VYTORIN 10MG/20MG TABLETS

Active substance: SIMVASTATIN

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Inegy® 10 mg/20 mg Tablets/
Vytorin® 10 mg/20 mg Tablets
(ezetimibe and simvastatin)
Your medicine is known by either of the above names but will be referred to
as Inegy throughout the following:
Patient Information Leaflet

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.

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.

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.

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 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 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.

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
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.

 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







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

Keep out of the sight and reach of children.
Do not use Inegy after the expiry date which is stated on the carton or
container after [EXP].
Do not store 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) Further information
What Inegy contain
The active substances are ezetimibe and simvastatin.
Each tablet contains 10 mg ezetimibe and 20 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 “312”
on one side. The tablets are not scored and should not be divided.
Inegy is available in blister packs containing 28 tablets.
Who makes and repackages your medicine?
PL 10383/2069

Inegy ® 10 mg/20 mg Tablets/ POM
Vytorin® 10 mg/20 mg Tablets

Your medicine is manufactured by Merck Sharp & Dohme (Italia) S.p.A. Via
Emilia, 21 27100-Pavia Italy. Procured from within the EU and repackaged by
the Product License holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 16.08.2013
.

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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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