ZOCOR 10MG FILM COATED TABLETS

Active substance: SIMVASTATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

ZOCOR 10mg Film-coated Tablets
(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.
The name of your medicine is ZOCOR 10mg Film-coated Tablets but
will be referred to as ZOCOR throughout this leaflet. Please note that
this leaflet also contains information about other strengths such as
ZOCOR 20mg, 40mg and 80mg Film-coated Tablets.
What is in this leaflet:
1. What ZOCOR is and what it is used for
2. What you need to know before you take ZOCOR
3. How to take ZOCOR
4. Possible side effects
5. How to store ZOCOR
6. Contents of the pack and other information

1. WHAT ZOCOR IS AND WHAT IT IS USED FOR
ZOCOR is a medicine used to lower levels of total cholesterol, “bad”
cholesterol (LDL cholesterol), and fatty substances called triglycerides
in the blood. In addition, ZOCOR raises levels of “good” cholesterol
(HDL cholesterol). ZOCOR is a member of the class of medicines
called statins.
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.
You should stay on a cholesterol-lowering diet while taking this
medicine.
ZOCOR is used in addition to your cholesterol–lowering diet if you
have:
a raised cholesterol level in your blood (primary
hypercholesterolaemia) or elevated fat levels in your blood (mixed
hyperlipidaemia)
a hereditary illness (homozygous familial hypercholesterolaemia)
that increases the cholesterol level in your blood. You may also
receive other treatments.
coronary heart disease (CHD) or are at high risk of CHD (because
you have diabetes, history of stroke, or other blood vessel disease).
ZOCOR may prolong your life by reducing the risk of heart disease
problems, regardless of the amount of cholesterol in your blood.
In most people, there are no immediate symptoms of high cholesterol.
Your doctor can measure your cholesterol with a simple blood test. Visit
your doctor regularly, keep track of your cholesterol, and discuss your
goals with your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOCOR
Do not take ZOCOR
if you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of this medicine (listed in
Section 6: Contents of the pack and other information).
if you currently have liver problems
if you are pregnant or breast‑feeding
if you are taking medicine(s) with one or more than one of the
following active ingredients:
o itraconazole, ketoconazole, posaconazole or voriconazole (used
to treat fungal infections)
o erythromycin, clarithromycin, or telithromycin (used to treat
infections)
o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir,
and saquinavir (HIV protease inhibitors are used for HIV
infections)
o boceprevir or telaprevir (used to treat hepatitis C virus infection)
o nefazodone (used to treat depression)
o gemfibrozil (used to lower cholesterol)
o ciclosporin (used in organ transplant patients)
o danazol (a man-made hormone used to treat endometriosis, a
condition in which the lining of the uterus grows outside the
uterus).
if 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.
if you have ever had liver disease. ZOCOR may not be right for
you.
if you are due to have an operation. You may need to stop taking
ZOCOR tablets for a short time.
Your doctor should do a blood test before you start taking ZOCOR and
if you have any symptoms of liver problems while you take ZOCOR.
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 ZOCOR.

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.
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 ZOCOR,
particularly the 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 consume large amounts of alcohol
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” or fibrates
you or a close family member have a hereditary muscle disorder.
Other medicines and ZOCOR
It is particularly important to tell your doctor if you are taking
medicine(s) with any of the following active ingredients. Taking ZOCOR
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 ZOCOR”).
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).
Medicine with an active ingredient like itraconazole, ketoconazole,
fluconazole, posaconazole or voriconazole (used to treat fungal
infections)
fibrates with an active ingredient 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)
colchicine (used to treat gout).
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 a prescription. In particular, tell your doctor if
you are taking medicine(s) with any of the following active ingredients:
medicines with an active ingredient to prevent blood clots, such as
warfarin, phenprocoumon or acenocoumarol (anticoagulants)
fenofibrate (also used to lower cholesterol)
niacin (also used to lower cholesterol)
rifampicin (used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or
niacin-containing product and are Chinese.

a

You should also tell any doctor who is prescribing a new medicine for
you that you are taking ZOCOR.
ZOCOR with food and drink
Grapefruit juice contains one or more components that alter how the
body uses some medicinal products, including ZOCOR. Consuming
grapefruit juice should be avoided.
Pregnancy and Breast-feeding
Do not take ZOCOR if you are pregnant, trying to get pregnant or think
you may be pregnant. If you get pregnant while taking ZOCOR, stop
taking it immediately and contact your doctor.
Do not take ZOCOR 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
Safety and effectiveness of ZOCOR have been studied in 10-17 year old
boys and in girls who had started their menstrual period (menstruation)
at least one year before (see section 3: HOW TO TAKE ZOCOR).
ZOCOR has not been studied in children under the age of 10 years. For
more information, talk to your doctor.
Driving and using machines
ZOCOR 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 ZOCOR.
ZOCOR contains lactose
ZOCOR 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 ZOCOR
Your doctor will determine the appropriate tablet strength for you,
depending on your condition, your current treatment and your personal
risk status.
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking ZOCOR.
Dosage:
The recommended dose is 1 ZOCOR 10mg, 20mg, 40mg, or 80mg
tablet by mouth once a day.
Adults:
The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your
doctor may adjust your dose after at least 4 weeks to a maximum of 80
mg a day.

