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INEGY 10 MG/80 MG TABLETS

Active substance: SIMVASTATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER



®

INEGY 10 mg/80 mg Tablets
(ezetimibe and simvastatin)
Read all of this leaflet carefully before you start taking this
medicine.
- 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
- 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.
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.
In this leaflet:
1. What INEGY is and what it is used for
2. Before you take INEGY
3. How to take INEGY
4. Possible side effects
5. How to store INEGY
6. Further 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). It is used for patients who cannot control their
cholesterol levels by diet alone. You should stay on a cholesterollowering diet while taking this medicine.
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.
INEGY is used in addition to 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.
2. Before you take INEGY
Do not take INEGY if:
• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any
of the other ingredients of INEGY Tablets (see Section 6: Further
information)
• 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, or telithromycin (antibiotics for
infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir,
and saquinavir (HIV protease inhibitors are used for HIV
infections)
• 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.
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)
• 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 your 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 the age of 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.
3. 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 take more INEGY than you should:

please contact your doctor or pharmacist









constipation; inflammation of the pancreas often with severe
abdominal pain
inflammation of the liver or yellowing of the skin and eyes, 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, 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

Additional possible side effects reported with some statins:
• sleep disturbances, including nightmares
• memory loss
• 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.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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.

4. Possible side effects
Like all medicines, INEGY can cause side effects, although not
everybody gets them (see Before you take INEGY).

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.

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

6. Further information
What INEGY contains
The active substances are ezetimibe and simvastatin. Each tablet
contains 10 mg ezetimibe and 80 mg simvastatin.

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:
• your cholesterol may rise again.

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
• breathing problems including persistent cough and/or shortness of
breath or fever

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

E0264-3

This leaflet was revised: 09/11/2012
® denotes registered trademark of MSP Singapore Company, LLC.

POM

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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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