Patient Medication Information: uses, side effects, how to take - SPC-Ezetimibe
Serious Warnings and Precautions
SPC-EZETIMIBE can cause serious side effects including:
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects. |
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What is SPC-EZETIMIBE used for?
SPC-EZETIMIBE is used along with a change in diet and lifestyle to lower the level of cholesterol and other fats (such as triglycerides) in the blood of children (10 years of age and older) and adults. In these children and adults, diet and other lifestyle changes alone were not effective in lowering their cholesterol.
SPC-EZETIMIBE may be used alone or with other cholesterol lowering medicines called statins or fenofibrate.
How does SPC-EZETIMIBE work?
SPC-EZETIMIBE belongs to a group of medicines called cholesterol absorption inhibitors. It works by lowering the amount of cholesterol that is absorbed in the small intestine.
What are the ingredients in SPC-EZETIMIBE?
Medicinal ingredient: Ezetimibe
Non-medicinal ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinised starch, povidone, and sodium lauryl sulphate.
SPC-EZETIMIBE comes in the following dosage forms:
Tablet 10 mg (white to off-white).
Do not use SPC-EZETIMIBE if:
- you/your child are allergic to ezetimibe or any of the non-medicinal ingredients in SPC-EZETIMIBE
- you/your child are taking a statin and have liver disease and/or active or unexplained increases in liver enzymes (blood tests of liver function).
you are pregnant and taking a statin or fenofibrate.
- you are nursing and taking a statin or fenofibrate.
are lactose intolerant or have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
because lactose is a non-medicinal ingredient in SPC-EZETIMIBE.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you/your child take SPC-EZETIMIBE. Talk about any health conditions or problems you/your child may have, including if you/your child:
- are pregnant, plan to become pregnant or think you might be pregnant.
- are breast-feeding or are planning to breast-feed. SPC-EZETIMIBE may be passed in your milk to your baby.
- have liver problems.
- are taking fibrates other than fenofibrate. Talk to your healthcare professional if you are not sure.
- have previously taken a statin and had persistent or severe muscle pain with no obvious cause.
Other warnings you should know about:
Liver function tests: If you/your child are taking SPC-EZETIMIBE alone or with a statin or fenofibrate, your healthcare professional may do liver function tests before and during treatment. This is to check and monitor the health of the liver.
Gallbladder problems: Taking SPC-EZETIMIBE and fenofibrate may cause gallbladder problems such as gallstones. Talk to your healthcare professional right away if you/your child has:
- severe abdominal pain
- nausea
- vomiting
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
If you/your child are taking SPC-EZETIMIBE with cyclosporine, your healthcare professional will monitor the amount of cyclosporine in your/their body.
The following may interact with SPC-EZETIMIBE:
- Bile acid sequestrants such as cholestyramine
- Fibrates
How to take SPC-EZETIMIBE:
- Always take SPC-EZETIMIBE exactly as your healthcare professional tells you.
Take SPC-EZETIMIBE with or without food but preferably at the same time each day.
- Keep taking your other cholesterol-lowering medicines known as statins or fenofibrate unless your healthcare professional tells you to stop. You can take SPC-EZETIMIBE at the same time as the statin or fenofibrate.
- If you/your child are also taking a bile acid sequestrant, take/give SPC-EZETIMIBE 2 hours before or at least 4 hours after taking the bile acid sequestrant.
- Carefully follow any measures that your healthcare professional has recommended for diet, exercise or weight control.
Usual dose:
Usual dose (children 10 years of age and older and adults): Take one 10 mg tablet each day.
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:
If you think you, or a person you are caring for, have taken too much SPC-EZETIMIBE, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you/your child miss a dose, skip the missed dose. Take your/give their next dose as scheduled. Do not take/give two doses at the same time to make up for the missed dose.
What are possible side effects from using SPC-EZETIMIBE?
These are not all the possible side effects you may have when taking SPC-EZETIMIBE. Some of these side effects may occur when taking SPC-EZETIMIBE or when taking SPC-EZETIMIBE with a statin or fenofibrate. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- abdominal pain
- diarrhea
- flatulence
- viral infection, throat infection (pharyngitis), nose infection (sinusitis) or upper chest infection
- pain including back pain, neck pain, joint pain (arthralgia), chest pain and pain in the arms and legs
- coughing
- elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function
- indigestion or heartburn
- nausea
- muscle spasms or weakness
- decreased appetite
- hot flush
- high blood pressure
- dizziness
- depression
- constipation
- unusual tiredness or weakness
- headache
- tingling sensation usually in the hands, arms, legs or feet
- dry mouth
- gastritis
- rash, hives or itching swelling, especially in the hands and feet
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning | √ | ||
| Gallbladder problems: severe abdominal pain, nausea, vomiting, fever, pain that radiates to your shoulder or back, severe pain in your upper right abdomen | √ | ||
| 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 | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Serious muscle problems (myopathy, rhabdomyolysis, myalgia): aching muscle, tenderness or weakness that you cannot explain, red-brown (tea coloured) urine | √ | ||
Serious skin reactions (Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS)): serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever; skin rash with pink-red blotches especially on palms of hands or soles of feet, which may blister. You may also have flu-like symptoms at the same time, such as fever, chills or aching muscle. | √ | ||
| Severe allergic reactions: swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash and hives | √ | ||
Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | √ | ||
If you/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/their daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Keep your medicine between 15°C and 30°C. Protect from moisture.
Keep SPC-EZETIMIBE and all medicines out of the reach of children.
Do not use this medicine after the date shown following EX (or EXP) on the container.
If you want more information about SPC-EZETIMIBE:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (Drug Product Database: Access the database); or by calling 1-866-840-1340.