Do not take more than 80 mg a day.
Your doctor may prescribe lower doses, particularly if you are taking
certain medicinal products listed above or have certain kidney
conditions.

Laboratory Values
Elevations in some laboratory blood tests of liver function and a
muscle enzyme (creatine kinase) have been observed.

The 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.

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.

Children:
For children (10-17 years old), the recommended usual starting dose
is 10mg a day in the evening. The maximum recommended dose is
40mg a day.

By reporting side effects, you can help provide more information on the
safety of this medicine.

Method and duration of administration:
Take ZOCOR in the evening. You can take it with or without food. Keep
taking ZOCOR unless your doctor tells you to stop.
If your doctor has prescribed ZOCOR along with another medicine for
lowering cholesterol containing any bile acid sequestrant, you should
take ZOCOR at least 2 hours before or 4 hours after taking the bile acid
sequestrant.
If you take more ZOCOR than you should
please contact your doctor or pharmacist.
If you forget to take ZOCOR
do not take an extra dose, just take your normal amount of ZOCOR
at the usual time the next day.
If you stop taking ZOCOR
talk to your doctor or pharmacist because your cholesterol may rise
again.

5. HOW TO STORE ZOCOR
Keep out of the sight and reach of children.
Do not store them above 30°C.
Do not put them into another container as they might get mixed up.
If you have any tablets left over when your doctor tells you to stop
taking them, return them to your doctor or pharmacist for safe disposal.
Only keep them if your doctor tells you to.
Do not take them past the expiry date, which is clearly marked on the
pack.
REMEMBER this medicine is for you. Do not share it with anyone else.
It may not suit them.
If the tablets become discoloured or show any signs of deterioration,
you should seek the advice of your pharmacist (chemist).

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

6. CONTENT OF THE PACK AND OTHER INFORMATION

Please find below a translation of the days of the week that appears on
the blister:

What ZOCOR contains

LUN
MAR
MIE
JUE
VIE
SAB
DOM

-

MONDAY
TUESDAY
WEDNESDAY
THURSDAY
FRIDAY
SATURDAY
SUNDAY

4. POSSIBLE SIDE EFFECTS
Like all medicines, ZOCOR can cause side effects, although not
everybody gets them.
The following terms are used to describe how often side effects have
been reported:
Rare (may affect up to 1 of 1000 patients)
Very rare (may affect up to 1 of 10,000 patients).
Not known (frequency cannot be estimated from the available data)
The following rare serious side effects were reported.
If any of these serious side effects happen, stop taking the
medicine and tell your doctor immediately or go to the emergency
room at your nearest hospital.
muscle pain, tenderness, weakness, or cramps. On rare occasions,
these muscle problems can be serious, including muscle
breakdown resulting in kidney damage; and very rare deaths have
occurred.
hypersensitivity (allergic) reactions including:
swelling of the face, tongue and throat which may cause
difficulty in breathing
severe muscle pain usually in the shoulders and hips
rash with weakness of limbs and neck muscles
pain or inflammation of the joints (polymyalgia rheumatica)
inflammation of the blood vessels (vasculitis)
unusual bruising, skin eruptions and swelling,
(dermatomyositis) hives, skin sensitivity to the sun, fever,
flushing
shortness of breath (dyspnoea) and feeling unwell
lupus-like disease picture (including rash, joint disorders, and
effects on blood cells)
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 (very rare)
inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported rarely:
low red blood cell count (anaemia)
numbness or weakness of the arms and legs
headache, tingling sensation, dizziness
digestive disturbances (abdominal pain, constipation, flatulence,
indigestion, diarrhoea, nausea, vomiting)
rash, itching, hair loss
weakness
trouble sleeping (very rare)
poor memory (very rare), memory loss, confusion.
The following side effects have also been reported but the frequency
cannot be estimated from the available information (frequency not
known):
erectile dysfunction
depression
inflammation of the lungs causing breathing problems including
persistent cough and/or shortness of breath or fever
tendon problems, sometimes complicated by rupture of the tendon.
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.

Each 10mg film coated tablet contains 10mg of simvastatin as the
active ingredient.
Also contains ascorbic acid, butylated hydroxyanisole, citric acid
monohydrate, hydroxypropylcellulose, microcrystalline cellulose,
pregelatinised maize starch, talc, red iron oxide (E172), hypromellose,
magnesium stearate, lactose, carnauba wax, titanium dioxide (E171)
and yellow iron oxide (E172).
What ZOCOR looks like and contents of the pack
Zocor tablets are film-coated, peach coloured oval shaped tablets
marked „MSD 735‟ on one side and plain on the reverse.
Zocor Tablets are available in calendar packs containing 28 tablets.
Manufactured by: Merck Sharp & Dohme, B.V., Waarderweg
39, 2031 BN Haarlem, The Netherlands.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
®

ZOCOR 10mg Film-coated Tablets
PL No: 18799/0859

POM

Leaflet date: 10.12.2014
ZOCOR is registered trademark of Merck & Co Inc., Whitehouse
Station, NJ, USA

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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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