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ZOCOR 5 MG FILM-COATED TABLETS

Active substance(s): SIMVASTATIN

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Package leaflet: Information for the patient
ZOCOR® 5,10, 20, 40 mg 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. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What ZOCOR is and what it is used for
What you need to know before you take ZOCOR
How to take ZOCOR
Possible side effects
How to store ZOCOR
Contents of the pack and other information

1. What ZOCOR is and what it is used for
ZOCOR contains the active substance simvastatin. 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 cobicistat
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)
Do not take more than 40 mg ZOCOR if you are taking lomitapide (used to treat a
serious and rare genetic cholesterol condition)


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

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.
Children and adolescents
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.
Other medicines and ZOCOR
Tell your doctor if you are taking, have recently taken or might take any other medicine(s)
with any of the following active ingredients. Taking ZOCOR with any of the following
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)
• medicines 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)
medicines with the active ingredient cobicistat
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)
lomitapide (used to treat a serious and rare genetic cholesterol condition)
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).
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.
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 ZOCOR 10 mg, 20 mg, 40 mg, or 80 mg 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.
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.
Use in children and adolescents:
For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the
evening. The maximum recommended dose is 40 mg a day.
Method 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 a double dose to make up for a forgotten tablet. 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.

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 (may affect up to 1 of 1000 people)
• Very rare (may affect up to 1 of 10,000 people)
• 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.
muscle pain, tenderness, or weakness that is constant that in very rare cases may not go
away after stopping ZOCOR.

Laboratory Values
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine
kinase) have been observed.
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 (see details below). By reporting side effects you can
help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal
5.

How to store ZOCOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (“EXP”) which is stated on the container.
Do not store above 25oC. Keep blister in outer carton in order to protect from moisture.
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 protect the
environment.
6.

Content of the pack and other information

What ZOCOR contains
The active substance is simvastatin (5 mg, 10 mg, 20 mg or 40 mg)
The other ingredients are: butylated hydroxyanisole (E320), ascorbic acid (E300), citric acid
monohydrate (E330), microcrystalline cellulose (E460), pregelatinized starch, magnesium
stearate (E572), and lactose monohydrate. The tablet coating contains hypromellose (E464),
hydroxypropylcellulose (E463), titanium dioxide (E171), and talc (E553b). The 10 mg and
20 mg tablets also contain yellow ferric oxide (E172) and red ferric oxide (E172). The 40 mg
tablets also contain red ferric oxide.
What ZOCOR looks like and contents of the pack
Zocor 5mg are buff-coloured, oval-shaped tablets marked 'Zocor 5'
Zocor 10mg are peach-coloured, oval-shaped tablets marked ‘MSD 735’
Zocor 20mg are tan-coloured, oval-shaped tablets marked ‘MSD 740’

Zocor 40mg are brick-red coloured, oval-shaped tablets marked ‘MSD 749’
Zocor Tablets are available in packs containing 28 tablets, 4 tablets or one tablet.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
The Marketing Authorisation Holder in the UK and Malta is Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. The Marketing Authorisation
Holder in Ireland is Merck Sharp & Dohme Ireland (Human Health) Ltd, Red Oak North,
South County Business Park, Leopardstown, Dublin 18, Ireland.
The manufacturer of the 10 mg and 20 mg tablets is Merck Manufacturing Division, Merck
Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland NE23 3JU, UK.
The manufacturer of the 40 mg tablets is Merck Sharp & Dohme BV, Waarderweg 39, 2031
BN, Haarlem, The Netherlands.
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria ZOCORD
Belgium ZOCOR
Denmark ZOCOR
Finland ZOCOR
France ZOCOR
Germany ZOCOR 5 mg Filmtabletten; ZOCOR 10 mg Filmtabletten; ZOCOR 20 mg
Filmtabletten; ZOCOR FORTE 40 mg Filmtabletten; ZOCOR FORTE XL 80 mg
Filmtabletten
Greece ZOCOR
Iceland ZOCOR
Ireland ZOCOR
Italy SINVACOR
Luxembourg ZOCOR
Netherlands ZOCOR
Norway ZOCOR
Portugal ZOCOR
Spain ZOCOR; ZOCOR FORTE (for 40 mg tablets)
Sweden ZOCORD
United Kingdom ZOCOR
This leaflet was last revised in: February 2015
© Merck Sharp & Dohme Limited 2015. All rights reserved.
PIL.ZCR.13.UK.3961-WS-055

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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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