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 ZIMYBE?
ZIMYBE contains the active ingredients ezetimibe and simvastatin. ZIMYBE is used 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.
For more information, see Section
1. Why am I using ZIMYBE? in the full CMI.
2. What should I know before I use ZIMYBE?
Do not use if you have ever had an allergic reaction to ezetimibe and simvastatin
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.
For more information, see Section
2. What should I know before I use ZIMYBE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with ZIMYBE and affect how it works. Check with your
doctor or pharmacist if you are not sure about what medicines, vitamins or supplements
you are taking and if these affect ZIMYBE.
A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How do I use ZIMYBE?
The recommended dose in adults (18 years and over) is one ZIMYBE 10/10, 10/20, 10/40
or 10/80 tablet once a day, in the evening.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia
is one ZIMYBE 10/10, 10/20 or 10/40 tablet once a day, in the evening. The maximum
recommended dose in adolescents is 10/40 mg.
5. What should I know while using ZIMYBE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ZIMYBE.
Have your blood fats checked when your doctor says, to make sure ZIMYBE is working.
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Things you should not do
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Do not take ZIMYBE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how ZIMYBE
affects you. Side effects reported with ZIMYBE may affect your ability to drive or
operate heavy machinery
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Drinking alcohol
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Avoid drinking large quantities of alcohol. Drinking large quantities of alcohol may
increase your chances of ZIMYBE causing liver problems.
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Looking after your medicine
|
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the pack, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Seek immediate medical attention if you experience any difficulty in breathing or
swallowing, swelling of the face, lips, mouth, throat or tongue and unexplained muscle
aches, tenderness or weakness not caused by exercise.
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 ZIMYBE. 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 ZIMYBE.
Where to find information in this leaflet:
1. Why am I using ZIMYBE?
ZIMYBE contains the active ingredients ezetimibe and simvastatin.
ZIMYBE is used 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.
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 the arteries forming plaque.
This narrowing can slow or block blood flow to vital organs such as the heart or the
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.
ZIMYBE reduces elevated total cholesterol, LDL (bad) cholesterol and triglycerides
and increases HDL
(good) cholesterol.
ZIMYBE also works by decreasing the absorption of cholesterol in the small intestines
and by reducing the amount of cholesterol made in the liver. ZIMYBE does not help
you lose weight.
If you have heart disease and a history of heart attack or hospitalisation for unstable
angina (chest pain), ZIMYBE reduces the risk of heart attack, stroke, surgery to increase
heart blood flow, or hospitalisation for chest pain.
Your doctor may have prescribed it for another reason.
ZIMYBE is not addictive.
ZIMYBE is available from pharmacies only with a doctor's
prescription.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Use in Children and Adolescents
ZIMYBE 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).
ZIMYBE is not recommended for use in children under 10 years of age as there have
been no studies on its effects in this age group. Your doctor will assess whether
ZIMYBE is suitable for your child. Depending on the pubertal development of your child,
ZIMYBE may not be suitable for him or her.
2. What should I know before I use ZIMYBE?
Warnings
Do not use ZIMYBE if:
you are allergic to simvastatin or ezetimibe, or 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
Always check the ingredients to make sure you can use this medicine.
you are pregnant.
you are breastfeeding.
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 hemihydrate and strong CYP3A4 inhibitors like itraconazole and ketoconazole.
Please see the section "What if I am taking other medicines?" in this CMI for more
information.
the packaging is torn or shows signs of tampering or after the expiry date printed
on the pack. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking ZIMYBE, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives, or dyes.
you have unexplained muscle pain, tenderness or weakness not caused by exercise. This
is because on the rare occasion, 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 or any other medical problems.
you drink alcohol regularly.
take any medicines for any other condition.
If you have not told your doctor about any of the above, tell him/her before you start
taking ZIMYBE.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take this medicine if you are pregnant. It may affect your developing baby
if you take it during pregnancy. ZIMYBE 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 birth defects or irreversible damage.
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 ZIMYBE. 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,
ritonavir, saquinavir
certain protease inhibitors, used to treat Hepatitis C virus infection, 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 hemihydrate, antibiotics
used to treat infections
ketoconazole, itraconazole, posaconazole and voriconazole used to treat certain fungal
infections.
If you are taking any of the above, your doctor may suggest stopping ZIMYBE temporarily
or permanently.
Some medicines may interfere with ZIMYBE and affect how it works. 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
These medicines may be affected by ZIMYBE, may affect how well it works or may increase
the risk of side effects with ZIMYBE. You may need different amounts of your medicines,
or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZIMYBE.
