EZETROL® 10 mg Tablets

ezetimibe

EZETROL is a medicine to lower increased levels of cholesterol.

EZETROL lowers levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, EZETROL raises levels of “good” cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient of EZETROL, works by reducing the cholesterol absorbed in your digestive tract.

EZETROL 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.

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

• a raised cholesterol level in your blood (primary hypercholesterolaemia [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 hypercholesterolaemia) 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 sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in your blood.

If you have heart disease, EZETROL combined with cholesterol lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalisation for chest pain.

EZETROL does not help you lose weight.

If you use EZETROL together with a statin, please read the package leaflet of that particular medicine.

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 EZETROL, you should be on a diet to lower your cholesterol.
• You should keep on this cholesterol lowering diet whilst taking EZETROL.

The recommended dose is one EZETROL 10 mg Tablet by mouth once a day.

Take EZETROL at any time of the day. You can take it with or without food.

If your doctor has prescribed EZETROL 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 EZETROL along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other medicine containing bile acid sequestrant, you should take EZETROL at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

• Very common (may affect more than 1 of 10 patients)
• Common (may affect up to 1 of 10 patients)
• Uncommon (may affect up to 1 of 100 patients)
• Rare (may affect up to 1 of 1,000 patients)
• Very rare (may affect up to 1 of 10,000 patients, including isolated reports).

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: abdominal pain; diarrhoea; flatulence; feeling tired.

Uncommon: 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: elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain, tenderness or weakness.

Uncommon: 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 (thrombocytopaenia); tingling sensation; depression: unusual tiredness or weakness; shortness of breath.

• 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 carton or container after "EXP." The expiry date refers to the last day of that month.
• Do not store EZETROL above 30°C.

Blisters: Store in the original package. Bottles: Keep bottles tightly closed. These measures will protect the product from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.