ZOCOR 10MG FILM COATED TABLETS

Active substance: SIMVASTATIN

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MOCK-UP
PACKAGE LEAFLET: INFORMATION FOR THE USER



Your doctor should do a blood test before you start taking
ZOCOR. This is to check how well your liver is working.



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.

®

ZOCOR 10mg Film-coated Tablets
(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.
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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What ZOCOR is and what it is used for
Before you take ZOCOR
How to take ZOCOR
Possible side effects
How to store ZOCOR
Further 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). You should stay on
a cholesterol-lowering diet while taking this medicine. ZOCOR
is a member of the class of drugs called statins.
ZOCOR is used along with 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. BEFORE YOU TAKE ZOCOR
Do not take ZOCOR


if you are allergic (hypersensitive) to simvastatin or any
of the other ingredients of ZOCOR Tablets (see Section 6:
Further Information).
 if you currently have liver problems
 if you are pregnant or breast‑feeding
 if you are taking one or more than one of the following
drugs at the same time:
o itraconazole, ketoconazole, or posaconazole (medicines
for fungal infections)
o erythromycin, clarithromycin, or telithromycin
(antibiotics for infections)
o HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir, and saquinavir (HIV protease inhibitors are
used for HIV infections)
o boceprevir or telaprevir (medicines for hepatitis C virus
infection)
o nefazodone (a medicine for depression)
o gemfibrozil (a medicine for lowering cholesterol)
o ciclosporin (a medicine often used in organ transplant
patients)
o danazol (a man-made hormone used to treat
endometriosis).



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.

Using other medicines
It is particularly important to tell your doctor if you are taking
any of the following drugs. Taking ZOCOR 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
ZOCOR”).
 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)
 colchicine (a medicine 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 any of the following:
 medicines to prevent blood clots, such as warfarin,
phenprocoumon or acenocoumarol (anticoagulants)
 fenofibrate (another medicine for lowering cholesterol)
 niacin (another medicine for lowering cholesterol)
 rifampicin (a medicine used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or
a niacin-containing product and are Chinese.
You should also tell any doctor who is prescribing a new
medicine for you that you are taking ZOCOR.

Taking 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 if you are not sure if your medicine is listed
above.

Ask your doctor or pharmacist for advice before taking any
medicine.

Take special care with ZOCOR

Children







Tell your doctor about all your medical conditions including
allergies.
Tell your doctor if you drink large amounts of alcohol.
Tell your doctor if you have ever had liver disease. ZOCOR
may not be right for you.
Tell your doctor if you are due to have an operation. You
may need to stop taking ZOCOR tablets for a short time.

Safety and effectiveness have been studied in 10-17 year old
boys and in girls who had started their menstrual period at least
one year before (see HOW TO TAKE ZOCOR). ZOCOR has not
been studied in children under the age of 10 years. For more
information, talk to your doctor.

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.

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.

Driving and using machines



Important information about some of the ingredients of
ZOCOR

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)

3. HOW TO TAKE ZOCOR



Always take ZOCOR exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

inflammation of the pancreas often with severe abdominal
pain.

The following side effects have also been reported rarely:

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.



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)

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.



rash, itching, hair loss



weakness



trouble sleeping (very rare)

The 80mg 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.



poor memory (very rare), memory loss, confusion.

You should stay on a cholesterol-lowering diet while taking
ZOCOR.
The dose is 1 ZOCOR 10mg, 20mg, 40mg, or 80mg tablet by
mouth once a day.

Your doctor will determine the appropriate tablet strength for
you, depending on your condition, your current treatment and
your personal risk status.
Take ZOCOR in the evening. You can take it with or without
food. The usual starting dose is 10, 20 or, in some cases, 40mg
a day. Your doctor may adjust your dose after at least 4 weeks
to a maximum of 80mg a day. Do not take more than 80mg a
day. Your doctor may prescribe lower doses, particularly if you
are taking certain medicinal products listed above or have
certain kidney conditions. Keep taking ZOCOR unless your
doctor tells you to stop.
If your doctor has prescribed ZOCOR along with any bile acid
sequestrant (medicines for lowering cholesterol), you should
take ZOCOR at least 2 hours before or 4 hours after taking the
bile acid sequestrant.

Please find below a translation of the days of the week that
appears on the blister:
LUN
MAR
MIE
JUE
VIE
SAB
DOM

-

MONDAY
TUESDAY
WEDNESDAY
THURSDAY
FRIDAY
SATURDAY
SUNDAY

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


your cholesterol may rise again.

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

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 (occurring in 1 or more of 10,000 and less than 1 of
1000 patients treated)



Very rare (occurring in less than 1 of 10,000 patients treated).



Frequency not known

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



inflammation of the blood vessels



unusual bruising, skin eruptions and swelling, hives, skin
sensitivity to the sun, fever, flushing



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.

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

6. FURTHER INFORMATION
What ZOCOR contains
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.

shortness of breath and feeling unwell

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: 28.05.2013
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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