Brand Name Choices
What Vytorin is and what it is used for
INEGY contains the active substances ezetimibe and simvastatin. INEGY is a medicine used to lower
levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called
triglycerides in the blood. In addition, INEGY raises levels of “good” cholesterol (HDL cholesterol).
INEGY works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the
cholesterol absorbed in your digestive tract. The active ingredient simvastatin belonging to the class
of “statins” inhibits the production of the cholesterol your body makes by itself Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made
up mainly of 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.
INEGY is used for patients who cannot control their cholesterol levels by diet alone. You should stay
on a cholesterol-lowering diet while taking this medicine.
INEGY is used in addition to your cholesterol-lowering diet if you have:
• a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or elevated fat levels in your blood (mixed hyperlipidaemia):
• that is not well controlled with a statin alone,
• for which you have used a statin and ezetimibe as separate tablets.
How to take Vytorin
Your doctor will determine the appropriate tablet strength for you, depending on your current
treatment and your personal risk status.
The tablets are not scored and should not be divided.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
• Before starting INEGY, you should be on a diet to lower your cholesterol.
• You should keep on this cholesterol-lowering diet while taking INEGY. Adults: The dose is 1 tablet INEGY by mouth once a day. Use in adolescents (10 to 17 years of age): The dose is 1 tablet INEGY by mouth once a day (a maximum dose of 10 mg/40 mg once daily must not be exceeded). The INEGY 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. Take INEGY in the evening. You can take it with or without food. If your doctor has prescribed INEGY along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other bile acid sequestrant, you should take INEGY at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more INEGY than you should:
• Please contact your doctor or pharmacist. If you forget to take INEGY:
• Do not take a double dose to make up for a forgotten tablet, just take your normal amount of INEGY at the usual time the next day. If you stop taking INEGY:
• Talk to your doctor or pharmacist because your cholesterol may rise again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, INEGY can cause side effects, although not everybody gets them (see Section 2,
What you need to know before you take INEGY).
The following common side effects were reported (may affect up to 1 in 10 people):
• muscle aches,
• elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function. The following uncommon side effects were reported (may affect up to 1 in 100 people):
• elevations in blood tests of liver function; elevations in blood uric acid; elevations in the time it takes for blood to clot; protein in urine; weight decreased,
• dizziness; headache; tingling sensation,
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn,
• rash; itching; hives,
• joint pain; muscle pain, tenderness, weakness or spasms; neck pain; pain in arms and legs; back pain,
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially in the hands and feet,
• sleep disorder; trouble sleeping. Additionally, the following side effects have been reported in people taking either INEGY or medicines containing the active ingredients ezetimibe or simvastatin:
• low red blood cell count (anaemia); reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia),
• numbness or weakness of the arms and legs; poor memory, memory loss, confusion,
• breathing problems including persistent cough and/or shortness of breath or fever,
• inflammation of the pancreas often with severe abdominal pain,
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark coloured urine or pale coloured stool, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting),
• hair loss; raised red rash, sometimes with target-shaped lesions (erythema multiforme),
• hypersensitivity reactions including some of the following: allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and requires treatment immediately (angioedema), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells). A serious very rare allergic reaction (which may affect up to 1 in 10000 people) may occur that causes difficulty in breathing or dizziness and requires immediate treatment (anaphylaxis).
• muscle pain, tenderness, weakness or cramps; muscle breakdown; tendon problems, sometimes complicated by rupture of the tendon,
• decreased appetite,
• hot flush; high blood pressure,
• erectile dysfunction,
• alterations in some laboratory blood tests for liver function. Additional possible side effects reported with some statins:
• sleep disturbances, including nightmares,
• sexual difficulties,
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping INEGY (frequency not known). Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . By reporting side effects you can help provide more information on the safety of this medicine
How to Store Vytorin
Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or container after [EXP].
• Do not store INEGY Tablets above 30°C. Blisters: Store in the original package in order to protect from moisture and light. Bottles: Keep bottles tightly closed in order to protect from moisture and light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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