VYTORIN 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.
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.
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.
VYTORIN is not recommended for use in children, as there have been no studies of its effects in children.
Do not take VYTORIN if:
If you are not sure whether you should start taking VYTORIN, talk to your doctor.
Tell your doctor if:
1. you are pregnant or intend to become pregnant.
2. you are breast-feeding.
3. 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.
4. you are taking niacin or a niacin-containing product, particularly if you are Chinese.
5. you have, or have had, any medical conditions, including liver disease or liver problems.
6. you have kidney disease or any other medical problems.
7. you drink alcohol regularly.
8. 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 VYTORIN.
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 VYTORIN. These include:
If you are taking any of the above, your doctor may suggest stopping VYTORIN temporarily or permanently.
Some medicines and VYTORIN may interfere with each other. These include:
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.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking VYTORIN.
You should also tell any doctor who is prescribing a new medication for you that you are taking VYTORIN.
Take VYTORIN only when prescribed by your doctor.
The recommended dose is one VYTORIN 10/10, 10/20, 10/40 or 10/80 tablet once a day, in the evening.
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 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.
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. A good time would be after your evening meal. However, it does not matter whether you take it before or after food.
However, take VYTORIN about the same time each day.
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 cholestyramine, take your VYTORIN either at least two hours before or four hours after taking the bile acid sequestrant.
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 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.
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much VYTORIN. Do this even if there are no signs of discomfort or poisoning.
If you become pregnant while taking VYTORIN, stop taking it and tell your doctor immediately.
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.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking 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.
Do not give VYTORIN to anyone else, even if they have the same condition as you.
Avoid drinking large quantities of alcohol.
Drinking large quantities of alcohol may increase your chance of VYTORIN causing liver problems.
Grapefruit juice should be avoided while taking VYTORIN.
Grapefruit juice contains one or more components that alter the metabolism of some medicines, including VYTORIN.
Be careful driving or operating machinery 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.
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 VYTORIN.
VYTORIN 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:
These are serious side effects. If you have them, you may have had a serious allergic reaction to VYTORIN. You may need urgent medical attention or hospitalisation. Serious side effects are rare.
Tell your doctor immediately if you notice any of the following:
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:
Tell your doctor immediately if you notice the following:
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 VYTORIN, 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:
These are the more common side effects of VYTORIN or of either ezetimibe or simvastatin.
Tell your doctor if you notice any of the following:
These are rare side effects of ezetimibe or simvastatin.
Do not be alarmed by these lists of possible side effects. You may not experience any of them.
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 VYTORIN 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 VYTORIN or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
VYTORIN comes in four types of tablets:
A starter pack of VYTORIN contains 5 or 10 tablets. A trade pack contains 30 tablets.
VYTORIN 10/10 -
10mg ezetimibe/10mg simvastatin per tablet
VYTORIN 10/20 -
10mg ezetimibe/20mg simvastatin per tablet
VYTORIN 10/40 -
10mg ezetimibe/ 40mg simvastatin per tablet
VYTORIN 10/80 -
10mg ezetimibe/ 80mg simvastatin per tablet
VYTORIN does not contain gluten, sucrose, tartrazine or any other azo dyes.