INEGY 10 MG/20 MG TABLETS

Active substance: SIMVASTATIN

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Inegy® 10 mg/20 mg Tablets

2443
25.03.13[2]

(ezetimibe/ simvastatin)

PATIENT INFORMATION LEAFLET
Your medicine is available by using the above name but will be r eferred to
as Inegy throughout the leaflet.
Inegy Tablets are also available in other strengths.
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.
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 cholesterol-lowering 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)
- 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 niacincontaining 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 breastfeeding, 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 the 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
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.
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 BEFORE YOU TAKE INEGY)
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.
5. HOW TO STORE INEGY
Keep your tablets out of the sight and reach of children.
Do not store above 30oC.
Store in the original package in order to protect from moisture and light.
Do not take the tablets if they are past the expiry date which is clearly
marked on the blister package and carton.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
Medicines should not be disposed of vi a w astewater or h ousehold w aste.
Ask y our p harmacist how to dispos e of medicines no longer r equired.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Inegy contains
The active substances are ezetimibe and simvastatin.
Each tablet contains 10 mg ezetimibe and 20 mg simvastatin.
The other non-active ingredients are: butylated hydroxyanisole, citric acid
monohydrate, hypromellose, croscarmellose sodium, lactose monohydrate,
magnesium stearate, microcrystalline cellulose and propyl gallate.
What Inegy looks like and contents of the pack
Inegy are white to off-white, capsule-shaped tablets marked with ‘312’ on
one side and plain on the other side.
Inegy is supplied in blister packs of 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER:
Manufactured by Merck Sharp & Dohme (Italia) S.p.A., Via Emilia, 21,
27100-Pavia, Italy. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2443

Leaflet revision and issue date (Ref) 25.03.13[2]
Inegy is a trademark of MSD International GmbH.

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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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