ZOCOR 10 MG TABLETS

Active substance: SIMVASTATIN

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Zocor® 10mg Tablets
Simvastatin 10mg Tablets
(simvastatin)
Your medicine is known by one of the above names, but will be referred to
as Zocor throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking Zocor.
 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Zocor is also available as 20mg, 40mg and 80mg strengths
In this leaflet:
1) What Zocor is and what it is used for
2) Before you take Zocor
3) How to take Zocor
4) Possible side effects
5) How to store Zocor
6) 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).
Ask your doctor if you are not sure if your medicine is listed above.
Take special care with Zocor
 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.
 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 cholesterollowering 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 niacincontaining 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 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
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.

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.
Important information about some of the ingredients of Zocor
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
Always take Zocor exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking Zocor.
The dose is 1 Zocor 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a
day.
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
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.
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 80 mg 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.
The translation of the days of the week on the blister strip is as follows:
Mon Tue
Wed Thu
Fri
Sat
Sun
Lun
Mar
Mie
Jue
Vie
Sab
Dom
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

 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.
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 all medicines out of the sight and reach of children.
 Do not take Zocor after the expiry date printed on the carton, label or
blister strip. The expiry date refers to the last day of the month.
 Do not store above 30°C. Store in a dry place.
 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 thrown in your bin or put down the drain. If
they are out of date, or no longer suitable for you, return them to your
pharmacist for safe disposal.

6) Further information
What Zocor contains:
Each film-coated tablet contains 10mg of the active ingredient simvastatin.
Zocor tablets also contain the following: lactose, ascorbic acid, citric acid,
butylated hydroxanisole, microcrystalline cellulose, pregelatinised maize
starch, magnesium stearate, methylhydroxypropylcellulose,
hydroxypropylcellulose, titanium dioxide (E171), talc, yellow iron oxide
(E172) and red iron oxide (E172).
What Zocor looks like and contents of the pack
Zocor tablets are peach-coloured, oval-shaped, film-coated tablets marked
‘MSD 735’ on one side and plain on the reverse.
Zocor Tablets are available as blister packs of 28 tablets.

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
 shortness of breath and feeling unwell

PL 10383/0297

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp & Dohme, B.V.,
Waarderweg 39, 2031 BN Haarlem, The Netherlands. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 22.04.2013
Zocor® is a 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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