CADUET


2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  

Active Ingredients: amlodipine besylate, atorvastatin calcium. 

The tablets for oral administration contain
amlodipine besylate and atorvastatin calcium equivalent to 
5 mg/10  mg, 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 amlodipine/atorvastatin dosage strengths, respectively. 

3.  PHARMACEUTICAL FORM 

Film-coated Tablets. 

Caduet tablets 5 mg/10 mg are white, oval shape, debossed
with “Pfizer” on one side and CDT 051 on 
the other side. 
Caduet tablets 5 mg/20 mg are white, oval shape, debossed
with “Pfizer” on one side and CDT 052 on 
the other side. 
Caduet tablets 5 mg/40 mg are white, oval shape, debossed
with “Pfizer” on one side and CDT 054 on 
the other side. 
Caduet tablets 5 mg/80 mg are white, oval shape, debossed
with “Pfizer” on one side and CDT 058 on 
the other side. 
Caduet tablets 10 mg/10 mg are
blue, oval shape, debossed with “Pfizer” on one side and
CDT 101 on 
the other side. 
Caduet tablets 10 mg/20 mg are blue, oval shape, debossed
with “Pfizer” on one side and CDT 102 on 
the other side. 
Caduet tablets 10 mg/40 mg are
blue, oval shape, debossed with “Pfizer” on one side
and CDT 104 on 
the other side. 
Caduet tablets 10 mg/80 mg are blue, oval shape, debossed
with “Pfizer” on one side and CDT 108 on 
the other side. 

4.  CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS

The amlodipine/atorvastatin combination product (henceforth in
this document termed 
“amlodipine/atorvastatin”) is indicated in
patients for whom treatment with both amlodipine and 
atorvastatin is a

Αρχείο Π.Χ.Π.

Page 1 of 34
CADUET
® TABLETS
1. TRADE NAME OF THE MEDICINAL PRODUCT
CADUET

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: amlodipine besylate, atorvastatin calcium.
The tablets for oral administration contain amlodipine besylate and
atorvastatin calcium equivalent
to 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg, and
10 mg/40 mg
amlodipine/atorvastatin dosage strengths, respectively.
3. PHARMACEUTICAL FORM
Film-coated Tablets.
Caduet tablets 5 mg/10 mg are white, oval shape, debossed with
“Pfizer” on one side and CDT 051
on the other side.
Caduet tablets 5 mg/20 mg are white, oval shape, debossed with
“Pfizer” on one side and CDT 052
on the other side.
Caduet tablets 5 mg/40 mg are white, oval shape, debossed with
“Pfizer” on one side and CDT 054
on the other side.
Caduet tablets 10 mg/10 mg are blue, oval shape, debossed with
“Pfizer” on one side and CDT 101
on the other side.
Caduet tablets 10 mg/20 mg are blue, oval shape, debossed with
“Pfizer” on one side and CDT 102
on the other side.
Caduet tablets 10 mg/40 mg are blue, oval shape, debossed with
“Pfizer” on one side and CDT 104
on the other side.
Not all presentations may be marketed.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
The amlodipine/atorvastatin combination product (henceforth in this
document termed
“amlodipine/atorvastatin”) is indicated in patients for whom
treatment with both amlodipine
and atorvastatin is appropriate:
AMLODIPINE
_HYPERTENSION_
The amlodipine component is indicated for the first-line treatment of
hypertension and can be
used as the sole agent to control blood pressure (BP) in the majority
of patients. Patients not
adequately controlled on a single antihypertensive agent (other than
amlodipine) may benefit
from the addition of the amlodipine component of
amlodipine/atorvastatin, in the same manner
as they would benefit from the addition of amlodipine alone.
Page 2 of 34
_CORONARY ARTERY DISEASE_
Chronic Stable Angina
Amlodipine is indicated for the symp