What is it used for?
- High blood cholesterol levels (primary hypercholesterolaemia).
- Inherited high blood cholesterol levels (familial hypercholesterolaemia).
- High levels of any or all of the fats in the blood, such as cholesterol, triglycerides and lipoproteins (mixed hyperlipidaemia).
How does it work?
Inegy tablets contain two active ingredients, simvastatin and ezetimibe. Both these medicines are used to lower cholesterol. They work in different and complementary ways.
For the sake of simplicity, there are two sorts of cholesterol; a 'bad' sort called low density lipoprotein (LDL) and a 'good' sort called high density lipoprotein (HDL). LDL is deposited in the arteries and increases the risk of heart disease by clogging and narrowing the arteries (atherosclerosis), while HDL actually protects the arteries against this.
Simvastatin is a type of medicine called a statin. It works by reducing the production of LDL cholesterol by the liver. It does this by blocking the action of the enzyme in the liver (called HMG-CoA reductase) that is responsible for its production. This decreases the amount of cholesterol in the liver cells, which causes them to take up LDL cholesterol from the blood. The decreased cholesterol production and increased removal of LDL cholesterol from the blood ultimately results in lowered blood cholesterol levels.
Simvastatin also causes a small decrease in the production of other 'bad fats' in the blood called triglycerides, and a small increase in the level of HDL cholesterol. This results in lowered levels of 'bad fats' and raised levels of 'good fats' in the blood.
Statins have an important role in coronary heart disease. They reduce the risk of excess cholesterol being deposited in the major blood vessels of the heart (atherosclerosis). Any blockage in these blood vessels limits the amount of blood and therefore oxygen being carried to the heart muscle. This can cause chest pain (angina) and in severe cases can result in a heart attack (myocardial infarction) or stroke. Simvastatin has been shown to reduce the risk of these complications of atherosclerosis.
Ezetimibe is a type of medicine called a cholesterol absorption inhibitor. It works by preventing cholesterol from being absorbed from the small intestine into the bloodstream. It prevents cholesterol and other plant sterols that are consumed in the diet from being absorbed into the bloodstream. It also prevents cholesterol that is released from the bile duct into the intestine from being reabsorbed into the bloodstream. The overall result is a reduction in cholesterol levels in the blood.
These medicines work in different ways, but they have an additive effect on high cholesterol levels. The combination is used to lower high cholesterol in people whose cholesterol has not been lowered sufficiently using a statin alone. Combining the medicines into one tablet aims to simplify treatment for those who need to take ezetimibe in combination with a statin to control their cholesterol.
It is important to continue to follow a cholesterol-lowering diet and exercise regime while taking Inegy. Ask your doctor for advice.
How do I take it?
- You will need to take this medicine every day on a long-term basis (unless otherwise directed by your doctor). This is because if you stop taking it, your body will start to make cholesterol again and your cholesterol levels will start to rise again.
- Inegy tablets should be taken at night either with or without food. This is because the body produces most cholesterol at night, so the simvastatin component of the tablet is more effective if it is taken in the evening.
- The dose of this medicine that is prescribed (how many tablets to take and what strength) will vary from person to person depending on your cholesterol levels, amongst other things. It is important to follow the instructions given by your doctor. These will be printed on the the dispensing label that your pharmacist has put on the packet of medicine.
- It is important that you continue to eat healthily and do regular exercise while you are taking this medicine. Discuss this with your doctor.
- You should avoid drinking grapefruit juice or eating grapefruit while taking this medicine. This is because grapefruit can affect the metabolism of simvastatin and could increase the amount of the medicine in your blood, thus increasing the risk of side effects.
- It is recommended that you avoid drinking excessive amounts of alcohol while taking this medicine, because this may increase the risk of liver problems or side effects on the muscles (see below).
- This medicine may occasionally have side effects on the muscles that may progress to cause kidney problems. For this reason, you should inform your doctor immediately if you experience any unexplained muscular symptoms, such as pain, tenderness, cramps or weakness, while taking this medicine. Your doctor may need to check for side effects on the muscles by taking a blood test to measure the level of a compound called creatine kinase (CK) in your blood. If this is the case, the test should not be done following strenuous exercise.
- This medicine may rarely cause liver problems. For this reason your doctor will want you to have blood tests to monitor your liver function (liver function tests) before starting treatment and regularly throughout treatment with this medicine. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine, as these could be signs of a liver problem.
- Statins may very rarely be associated with a type of lung disease. For this reason, you should consult your doctor if you experience shortness of breath or difficulty breathing, a non-productive cough and deterioration in your general health (eg weight loss, fever, fatigue) while taking this medicine.
- This medicine is not licensed for children under 10 years of age. There is currently only limited experience of the long-term safety of the medicine in children aged 10 to 18 years. If you are concerned about your child taking this medicine you can ask your doctor or pharmacist for more information and advice.
Use with caution in
- People aged over 70 years.
- People with decreased liver function or a history of liver disease.
- People who drink large amounts of alcohol.
- People with decreased kidney function.
- People with an underactive thyroid gland (hypothyroidism).
- Personal or family history of hereditary muscle disorders.
- People who have previously experienced muscular side effects while taking a statin or fibrate medicine.
- Hereditary blood disorders called porphyrias.
Not to be used in
- People with active liver disease or moderate to severely decreased liver function.
- People with unexplained raised results in liver function tests.
