AMLODIPINE/ATORVASTATIN-ZP 10/80 amlodipine (as besilate) 10mg / atorvastatin (as calcium) 80mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg; atorvastatin calcium trihydrate, Quantity: 86.8 mg

Available from:

Medis Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMLODIPINE/ATORVASTATIN-ZP (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: Film-coated tablet, oval, biconvex, blue, "A39" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-04-02

Patient Information leaflet

AMLOPDOPINE/ATORVASTATIN-ZP CMI ver002 06-16
Page 1 of 13
AMLODIPINE/ATORVASTATIN-ZP
_Amlodipine Besilate and Atorvastatin Calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
AMLODIPINE/ATORVASTATIN-ZP. 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
AMLODIPINE/ATORVASTATIN-ZP 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 AMLODIPINE/ATORVASTATIN-ZP IS USED FOR
AMLODIPINE/ATORVASTATIN-ZP is used to treat high blood pressure and
high cholesterol
(fat in the blood). AMLODIPINE/ATORVASTATIN-ZP can also be used for
angina (a certain
type of chest pain). AMLODIPINE/ATORVASTATIN-ZP 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,
AMLODIPINE/ATORVASTATIN-ZP 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.
AMLOPDOP

Summary of Product characteristics

Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets
PRODUCT INFORMATION
Medis Pharma Pty Ltd
EZETIMIBE/SIMVASTATIN-ZP PI 0917 V5
Page
1 of 41
PRODUCT INFORMATION
EZETIMIBE/SIMVASTATIN-ZP
(ezetimibe and simvastatin)
NAME OF THE MEDICINE
_EZETIMIBE _
Chemical name:
1-(4-fluorophenyl)-3(_R_)-[3-(4-fluorophenyl)-3(_S_)-
hydroxypropyl]-4(_S_)-(4-hydroxyphenyl)-2-azetidinone.
Molecular formula:
C
24
H
21
F
2
NO
3
Molecular weight:
409.4
CAS registry number: 163222-33-1
Its structural formula is:
_SIMVASTATIN _
Chemical name:
Simvastatin, an inactive lactone, is hydrolysed to the corresponding
β-hydroxyacid form,
which is an inhibitor of HMG-CoA reductase. Simvastatin is
(1_S_,3_R_,7_S_,8_S_,8a_R_)-8-[2-
[(2_R_,4_R_)-4-Hydroxy-6-oxotetrahydro-2_H_-pyran-2-yl]ethyl]-3-7-dimethyl-
1,2,3,7,8,8ahexahydronaphtalen-1-yl 2,2-dimethylbutonate.
Molecular formula:
C
25
H
38
O
5
Molecular weight:
418.57
CAS registry number: 79902-63-9
Structural formula:
Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets
PRODUCT INFORMATION
Medis Pharma Pty Ltd
EZETIMIBE/SIMVASTATIN-ZP PI 0917 V5
Page
2 of 41
DESCRIPTION
Ezetimibe is a white, crystalline powder that is freely to very
soluble in ethanol, methanol,
and acetone and practically insoluble in water.
Simvastatin is a white to off-white, non-hygroscopic, crystalline
powder that is practically
insoluble in water, and freely soluble in chloroform, methanol and
ethanol.
EZETIMIBE/SIMVASTATIN-ZP (ezetimibe/simvastatin) is a lipid-lowering
product that
selectively inhibits the intestinal absorption of cholesterol and
related plant sterols and
inhibits the endogenous synthesis of cholesterol.
EZETIMIBE/SIMVASTATIN-ZP is available for oral use as tablets
containing 10 mg of
ezetimibe, and 10 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/10),
20 mg of
simvastatin
(EZETIMIBE/SIMVASTATIN-ZP
10/20),
40
mg
of
simvastatin
(EZETIMIBE/SIMVASTATIN-ZP
10/40), or 80 mg of simvastatin
(EZETIMIBE/SIMVASTATIN-ZP 10/80).
Each tablet contains the following inactive ingredien