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Act Ezetimibe: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
10 mg
Active ingredient:
ATC code:
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Act Ezetimibe

What the medication is used for:

ACT EZETIMIBE helps to reduce the amount of cholesterol and triglycerides in your blood in conjunction with lifestyle changes including exercise, diet, and weight management, when a response to such changes has been inadequate.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of low density lipoprotein cholesterol and high density lipoprotein cholesterol (LDL and HDL cholesterol).

WARNINGS AND PRECAUTIONS

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.

ACT EZETIMIBE may be taken alone or with other cholesterol-lowering medicines known as statins, in addition to diet and other lifestyle changes (see INTERACTIONS WITH THIS MEDICATION). ACT EZETIMIBE adds to the cholesterol-lowering effect of statins. Statins lower cholesterol in a different way; they work in the liver.

What it does:

ACT EZETIMIBE works by decreasing the absorption of cholesterol in the small intestine.

When it should not be used:

  • Patients who are hypersensitive (allergic) to ezetimibe or any of the nonmedicinal ingredients should not take ACT EZETIMIBE.
  • Patients with liver disease, active or unexplained increases in liver enzymes (blood tests of liver function) should not take ACT EZETIMIBE together with a statin.

  • Patients who are pregnant should not take ACT EZETIMIBE together with a statin.

  • Patients who are nursing should not take ACT EZETIMIBE together with a statin.

What the medicinal ingredient is:

Ezetimibe.

What the important nonmedicinal ingredients are:

Lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, crospovidone, microcrystalline cellulose and magnesium stearate.

What dosage forms it comes in:

Tablet 10 mg (white to off-white, capsule shaped tablet).

Serious Warnings and Precautions

  • Liver disease (Hepatitis)
  • Pancreas disease (Pancreatitis)
  • Muscle pain (Myopathy/Rhabdomyolysis, myalgia)
  • Severe allergic reaction (Anaphylaxis)

Before you use ACT EZETIMIBE talk to your doctor if you:

  • are pregnant, plan to become pregnant or think you might be pregnant.
  • are breast-feeding. ACT EZETIMIBE may be passed in your milk to your baby.
  • have now or have had in the past any medical problems (including liver disease or liver problems).

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

INTERACTIONS WITH THIS MEDICATION

You should always tell your doctor about all drugs that you are taking or plan to take as well as those obtained without a prescription.

Drugs that may interact with ACT EZETIMIBE include:

  • Cyclosporine
  • Cholestyramine (a resine/bile acid sequestrant) or any other bile acid sequestrant. In that case, ACT EZETIMIBE should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

PROPER USE OF THIS MEDICATION

Usual dose:

  • ACT EZETIMIBE should be taken as directed. Take one 10 mg tablet by mouth each day, preferably at the same time of day. ACT EZETIMIBE can be taken with or without food.

  • Continue taking your other cholesterol-lowering medicines known as statins unless your doctor tells you to stop.
  • If you are taking a statin, ACT EZETIMIBE can be taken at the same time.
  • Even if you are taking medication to treat high cholesterol, it is important to have your cholesterol measured regularly. You should also know your cholesterol levels and goals.

Overdose:

Take ACT EZETIMIBE only as prescribed for you. If you take more ACT EZETIMIBE than you were prescribed, contact your doctor or pharmacist.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose, just resume the usual schedule of one tablet daily.

ACT EZETIMIBE is generally well tolerated.

  • When used alone, the following common side effects have been reported: abdominal pain; diarrhea; flatulence; tiredness; viral infection; throat infection (pharyngitis); nose infection (sinusitis); joint pain (arthralgia); back pain; and coughing.

The following uncommon side effects have been reported: elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function; indigestion; heartburn; nausea; muscle spasms; neck pain; decreased appetite; hot flush; high blood pressure; chest pain and pain

  • When used with a statin, the following common side effects have been reported: headache; tiredness; abdominal pain; diarrhea; joint pain (arthralgia); muscle pain (myalgia); back pain; throat infection (pharyngitis); nose infection (sinusitis); upper chest infection (respiratory tract); and changes in certain laboratory blood tests.

The following uncommon side effects have been reported: tingling sensation; dry mouth; gastritis; itching; rash; hives; muscular weakness; pain in arms and legs; unusual tiredness or weakness; and swelling, especially in the hands and feet.

If you are prescribed ACT EZETIMIBE with a statin, your doctor will order routine blood tests to check your liver function before and after starting treatment.

Talk to your doctor anytime you have a medical problem you think may be related to ACT EZETIMIBE.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
Rare
  • Muscle aches and pains (Myopathy/ Rhabdomyolysis)
√
  • Sudden severe allergic reactions (swelling of the face, lips, tongue,and/or throat that may cause difficulty in breathing or swallowing, rash and hives).
√
  • Symptoms of liver problems (severe abdominal pain, especially if felt on the upper right side below the ribs, dark urine, general itchiness, severe nausea or vomiting, pale stools, yellowing of skin or eyes)
√
  • Symptoms of gallstones or inflammation of the gall bladder (severe abdominal pain, nausea, vomiting)
√
  • Symptoms of pancreas problems (severe abdominal pain)
√

HOW TO STORE IT

MORE INFORMATION

This is not a complete list of side effects. For any unexpected effects while taking ACT EZETIMIBE, contact your doctor or pharmacist.

Keep your medicine between 15°C and 30°C. Protect from moisture. Bottle should be kept tightly closed. Do not remove the desiccant from the bottle.

Keep ACT EZETIMIBE and all medicines out of the reach of children.

Do not use this medicine after the expiry date on the container.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
  • o Fax toll-free to 1-866-678-6789, or

  • o Mail to:

    • Canada Vigilance Program
    • Health Canada
    • Postal Locator 0701E
    • Ottawa, Ontario
    • K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, contact your health professional. The Canada Vigilance Program do not provide medical advice.

You may obtain further information from your doctor or pharmacist.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals, at:

1-866-254-6111.

Actavis Pharma Company

6733 Mississauga Road, Unit 400

Mississauga ON

L5N 6J5

Last revised: July 10, 2014

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02414716

Revision date stated in the text: July 10, 2014

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Act Ezetimibe

Rx or OTC
Prescription (Rx)?
DIN 02414716
Schedule(s) PRESCRIPTION
Active ingredient(s) Ezetimibe 10 MG
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. C Cardiovascular system drugs
    1. C10 Lipid modifying agents
      1. C10A Lipid modifying agents, plain
        1. C10AX Other lipid modifying agents
          1. C10AX09 Ezetimibe
Company ACTAVIS PHARMA COMPANY
Current status Cancelled Post Market
Current status date June 12, 2018

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.