Each tablet contains 10 mg ezetimibe.
Excipients/Inactive Ingredients: The other ingredients are: sodium laurilsulfate, povidone K30, mannitol, croscarmellose sodium, microcrystalline cellulose, sodium stearyl fumarate.
Ezetimibe, the active ingredient of Ezoleta, works by reducing the cholesterol absorbed in the digestive tract.
Ezoleta adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol the body makes by itself.
Cholesterol is one of several fatty substances found in the bloodstream. The 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 the 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 the blood that may increase the risk for heart disease.
Ezoleta is a medicine used to lower increased levels of cholesterol.
Ezoleta lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezoleta raises levels of "good" cholesterol (HDL cholesterol).
It is used for patients who cannot control their cholesterol levels by cholesterol lowering diet alone.
Patients should stay on cholesterol lowering diet while taking this medicine.
Ezoleta is used in addition to cholesterol lowering diet if patients have: A raised cholesterol level in the blood (primary hypercholesterolaemia - heterozygous familial and non-familial): together with a statin, when the 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 the blood. Patients will also be prescribed a statin and may also receive other treatments.
Ezoleta does not help lose weight.
Always take this medicine exactly as advised by the doctor. Continue taking other cholesterol lowering medicines unless the doctor tells to stop. The patient should check with the doctor or pharmacist if not sure.
Before starting Ezoleta, the patient should be on a diet to lower the cholesterol.
The patient should keep on this cholesterol lowering diet whilst taking Ezoleta.
The recommended dose is one Ezoleta 10 mg Tablet by mouth once a day.
Take Ezoleta at any time of the day. The patient can take it with or without food.
If the doctor has prescribed Ezoleta 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 the doctor has prescribed Ezoleta along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other medicine containing bile acid sequestrant, the patient should take Ezoleta at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If the patient forgets to take Ezoleta: Do not take a double dose to make up for a forgotten tablet. Just take the normal amount of Ezoleta at the usual time the next day.
If the patient stops taking Ezoleta: If the patient stops taking Ezoleta, the blood cholesterol may increase again.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.
If the patient takes more Ezoleta than he/she should: Please contact the doctor or pharmacist.
Do not take Ezoleta: if allergic to ezetimibe or any of the other ingredients of this medicine (listed in Description).
Do not take Ezoleta together with a statin if: currently have liver problems; pregnant or breast-feeding.
If Ezoleta is used together with a statin, please read the package leaflet of that particular medicine.
Talk to the doctor or pharmacist before taking Ezoleta.
Tell the doctor about all medical conditions including allergies.
The doctor should do a blood test before taking Ezoleta with a statin is started. This is to check how well the liver is working.
The doctor may also want to have blood tests to check how well the liver is working after taking Ezoleta with a statin is started.
If the patient has moderate or severe liver problems, Ezoleta is not recommended.
The safety and effectiveness of the combined use of Ezoleta and fibrates (medicines for lowering cholesterol) have not been established.
Driving and using machines: Ezoleta is not expected to interfere with the ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking Ezoleta.
Use in Children: Do not give this medicine to children and adolescents between 6 and 17 years 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.
Do not take Ezoleta with a statin if pregnant, trying to get pregnant or may be pregnant. If the patient gets pregnant while taking Ezoleta with a statin, taking both medicines must be stopped immediately and the doctor must be told.
There is no experience from the use of Ezoleta without a statin during pregnancy. Ask the doctor for advice before using Ezoleta if pregnant.
Do not take Ezoleta with a statin if breast-feeding, because it is not known if the medicines are passed into breast milk.
Ezoleta without a statin should not be used if breast-feeding. Ask the doctor for advice.
Ask the doctor or pharmacist for advice before taking any medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact the doctor immediately if experiencing 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.
If getting any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Other medicines and Ezoleta: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines. In particular, tell the doctor if taking medicine(s) with any of the following active ingredients: ciclosporin (a medicine often used in organ transplant patients); medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants); colestyramine (a medicine for lowering cholesterol), because it affects the way Ezoleta works; fibrates (medicines for lowering cholesterol).
Ezoleta with food and drink: Ezoleta can be taken with or without food.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Do not store above 30 °C.
Store in the original package in order to protect from moisture.
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
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