Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using VYTORIN?
VYTORIN contains the active ingredient ezetimibe and simvastatin. VYTORIN is used
in people whose cholesterol levels are too high and when diet alone cannot lower these
levels adequately.
2. What should I know before I use VYTORIN?
Do not use if you have ever had an allergic reaction to VYTORIN or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with VYTORIN and affect how it works.
4. How do I use VYTORIN?
The recommended dose is one VYTORIN 10/10, 10/20, 10/40 or 10/80 tablet once a day,
in the evening.
For the best effect take VYTORIN at about the same time each day.
5. What should I know while using VYTORIN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using VYTORIN.
If you become pregnant while taking VYTORIN, tell your doctor.
Have any blood tests your doctor requests to make sure VYTORIN is right for you.
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Things you should not do
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Do not give VYTORIN to anyone else, even if they have the same condition as you.
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Driving or using machines
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Side effects have been reported that may affect your ability to drive or operate machinery.
Be careful driving or operating machinery until you know how VYTORIN affects you.
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Drinking alcohol
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Drinking large quantities of alcohol while taking VYTORIN may increase your chance
of getting liver problems.
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Looking after your medicine
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Keep VYTORIN in a cool dry place where the temperature stays below 30°C
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6. Are there any side effects?
Common side effects of VYTORIN are diarrhoea and muscle pain.
Allergic reactions to ezetimibe, simvastatin or other ingredients of VYTORIN occur
very rarely.
Serious side effects are rare, but may need urgent medical attention. For more information,
including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
ezetimibe and simvastatin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VYTORIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VYTORIN.
Where to find information in this leaflet:
1. Why am I using VYTORIN?
VYTORIN contains the active ingredients ezetimibe and simvastatin. VYTORIN helps to lower cholesterol and triglyceride levels.
VYTORIN is used in people whose cholesterol levels are too high and when diet alone
cannot lower these levels adequately..
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
Triglycerides are another form of fat in your blood that may increase your risk for
heart disease.
How VYTORIN works
VYTORIN reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides
and increases HDL (good) cholesterol.
VYTORIN works by decreasing the absorption of cholesterol in the small intestine and
by reducing the amount of cholesterol made in the liver. VYTORIN does not help you
lose weight.
If you have heart disease and a history of heart attack or hospitalisation for unstable
angina (chest pain), VYTORIN reduces the risk of heart attack, stroke, surgery to
increase heart blood flow, or hospitalisation for chest pain.
Your doctor may have prescribed VYTORIN for another reason. Ask your doctor if you
have any questions about why VYTORIN has been prescribed for you.
VYTORIN is not addictive.
2. What should I know before I use VYTORIN?
Warnings
Do not use VYTORIN if:
you are allergic to ezetimibe, simvastatin, or any of the ingredients listed at the
end of this leaflet. Symptoms of an allergic reaction may include skin rash, itchiness,
shortness of breath, swelling of the face, lips, mouth, tongue or throat.
Always check the ingredients to make sure you can use this medicine.
you are pregnant or breast feeding. VYTORIN is contraindicated (i.e. should not be
used) during pregnancy and breastfeeding. If you take this medicine during pregnancy
and breastfeeding, your baby may absorb this medicine and it may affect your baby's
normal development causing foetal malformations (birth defects) or irreversible damage.
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, ciclosporin, danazol, fusidic
acid and strong CYP3A4 inhibitors like itraconazole and ketoconazole. Please see 3.
"What if I am taking other medicines" in this CMI for more information.
the packaging is torn or shows signs of tampering.
Check with your doctor if you:
have kidney disease, diabetes or any other medical conditions
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.
are Asian.
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.
drink alcohol regularly.
have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
have or have had myasthenia gravis (a disease causing general muscle weakness including
in some cases muscles used for breathing) or ocular myasthenia (a disease causing
eye muscle weakness) as statins may lead to occurrence of myasthenia or aggravate
the condition.
are taking niacin or a niacin-containing product.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. VYTORIN should
not be used during pregnancy.
If you become pregnant while taking VYTORIN, stop taking it and tell your doctor immediately.
Talk to your doctor if you are breastfeeding or intend to breastfeed. VYTORIN should
not be used while breast feeding.
Use in Children and Adolescents
VYTORIN 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).
VYTORIN 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 VYTORIN is suitable for your child. Depending on the
pubertal development of your child, VYTORIN may not be suitable for him or her.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines should not be taken with VYTORIN. If you are taking any of them, your
doctor may suggest stopping VYTORIN temporarily or permanently. These include:
nefazodone, used to treat depression
medicines containing cobicistat, a drug used in the treatment of HIV infection.
protease inhibitors, including indinavir, nelfinavir, ritonavir, saquinavir, used
to treat HIV infection
certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
gemfibrozil, used to treat high cholesterol levels
ciclosporin, used to suppress the immune system
danazol
erythromycin, clarithromycin, telithromycin and fusidic acid, antibiotics used to
treat infections
ketoconazole, itraconazole, posaconazole and voriconazole used to treat certain fungal
infections
Some medicines and VYTORIN may interfere with each other. These medicines may be affected
by VYTORIN, may affect how well it works, or may increase the risk of side effects
with VYTORIN. You may need different amounts of your medicine, or you may need to
take different medicines or take your medicines at different times. These include:
certain hepatitis C antiviral agents, such as elbasvir, or grazoprevir
bile acid sequestrants, such as colestyramine, used to lower cholesterol levels.
other medicines to lower cholesterol levels, for example, other fibrates, nicotinic
acid (also known as niacin).
warfarin, fluindione, ticagrelor 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)
daptomycin, a drug used to treat complicated skin and skin structure infections and
bacteraemia
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while taking VYTORIN.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VYTORIN.
