INEGY 10 MG/80 MG TABLETS

Active substance: SIMVASTATIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
®

INEGY 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.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
This medicine is called INEGY® 10mg/80mg Tablets but will be
referred to as INEGY throughout the remainder of this leaflet.
Inegy tablets are also available in other strengths.
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 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 of 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:




a raised cholesterol level in your blood (primary
hypercholesterolaemia [heterozygous familial and non-familial]) 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.

INEGY does not help you lose weight.
2. Before you take INEGY
Do not take INEGY if:
• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any
of the other ingredients of this medicine (listed in Section 6:
Contents of the pack and other information)
• you currently have liver problems
• you are pregnant or breast-feeding
• you are taking medicine(s) with one or more than one of the
following active ingredients:
• itraconazole, ketoconazole, posaconazole or voriconazole
(used to treat fungal infections)
• erythromycin, clarithromycin, or telithromycin (used to treat
infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir,
and saquinavir (HIV protease inhibitors are used to treat HIV
infections)
• boceprevir or telaprevir (used to treat hepatitis C virus
infections)
• nefazodone (used to treat depression)
• gemfibrozil (used to lower cholesterol)
• ciclosporin (often used in organ transplant patients)
• danazol (a man-made hormone used to treat endometriosis, a
condition in which the lining of the uterus grows outside the
uterus).
• you are taking or, in the last 7 days, have taken or been given a
medicine called fusidic acid (used to treat bacterial infection).
Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions
Tell your doctor:
• about all your medical conditions including allergies.
• if you drink large amounts of alcohol or have ever had liver
disease. INEGY may not be right for you.
• 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 (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 10/80mg-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
Other medicines and INEGY
It is particularly important to tell your doctor if you are taking
medicine(s) with any of the following active ingredients. Taking INEGY
with any of these medicines can increase the risk of muscle problems
(some of these have already been listed in the above section “Do not
take INEGY if").
• ciclosporin (often used in organ transplant patients)
• danazol (a man-made hormone used to treat endometriosis, a
condition in which the lining of the uterus grows outside the uterus)
• medicines with an active ingredient like itraconazole,
ketoconazole, fluconazole, posaconazole, or voriconazole (used to
treat fungal infections)
• fibrates with active ingredients like gemfibrozil and bezafibrate
(used to lower cholesterol)
• erythromycin, clarithromycin, telithromycin, or fusidic acid (used to
treat bacterial infections). Do not take fusidic acid while using this
medicine. Also see section 4 of this leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and
saquinavir (used to treat AIDS)
• boceprevir or telaprevir (used to treat hepatitis C virus infections)
• nefazodone (used to treat depression)
• amiodarone (used to treat an irregular heartbeat)
• verapamil, diltiazem, or amlodipine (used to treat 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
(also used to lower cholesterol)
• colchicine (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 with an active ingredient to prevent blood clots, such as
warfarin, fluindione, phenprocoumon or acenocoumarol
(anticoagulants)
• colestyramine (also used to lower cholesterol), because it affects
the way INEGY works
• fenofibrate (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).
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.



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.
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.



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
(erythema multiforme)
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, lupuslike 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

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.
• Before starting INEGY, you should be on a diet to lower your
cholesterol.
• You should keep on this cholesterol-lowering diet while taking
INEGY.

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

Adults: The dose is 1 tablet by mouth once a day.
Adolescents (10 to 17 years of age): The dose is 1 tablet by mouth
once a day (a maximum dose of 10mg/40mg once daily must not be
exceeded).

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.

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 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 colestyramine 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:

please contact your doctor or pharmacist
If you forget to take INEGY:
• do not take an extra dose, just take your normal amount of INEGY
at the usual time the next day
If you stop taking INEGY:
• talk to your doctor or pharmacist because your cholesterol may
rise again.
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 Before you take INEGY).
The following common side effects were reported(may affect up to 1
in 10 patients):
• muscle aches
• elevations in laboratory blood tests of liver (transaminases) and/or
muscle (CK) function
The following uncommon side effects were reported (may affect up to
1 in 100 patients):
• 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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store INEGY
• Keep out of the sight and reach of children.
• Do not use INEGY after the expiry date stated on the carton or
container after [EXP].
• Do not store INEGY Tablets above 30°C.

Store in the original package in order to protect from moisture and
light.
• If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
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.
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 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 “315” on one side. The tablets are not scored and should not be
divided.
Available in pack sizes of 30 tablets.
Manufacturer:
Merck Sharp & Dohme (Italia) S.p.A.
Via Emilia 21, 27100 – Pavia, Italy
Procured from within the E.U. and re-packaged by Munro Wholesale
Medical Supplies Ltd., 3 Young Place, East Kilbride, G75 0TD.
Product Licence holder: Ecosse Pharmaceuticals Ltd., 3 Young Place,
East Kilbride, G75 0TD.
PL 19065/0264

E0264-5

This leaflet was revised: 26/03/2014
Additionally, the following side effects have been reported in people
taking either INEGY or medicines containing the active ingredients
ezetimibe or simvastatin:
• 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

® denotes registered trademark of MSP Singapore Company, LLC
.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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