Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about APO-Ezetimibe/Simvastatin. 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
APO-Ezetimibe/Simvastatin 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 this medicine is used for
APO-Ezetimibe/Simvastatin helps to lower cholesterol and triglyceride levels. It is
used in people whose cholesterol levels are too high and when diet alone cannot lower
these levels adequately is used to treat high cholesterol.
Cholesterol is one of several fatty substances found in the bloodstream. Your total
cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called 'bad' cholesterol because it can build up in the walls
of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing
of the arteries.
This narrowing can slow or block blood flow to vital organs such as the heart and
brain. This blocking of blood flow can result in a heart attack or stroke.
HDL cholesterol is often called 'good' cholesterol because it helps keep the bad cholesterol
from building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in your blood that may increase your risk for
How APO-Ezetimibe/Simvastatin works
APO-Ezetimibe/Simvastatin reduces elevated total-cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL (good) cholesterol.
APO-Ezetimibe/Simvastatin works by decreasing the absorption of cholesterol in the
small intestine and by reducing the amount of cholesterol made in the liver. APO-
Ezetimibe/Simvastatin does not help you lose weight.
If you have heart disease and a history of heart attack or hospitalisation for unstable
angina (chest pain), APO- Ezetimibe/Simvastatin reduces the risk of heart attack,
stroke, surgery to increase heart blood flow, or hospitalisation for chest pain.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
APO-Ezetimibe/Simvastatin is not addictive.
This medicine is available only with a doctor's prescription.
Use in Children and Adolescents
APO-Ezetimibe/Simvastatin is used in children and adolescents (10 to 17 years of age)
to treat familial hypercholesterolaemia, a type of high cholesterol that is hereditary
(i.e. passed on through families).
APO-Ezetimibe/Simvastatin is not recommended for use in children under 10 years of
age, as there have been no studies of its effects in this age group.
Your doctor will assess whether APO-Ezetimibe/Simvastatin is suitable for your child.
Depending on the pubertal development of your child, APO-Ezetimibe/Simvastatin may
not be suitable for him or her.
Before you take this medicine
When you must not take it
Do not take APO- Ezetimibe/Simvastatin if you have an allergy to:
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if:
you have active liver disease or repeated blood tests indicating possible liver problems.
you have had muscle pain, tenderness or weakness from other medicines used to treat
high cholesterol or triglycerides.
you are taking certain medicines such as gemfibrozil, cyclosporin, danazol, fusidic
acid and strong CYP3A4 inhibitors like itraconazole and ketoconazole. Please see the
section "Taking other medicines" in this CMI for more information.
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy, causing foetal
malformations (birth defects) or irreversible damage.
Do not breastfeed if you are taking this medicine.
The active ingredient in this medicine passes into breast milk (if applicable) and
there is a possibility that your baby may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if:
you have unexplained muscle pain, tenderness or weakness not caused by exercise. This
is because on rare occasions, muscle problems can be serious, including muscle breakdown
resulting in kidney damage that can lead to death. Your doctor may do a blood test
to check for certain muscle problems.
you are Asian.
you are taking niacin or a niacin-containing product.
you have, or have had, any medical conditions, including liver disease or liver problems.
Your doctor will do a blood test to make sure you have no problems with your liver.
you have kidney disease, diabetes or any other medical problems.
you drink alcohol regularly.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start
taking this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you
buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines should not be taken with APO-Ezetimibe/Simvastatin. These include:
nefazodone, used to treat depression
medicines containing cobicistat, a drug used in the treatment of HIV infection
protease inhibitors used to treat HIV infection, including indinavir, nelfinavir,
certain protease inhibitors used to treat Hepatitis C virus infection, such as boceprevir
gemfibrozil, used to treat high cholesterol levels
cyclosporin, used to suppress the immune system
erythromycin, clarithromycin, telithromycin and fusidic acid, antibiotics used to
ketoconazole, itraconazole, posaconazole and voriconazole, used to treat certain fungal
If you are taking any of the above, your doctor may suggest stopping APO-Ezetimibe/Simvastatin
temporarily or permanently.
Some medicines and APO- Ezetimibe/Simvastatin may interfere with each other. These
bile acid sequestrants, such as cholestyramine, used to lower cholesterol levels
other medicines to lower cholesterol levels, for example, other fibrates, nicotinic
acid (also known as niacin)
warfarin, fluindione, or other drugs used to prevent blood clots
colchicine, used for gout
verapamil, used to treat high blood pressure and angina
diltiazem, used to treat angina
amiodarone, used to treat irregular heart beat
amlodipine, used to treat high blood pressure and angina
digoxin, used to treat heart failure
lomitapide (a drug used to treat a serious and rare genetic cholesterol condition)
These medicines may be affected by this medicine or may affect how well it works.
