5 MG/ 10 MG/ 20 MG/ 40 MG
Contains the active ingredient rosuvastatin calcium
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about rosuvastatin. It does not contain
all the available information. It does not take the place of talking to your doctor
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 taking
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 need to read it again.
What this medicine is used for
The name of your medicine is APO-Rosuvastatin. It contains the active ingredient rosuvastatin
(as rosuvastatin calcium).
This medicine is used to lower high cholesterol levels.
Even though you may have normal cholesterol, this medicine can also be used to reduce
the risk of you having a stroke or heart attack if you are a man 50 or more years
old or a woman 60 or more years old and have at least 2 risk factors for having a
heart attack or stroke. Risk factors include: high blood pressure, low levels of good
cholesterol (HDL), smoking or a family history of premature coronary heart disease.
Your doctor may also do a blood test to measure a substance called C Reactive Protein
to help decide if you should be given this medicine for this use.
Cholesterol and triglycerides
Everyone has cholesterol and triglycerides in their blood. They are fatty substances
needed by the body for many things.
Triglycerides are an energy source for the body. Cholesterol is used for such things
as building cells, making bile acids (which help to digest foods) and making some
There are different types of cholesterol. Too much of the "bad" cholesterol (LDL)
can block the blood vessel that supply your heart and brain with blood, and can cause
heart attack, angina and stroke. The "good" cholesterol (HDL) helps to remove the
bad cholesterol from the blood vessels. High levels of triglycerides can be associated
with a low level of "good" cholesterol and may increase the risk of heart disease.
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
Rosuvastatin belongs to a group of medicines known as HMG-CoA reductase inhibitors
(also known as 'statins'). It lowers the "bad" cholesterol and raises the "good" cholesterol
when exercise and changes to diet are not enough on their own.
Cholesterol is present in many foods and is also made by your body. Rosuvastatin does
not reduce the cholesterol that comes from fat in food. Because of this, when you
are taking rosuvastatin, you need to follow a low-fat diet, control your weight and
High cholesterol is also more likely to occur with certain diseases or if you have
a family history of high cholesterol.
Your doctor will have explained why you are being treated with rosuvastatin and told
you what dose to take. Your doctor may need to check your cholesterol levels before
prescribing rosuvastatin or changing your dose.
There is no evidence that this medicine is addictive.
Use in children
This medicine should not be used in children.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You have active liver disease. If tests show you have elevated levels of liver enzymes,
this may indicate that you have a problem with your liver.
You have been prescribed any medicine containing fusidic acid.
You are pregnant, you intend to become pregnant or you are not taking an effective
method of contraception.
Rosuvastatin may affect your developing baby if you take it during pregnancy. Ask
your doctor about effective methods of contraception. If you become pregnant, stop
taking this medicine as soon as you find out and see your doctor immediately.
You are breastfeeding.
Rosuvastatin may pass into human breast milk.
You are hypersensitive to, or have had an allergic reaction to, rosuvastatin 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.You
must not use APO-Rosuvastatin 40 mg if you have:
low thyroid hormone levels (hypothyroidism)
personal or family history of hereditary muscular disorders
history of muscular problems from using other lipid-lowering agents
history of heavy alcohol use
been prescribed another class of lipid-lowering agent called a fibrate
severe kidney impairment
situations that may increase rosuvastatin blood levels (ask your doctor).
Before you start to take it
Before you start taking this, tell your doctor if:
1. You have allergies to:
any other statins such as simvastatin, pravastatin, atorvastatin, fluvastatin
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
low thyroid hormone levels (hypothyroidism)
personal or family history of muscle disorders
history of muscle problems from using other lipid-lowering agents
unexplained aches or pains in your muscles.
3. You regularly drink large amounts of alcohol. Excessive alcohol consumption may not
be safe in patients taking this medicine.
4. You are currently pregnant, you plan to become pregnant or you are not taking an effective
method of contraception. Do not take this medicine whilst pregnant.
5. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine
6. You are planning to have surgery or an anaesthetic.
7. You are currently receiving or are planning to receive dental treatment.
8. 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
Some medicines may interact with rosuvastatin. These include:
cyclosporins (may be used after organ transplant)
antacids (medicines used to treat heartburn and indigestion). This medicine can be
taken 2 hours before or 2 hours after taking an antacid
warfarin (used to stop blood clots)
clopidogrel (used to prevent blood clots)
gemfibrozil (used to lower blood lipids)
fusidic acid used to treat some infections, you must not take this medicine with fusidic
various protease inhibitors used in combination with ritonavir to treat HIV infection.
