CADUET FILM-COATED TABLET 5MG/10MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Boleh didapati daripada:

UPJOHN (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Unit dalam pakej:

30Tablet Tablets; 7Tablet Tablets

Dikeluarkan oleh:

Pfizer Manufacturing Deutschland GmbH.

Risalah maklumat

Pfizer Confidential
_Consumer Medication Information Leaflet (RiMUP) _
CADUET
_®_
FILM-COATED TABLET
Amlodipine besylate, Atorvastatin calcium (5 mg/10 mg, 5 mg/20 mg, 5
mg/40 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg)
1
WHAT IS IN THIS LEAFLET
1 What CADUET is used for
2 How CADUET works
3 Before you use CADUET
4 How to use CADUET
5 While you are using it
6 Side effects
7 Storage and Disposal of CADUET
8 Product Description
9 Manufacturer and Product Registration
Holder
10 Date of Revision
11. Serial Number
WHAT CADUET IS USED FOR
CADUET is a prescription drug that
combines amlodipine besylate and
atorvastatin calcium in one pill.
CADUET is used in adults who need
both amlodipine besylate and
atorvastatin calcium.
Amlodipine besylate is used to treat:
• High blood pressure (hypertension) and
• Chest pain (angina).
Atorvastatin calcium is used to lower
“bad” cholesterol and triglycerides in
your blood. It can also raise the levels of
“good” cholesterol.
Atorvastatin calcium is also used to
lower the risk for heart attack, stroke,
certain types of heart surgery, and chest
pain in patients who have heart disease
or risk factors for heart disease such as:
• Age, smoking, high blood pressure, low
HDL-C, heart disease in the family.
Atorvastatin calcium can lower the risk
for heart attack or stroke in patients with
diabetes and risk factors such as:
• Diabetic eye problems, kidney
problems, smoking, or high blood
pressure.
HOW CADUET WORKS
CADUET is a product that contains two
active ingredients amlodipine (calcium
antagonist) and atorvastatin (statin) and
is to be used when your doctor considers
it appropriate to use both medications.
Amlodipine is used to treat high blood
pressure (hypertension) and atorvastatin
to lower cholesterol levels.
BEFORE YOU USE CADUET
-
_When you must not use it _
Do not take CADUET:
• if you are allergic (hypersensitive) to
amlodipine or atorvastatin or any other
calcium channel blocker;
• if you are allergic (hypersensitive) to
any of the ingredients in this medicin

Ciri produk

Pfizer Confidential
1
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 tablet.
Amlodipine/atorvastatin 5 mg/10 mg is white, oval, film-coated tablets
debossed with “Pfizer”
on one side and product code on the other: “CDT” and “051”.
Amlodipine/atorvastatin 5 mg/20 mg is white, oval, film-coated tablets
debossed with “Pfizer”
on one side and product code on the other: “CDT” and “052”.
Amlodipine/atorvastatin 5 mg/40 mg is white, oval, film-coated tablets
debossed with “Pfizer”
on one side and product code on the other: “CDT” and “054”.
Amlodipine/atorvastatin 10 mg/10 mg is blue, oval, film-coated tablets
debossed with “Pfizer”
on one side and product code on the other: “CDT” and “101”.
Amlodipine/atorvastatin 10 mg/20 mg is blue, oval, film-coated tablets
debossed with “Pfizer”
on one side and product code on the other: “CDT” and “102”.
Amlodipine/atorvastatin 10 mg/40 mg is blue, oval, film-coated tablets
debossed with “Pfizer”
on one side and product code on the other: “CDT” and “104”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CADUET (amlodipine and atorvastatin) is indicated in patients for whom
treatment with both
amlodipine and atorvastatin is considered appropriate.
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 amlodipine
component of amlodipine/atorvastatin, in the same manner as
they would b