You may need different amounts of your medicines, or you may need to take different
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
How much to take
Take APO-Ezetimibe/Simvastatin only when prescribed by your doctor.
The recommended dose in adults (18 years and over) is one APO- Ezetimibe/Simvastatin
10/10, 10/20, 10/40 or 10/80 tablet once a day, in the evening. Your doctor will adjust
your APO-Ezetimibe/Simvastatin dose depending on your response.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia
is one APO-Ezetimibe/Simvastatin 10/10, 10/20 or 10/40 tablet once a day, in the evening.
The maximum recommended dose in adolescents is 10/40 mg.
Because of the increased risk of muscle problems, the APO- Ezetimibe/Simvastatin 10/80
tablet is only for patients at high risk of heart disease problems who have not yet
reached their cholesterol goal on lower doses.
How to take it
Swallow APO-Ezetimibe/Simvastatin tablets whole with a full glass of water.
When to take it
APO-Ezetimibe/Simvastatin should be taken once a day, in the evening.
The liver produces its greatest amount of cholesterol when the body is at rest and
when there is no dietary intake. For most people this is at night when asleep. Therefore,
APO- Ezetimibe/Simvastatin is more effective when taken in the evening. A good time
would be after your evening meal. However, it does not matter whether you take it
before or after food.
However, take APO- Ezetimibe/Simvastatin about the same time each day.
Taking APO-Ezetimibe/Simvastatin at the same time each day will have the best effect.
It will also help you remember when to take your dose.
Your doctor may ask you to take APO-Ezetimibe/Simvastatin with other cholesterol lowering
agents such as bile acid sequestrants.
If you are taking a bile acid sequestrant, such as cholestyramine, take your APO-Ezetimibe/Simvastatin
either at least two hours before or four hours after taking the bile acid sequestrant.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
APO-Ezetimibe/Simvastatin helps lower your cholesterol. It does not cure your condition.
Therefore, you must continue to take it as directed by your doctor if you expect to
lower your cholesterol and keep it down.
You may have to take cholesterol lowering medicine for the rest of your life. If you
stop taking APO- Ezetimibe/Simvastatin , your cholesterol levels may rise again.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose when you are meant to.
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 the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much of this medicine. Do this even
if there are no signs of discomfort or poisoning.
While you are using this medicine
Things you must do
If you become pregnant while taking APO-Ezetimibe/Simvastatin, stop taking it and
tell your doctor immediately.
Have your blood fats checked when your doctor says, to make sure APO- Ezetimibe/Simvastatin
Even if you are taking medicines to treat high cholesterol, it is important to have
your cholesterol measured regularly. You should also know your cholesterol levels
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking APO-Ezetimibe/Simvastatin.
If you are about to have elective surgery, tell your doctor that you are taking APO-
Your doctor may suggest stopping the tablets a few days before surgery.
Things you must not do
Do not give APO- Ezetimibe/Simvastatin to anyone else, even if they have the same
condition as you.
Things to be careful of
Avoid drinking large quantities of alcohol.
Drinking large quantities of alcohol may increase your chance of APO- Ezetimibe/Simvastatin
causing liver problems.
Grapefruit juice should be avoided while taking APO- Ezetimibe/Simvastatin.
Grapefruit juice contains one or more components that alter the metabolism of some
medicines, including APO- Ezetimibe/Simvastatin.
Be careful driving or operating machinery until you know how APO-Ezetimibe/Simvastatin
There have been side effects reported with APO-Ezetimibe/Simvastatin that may affect
your ability to drive or operate machinery.
Individual responses to APO- Ezetimibe/Simvastatin may vary.
High cholesterol can be treated in two main ways:
This includes a cholesterol-lowering diet, increasing physical activity, and weight
management. Ask your doctor for advice before increasing physical activity.
Cholesterol-lowering medicines are used together with lifestyle changes to help lower
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking APO- Ezetimibe/Simvastatin.