- People taking ciclosporin, danazol, fibrate medicines, such as bezafibrate or gemfibrozil, the antifungals itraconazole, ketoconazole or posaconazole, the antibiotics erythromycin, clarithromycin or telithromycin, a protease inhibitor for HIV infection, or the antidepressant nefazodone (see end of factsheet for more information).
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Inegy tablets contain lactose).
- This medicine is not recommended for children under 10 years of age or who have not yet reached puberty.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine should not be used during pregnancy because it may be harmful to a developing baby. Pregnancy should also be avoided for one month after stopping treatment. Women who could get pregnant should use an effective method of contraception to prevent pregnancy both during treatment with this medicine and for one month after stopping treatment. Talk to your doctor straight away if you think you could be pregnant while taking this medicine, or want to try for a baby.
- It is not known if this medicine passes into breast milk. However, because it has the potential to cause serious side effects in a nursing infant, the manufacturer states that it should not be taken by women who are breastfeeding. Women who need to take this medicine should not breastfeed their babies and use formula instead. Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Pins and needles (paraesthesia).
- Disturbances of the gut, such as constipation, abdominal pain, flatulence (wind), indigestion, diarrhoea, nausea and vomiting.
- Rash or itching.
- Weight loss.
- Feeling weak or tired.
- Swollen ankles due to fluid retention.
- Pain in the muscles or joints.
- Muscle spasms or weakness.
- Difficulty sleeping (insomnia).
- Muscle problems such as muscle pain or cramps, inflammation of the muscles (myositis) or muscle breakdown (rhabdomyolysis) - see warning section above for symptoms to look out for and report to your doctor.
- Decreased number of blood cells called platelets in the blood (thrombocytopenia).
- Hair loss.
- Memory loss.
- Interstitial lung disease (see warning section above).
- Inflammation of the pancreas (pancreatitis).
- Inflammation of the stomach (gastritis).
- Inflammation of the liver (hepatitis) or liver failure.
- Yellowing of the skin and whites of the eyes (jaundice).
- Inflammation of the gallbladder or formation of gallstones.
- Tendon injury.
- Sleep disturbances, including nightmares.
- Erectile dysfunction.
- Hot flushes.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor what medicines you are taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
There may be an increased risk of side effects on the muscles (myopathy) if this medicine is taken with any of the following medicines:
- amiodarone (your daily dose of simvastatin should not be higher than 20mg if you are taking this medicine as well)
- amlodipine (your daily dose of simvastatin should not be higher than 20mg if you are taking this medicine as well)
- boceprevir (should not be taken in combination with Inegy)
- ciclosporin (should not be taken in combination with Inegy)
- clarithromycin (should not be taken in combination with Inegy - see below)
- danazol (should not be taken in combination with Inegy)
- diltiazem (your daily dose of simvastatin should not be higher than 20mg if you are taking this medicine as well)
- erythromycin (should not be taken in combination with Inegy - see below)
- fibrates for lowering cholesterol, eg bezafibrate, fenofibrate, gemfibrozil (should not be taken in combination with Inegy)
- fusidic acid (this is not recommended with Inegy - if you need to take a course of this antibiotic your doctor may recommend that you temporarily stop taking Inegy during the course and not start it again until seven days after you finish the course of fusidic acid)
- itraconazole (should not be taken in combination with Inegy - see below)
- ketoconazole (should not be taken in combination with Inegy - see below)
- nefazadone (should not be taken in combination with Inegy)
- nicotinic acid or niacin (your daily dose of simvastatin should not be higher than 20mg if you are taking 1g or more per day of niacin, particularly if you are Chinese)
- protease inhibitors for HIV infection, eg nelfinavir (should not be taken in combination with Inegy)
- posaconazole (should not be taken in combination with Inegy - see below)
- telaprevir (should not be taken in combination with Inegy)
- telithromycin (should not be taken in combination with Inegy - see below)
- verapamil (your daily dose of Inegy should not be higher than 20mg if you are taking this medicine as well).
- voriconazole (should not be taken in combination with Inegy - see below)
If you are prescribed any of the medicines listed above in combination with Inegy, it is important to let your doctor know if you experience any unexplained muscle symptoms, such as pain or tenderness, muscle weakness or muscle cramps.
If treatment with the antifungals itraconazole, ketoconazole, posaconazole or voriconazole, or the antibiotics erythromycin, clarithromycin, telithromycin or fusidic acid is essential for treating an infection, your doctor will ask you to stop taking Inegy temporarily during the course of treatment.
The anti-blood-clotting effect of anticoagulants such as warfarin may be affected by this medicine. For this reason, if you are taking an anticoagulant your doctor may want to check your blood-clotting time when you start or stop treatment with Inegy, and if your Inegy dose is altered.
The following medicines may reduce the amount of simvastatin in your blood. As this could make the simvastatin less effective, your doctor may prescribe you a higher dose of simvastatin if you are taking one of these:
- the herbal remedy St John's wort (Hypericum perforatum).
If you are also taking a bile acid sequestrant to lower your cholesterol, for example colestipol or colestyramine, your dose of Inegy should be taken either at least two hours before or at least four hours after it. This is because these medicines can reduce the absorption of simvastatin and ezetimibe from the gut.
Other medicines containing the same active ingredients
There are currently no other medicines available in the UK that contain both simvastatin and ezetimibe as the active ingredients.
Simvastatin is available on its own.
Ezetrol contains just ezetimibe.