Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Ezetimibe/Simvastatin Sandoz. 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 Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz is used for
Ezetimibe/Simvastatin Sandoz 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.
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 heart disease.
How Ezetimibe/Simvastatin Sandoz works
Ezetimibe/Simvastatin Sandoz reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol.
Ezetimibe/Simvastatin Sandoz works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. Ezetimibe/Simvastatin Sandoz does not help you lose weight.
If you have heart disease and a history of heart attack or hospitalisation for unstable angina (chest pain), Ezetimibe/Simvastatin Sandoz reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalisation for chest pain.
Your doctor may have prescribed Ezetimibe/Simvastatin Sandoz for another reason. Ask your doctor if you have any questions about why Ezetimibe/Simvastatin Sandoz has been prescribed for you.
Ezetimibe/Simvastatin Sandoz is not addictive.
Use in Children and Adolescents
Ezetimibe/Simvastatin Sandoz 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).
Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz is suitable for your child. Depending on the pubertal development of your child, Ezetimibe/Simvastatin Sandoz may not be suitable for him or her.
Before you take Ezetimibe/Simvastatin Sandoz
When you must not take it
Do not take Ezetimibe/Simvastatin Sandoz if:
- you have allergy to Ezetimibe/Simvastatin Sandoz 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.
- you are pregnant or breast feeding
Ezetimibe/Simvastatin Sandoz 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 the section "Taking other medicines" in this CMI for more information.
- the packaging is torn or shows signs of tampering.
- the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking Ezetimibe/Simvastatin Sandoz, talk to your doctor.
Before you start to take it
Tell your doctor if:
- you are pregnant or intend to become pregnant.
Ezetimibe/Simvastatin Sandoz should not be used during pregnancy.
- you are breast-feeding.
Ezetimibe/Simvastatin Sandoz should not be used while breast feeding.
- 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.
- you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you take any Ezetimibe/Simvastatin Sandoz.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines should not be taken with Ezetimibe/Simvastatin Sandoz. 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
- erythromycin, clarithromycin, telithromycin and fusidic acid, 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 Ezetimibe/Simvastatin Sandoz temporarily or permanently.
Some medicines and Ezetimibe/Simvastatin Sandoz may interfere with each other. These include:
- certain hepatitis C antiviral agents, such as elbasvir, or grazoprevir
- 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
- 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 Ezetimibe/Simvastatin Sandoz, may affect how well it works, or may increase the risk of side effects with Ezetimibe/Simvastatin Sandoz. You may need different amounts of your medicine, or you may need to take different medicines or take your medicines at different times.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Ezetimibe/Simvastatin Sandoz.
You should also tell any doctor who is prescribing a new medication for you that you are taking Ezetimibe/Simvastatin Sandoz.
How to take Ezetimibe/Simvastatin Sandoz
How much to take
Take Ezetimibe/Simvastatin Sandoz only when prescribed by your doctor.
The recommended dose in adults (18 years and over) is one Ezetimibe/Simvastatin Sandoz 10/10, 10/20, 10/40 or 10/80 tablet once a day, in the evening. Your doctor will adjust your Ezetimibe/Simvastatin Sandoz dose depending on your response.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia is one Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz with a glass of water.
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
When to take it
Ezetimibe/Simvastatin Sandoz 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, Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz about the same time each day. Taking Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz with other cholesterol lowering agents such as bile acid sequestrants.
If you are taking a bile acid sequestrant, such as cholestyramine, take your Ezetimibe/Simvastatin Sandoz either at least two hours before or four hours after taking the bile acid sequestrant.
How long to take it
Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz, your cholesterol levels may rise again.
If you forget to take it
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.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablet, ask your pharmacist for some hints.
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 Ezetimibe/Simvastatin Sandoz. Do this even if there are no signs of discomfort or poisoning.
While you are taking Ezetimibe/Simvastatin Sandoz
Things you must do
If you become pregnant while taking Ezetimibe/Simvastatin Sandoz, stop taking it and tell your doctor immediately.
Have your blood fats checked when your doctor says, to make sure Ezetimibe/Simvastatin Sandoz 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.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Ezetimibe/Simvastatin Sandoz.
If you are about to have elective surgery, tell your doctor that you are taking Ezetimibe/Simvastatin Sandoz. Your doctor may suggest stopping the tablets a few days before surgery.
Things you must not do
Do not give Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz causing liver problems.
