Chemmart

Main information

Trade name:
Chemmart Amlodipine/Atorvastatin 5/10 amlodipine (as besilate) + atorvastatin (as ca propylene glycol solvate) 5mg/10mg film-coa

Active ingredient:
amlodipine besilate,Atorvastatin calcium propylene glycol solvate

Available from:
Apotex Pty Ltd

INN (International Name):
amlodipine besilate,Atorvastatin calcium propylene glycol solvate

Medicine domain:
Humans

Medicine type:
Allopathic drug

Documents

for the general public:
Patient Information leaflet

for healthcare professionals:
Summary of Product characteristics

for the general public:
Public Assessment Report

Localization

Available in:
Australia

Language:
English

Other information

Status

Source:
Dept. of Health,Therapeutic Goods Administration - Australia

Authorization number:
214361

Last update:
09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214361

Chemmart Amlodipine/Atorvastatin 5/10 amlodipine (as besilate) + atorvastatin (as ca propylene glycol

solvate) 5mg/10mg film-coated tablet blister

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/07/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Chemmart Amlodipine/Atorvastatin 5/10 amlodipine (as besilate) + atorvastatin (as ca propylene glycol

solvate) 5mg/10mg film-coated tablet blister

Product Type

Single Medicine Product

Effective date

10/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Amlodipine and atorvastatin combination tablets are 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Chemmart Amlodipine/Atorvastatin 5/10 amlodipine (as besylate) + atorvastatin (as ca propylene glycol solvate) 5mg/10mg film-coated

tablet blister

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, oval, biconvex, coated tablet. Engraved "5/10" on one

side, "APO" on the other side.

Active Ingredients

amlodipine besilate

7 mg

Atorvastatin calcium propylene glycol solvate

11 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:15:23 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 26.11.2017 at 10:15:23 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Chemmart Amlodipine /

Atorvastatin

5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 & 10/80 TABLETS

Contains the active ingredients amlodipine (as besylate) and atorvastatin (as calcium propylene glycol

solvate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about amlodipine and

atorvastatin combination tablets. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Chemmart Amlodipine/Atorvastatin,

Tablets. It contains the active

ingredients amlodipine besylate and

atorvastatin calcium propylene glycol

solvate.

It is used to:

treat high blood pressure

treat high cholesterol

treat angina (type of chest pain)

reduce the risk of heart attack or

stroke in patients with high blood

pressure who have coronary heart

disease (CHD) or multiple risk

factors for CHD.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

This medicine contains a

combination of amlodipine and

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 HMG-CoA

reductase inhibitors. 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 having a heart

attack or stroke.

There is no evidence that this

medicine is addictive.

Use in children

There is not enough information to

recommend the use of this medicine

in children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have active liver disease or

your liver function test results

are persistently elevated (check

with your doctor).

CHEMMART AMLODIPINE/ATORVASTATIN TABLETS

You are taking the antibiotic

fusidic acid which is used to

treat infections.

You are pregnant or are a

female of childbearing age and

are not using effective

contraception.

Amlodipine and atorvastatin

combination tablets may affect

your developing baby if it is

taken during pregnancy.

You are breastfeeding.

Amlodipine and atorvastatin

combination tablets may pass into

human breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

amlodipine or atorvastatin or

any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

heart problems, including heart

failure

stroke or transient ischaemic

attack (known as 'mini stroke') in

the last 6 months

low blood pressure

liver problems

kidney problems

muscle pain, tenderness or

weakness when taking medicines

used to treat high cholesterol or

triglycerides

breathing problems when taking

medicines used to treat high

cholesterol or triglycerides.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breastfeeding

or you plan to breastfeed. Do not

take this medicine whilst

breastfeeding.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

amlodipine/atorvastatin. These

include:

other medicines used to treat high

cholesterol or triglycerides, such

as colestipol

other medicines used to treat high

blood pressure

digoxin, a medicine to treat heart

problems

some antibiotics such as

erythromycin, clarithromycin,

rifampicin and fusidic acid

phenytoin, a medicine used to

treat epilepsy (seizures)

oral contraceptives

cyclosporine, a medicine used to

suppress the immune system

some medicines used to treat

fungal infections, such as

ketoconazole and itraconazole

efavirenz and protease inhibitors

such as ritonavir, tipranavir and

telaprevir, for the treatment of

HIV infection and/or hepatitis C

diltiazem, a medicines used to

treat angina

cimetidine and antacids,

medicines used to treat reflux or

ulcers

spironolactone, a medicine used

to treat high blood pressure and

certain types of swelling

colchicine, a medicine used to

treat a disease with painful

swollen joints caused by uric acid

crystals

vitamin B3

St John's Wort

grapefruit juice.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with amlodipine

and/or atorvastatin.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Amlodipine and atorvastatin

combination tablet is taken once a

day. Your doctor will tell you how

much of this medicine you should

take. This will depend on your

condition and whether you are taking

any other medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

CHEMMART AMLODIPINE/ATORVASTATIN TABLETS

How to take it

Swallow the tablet(s) whole with a

full glass of water.

