CADUET 5/20 amlodipine (as besilate) and atorvastatin (as calcium trihydrate) 5mg/20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg); atorvastatin calcium trihydrate, Quantity: 21.7 mg (Equivalent: atorvastatin, Qty 20 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

amlodipine besilate,Atorvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; hyprolose; microcrystalline cellulose; calcium carbonate; polysorbate 80; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CADUET (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented. The indications for amlodipine are: 1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. 2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. The indications for atorvastatin are: 1. Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. 2. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see Clinical Trials, Prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Product summary:

Visual Identification: white oval film-coated tablets debossed with "A5" on one side and "AT20" on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2005-07-20

Patient Information leaflet

1
CADUET
®
_Amlodipine Besilate and Atorvastatin Calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Caduet.
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 Caduet 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 CADUET IS USED
FOR
Caduet is used to treat high blood
pressure and high cholesterol (fat in
the blood). Caduet can also be used
for angina (a certain type of chest
pain). Caduet 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, Caduet 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 low-density
lipoprotein, is the 'bad' cholesterol
that can b

Summary of Product characteristics

Page 1 of 38
AUSTRALIAN
PRODUCT
INFORMATION
-
CADUET 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40
AND
10/80
(AMLODIPINE
BESILATE
AND
ATORVASTATIN
CALCIUM)
1. NAME OF THE MEDICINE
amlodipine (as besilate) and atorvastatin (as calcium)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CADUET contains the active ingredients amlodipine besilate and
atorvastatin calcium.
Each 5 mg/ 10mg tablet contains 5 mg amlodipine (as besilate) and 10
mg atorvastatin (as
calcium)
Each 5 mg/ 20mg tablet contains 5 mg amlodipine (as besilate) and 20
mg atorvastatin (as
calcium)
Each 5 mg/ 40mg tablet contains 5 mg amlodipine (as besilate) and 40
mg atorvastatin (as
calcium)
Each 5 mg/ 80mg tablet contains 5 mg amlodipine (as besilate) and 80
mg atorvastatin (as
calcium)
Each10 mg/ 10mg tablet contains 10 mg amlodipine (as besilate) and 10
mg atorvastatin (as
calcium)
Each 10 mg/ 20mg tablet contains 10 mg amlodipine (as besilate) and 20
mg atorvastatin (as
calcium)
Each 10 mg/ 40mg tablet contains 10 mg amlodipine (as besilate) and 40
mg atorvastatin (as
calcium)
Each 10 mg/ 80mg tablet contains 10 mg amlodipine (as besilate) and 80
mg atorvastatin (as
calcium)
For the full list of excipients, see section 6.1, List of excipients.
3. PHARMACEUTICAL FORM
CADUET,
amlodipine
besilate/atorvastatin
calcium
tablets,
are
formulated
for
oral
administration and are available in combinations of 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.
CADUET 5 mg/10 mg is available as white, oval, film coated tablets
debossed with “Pfizer”
on one side and “CDT” and “051” on the other.
Page 2 of 38
CADUET 5 mg/20 mg is available as white, oval, film coated tablets
debossed with “Pfizer”
on one side and “CDT” and “052” on the other.
CADUET 5 mg/40 mg is available as white, oval, film coated tablets
debossed with “Pfizer”
on one side and “CDT” and “054” on the other.
CADUET 5 mg/80 mg is available as white, oval, film coated tablets
debossed with “Pfizer”
on one side an