4. How do I use ZIMYBE?
How much to take
Take ZIMYBE only when prescribed by your doctor.
The recommended dose in adults (18 years and over) is one ZIMYBE 10/10, 10/20, 10/40
or 10/80 tablet once a day, in the evening. Your doctor will adjust your ZIMYBE dose
depending on your response.
Because of the increased risk of muscle problems, the ZIMYBE 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.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia
is one ZIMYBE 10/10, 10/20 or 10/40 tablet once a day, in the evening. The maximum
recommended dose in adolescents is 10/40 mg.
Follow the instructions provided and use ZIMYBE until your doctor tells you to stop.
When to take ZIMYBE
ZIMYBE 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, ZIMYBE is more effective
when taken in the evening.
A good time would be after your evening meal. It does not matter if you take it before
or after food.
Take your medicine at about the same time each day. Taking it 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 ZIMYBE with other cholesterol lowering agents such
as bile acid sequestrants.
If you are taking a bile acid sequestrant, such as colestyramine, take your ZIMYBE
either at least two hours before or four hours after taking the bile acid sequestrant.
How long to take ZIMYBE for
ZIMYBE helps lower your cholesterol. It does not cure your condition. It is important
to keep taking you medicine even if you feel well.
Continue taking ZIMYBE 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 ZIMYBE, your cholesterol levels may rise again.
How to take ZIMYBE
Swallow ZIMYBE tablets whole with a full glass of water.
If you forget to take ZIMYBE
ZIMYBE should be used regularly at the same time each day. If you miss your dose at
the usual time, take it as soon as you remember, and then go back to taking your medicines
as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you are not sure what to do or whether to skip the dose, ask your doctor or pharmacist.
If you use too much ZIMYBE
If you think that you have used too much ZIMYBE, 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 ZIMYBE?
Things you should do
Have your blood fats checked when your doctor says, to make sure ZIMYBE 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.
Call your doctor straight away if you:
Are about to be started on any new medicines
Are going to have surgery. Tell the surgeon or anesthetist that you are taking this
medicine. It may affect other medicines used during surgery. Your doctor may suggest
stopping the tablets a few days before surgery.
Become pregnant while taking this medicine.
Remind any doctor, dentist or pharmacist you visit that you are using ZIMYBE.
Things you should not do
Do not take ZIMYBE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
Lifestyle measures that help reduce heart disease risk
By following these simple measures, you can further reduce the risk from heart disease.
Quit smoking and avoid secondhand smoke.
Limit alcohol intake.
Enjoy healthy eating by:
eating plenty of vegetables and fruit;
reducing your saturated fat intake (eat less fatty meats, full fat dairy products,
butter, coconut and palm oils, most take-away foods, commercially-baked products).
Be active. Progress, over time, to at least 30 minutes of moderate intensity physical
activity on 5 or more days each week. Can be accumulated in shorter bouts of 10 minutes
duration. If you have been prescribed anti-angina medicine, carry it with you when
being physically active.
Maintain a healthy weight.
Discuss your lifestyle and lifestyle plans with your doctor.
For more information and tools to improve your heart health, call Heartline, the Heart
Foundation's national telephone information service, on 1300 36 27 87 (local call
cost).
Know warning signs of heart attack and what to do:
Tightness, fullness, pressure, squeezing, heaviness or pain in your chest, neck, jaw,
throat, shoulders, arms or back.
You may also have difficulty breathing, or have a cold sweat or feel dizzy or light
headed or feel like vomiting (or actually vomit).
If you have heart attack warning signs that are severe, get worse or last for 10 minutes
even if they are mild, call triple zero (000). Every minute counts.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ZIMYBE
affects you.
There have been side effects reported with ZIMYBE that may affect your ability to
drive or operate heavy machinery. Individual responses to ZIMYBE may vary.
Grapefruit juice
Grapefruit juice should be avoided while taking ZIMYBE.
Grapefuit juice contains one or more components that alter the metabolism of some
medicines, including
ZIMYBE.
Drinking alcohol
Avoid drinking large quantities of alcohol.
Drinking large quantities of alcohol may increase your chances of ZIMYBE causing liver
problems.
Looking after your medicine
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the pack, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
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.
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. Tell your doctor or pharmacist as
soon as possible if you do not feel well while you are taking ZIMYBE.
