Ezeta

Ezetimibe
Tablet

What Ezeta® is and what it is used for?
Ezeta® is a medicine to lower increased levels of cholesterol.
Ezeta® lowers levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezeta® raises levels of “good” cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of Ezeta®, works by reducing the cholesterol absorbed in your digestive tract.

Ezeta® adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself.
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.
It is used for patients who cannot control their cholesterol levels by cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine.

Ezeta® is used in addition to your cholesterol lowering diet if you have:

  • a raised cholesterol level in your blood (primary hypercholesterolemia [heterozygous familial and non-familial])
    • together with a statin, when your cholesterol level is not well controlled with a statin alone.
    • alone, when statin treatment is inappropriate or is not tolerated.
  • a hereditary illness (homozygous familial hypercholesterolemia) that increases the cholesterol level in your blood. You will also be prescribed a statin and may also receive other treatments.
  • a hereditary illness (homozygous sitosterolemia, also known as phytosterolemia) that increases the levels of plant sterols in your blood.

If you have heart disease, Ezeta® combined with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain.
Ezeta® does not help you lose weight.

What you need to know before you take Ezeta®
If you use Ezeta® together with a statin, please read the package leaflet of that particular medicine.
Do not take Ezeta® if:

  • you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine

Do not take Ezeta® together with a statin if:

  • you currently have liver problems.
  • you are pregnant or breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ezeta®.
Tell your doctor about all your medical conditions including allergies.
Your doctor should do a blood test before you start taking Ezeta® with a statin. This is to check how well your liver is working.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Ezeta® with a statin.
If you have moderate or severe liver problems, Ezeta® is not recommended.
The safety and efficacy of the combined use of Ezeta® and certain cholesterol lowering medicines, the fibrates have not been established.

Children and adolescents
Ezetrol is not recommended for children under age of 10.

Other medicines and Ezeta®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:

  • cyclosporine (often used in organ transplant patients)
  • medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
  • cholestyramine (also used to lower cholesterol), because it affects the way Ezeta® works
  • fibrates (also used to lower cholesterol)

Pregnancy and breast-feeding
Do not take Ezeta® with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking Ezeta® with a statin, stop taking both medicines immediately and tell your doctor.
There is no experience from the use of Ezeta® without a statin during pregnancy. Ask your doctor for advice before using Ezeta® if you are pregnant.
Do not take Ezeta® with a statin if you are breast-feeding, because it is not known if the medicines are passed into breast milk.
Ezeta® without a statin should not be used if you are breast-feeding. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Ezeta® is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking Ezeta®.

Ezeta® contains lactose.
Ezeta® tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Ezeta®
Always take this medicine exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. You should check with your doctor or pharmacist if you are not sure.

  • Before starting Ezeta®, you should be on a diet to lower your cholesterol.
  • You should keep on this cholesterol lowering diet while taking Ezeta®.

Adults, adolescents and children (10 to 17 years of age): The recommended dose is one Ezeta® 10 mg Tablet by mouth once a day. However, consult your doctor if you give Ezeta® to children of 10 to 17 years of age.
Take Ezeta® at any time of the day. You can take it with or without food.
If your doctor has prescribed Ezeta® along with a statin, both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of that particular medicine.
If your doctor has prescribed Ezeta® along with another medicine for lowering cholesterol containing the active ingredient cholestyramine or any other medicine containing bile acid sequestrant, you should take Ezeta® at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezeta® than you should
Please contact your doctor or pharmacist.

If you forget to take Ezeta®
Do not take a double dose to make up for a forgotten tablet, just take your normal amount of Ezeta® at the usual time the next day.

If you stop taking Ezeta®
Talk to your doctor or pharmacist because your cholesterol may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:

  • unexplained muscle pain,
  • tenderness, or
  • weakness

This is because on rare occasions, muscle problems, including muscle breakdown resulting in kidney damage, can be serious and may become a potentially life-threatening condition.
Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which requires treatment right away) have been reported in general use.

When used alone, the following side effects were reported:
Common (may affect up to 1 in 10 people):
Abdominal pain; diarrhea; flatulence; feeling tired.
Uncommon (may affect up to 1 of 100 patients):
Elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function; cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite, pain, chest pain, hot flush; high blood pressure.
Additionally, when used with a statin, the following side effects were reported:
Common (may affect up to 1 in 10 people):
Elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain, tenderness or weakness.
Uncommon (may affect up to 1 of 100 patients):
Tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially in the hands and feet.

When used with fenofibrate, the following common side effect was reported: abdominal pain. Additionally, the following side effects have been reported in general use: dizziness; muscle aches; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often with severe abdominal pain; constipation, reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression: unusual tiredness or weakness; shortness of breath.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

How to store Ezeta®

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label, carton or container. The expiry date refers to the last day of that month.
  • Do not store Ezeta® above 30°C.
  • Store in the original package.
  • These measures will protect the product from moisture.
  • Do not throw away any medicines via wastewater or household waste. Ask your physician or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


Ezeta Prescribing Information

Located in: Cardiovascular