INEGY 10 mg/20 mg, 10 mg/40 mg, or 10 mg/80 mg Tablets
Ezetimibe and simvastatin
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What INEGY is and what it is used for
- 2. Before you take INEGY
- 3. How to take INEGY
- 4. Possible side effects
- 5. How to store INEGY
- 6. Further information
What Inegy Is And What Is It Used For
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). It 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 works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. INEGY does not help you lose weight.
INEGY is used in addition to 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
- a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
Before You Take Inegy
Do not take INEGY if:
- you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of INEGY Tablets (see Section 6: FURTHER INFORMATION)
- you currently have liver problems
- you are pregnant or breast-feeding
- you are taking:
- itraconazole or ketoconazole (medicines for fungal infections)
- erythromycin, clarithromycin, or telithromycin (antibiotics for infections)
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)
- nefazodone (a medicine for depression)
Take special care with INEGY
- Tell your doctor about all your medical conditions including allergies.
- Tell your doctor if you drink large amounts of alcohol or have ever had liver disease. INEGY may not be right for you.
- Tell your doctor if you are due to have an operation. You may need to stop taking INEGY tablets for a short time.
- Your doctor should do a blood test before you start taking INEGY. This is to check how well your liver is working.
- Your doctor may also want you to have blood tests to check how well your liver is working after you start taking INEGY.
The combined use of INEGY and fibrates (medicines for lowering cholesterol) should be avoided since the combined use of INEGY and fibrates has not been studied.
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.
The risk of muscle breakdown is greater at higher doses of INEGY and is greater in certain patients. Tell your doctor if any of the following applies to you:
- kidney problems
- thyroid problems
- you are more than 70 years old
- you have ever had muscle problems during treatment with cholesterol lowering medicines called “statins” (like simvastatin, atorvastatin, and rosuvastatin) or fibrates (like gemfibrozil and bezafibrate)
- you or close family members have a hereditary muscle disorder
Taking other medicines
It is particularly important to tell your doctor if you are taking any of the following drugs. Taking INEGY with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take INEGY if").
- ciclosporin (a medicine often used in organ transplant patients)
- danazol (a man-made hormone used to treat endometriosis)
- medicines like itraconazole or ketoconazole (medicines for fungal infections)
- fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol)
- erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections)
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS)
- nefazodone (a medicine for depression)
- amiodarone (a medicine for an irregular heartbeat)
- verapamil or diltiazem (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions)
- large amounts (1 gram or more each day) of niacin or nicotinic acid (medicines for lowering cholesterol)
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription. In particular, tell your doctor if you are taking any of the following:
- medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants)
- colestyramine (a medicine for lowering cholesterol), because it affects the way INEGY works
- fenofibrate (another fibric acid derivative)
Taking INEGY with food and drink
Grapefruit juice contains one or more components that alter the metabolism of some medications, including INEGY. Consuming grapefruit juice should be avoided as it may increase your risk of muscle problems.
Pregnancy and Breast-feeding
Do not take INEGY if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking INEGY, stop taking it immediately and tell your doctor. Do not take INEGY if you are breast-feeding, because it is not known if the medicine is passed into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Children
INEGY is not recommended for children.
Driving and using machines
INEGY is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking INEGY.
Important information about some of the ingredients of INEGY
INEGY tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Inegy
Always take INEGY exactly as your doctor has told you. You should 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 diet while taking INEGY.
The dose is 1 INEGY 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, or 10 mg/80 mg Tablet by mouth once a day.
The 10 mg/80 mg dose is only recommended for patients with very high cholesterol levels and at high risk of heart disease problems.
Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your personal risk status.
Take INEGY in the evening. You can take it with or without food.
If your doctor has prescribed INEGY along with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), 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 an extra dose, just take your normal amount of INEGY at the usual time the next day
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
INEGY Tablets Side Effects
The following common side effects were reported (observed in 1 or more in 100 and less than 1 in 10 patients treated): (see BEFORE YOU TAKE INEGY).
- headache
- flatulence
- muscle aches
- elevations in blood tests of liver function (transaminases)
Additionally, the following side effects have been reported in people taking either INEGY or ezetimibe or simvastatin tablets:
- low red blood cell count (anaemia), reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia)
- dizziness, tingling sensation, numbness or weakness of the arms and legs
- abdominal pain, constipation, indigestion, diarrhoea, nausea, vomiting, inflammation of the pancreas often with severe abdominal pain
- inflammation of the liver or yellowing of the skin and eyes, liver failure, gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
- rash, itching, hair loss
- a hypersensitivity reaction including some of the following: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and requires treatment immediately, 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))
- joint pain, muscle pain, tenderness, weakness or cramps, muscle breakdown
- weakness, tiredness
- depression
- alterations in some laboratory blood tests for liver and muscle function
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Inegy
- Keep out of the reach and sight of children.
- Do not use INEGY after the expiry date stated on the carton or container.
- Do not store INEGY Tablets above 30°C.
Blisters: Store in the original package. Bottles: Keep bottles tightly closed. Protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What INEGY contains
The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg ezetimibe and 20 mg, 40 mg, or 80 mg simvastatin.
The other ingredients are: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate.
What INEGY looks like and contents of the pack
INEGY Tablets are white to off-white, capsule-shaped tablets with code “312”, “313”, or “315” on one side.
Pack sizes:
7, 10, 14, 28, 30, 50, 56, 84, 90, 98, 100, or 300 tablets
Not all pack sizes may be available.
Marketing Authorisation Holder
Manufacturer:
This medicinal product is authorised under the name INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.
The leaflet was last approved: January 2010
denotes registered trademark of MSP Singapore Company, LLC.
© MSD-SP Limited, 2010 All rights reserved.
PIL.VYT.08.UK.2924 (II/28)
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