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EZETIMIBE/SIMVASTATIN 10MG/20MG TABLETS

Active substance(s): EZETIMIBE / SIMVASTATIN / EZETIMIBE / SIMVASTATIN / EZETIMIBE / SIMVASTATIN

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Package leaflet: Information for the user
Ezetimibe/Simvastatin 10 mg/20 mg Tablets
Ezetimibe/Simvastatin 10 mg/40 mg Tablets
Ezetimibe/Simvastatin 10 mg/80 mg Tablets
Read all of this leaflet carefully before you start using 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. See section 4.
What is in this leaflet
1.
What Ezetimibe/Simvastatin Tablets is and what it is used for
2.
What you need to know before you take Ezetimibe/Simvastatin Tablets
3.
How to take Ezetimibe/Simvastatin Tablets
4.
Possible side effects
5.
How to store Ezetimibe/Simvastatin Tablets
6.
Contents of the pack and other information

1.

What Ezetimibe/Simvastatin Tablets is and what it is used for

Ezetimibe/Simvastatin Tablets is a medicine used to lower levels of total cholesterol, “bad” cholesterol
(LDL cholesterol), and fatty substances called triglycerides in the blood. In addition,
Ezetimibe/Simvastatin raises levels of “good” cholesterol (HDL cholesterol).
Ezetimibe/Simvastatin 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 for heart disease.
Ezetimibe/Simvastatin 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.
Ezetimibe/Simvastatin 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.

Ezetimibe/Simvastatin does not help you lose weight.
2.

What you need to know before you take Ezetimibe/Simvastatin Tablets

Do not take Ezetimibe/Simvastatin if you:

are allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in
section 6)

currently have liver problems

are pregnant or breast-feeding

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 for HIV infections)
boceprevir or telaprevir (used to treat hepatitis C virus infection)
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)

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
Talk to your doctor or pharmacist before taking Ezetimibe/Simvastatin if you:

have any medicinal conditions including allergies

drink large amounts of alcohol or have ever had liver disease. Ezetimibe/Simvastatin may not be
right for you

are due to have an operation. You may need to stop taking Ezetimibe/Simvastatin for a short
time

are Asian, because a different dose may be applicable to you

have severe lung disease.
Your doctor should do a blood test before you start taking Ezetimibe/Simvastatin. 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 Ezetimibe/Simvastatin.
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 Ezetimibe/Simvastatin and fibrates (certain medicines for lowering cholesterol)
should be avoided since the combined use of Ezetimibe/Simvastatin 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.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests
and medicines may be needed to diagnose and treat this.
The risk of muscle breakdown is greater at higher doses of Ezetimibe/Simvastatin, particularly the
10 mg/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.
Children and adolescents
Ezetimibe/Simvastatin is not recommended for children under age 10.
Other medicines and Ezetimibe/Simvastatin
It is particularly important to tell your doctor if you are taking medicine(s) with any of the following
active ingredients. Taking Ezetimibe/Simvastatin 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
Ezetimibe/Simvastatin").

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 infection)

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).
As well as the medicines listed above, tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. 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 Ezetimibe/Simvastatin
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
Ezetimibe/Simvastatin.

Ezetimibe/Simvastatin with food and drink
Grapefruit juice contains one or more components that alter the metabolism of some medications,
including Ezetimibe/Simvastatin. Consuming grapefruit juice should be avoided as it may increase
your risk of muscle problems.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Do not take Ezetimibe/Simvastatinif you are pregnant. If you get pregnant while taking
Ezetimibe/Simvastatin, stop taking it immediately and tell your doctor. Do not take
Ezetimibe/Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into
breast milk.
Driving and using machines
Ezetimibe/Simvastatin 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
Ezetimibe/Simvastatin.
Ezetimibe/Simvastatin Tablets contains lactose
Ezetimibe/Simvastatin 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 Ezetimibe/Simvastatin Tablets

Your doctor will determine the appropriate tablet strength for you, depending on your current
treatment and your personal risk status.
The tablets are not scored and should not be divided.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.

Before starting Ezetimibe/Simvastatin, you should be on a diet to lower your cholesterol.

You should keep on this cholesterol-lowering diet while taking Ezetimibe/Simvastatin.
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
10 mg/40 mg once daily must not be exceeded).
The Ezetimibe/Simvastatin 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 Ezetimibe/Simvastatin in the evening. You can take it with or without food.
If your doctor has prescribed Ezetimibe/Simvastatin along with another medicine for lowering
cholesterol containing the active ingredient colestyramine or any other bile acid sequestrant, you
should take Ezetimibe/Simvastatin at least 2 hours before or 4 hours after taking the bile acid
sequestrant.
If you take more Ezetimibe/Simvastatin Tablets than you should

Please contact your doctor or pharmacist.
If you forget to take Ezetimibe/Simvastatin Tablets
Do not take an extra dose, just take your normal amount of Ezetimibe/Simvastatin at the usual time the
next day.
If you stop taking Ezetimibe/Simvastatin Tablets
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, this medicine can cause side effects, although not everybody gets them (see section
2).
The following common side effects were reported (may affect up to 1 in 10 people):

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 people):

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 combination of
ezetimibe and simvastatin or 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

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, 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.

Muscle weakness that is constant (not known: cannot be estimated from the available data)
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Ezetimibe/Simvastatin Tablets

Keep this medicine out of the sight and reach of children.
Do not use Ezetimibe/Simvastatin Tablets after the expiry date which is stated on the carton or
container after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Ezetimibe/Simvastatin Tablets contains
The active substances are ezetimibe and simvastatin.
Each 10 mg / 20 mg Ezetimibe/Simvastatin tablet contains 10 mg ezetimibe and 20 mg simvastatin.
Each 10 mg / 40 mg Ezetimibe/Simvastatin tablet contains 10 mg ezetimibe and 40 mg simvastatin.
Each 10 mg / 80 mg Ezetimibe/Simvastatin tablet contains 10 mg ezetimibe and 80 mg simvastatin.
The other ingredients are:
Tablet core: lactose monohydrate, hypromellose, croscarmellose sodium, microcrystalline cellulose,
ascorbic acid, citric acid anhydrous, butylated hydroxyanisole, propyl gallate, magnesium stearate.
Pigment blend: iron oxide yellow, iron oxide red and iron oxide black.
What Ezetimibe/Simvastatin Tablets looks like and contents of the pack
Ezetimibe/Simvastatin Tablets 10 mg/20 mg tablets are light tan, mottled, round, 8 mm in diameter,
biconvex tablets, market with “512” on one side.
Ezetimibe/Simvastatin Tablets 10 mg/40 mg tablets are light tan, mottled, round, 10 mm in diameter,
biconvex tablets, market with “513” on one side.

Ezetimibe/Simvastatin Tablets 10 mg/80 mg tablets are light tan, mottled, capsule shaped,
17.5 x 7.55 mm, biconvex tablets, market with “515” on one side.
Pack sizes:
Blister packs: 30 and 100 tablets
HDPE tablet container: 100 and 180 tablets
Not all packs may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjördur, Iceland
Manufacturer
Balkanpharma-Dupnitsa AD, Balkanpharma-Dupnitsa AD, Dupnitza 2600, Bulgaria
This leaflet was last revised in 10/2016
PL 30306/0797
PL 30306/0798
PL 30306/0799

Expand Transcript

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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