Inegy (simvastatin and ezetimibe)

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 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.

As these medicines work in different ways 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.

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 taken in the evening.

It is important to continue to follow a cholesterol-lowering diet and exercise regime while taking Inegy. Ask your doctor for advice.

What is it used for?

High blood cholesterol levels.

High levels of any or all of the fats in the blood, such as cholesterol, triglycerides and lipoproteins (mixed hyperlipidaemia).

Inherited high blood cholesterol levels.

Warning!

It is recommended that you avoid drinking excessive amounts of alcohol while taking this medicine.

You should avoid drinking grapefruit juice while taking this medicine. This is because grapefruit juice can affect the metabolism of simvastatin and could increase the amount of the medicine in your blood, thus increasing the risk of side effects.

This medicine may occasionally have side effects on the muscles. 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, you should not do strenuous exercise before the test.

You should have blood tests to monitor your liver function (liver function tests) before starting treatment and regularly throughout treatment with this medicine.

This medicine is not recommended for people with moderate to severely decreased liver function.

The safety and efficacy of this medicine in children have not been studied. It is not recommended for children.

Use with caution in

People over 70 years of age.

Decreased kidney function.

Underactive thyroid gland.

Personal or family history of hereditary muscle disorders.

History of muscular side effects during previous treatment with a statin or fibrate medicine.

Individuals who consume large quantities of alcohol.

History of liver disease.

Hereditary blood disorders called porphyrias.

Not to be used in

Active liver disease.

Unexplained raised results in liver function tests.

Breastfeeding.

Pregnancy.

People taking the antifungals itraconazole or ketoconazole, the antibiotics erythromycin, clarithromycin or telithromycin, a protease inhibitor for HIV infection, or the antidepressant nefazodone.

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Inegy tablets contain lactose).

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 used by women who are pregnant, trying to get pregnant, or suspect they could be pregnant. Seek further medical advice from your doctor.

It is not known if this medicine passes into breast milk. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

Side effects

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Dizziness.

Headache.

Pain in the muscles or joints.

Feeling of weakness.

Abdominal pain.

Diarrhoea.

Nausea.

Constipation.

Flatulence.

Pins and needles (paraesthesia).

Indigestion.

Rash or itching.

Hair loss.

Liver disorders.

Muscle disorders.

The side effects listed above may not include all of the side effects reported by the drug'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.

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