Ezetimibe 10 mg tablets

The name of your medicine is Ezetimibe 10 mg tablets (called ezetimibe throughout this leaflet). It contains the active substance ezetimibe. Ezetimibe is a medicine to lower increased levels of cholesterol.

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

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

Ezetimibe 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.

Ezetimibe 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

If you have heart disease, ezetimibe 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.

Ezetimibe does not help you lose weight.

If you use ezetimibe 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. Check with your doctor or pharmacist if you are not sure.

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

The recommended dose is 1 ezetimibe 10 mg tablet by mouth once a day.

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

If your doctor has prescribed ezetimibe 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 ezetimibe along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other medicine containing bile acid sequestrant, you should take ezetimibe 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.

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, or when used with a statin, the following side effects were reported:

Common (may affect up to 1 in 10 people):

• Abdominal pain, diarrhoea, flatulence
• Feeling tired
• Headache
• Elevations in some laboratory blood tests of liver function (transaminases)

Uncommon (may affect up to 1 in 100 people):

• Elevations in some laboratory blood tests for muscle (CK) function
• Cough
• Indigestion, heartburn, nausea, dry mouth, inflammation of the stomach
• Joint pain, muscle spasms, neck pain, back pain, pain in arms and legs
• Decreased appetite
• Pain, chest pain, unusual tiredness or weakness, swelling, especially in the hands and feet.
• hot flushes, high blood pressure
• Itching, rash, hives
• Tingling sensation

Additionally, the following side effects have been reported with the frequency not known (cannot be estimated from available data):

• Dizziness
• Raised red rash, sometimes with target-shaped lesions (erythema multiforme)
• Inflammation of the liver, 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)
• Depression
• Shortness of breath

When used with fenofibrate, the following common side effect was reported:

• Abdominal pain.

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 outer packaging and blister after “EXP”. The expiry date refers to the last day of that month.

Store below 30 °C. Store in the original package in order to protect from moisture.

Do not use this medicine if you notice visible signs of deterioration.

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.