Ezetrol tablets contain the active ingredient ezetimibe, which is type of medicine known as a cholesterol absorption inhibitor. It is used to lower high cholesterol levels.

How does it work?

Ezetrol tablets contain the active ingredient ezetimibe, which is type of medicine known as a cholesterol absorption inhibitor. It is used to lower high cholesterol levels.

Ezetimibe works by preventing cholesterol from being absorbed from the small intestine into the bloodstream. It prevents cholesterol and other plant sterols that are consumed in the diet from being absorbed into the bloodstream. It also prevents cholesterol released from the bile duct into the intestine from being reabsorbed into the bloodstream. The overall result is a reduction in cholesterol levels in the blood.

Ezetimibe is used to lower cholesterol in people with high cholesterol levels (primary hypercholesterolaemia). It is normally used when another type of cholesterol-lowering medicine called a statin (for example simvastatin, atorvastatin), together with a low cholesterol diet and increased exercise, has not lowered cholesterol sufficiently. Ezetimibe is added to the statin treatment because it works in a different way to statins (which lower cholesterol by preventing its production by the liver) and so it can boost their cholesterol lowering effect.

Ezetimibe may also be used on its own to lower cholesterol in people with primary hypercholesterolaemia who cannot take statins.
Ezetimibe is used in conjunction with a statin and a cholesterol-lowering diet to lower cholesterol in people with inherited high cholesterol levels (familial hypercholesterolaemia).

Lastly, ezetimibe can be used to treat people with a rare inherited disorder called homozygous sitosterolaemia, where there are raised levels of plant sterols that are similar to cholesterol in the blood. In this case ezetimibe is used on its own, together with a cholesterol-lowering diet.
It is important to continue to follow a cholesterol-lowering diet and exercise regime while taking ezetimibe.

What is it used for?

  • High blood cholesterol levels (primary hypercholesterolaemia).
  • Inherited high blood cholesterol levels (familial hypercholesterolaemia).
  • A rare inherited disease with raised levels of plant sterols similar to cholesterol in the blood (homozygous sitosterolaemia or phytosterolaemia).

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

If you have been prescribed a bile acid sequestrant, such as cholestyramine or colestipol, as well as this medicine, you should take this medicine at least two hours before, or at least four hours after taking the cholestyramine or colestipol. This is because these medicines can make ezetimibe less effective if they are taken at the same time.

There may be an increased risk of gallstones if this medicine is taken in combination with fibrate medicines to lower cholesterol, eg fenofibrate, gemfibrozil. These medicines may also increase the amount of ezetimibe in the blood.

The immunosuppressant ciclosporin may increase the body's exposure to ezetimibe. Conversely, ezetimibe may increase the blood level of ciclosporin. The manufacturer of this medicine recommends that it should be used with caution in people taking ciclosporin and that, if the combination is used, ciclosporin blood levels should be monitored.

People who are taking an anticoagulant medicine, for example warfarin, should have their blood-clotting time (INR) monitored after they start taking this medicine, in order to check that this medicine has not affected the action of the anticoagulant.

Are there any other precautions or warnings for Ezetrol?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, swollen face, or difficulty breathing. If these occur, contact your doctor immediately.

Combination treatment: In some situations, this medication may be used in combination with another type of cholesterol-lowering medication called a "statin" (e.g., atorvastatin, pravastatin). If this combination is used, your liver function should be monitored by your doctor. This combination should not be used by pregnant women or people with active liver disease or unexplained, persistently abnormal tests of liver function.

Liver damage: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

This medication may cause liver damage. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Muscle pain or damage: This medication may cause muscle pain or damage. If you have unexpected muscle pain, weakness, or tenderness, see your doctor right away, especially if these symptoms do not seem to go away.

Pancreatitis (inflammation of the pancreas): This medication may cause the pancreas to become inflamed. This is called pancreatitis. If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor. If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this. If you have sudden stomach or abdominal pains while taking this medication, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if ezetimibe passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using ezetimibe have not been established for children under 10 years of age. Ezetimibe is not recommended for children less than 10 years of age.

Not to be used in

  • Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Ezetrol tablets contain lactose).
  • Active liver disease (if taken with a statin).
  • People with unexplained raised results in liver function tests (if taken with a statin).
  • Pregnancy (if taken with a statin).
  • Breastfeeding.
  • This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
  • If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
  • Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used during pregnancy if it is taken with a statin. If it is not taken with a statin, it should only be used during pregnancy if considered essential by your doctor. This is because its safety during pregnancy has not yet been established. Seek medical advice from your doctor.
It is not known if this medicine passes into breast milk. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.patient.co.uk/medicine/ezetimibe

http://www.netdoctor.co.uk/heart-and-blood/medicines/ezetrol.html

http://chealth.canoe.ca/drug_info_details.asp?channel_id=0&brand_name_id=1822&page_no=2#Warnings

http://en.wikipedia.org/wiki/Ezetimibe

http://www.merck.ca/assets/en/pdf/products/ci/EZETROL-CI_E.pdf

http://www.medsafe.govt.nz/consumers/cmi/e/ezetrol.pdf

http://www.nhs.uk/medicine-guides/pages/MedicineSideEffects.aspx?condition=Sitosterolaemia&medicine=Ezetrol