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Name of the medicinal product: EREZEL

Content: Each film coated tablet contains 75 mg of Ezetimibe

Pharmaceutical form: Tablets

Pharmacotherapeutic group: Other lipid modifying agents

Packaging Description: Paper Carton containing 30 tablets placed in blisters.

EREZEL is a medicine to lower increased levels of cholesterol.
EREZEL lowers levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, EREZEL raises levels of “good” cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of EREZEL, works by reducing the cholesterol absorbed in your digestive tract.
EREZEL 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.
EREZEL 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, EREZEL 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. EREZEL does not help you lose weight.
Do not take EREZEL if:
  • you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine.
  • you currently have liver problems.
  • you are pregnant or breast-feeding.
  • Talk to your doctor or pharmacist before taking EREZEL.
  • Tell your doctor about all your medical conditions including allergies.
  • Your doctor should do a blood test before you start taking EREZEL 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 EREZEL with a statin.
  • If you have moderate or severe liver problems, EREZEL is not recommended.
  • The safety and efficacy of the combined use of EREZEL and certain cholesterol lowering medicines, the fibrates have not been established.
  • Children and adolescents: Do not give this medicine to children and adolescents (6 to 17 years of age) unless prescribed by a specialist because there are limited data on safety and efficacy. Do not give this medicine to children less than 6 years old because there is no information in this age group.
  • 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: ● ciclosporin (often used in organ transplant patients) ● medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants) ● colestyramine (also used to lower cholesterol), because it affects the way EREZEL works ● fibrates (also used to lower cholesterol)
  • Do not take EREZEL with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking EREZEL with a statin, stop taking both medicines immediately and tell your doctor. There is no experience from the use of EREZEL without a statin during pregnancy. Ask your doctor for advice before using EREZEL if you are pregnant.
  • Do not take EREZEL with a statin if you are breast-feeding, because it is not known if the medicines are passed into breast milk. EREZEL without a statin should not be used if you are breast-feeding. Ask your doctor for advice.
  • EREZEL contains lactose. EREZEL 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.
  • 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 of 10 patients): abdominal pain; diarrhoea; 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 of 10 patients): 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 (thrombocytopaenia); tingling sensation; depression: unusual tiredness or weakness; shortness of breath.

What EREZEL contains:
The active substance is ezetimibe. Each tablet contains 10 mg ezetimibe.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, sodium laurilsulfate, magnesium stearate