Patient Leaflet Updated 31-Jan-2024 | Glenmark Pharmaceuticals Europe Ltd
Ezetimibe 10 mg Tablets
Ezetimibe 10 mg Tablets
Ezetimibe
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
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 tablets, 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.
Ezetimibe 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 does not help you lose weight.
If you use Ezetimibe together with a statin, please read the package leaflet of that particular medicine.
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.
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 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. Ask your doctor for advice before using Ezetimibe if you are pregnant.
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. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.
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 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 Ezetimibe 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 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 any medicine containing colestyramine or any other medicine containing the bile acid sequestrant , you should take Ezetimibe at least 2 hours before or 4 hours after taking the bile acid sequestrant .
Please contact your doctor or pharmacist.
Do not 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.
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.
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Additionally, when used with a statin, the following side effects were reported:
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Common side effect (may affect up to 1 in 10 people):
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:
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.
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.
The active substance is ezetimibe. Each tablet contains 10 mg ezetimibe.
The other ingredients are:
lactose monohydrate; sodium lauryl sulphate, croscarmellose sodium, povidone K-30 and magnesium stearate.
Ezetimibe tablets are white to off-white, capsule shaped, approximately 8.0 x 4.0 x 2.6 mm in size, flat, beveled edged uncoated tablets engraved with ‘G’ on one side and “44” on the other side.
Ezetimibe 10 mg tablets are available in PVC/Aclar- aluminium foil blisters of 14, 28, 30, 50, 90, 98 and 100 tablets and HDPE bottles of 100 tablets.
*Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 01/2024.
Building 2, Croxley Park, Watford, WD18 8YA
+44 (0)1923 251137
www.glenmarkpharma.com
+44 (0)1923 202 950
0800 458 0383
+44 (0)1923 202 950