If you are taking any of these you may need a different dose or you may need to take
Other medicines not listed above may also interact with rosuvastatin.
Your doctor can tell you what to do if you are taking any of these medicines. These
medicines may affect the way rosuvastatin works.
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
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition, your ethnicity and whether you are taking any other medicines.
If you have high cholesterol, your doctor will probably start you on 5 mg or 10 mg
tablet taken once daily. Your doctor will then monitor your cholesterol and triglyceride
levels during your treatment and, if needed, may increase your rosuvastatin dose to
20 mg once daily. For most patients, a maximum 20 mg rosuvastatin daily dose is sufficient
to treat their condition.
A small number of patients may need to further increase their rosuvastatin dose to
40 mg once daily, for example, patients whose high cholesterol is hereditary.
If your cholesterol is not high but you have risks for having a heart attack or stroke,
your doctor may start you on 20 mg.
Your doctor will advise you on the dose that's right for your condition. The daily
dose of rosuvastatin must not exceed 40 mg.
DO NOT INCREASE OR ADJUST YOUR ROSUVASTATIN DOSE YOURSELF.
How to take it
Tablets must not be broken or crushed and must be swallowed whole with a glass of
When to take it
Take this medicine once a day, at about 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 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.
This medicine helps lower your blood cholesterol and triglycerides. It does not cure
your condition. If you stop taking this medicine, your cholesterol and triglyceride
levels may rise again.
You may have to take cholesterol-lowering medicines for the rest of your life.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is within 6 hours your next dose is due, 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
Do this even if there are no signs of discomfort or poisoning. You may need urgent
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, are planning to become pregnant or are not taking an effective method
of contraception. Stop taking this medicine immediately if you are 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.
Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
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
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
While taking this medicine, you also need to follow a low-fat diet, to control your
weight and to exercise regularly.
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking
rosuvastatin 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, most of
the time they are not.
Tell your doctor if you notice any of the following:
nausea (feeling sick)
stiff or painful joints (arthralgia).
Tell your doctor if you notice an increase in your need to urinate if you are more
hungry or thirsty than usual.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following.
These may be serious side effects and you may need medical attention:
aching muscles, muscle tenderness or weakness not caused by exercise, particularly
if you also have a fever or generally feel unwell
severe skin reaction with painful red areas, large blisters and peeling of layers
of the skin, may be accompanied by fever and chills, aching muscles and generally
difficulty breathing, coughing, particularly if you also feel generally unwell (e.g.
fatigue, weight loss, fever).
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to rosuvastatin, 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
hay fever-like symptoms.
Storage and disposal
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 30°C
and protected from light and moisture.
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, light and dampness can destroy
Keep it 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.
If your doctor tells you to stop taking this medicine or it has passed its expiry
date, ask your pharmacist what to do with any medicine that is left over.
What this medicine looks like*
APO-Rosuvastatin 5mg tablets:
White, round, biconvex, film coated tablet, engraved "APO" on one side, "ROS" over
"5" on the other side.
APO-Rosuvastatin 10mg tablets:
White, round, biconvex, film-coated tablet, engraved "APO" on one side, "ROS" over
"10" on the other side.
APO-Rosuvastatin 20mg tablets:
White, round, biconvex, film-coated tablet, engraved "APO" on one side, "ROS" over
"20" on the other side.
APO-Rosuvastatin 40mg tablets:
White, oval, biconvex, film-coated tablet, engraved "APO" on one side, "ROS40" on
the other side.
Tablets are packaged in blister packs of 7 and 30.
Tablets are also packaged in bottles of 30, 100 and 500.
* Not all strengths, pack types and/or pack sizes are marketed. Alternative brands
should be used if required.
Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin calcium, as the active
The tablets also contain the following inactive ingredients:
colloidal anhydrous silica
This medicine is gluten-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Rosuvastatin 5 mg tablets (blister pack): AUST R 183061.
APO-Rosuvastatin 10 mg tablets (blister pack): AUST R 183073.
APO-Rosuvastatin 20 mg tablets (blister pack): AUST R 183057.
APO-Rosuvastatin 40 mg tablets (blister pack): AUST R 183074.
APO-Rosuvastatin 5 mg tablets (bottle): AUST R 183075.
APO-Rosuvastatin 10 mg tablets (bottle): AUST R 183067.
APO-Rosuvastatin 20 mg tablets (bottle): AUST R 183060.
APO-Rosuvastatin 40 mg tablets (bottle): AUST R 183059.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in August 2018.