CADIVAST 10/80 amlodipine (as besilate) and atorvastatin (as calcium) 10 mg/80 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.88 mg (Equivalent: amlodipine, Qty 10 mg); atorvastatin calcium trihydrate, Quantity: 86.751 mg (Equivalent: atorvastatin, Qty 80 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

amlodipine besilate,atorvastatin calcium trihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; magnesium stearate; arginine; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; colloidal anhydrous silica; sodium carbonate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

500 (for dispensing only, no CRC), 30, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amlodipine besilate and atorvastatin calcium trihydrate tablet 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 Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials, Atorvastatin Component, 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: A blue, film-coated, capsule shaped, biconvex tablet debossed with AA 11 on one side of the tablet and M on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-01-09

Patient Information leaflet

CADIVAST
_Amlodipine (as besilate) and atorvastatin (as calcium trihydrate)
tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cadivast. 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 Cadivast
against the benefits they expect it
will 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 CADIVAST IS USED
FOR
Cadivast is used to treat:
•
high blood pressure and high
cholesterol (fat in the blood).
•
angina (a certain type of chest
pain).
•
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, Cadivast is used to
help reduce the risk of having a
heart attack or stroke.
Cadivast contains a combination of
two medicines. One is amlodipine
and the other is atorvastatin.
Amlodipine belongs to a group of
medicines called calcium channel
blockers. They work by relaxing your
blood vessels, making it easier for
your heart to pump blood around the
body and help increase the supply of
blood and oxygen to your heart.
Calcium channel blockers do not
change the amount of calcium in
your blood or bones.
Atorvastatin belongs to a group of
medicines called statins. It works by
reducing the amount of cholesterol
made by the liver. It reduces the 'bad'
cholesterol and can raise the 'good'
cholesterol. Atorvastatin also helps to
protect you from a heart attack or
stroke.
Cadivast may be used alone, or in
combination with other medicines, to
treat your condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CADIVAST
®
_Amlodipine (as besilate) and atorvastatin (as calcium trihydrate)
tablets _
1
NAME OF THE MEDICINE
Amlodipine (as besilate) and atorvastatin (as calcium trihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients in Cadivast are amlodipine besilate and
atorvastatin calcium trihydrate.
Excipients with known effect: Soya bean products
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CADIVAST 5/10 TABLETS
:
A white to off-white, film-coated, oval, biconvex tablet debossed with
“AA
4” on one side of the tablet and “M” on the other side.
CADIVAST 5/20 TABLETS
:
A white to off-white, film-coated, round, biconvex tablet debossed
with “AA
5” on one side of the tablet and “M” on the other side.
CADIVAST 5/40 TABLETS
:
A white to off-white, film-coated, capsule shaped, biconvex tablet
debossed
with “AA 6” on one side of the tablet and “M” on the other
side.
CADIVAST 5/80 TABLETS
:
A white to off-white, film-coated, oval, biconvex tablet debossed with
“AA
7” on one side of the tablet and “M” on the other side
CADIVAST 10/10 TABLETS
:
A blue, film-coated, barrel shaped, biconvex tablet debossed with
“AA 8” on
one side of the tablet and “M” on the other side.
CADIVAST 10/20 TABLETS
:
A blue, film-coated, oval, biconvex tablet debossed with “AA 9” on
one side
of the tablet and “M” on the other side.
CADIVAST 10/40 TABLETS
:
A blue, film-coated, round, biconvex tablet debossed with “AA 10”
on one
side of the tablet and “M” on the other side.
CADIVAST 10/80 TABLETS
:
A blue, film-coated, capsule shaped, biconvex tablet debossed with
“AA 11”
on one side of the tablet and “M” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amlodipine besilate and atorvastatin calcium trihydrate tablet is
indicated for patients in whom treatment
with amlodipine and atorvastatin is appropriate at the doses
presented.
THE INDICATIONS FOR AMLODIPINE ARE:
1.
Hyperte