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The product code(s) for this leaflet is: PL 19945/0001.
Ezetrol 10mg Tablets
EZETROL® 10 mg Tablets
ezetimibe
1. What EZETROL is and what it is used for
2. What you need to know before you take EZETROL
3. How to take EZETROL
4. Possible side effects
5. How to store EZETROL
6. Contents of the pack and other information
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:
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.
Talk to your doctor or pharmacist before taking EZETROL.
If you have moderate or severe liver problems, EZETROL is not recommended.
The safety and efficacy of the combined use of EZETROL and certain cholesterol lowering medicines, the fibrates have not been established.
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:
Do not take EZETROL with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking EZETROL with a statin, stop taking both medicines immediately and tell your doctor.
There is no experience from the use of EZETROL without a statin during pregnancy.
Ask your doctor for advice before using EZETROL if you are pregnant.
Do not take EZETROL with a statin if you are breast-feeding, because it is not known if the medicines are passed into breast milk.
EZETROL 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.
EZETROL 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 EZETROL.
EZETROL 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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.
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.
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.
Please contact your doctor or pharmacist.
Do not take a double dose to make up for a forgotten tablet, just take your normal amount of EZETROL at the usual time the next day.
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.
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:
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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
EZETROL tablets are white to off-white, capsule-shaped tablets with code “414” on one side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in push-through blisters or unit dose peelable blisters;
84 or 90 tablets in push-through blisters;
50, 100 or 300 tablets in unit dose push-through blisters;
100 tablets in bottles.
Not all pack sizes may be available.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised under the name EZETROL in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.
This leaflet was last revised in November 2022.
© 2022 Organon group of companies. All rights reserved.
PIL.EZE.22.UK.0145.IA-ORG-Heist.NORCN