Grapefruit juice should be avoided while taking Ezetimibe/Simvastatin Sandoz. Grapefruit juice contains one or more components that alter the metabolism of some medicines, including Ezetimibe/Simvastatin Sandoz.
Be careful driving or operating machinery until you know how Ezetimibe/Simvastatin Sandoz affects you. There have been side effects reported with Ezetimibe/Simvastatin Sandoz that may affect your ability to drive or operate machinery. Individual responses to Ezetimibe/Simvastatin Sandoz may vary.
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.
cholesterol-lowering medicines are used together with lifestyle changes to help lower cholesterol.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ezetimibe/Simvastatin Sandoz.
Ezetimibe/Simvastatin Sandoz 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 Ezetimibe/Simvastatin Sandoz. 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
- joint pain
- bleeding or bruising more easily than normal
- steady abdominal pa
in 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 problems:
- feel tired or weak
- loss of appetite
- upper belly pain
- dark urine
- 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 Ezetimibe/Simvastatin Sandoz).
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 Ezetimibe/Simvastatin Sandoz, 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 problems.
Serious side effects are rare.
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:
- Muscle aches
- Feeling tired
- Stomach irritation
- Decreased appetite
- Weight decreased
- Abdominal bloating
- Dry mouth
- Heart burn
- Hot flush
These are the more common side effects of Ezetimibe/Simvastatin Sandoz or of either ezetimibe or simvastatin.
Tell your doctor if you notice any of the following:
- Tingling or numbness of the hands or feet
- Trouble sleeping
- Poor memory
- Erectile dysfunction
- 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 Ezetimibe/Simvastatin Sandoz 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.
After using Ezetimibe/Simvastatin Sandoz
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister they may not keep well.
Keep Ezetimibe/Simvastatin Sandoz in a cool dry place where the temperature stays below 25°C.
Do not store it any other medicine in the bathroom or near a sink.
Do not leave it in the car or on a 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 Ezetimibe/Simvastatin Sandoz or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
Ezetimibe/Simvastatin Sandoz comes in four types of tablets:
- Ezetimibe/Simvastatin Sandoz 10/10 – 10 mg Ezetimibe/10 mg Simvastatin: Light tan, mottled, round, biconvex, 6 mm tablets with markings “511” on one side.
- Ezetimibe/Simvastatin Sandoz 10/20 – 10 mg Ezetimibe/20 mg Simvastatin: Light tab, mottled, round, biconvex, 8 mm tablets with markings “512” on one side.
- Ezetimibe/Simvastatin Sandoz 10/40 – 10 mg Ezetimibe/40 mg Simvastatin: Light tan, mottled, round, biconvex, 10 mm tablets with markings “513” on one side.
- Ezetimibe/Simvastatin Sandoz 10/80 – 10 mg Ezetimibe/80 mg Simvastatin: Light tab, mottled, capsule shaped, biconvex, 17.5 x 7.55 mm tablets with markings “515” on one side.
A trade blister pack contains 30 tablets.
Ezetimibe/Simvastatin Sandoz 10/10 –
10 mg ezetimibe/10 mg simvastatin per tablet
Ezetimibe/Simvastatin Sandoz 10/20 –
10 mg ezetimibe/20 mg simvastatin per tablet
Ezetimibe/Simvastatin Sandoz 10/40 –
10 mg ezetimibe/40 mg simvastatin per tablet
Ezetimibe/Simvastatin Sandoz 10/80 –
10 mg ezetimibe/80 mg simvastatin per tablet
- butylated hydroxyanisole
- citric acid
- croscarmellose sodium
- lactose monohydrate
- ascorbic acid
- magnesium stearate
- microcrystalline cellulose
- propyl gallate
- iron oxide yellow
- iron oxide red
- iron oxide black
Ezetimibe/Simvastatin Sandoz does not contain gluten, sucrose, tartrazine or any other azo dyes.
Ezetimibe/Simvastatin Sandoz is supplied in Australia by:
Sandoz Pty Ltd
54 Waterloo Road,
Macquarie Park, NSW 2113,
Tel: 1800 726 369
This leaflet was prepared in June 2019
Australian Register Numbers:
10 mg/10 mg tablet blister pack –
AUST R 279097
10 mg/20 mg tablet blister pack –
AUST R 279102
10 mg/40 mg tablet blister pack –
AUST R 279098
10 mg/80 mg tablet blister pack –
AUST R 279117
Published by MIMS August 2019