Do not chew or crush tablets.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

It is important to keep taking your

medicine even if you feel well. If you

stop taking amlodipine/atorvastatin

your blood pressure and cholesterol

levels may rise again.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is less than 12 hours before your

next dose, skip the missed dose and

take your next dose at the usual time.

Otherwise, take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Amlodipine and atorvastatin

combination tablets may cause

dizziness or drowsiness in some

people and affect alertness.

Avoid drinking large quantities of

alcohol, as this may increase the

chance of you experiencing liver

problems.

Avoid eating large quantities of

grapefruit or drinking large quantities

of grapefruit juice, as this may

increase the chance of you

experiencing side effects.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking amlodipine and atorvastatin

combination tablets or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but

most of the time they are not. Tell

your doctor if you notice any of the

following:

swelling of the ankles, feet, face

or hands

muscle and joint pain, muscle

weakness

headache

flushing

fast or irregular heart beats

dizziness

tiredness or weakness

drowsiness or sleepiness

stomach pain or nausea

constipation, diarrhoea, wind

heartburn, indigestion or wind

urine infection or other infections

stuffy or runny nose

nose bleeds

rash.

Tell your doctor as soon as possible

if you notice any of the following.

CHEMMART AMLODIPINE/ATORVASTATIN TABLETS

These may be serious side effects and

you may need medical attention:

symptoms of liver disease such as

itching, yellowing of the skin and

eyes and dark coloured urine

feeling weak and tired,

excessively thirsty and passing

more urine

dizziness or lightheadedness on

standing up from a sitting or lying

position

problems with breathing,

including shortness of breath,

persistent cough and fever

eye pain or change in vision

changes in mood, feeling anxious

or nervous

chest pain associated with

exertion (angina) that lasts longer,

is more severe or occurs more

often

chest pain.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

unexpected muscle pain,

tenderness or weakness not

caused by exercise

tingling in the hands or feet

changes in heart beat either fast

or slow

sudden severe headache, which

may be accompanied by nausea,

vomiting, loss of sensation,

tingling in any part of the body or

ringing in the ears

severe blisters and bleeding of the

lips, eyes, mouth, nose or genitals

severe upper stomach pain, often

with nausea and vomiting.

If you are 65 years old or over, you

may be more likely to experience

side effects such as swelling of the

feet and ankles, muscle cramps and

dizziness.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to amlodipine and

atorvastatin combination tablets,

do not take any more of this

medicine and tell your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Chemmart Amlodipine/

Atorvastatin Tablets looks

like

5/10mg tablets

White to off-white, oval, biconvex,

coated tablet. Engraved "5/10" on

one side, "APO" on the other side.

5/20mg tablets

White to off-white, oval, biconvex,

coated tablet. Engraved "5/20" on

one side, "APO" on the other side.

5/40mg tablets

White to off-white, oval, biconvex,

coated tablet. Engraved "5/40" on

one side, "APO" on the other side.

5/80mg tablets

White to off-white, oval, biconvex,

coated tablet. Engraved "5/80" on

one side, "APO" on the other side.

10/10mg tablets

Light blue, oval, biconvex, coated

tablet. Engraved "10/10" on one side,

"APO" on the other side.

10/20mg tablets

Light blue, oval, biconvex, coated

tablet. Engraved "10/20" on one side,

"APO" on the other side.

10/40mg tablets

Light blue, oval, biconvex, coated

tablet. Engraved "10/40" on one side,

"APO" on the other side.

10/80mg tablets

Light blue, oval, biconvex, coated

tablet. Engraved "10/80" on one side,

"APO" on the other side.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each tablet contains 5mg or 10mg of

amlodipine (as besylate) and 10mg,

20mg, 40mg or 80mg of atorvastatin

CHEMMART AMLODIPINE/ATORVASTATIN TABLETS

(as calcium propylene glycol solvate)

as the active ingredients.

It also contains the following inactive

ingredients:

croscarmellose sodium

microcrystalline cellulose

iron oxide yellow

magnesium stearate

colloidal anhydrous silica

calcium acetate

blue colourant (ARTG #10379)

(10mg/10mg, 10mg/20mg, 10mg/

40mg and 10mg/80mg strengths

only)

white colourant (ARTG #108944)

(5mg/10mg, 5mg/20mg, 5mg/

40mg and 5mg/80mg strengths

only).

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers