Active ingredient
- simvastatin
- ezetimibe
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00025/0610.
INEGY Tablets
Package leaflet: Information for the patient
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 because it contains important information for you.
What is in this leaflet:
1. What INEGY is and what it is used for
2. What you need to know before you take INEGY
3. How to take INEGY
4. Possible side effects
5. How to store INEGY
6. Contents of the pack and other information
1. What INEGY 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:
INEGY does not help you lose weight.
2. What you need to know before you take INEGY
Do not take INEGY if:
Do not take more than 10/40 mg INEGY if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
Ask your doctor if you are not sure if your medicine is listed above.
Warnings and precautions
Tell your doctor:
Your doctor should do a blood test before you start taking INEGY and if you have any symptoms of liver problems while you take 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.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Tell your doctor if you have severe lung disease.
The combined use of INEGY and fibrates (certain 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, particularly the 10/80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
Children and adolescents
Other medicines and INEGY
Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking INEGY with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take INEGY if").
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:
You should also tell any doctor who is prescribing a new medicine for you that you are taking INEGY.
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.
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.
INEGY contains lactose
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.
INEGY contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.
3. How to take INEGY
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.
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 cholestyramine 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:
If you forget to take INEGY:
If you stop taking INEGY:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. 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):
The following uncommon side effects were reported (may affect up to 1 in 100 people):
Additionally, the following side effects have been reported in people taking either INEGY or medicines containing the active ingredients ezetimibe or simvastatin:
Additional possible side effects reported with some statins:
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.
5. How to store INEGY
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.
6. Contents of the pack and other 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. The tablets are not scored and should not be divided.
Pack sizes:
7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multi-pack containing 98 (2 cartons of 49), 100, or 300 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
The manufacturer of the 10 mg/20 mg tablets is
The manufacturer of the 10 mg/40 mg and 10 mg/80 mg tablets is
This medicinal product is authorised in the Member States of the EEA under the following name:
INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.
VYTORIN in Germany, Italy, Portugal and Spain.
GOLTOR in Germany and Italy.
The leaflet was last revised in March 2020
© Merck Sharp & Dohme Limited, 2020. All rights reserved.
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