POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0791.
Ezetimibe 10mg Tablets
Package leaflet: Information for the patient
EZETIMIBE 10 MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What ezetimibe is and what it is used for
2. What you need to know before you take ezetimibe
3. How to take ezetimibe
4. Possible side effects
5. How to store ezetimibe
6. Contents of the pack and other information
1. WHAT EZETIMIBE IS AND WHAT IT IS USED FOR
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:
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETIMIBE
If you use ezetimibe together with a statin, please read the package leaflet of that particular medicine.
Do not take ezetimibe:
Do not take ezetimibe together with a statin:
Warnings and precautions
Talk to your doctor or pharmacist before taking ezetimibe.
If you have moderate or severe liver problems, ezetimibe is not recommended.
The safety and efficacy of the combined use of ezetimibe 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.
Other medicines and ezetimibe
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:
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take ezetimibe with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking ezetimibe with a statin, stop taking both medicines immediately and tell your doctor.
There is no experience from the use of ezetimibe without a statin during pregnancy.
Do not take ezetimibe with a statin if you are breast-feeding, because it is not known if the medicines are passed into breast milk.
Ezetimibe without a statin should not be used if you are breast-feeding.
Driving and using machines
Ezetimibe 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 ezetimibe.
Ezetimibe contains lactose and sodium
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'.
3. HOW TO TAKE EZETIMIBE
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.
The recommended dose is one 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 take more ezetimibe than you should
Please contact your doctor or pharmacist.
If you forget to take ezetimibe
Do not take a double dose to make up for a forgotten tablet, just take your normal amount of ezetimibe at the usual time the next day.
If you stop taking ezetimibe
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.
4. POSSIBLE SIDE EFFECTS
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. the following side effects were reported:
Common (may affect up to 1 in 10 people)
Abdominal pain; diarrhoea; flatulence; feeling tired.
Uncommon (may affect up to 1 in 100 people)
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 in 10 people)
Elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain, tenderness or weakness.
Uncommon (may affect up to 1 in 100 people)
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.
Reporting of side effects
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.
5. HOW TO STORE EZETIMIBE
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 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ezetimibe contains
What ezetimibe looks like and contents of the pack
Ezetimibe 10 mg are white, oblong tablets with length approx. 8.10 mm and width approx. 4.10 mm, plain on both sides.
Pack sizes: 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in July 2019