Inegy ® Tablets

INEGY is a medicine used to lower levels of total cholesterol, LDL cholesterol, and fatty substances called triglycerides in the blood. In addition, INEGY raises levels of 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 INEGY.

If you have heart disease, INEGY reduces the risk of heart attack, stroke, surgery to increase heart blood flow or hospitalisation for chest pain.

How does INEGY work?

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.

Do not take INEGY:

• if you are hypersensitive (allergic) to ezetimibe, simvastatin, or any of the other ingredients of INEGY Tablets (listed in Section 6)
• have active liver disease
• are pregnant or breastfeeding
• are taking any of the following medicines:

• certain antifungal medicines (such as itraconazole, ketoconazole, posaconazole or voriconazole)
• HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir)
• certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
• certain antibiotics (such as erythromycin, clarithromycin or telithromycin)
• the antidepressant nefazodone
• medicines containing cobicistat
• gemfibrozil (a fibric acid medicine for lowering cholesterol)
• ciclosporin
• danazol.

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Take special care with INEGY

It is important that you continue taking INEGY daily as prescribed by your doctor. Even if you are taking medication to treat high cholesterol, it is important to have your cholesterol measured regularly. You should also know your cholesterol levels and goals.

Medical problems or allergies: Talk about any medical problems (including liver disease or kidney disease) or allergies you have now or have had in the past. Tell your doctor if you consume substantial quantities of alcohol or have a past history of liver disease. Tell your doctor if you are Asian. Contact your doctor promptly if you experience unexplained muscle pain, tenderness or weakness. This is because muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death. 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 for older patients (65 years of age and older), female patients, patients with kidney problems, and patients with thyroid problems.

Always take INEGY exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

• The dose for adults: Take one INEGY 10/10, 10/20, 10/40 or 10/80 Tablet by mouth each day, in the evening.
• Because of the increased risk of muscle problems, INEGY 10/80 Tablet is only for patients at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.
• Adolescents (10 to 17 years of age): Take one INEGY 10/10, 10/20 or 10/40 Tablet by mouth each day, in the evening.
• INEGY is not recommended in children under 10 years of age.
• Take INEGY with or without food.
• If your doctor has prescribed INEGY along with cholestyramine (a bile acid sequestrant) or any other bile acid sequestrant, INEGY should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.
• INEGY should be taken as directed by your healthcare provider.
• Your doctor will tell you how long your treatment with INEGY will last. Do not stop treatment early. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop.
• Do not share medicines prescribed for you with others.
• If you have the impression that the effect of INEGY is too strong or too weak, tell your doctor or pharmacist.

If you take more INEGY than you should

Take INEGY only as prescribed for you. If you take more INEGY than you were prescribed consult your doctor or pharmacist. If neither is available, rush to the nearest hospital or poison control centre.

If you forget to take INEGY

Try to take INEGY as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet daily. Do not take a double dose to make up for the missed dose.

INEGY can have side effects. Not all side effects reported for INEGY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking INEGY and tell your doctor immediately or go to the casualty department at your nearest hospital:

• allergic reactions including swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing (which may require urgent treatment right away); rash and hives; raised red rash, sometimes with target-shaped lesions. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to INEGY. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: unexplained muscle pain, tenderness or weakness (that may not go away after stopping INEGY). This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• muscle aches and muscle pain (see Other medicines and INEGY).

Less frequent side effects:

• elevations in the time it takes for blood to clot; 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 general use with either INEGY, ezetimibe or simvastatin tablets (tablets that contain the active ingredients of INEGY):

• inflammation of the pancreas often with severe abdominal pain
• constipation
• depression
• gallstones
• inflammation of the gallbladder which may cause abdominal pain, nausea, vomiting
• poor memory
• memory loss
• confusion
• erectile dysfunction
• breathing problems including persistent cough and/or shortness of breath or fever
• Myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing)
• Ocular myasthenia (a disease causing eye muscle weakness)

Contact your doctor if you experience weakness in your arms or legs that worsens after periods of activity, difficulty swallowing, or shortness of breath (symptoms of myasthenia gravis), or double vision or drooping of your eyelids (symptoms of ocular myasthenia). Tell your doctor if you have a medical problem that you think may be related to INEGY. If you are prescribed INEGY, your healthcare professional may want to conduct routine blood tests to check your liver function before and after starting treatment and if you have any symptoms of liver problems while you take INEGY. Call your doctor right away if you have the following symptoms of liver problems:

• feel tired or weak
• loss of appetite
• upper belly pain
• dark urine
• yellowing of your skin or the whites of your eyes.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Do not use INEGY after the month and year following EXP.: on the carton. Store at or below 30 °C. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).