Riva-Ezetimibe: Uses, Side Effects and Dosage

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

ABOUT THIS MEDICATION

What the medication is used for:

What it does:

When it should not be used:

What the medicinal ingredient is:

What the important nonmedicinal ingredients are:

What dosage forms it comes in:

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

Usual dose:

Overdose:

Missed dose:

HOW TO STORE IT

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

RIVA-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.

RIVA-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). RIVA-EZETIMIBE adds to the cholesterol-lowering effect of statins and fenofibrate. Statins and fenofibrate lower cholesterol in a different way; they work in the liver.

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

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

Ezetimibe.

Lactose monohydrate, Croscarmellose sodium, Sodium lauryl sulphate, Hypromellose, Colloidal silicon dioxide, Microcrystalline cellulose, Hydrogenated castor oil, Sodium stearyl fumerate.

Tablet 10 mg (white to off-white).

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

Before you use RIVA-EZETIMIBE talk to your doctor if you:

are pregnant, plan to become pregnant or think you might be pregnant.
are breast-feeding. RIVA-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).

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 RIVA-EZETIMIBE include:

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

RIVA-EZETIMIBE should be taken as directed. Take
one 10 mg tablet by mouth each day, preferably at the same time of day. RIVA-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, RIVA-
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.

Take RIVA-EZETIMIBE only as prescribed for you. If you take more RIVA-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.

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

SIDE EFFECTS AND WHAT TO ABOUT THEM

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.
When used with fenofibrate, the following side effect was reported: abdominal pain
- 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 RIVA-EZETIMIBE.

If you are prescribed RIVA-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 RIVA-EZETIMIBE.

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND
	WHAT TO DO ABOUT THEM
Symptoms / effects			Talk with your doctor or pharmacist		Stop taking drug and seek immediate emergency medical attention.
			Only if severe	In 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)		✓

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

Keep your medicine between 15°C and 30°C. Protect from moisture.

Keep RIVA-EZETIMIBE and all medicines out of the reach of children. Do not use this medicine after the date shown following EXP on the container.

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:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
  Canada Vigilance Program
  Health Canada
  Postal Locator 0701D
  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, Laboratoire Riva Inc., at: 1-800-363-7988.

Laboratoire Riva Inc.

660 Boul. Industriel

Blanville, QC

Canada, J7C 3V4

Date of Preparation: May 26, 2014

Rx or OTC	Prescription (Rx)?
DIN	02424436
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Ezetimibe 10 MG
Dosage form(s)	Tablet
Route(s) of administration	Oral
Drug class (WHO ATC)	C Cardiovascular system drugs C10 Lipid modifying agents C10A Lipid modifying agents, plain C10AX Other lipid modifying agents C10AX09 Ezetimibe
Company	LABORATOIRE RIVA INC.
Current status	Cancelled Post Market
Current status date	April 1, 2020

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND

WHAT TO DO ABOUT THEM

Symptoms / effects

Talk with your
doctor or pharmacist

Stop
taking drug and call your doctor or pharmacist

Only if severe

In all cases

Symptoms of gallstones or inflammation of the gallbladder (severe abdominal pain, nausea, vomiting)

Symptoms of pancreas problems (severe abdominal pain)