APO-Ezetimibe/Simvastatin helps most people with high cholesterol, but it may have
unwanted side effects in a few people. All medicines can have side effects. Sometimes
they are serious, most of the time they are not. You may need medical treatment if
you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately or go to accident and emergency at your nearest hospital,
if you notice any of the following:
swelling of the face, lips, mouth, throat or tongue which may cause difficulty in
swallowing or breathing
These are serious side effects. If you have them, you may have had a serious allergic
reaction to APO- Ezetimibe/Simvastatin. You may need urgent medical attention or hospitalisation.
Serious side effects are rare.
Tell your doctor immediately if you notice any of the following:
skin rash and hives
raised red rash, sometimes with target-shaped lesions
dark coloured urine
light coloured bowel motions
bleeding or bruising more easily than normal
steady abdominal pain with nausea and vomiting.
These may be serious side effects. You may need urgent medical attention. Serious
side effects are rare.
Liver problems can also occur and may be serious. Your doctor may do blood tests to
check your liver
Tell your doctor immediately if you notice any of the following symptoms of liver
feel tired or weak
loss of appetite
upper belly pain
yellowing of the skin or the white of your eyes.
Tell your doctor immediately if you notice the following:
unexplained muscle aches, tenderness or weakness, not caused by exercise (in very
rare cases this may not go away after stopping APO- Ezetimibe/Simvastatin).
This may be a serious side effect. This is because on rare occasions, muscle problems
can be serious, including muscle breakdown resulting in kidney damage that can lead
to death. You may need urgent medical attention.
The risk of muscle breakdown is greater at higher doses of APO- Ezetimibe/Simvastatin,
particularly the 10/80 mg dose.
The risk of muscle breakdown is also greater for older patients (65 years of age and
older), female patients, patients with kidney problems, and patients with thyroid
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice any other effects.
Tell your doctor if you notice any of the following:
These are the more common side effects of APO- Ezetimibe/Simvastatin or of either
ezetimibe or simvastatin.
Tell your doctor if you notice any of the following:
Tingling or numbness of the hands or feet
Breathing problems including persistent cough and/or shortness of breath, that may
also occur with fatigue, unexplained weight loss or fever
These are rare side effects of ezetimibe or simvastatin.
In adolescent patients (10 to 17 years of age) there have been no studies longer than
1 year of the effect of taking APO-Ezetimibe/Simvastatin on bone development, growth,
social and emotional development, or fertility.
Do not be alarmed by these lists of possible side effects. You may not experience
any of them.
Storage and Presentation
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep APO-Ezetimibe/Simvastatin in a cool dry place where the temperature stays below
25°C. Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
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 APO-Ezetimibe/Simvastatin or the tablets have
passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
APO-Ezetimibe/Simvastatin comes in four types of tablets:
APO-Ezetimibe/Simvastatin 10/10 - 10mg Ezetimibe/10mg Simvastatin: Light tan, mottled,
round, biconvex, 6mm tablets with markings "511" on one side - AUST R 279116.
APO-Ezetimibe/Simvastatin 10/20 - 10mg Ezetimibe/ 20mg Simvastatin: Light tab, mottled,
round, biconvex, 8mm tablets with markings "512" on one side - AUST R 279099.
APO-Ezetimibe/Simvastatin 10/40 - 10mg Ezetimibe/ 40mg Simvastatin: Light tan, mottled,
round, biconvex, 10mm tablets with markings "513" on one side - AUST R 279121.
APO-Ezetimibe/Simvastatin 10/80 - 10mg Ezetimibe/ 80mg Simvastatin: Light tab, mottled,
capsule shaped, biconvex, 17.5 x 7.55mm tablets with markings "515" on one side -
AUST R 279123.
A starter blister pack of APO- Ezetimibe/Simvastatin contains 5 or 10 tablets. A trade
blister pack contains 30 tablets.
APO-Ezetimibe/Simvastatin 10/10 -
10mg ezetimibe/10mg simvastatin per tablet
APO-Ezetimibe/Simvastatin 10/20 -
10mg ezetimibe/20mg simvastatin per tablet
APO-Ezetimibe/Simvastatin 10/40 -
10mg ezetimibe/ 40mg simvastatin per tablet
APO-Ezetimibe/Simvastatin 10/80 -
10mg ezetimibe/ 80mg simvastatin per tablet
iron oxide yellow (E172)
iron oxide red (E172)
iron oxide black (E172)
APO-Ezetimibe/Simvastatin does not contain gluten, sucrose, tartrazine or any other
This medicine is supplied in Australia by:
Medis Pharma Pty Limited
1002/53 Walker Street,
North Sydney, NSW, 2060
This medicine is distributed in Australia by:
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was prepared in June 2018.