Details for: ACH-EZETIMIBE
Company: ACCORD HEALTHCARE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02425610 | ACH-EZETIMIBE | EZETIMIBE | 10 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ACH-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).
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.
ACH-Ezetimibe may be taken alone or with other
cholesterol-lowering medicines known as statins or with
another medicine known as fenofibrate, in addition to diet
and other lifestyle changes (see INTERACTIONS WITH
THIS MEDICATION). Ezetimibe adds to the cholesterollowering effect of statins and fenofibrate. Statins and
fenofibrate lower cholesterol in a different way; they work
in the liver.
What it does
ACH-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 ACH-Ezetimibe.
- Patients with liver disease, active or unexplained increases in liver enzymes (blood tests of liver function) should not take ACH-Ezetimibe together with a statin.
- Patients who are pregnant should not take ACH-EZETIMIBEtogether with a statin.
- Patients who are nursing should not take ACH-EZETIMIBEtogether with a statin
What the medicinal ingredient is
Ezetimibe.
What the non-medicinal ingredients are
Croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K-30, polysorbate 80 and sodium lauryl sulfate.
What dosage form it comes in
Tablet 10 mg (white to off-white, capsule-shaped, flat faced with beveled edge, uncoated tablets, debossed with “10” on one side and plain on other side).
Warnings and precautions
Serious Warnings and Precautions
- Liver disease (Hepatitis)
- Pancreas disease (Pancreatitis)
- Muscle pain (Myopathy/Rhabdomyolysis, myalgia)
- Severe allergic reaction (Anaphylaxis)
Before you use ACH-Ezetimibe talk to your doctor if you:
- are pregnant, plan to become pregnant or think you might be pregnant.
- are breast-feeding. 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)
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 ezetimibe include:
- Cyclosporine
- Cholestyramine (a resine/bile acid sequestrant) or any other bile acid sequestrant. In that case, ACH-EZETIMIBE should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.
- Fibrates
Proper use of this medication
Usual Dose
- ACH-Ezetimibe should be taken as directed. Take one 10 mg tablet by mouth each day, preferably at the same time of day. ACH-EZETIMIBE can be taken with or without food.
- Continue taking your other cholesterol-lowering medicines known as statins or fenofibrate unless your doctor tells you to stop.
- If you are taking a statin or fenofibrate, ACH-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 ACH-Ezetimibe only as prescribed for you. If you take more ACH-Ezetimibe than you were prescribed, contact your doctor or pharmacist.
Missed Dose
If you miss a dose, just resume the usual schedule of one tablet daily.
Side effects and what to do about them
ACH-Ezetimibe tablets are 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.
- In general use, the following side effects have been reported: raised red rash, sometimes with target-shaped lesions; dizziness; depression; tingling sensation; constipation; and unusual tiredness or weakness
- You should contact your doctor if you develop persistent and severe muscle aches or pains with no obvious explanation at any time after starting to take ACH-EZETIMIBE.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 gallbladder (severe abdominal pain, nausea, vomiting) | ✔ | ||
| Symptoms of pancreas problems (severe abdominal pain) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACH-Ezetimibe, contact your doctor or pharmacist.
How to store
Keep your medicine between 15°C and 30°C. Protect from
moisture.
Keep ACH-Ezetimibe and all medicines out of the reach
and sight of children.
Do not use this medicine after the date shown following
EX (or EXP) on the container
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about ACH-Ezetimibe:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Last revised: July 3, 2019