Less serious side effects
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Less serious side effects
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What to do
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headache
nausea
muscle aches
dizziness
cough
feeling tired
stomach irritation
diarrhoea
decreased appetite
hot flush
hypertension (high blood pressure)
pain
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Speak to your doctor if you have any of these less serious side effects and they worry
you. These are the more common side effects of ZIMYBE or of either ezetimibe or simvastatin.
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depression
tingling or numbness of the hands or feet
trouble sleeping
poor memory
confusion
blurred vision and impaired vision
erectile dysfunction
breathing problems including persistent cough and/or shortness of breath or fever
gynaecomastia (breast enlargement in men) (very rare)
muscle rupture (very rare)
rash that occurs on the skin or sores in the mouth (lichenoid drug eruptions) (very
rare)
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Tell your doctor if you notice any of the following.
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Serious side effects
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Serious side effects
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What to do
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Swelling of the face, lips, mouth, throat or tongue which may cause difficulty in
swallowing or breathing
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Call your doctor immediately or go straight to the Emergency Department at your nearest
hospital if you notice any of these serious side effects. If you have them, you may
have had a serious reaction to ZIMYBE. You may require urgent medical attention or
hospitalisation.
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skin rash and hives
severe skin problems
dark coloured urine
light coloured bowel motions
joint pain
bleeding or bruising more easily than normal
steady abdominal pain with nausea and vomiting
weakness in your arms or legs that worsens after periods of activity, double vision
or drooping of your eyelids, difficulty swallowing, or shortness of breath (symptoms
of myasthenia).
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Tell your doctor immediately if you notice any of the following. These are serious
side effects that may require medical attention.
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feel tired or weak
loss of appetite
upper belly pain
dark urine
yellowing of the skin or the white of your eyes.
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Tell your doctor immediately if you notice any of the following symptoms of liver
problems.
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unexplained muscle aches, 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. The risk of muscle breakdown
is greater at higher doses of ZIMYBE particularly the 10/80 mg dose. The risk of muscle
breakdown is also greater for older patients (65 years of age or older), female patients,
patients with kidney problems and patients with thyroid problems.
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Tell your doctor immediately if you notice any of the following. These are serious
side effects that may require urgent medical attention. Serious side effects are rare.
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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 ZIMYBE 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 ZIMYBE contains
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Active ingredient
(main ingredient)
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ZIMYBE 10/10 - 10 mg ezetimibe and 10 mg simvastatin.
ZIMYBE 10/20 - 10 mg ezetimibe and 20 mg simvastatin.
ZIMYBE 10/40 - 10 mg ezetimibe and 40 mg simvastatin
ZIMYBE 10/80 - 10 mg ezetimibe and 80 mg simvastatin.
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Other ingredients
(inactive ingredients)
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Butylated hydroxyanisole
Citric acid monohydrate
Ascorbic acid
Croscarmellose sodium
Hypromellose
Lactose
Sodium lauryl sulphate
Magnesium stearate
Microcrystalline cellulose
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Potential allergens
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ZIMYBE 10/10 contains lactose.
ZIMYBE 10/20, ZIMYBE 10/40 &
ZIMYBE 10/80: Contains sugars (as lactose).
|
Do not take this medicine if you are allergic to any of these ingredients.
ZIMYBE does not contain, sucrose, gluten, tartrazine or any other azo dyes.
What ZIMYBE looks like
ZIMYBE tablets are available in 4 different strengths:
ZIMYBE 10/10 - 10mg ezetimibe/10mg simvastatin: A
white to off-white, oval, biconvex tablet debossed with M on one side of the tablet
and ES1 on the
other side. Blister packs of 30. (AUST R 206627)
ZIMYBE 10/20 - 10mg ezetimibe/20mg simvastatin: A
white to off-white, oval, biconvex tablet debossed with M on one side of the tablet
and ES2 on the other side. Blister packs of 30. (AUST R 206629)
ZIMYBE 10/40 - 10mg ezetimibe/40mg simvastatin: A
white to off-white, oval, biconvex tablet debossed with M on one side of the tablet
and ES3 on the other side. Blister packs of 30. (AUST R 206631)
ZIMYBE 10/80 - 10mg ezetimibe/ 80mg simvastatin: A
white to off-white, oval, biconvex tablet debossed with M on one side of the tablet
and ES4 on the other side. Blister packs of 30. (AUST R 206628)
Who distributes ZIMYBE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
ZIMYBE® is a Viatris company trade mark
This leaflet was prepared in December 2023.
ZIMYBE_cmi\Dec23/00