Inegy Tablets

Inegy is used in addition to diet if you have:

• a raised cholesterol level in your blood (primary hypercholesterolaemia 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.
   

Do not take Inegy if:

• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of Inegy Tablets 
• you currently have liver problems
• you are pregnant or breast-feeding

you are taking one or more than one of the following drugs at the same time:

• itraconazole, ketoconazole, or posaconazole (medicines for fungal infections)
• erythromycin, clarithromycin (antibiotics for infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)
• boceprevir or telaprevir (medicines for hepatitis C virus infection)
• nefazodone (a medicine for depression)
• gemfibrozil (a medicine for lowering cholesterol)
• ciclosporin (a medicine often used in organ transplant patients)
• danazol (a man-made hormone used to treat endometriosis).

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

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 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 (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:

• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• 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, ketoconazole, fluconazole or posaconazole (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)
• boceprevir or telaprevir (medicines for hepatitis C virus infection)
• nefazodone (a medicine for depression)
• amiodarone (a medicine for an irregular heartbeat)
• verapamil, diltiazem, or amlodipine (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)
• colchicine (a medicine used to treat gout).

Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.
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)
• rifampicin (a medicine used to treat tuberculosis).

You should also tell any doctor who is prescribing a new medicine for you that you are taking Inegy.

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 under age 10.

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.

• For adults the dose is 1 tablet (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.
• For adolescents (10 to 17 Years of age), the dose is 1 tablet (1 INEGY 10 mg/10 mg, 10 mg/20 mg or 10 mg/40 mg tablet) by mouth once a day.

The tablets are not scored and should not be divided. The 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.
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Inegy can cause side effects, although not everybody gets them.

The following common side effects were reported (observed in 1 or more in 100 and less than 1 in 10 patients treated):

• muscle aches
• elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function
• The following uncommon side effects were reported (observed in 1 or more in 1000 and less than 1 in 100 patients treated):
• elevations in blood tests of liver function; elevations in blood uric acid; elevations in the time it takes for blood to clot; protein in urine; 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 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)
• numbness or weakness of the arms and legs; poor memory, memory loss, confusion
• breathing problems including persistent cough and/or shortness of breath or fever
• constipation; inflammation of the pancreas often with severe abdominal pain
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching,
• dark coloured urine or pale coloured stool, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• hair loss; raised red rash, sometimes with target-shaped lesions
• 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))
• muscle pain, tenderness, weakness or cramps; muscle breakdown; tendon problems, sometimes complicated by rupture of the tendon
• decreased appetite
• hot flush; high blood pressure
• pain
• erectile dysfunction
• depression
• alterations in some laboratory blood tests for liver function
• Additional possible side effects reported with some statins:
• sleep disturbances, including nightmares
• sexual difficulties
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine

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 which is stated on the carton or container after [EXP].
• Do not store Inegy Tablets above 30°C.
• 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.

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.

References:

http://medical-dictionary.thefreedictionary.com/Inegy

http://www.netdoctor.co.uk/heart-and-blood/medicines/inegy.html

https://www.medicines.org.uk/guides/inegy/Cholesterol/

http://www.nhs.uk/medicine-guides/pages/MedicineOverview.aspx?condition=Cholesterol&medicine=Inegy&preparationInegy%2010mg/20mg%20tablets

http://www.martinfrost.ws/htmlfiles/sept2008/inegy-possible-problems.html

http://www.ukmi.nhs.uk/NewMaterial/html/docs/InegyNMP0705.pdf

http://en.wikipedia.org/wiki/Ezetimibe/simvastatin

http://www.medicines.org.uk/emc/medicine/15658/PIL