4. How do I use VYTORIN?
How much to take
The recommended dose in adults (18 years and over) is one VYTORIN 10/10, 10/20, 10/40
or 10/80 tablet once a day, in the evening. Your doctor will adjust your VYTORIN dose
depending on your response.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia
is one VYTORIN 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 VYTORIN 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.
Swallow VYTORIN with a glass of water.
Follow the instructions provided and take VYTORIN until your doctor tells you to
stop.
When to take VYTORIN
VYTORIN 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, VYTORIN is more effective
when taken in the evening.
Take VYTORIN about the same time each day. A good time would be after your evening
meal. However, it does not matter whether you take it before or after food.
Taking VYTORIN 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 VYTORIN with other cholesterol lowering agents such
as bile acid sequestrants. If you are taking a bile acid sequestrant, such as colestyramine,
take your VYTORIN either at least two hours before or four hours after taking the
bile acid sequestrant.
How long to take it
VYTORIN 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 VYTORIN, your cholesterol levels may rise again.
If you forget to take VYTORIN
VYTORIN should be used regularly at the same time each day.
If it is almost time for 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 tablet as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your tablet, ask your pharmacist for some
hints.
If you use too much VYTORIN
If you think that you have used too much VYTORIN, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using VYTORIN?
Things you should do
Call your doctor straight away and stop taking VYTORIN if you become pregnant while
you are taking VYTORIN.
Have your blood fats checked when your doctor says, to make sure VYTORIN is working.
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
and goals.
Remind any doctor, dentist or pharmacist you visit that you are using VYTORIN.
If you are about to have elective surgery, tell your doctor that you are taking VYTORIN.
Your doctor may suggest stopping the tablets a few days before surgery.
Things you should not do
Do not give VYTORIN to anyone else, even if they have the same condition as you.
Things to be careful of
Grapefruit juice should be avoided while taking VYTORIN. Grapefruit juice contains
one or more components that alter the metabolism of some medicines, including VYTORIN.
Things that may help your condition
High cholesterol can be treated in two main ways.
Lifestyle Changes
This includes a cholesterol-lowering diet, increasing physical activity, and weight
management. Ask your doctor for advice before increasing physical activity.
Medicines
Cholesterol-lowering medicines are used together with lifestyle changes to help lower
cholesterol.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VYTORIN
affects you.
There have been side effects reported with VYTORIN that may affect your ability to
drive or operate machinery. Individual responses to VYTORIN may vary.
Drinking alcohol
Avoid drinking large quantities of alcohol.
Drinking large quantities of alcohol may increase your chance of VYTORIN causing liver
problems.
Looking after your medicine
Keep VYTORIN in a cool dry place where the temperature stays below 25°C.
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.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date. If you take this medicine after the
expiry date has passed, it may not work.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
In adolescent patients (10 to 17 years of age) there have been no studies longer than
1 year of the effect of taking VYTORIN on bone development, growth, social and emotional
development, or fertility.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What VYTORIN contains
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Active ingredients
(main ingredients)
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ezetimibe 10 mg per tablet
simvastatin 10, 20, 40 or 80 mg per tablet
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Other ingredients
(inactive ingredients)
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butylated hydroxyanisole
citric acid monohydrate
croscarmellose sodium
hypromellose
lactose monohydrate
magnesium stearate
microcrystalline cellulose
propyl gallate
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Potential allergens
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VYTORIN contains lactose.
VYTORIN does not contain gluten, sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What VYTORIN looks like
VYTORIN comes in four different strengths:
VYTORIN 10/10 mg is a white to off-white, capsule shaped, biconvex compressed tablet
marked with "311". (AUST R 98100)
VYTORIN 10/20 mg is a white to off-white, capsule shaped, biconvex compressed tablet
marked with "312". (AUST R 98111)
VYTORIN 10/40 mg is a white to off-white, capsule shaped, biconvex compressed tablet
marked with "313". (AUST R 98115)
VYTORIN 10/80 mg is a white to off-white, capsule shaped, biconvex compressed tablet
marked with "315". (AUST R 98117)
Who distributes VYTORIN
Organon Pharma Pty Limited
Building A, 26 Talavera Road
MACQUARIE PARK NSW 2113
This leaflet was prepared in September 2023.
S-WPPI-OG0653A-T-062023