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
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation
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
Chemmart Amlodipine/Atorvastatin
5/10 tablets (blister pack 30):
AUST R 214361.
Chemmart Amlodipine/Atorvastatin
5/20 tablets (blister pack 30):
AUST R 214368.
Chemmart Amlodipine/Atorvastatin
5/40 tablets (blister pack 30):
AUST R 214355
Chemmart Amlodipine/Atorvastatin
5/80 tablets (blister pack 30):
AUST R 214351.
Chemmart Amlodipine/Atorvastatin
10/10 tablets (blister pack 30):
AUST R 214357.
Chemmart Amlodipine/Atorvastatin
10/20 tablets (blister pack 30):
AUST R 214389.
Chemmart Amlodipine/Atorvastatin
10/40 tablets (blister pack 30):
AUST R 214366.
Chemmart Amlodipine/Atorvastatin
10/80 tablets (blister pack 30):
AUST R 214401.
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was last updated in July
2014
CHEMMART AMLODIPINE/ATORVASTATIN TABLETS
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