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ZOCOR 40 MG FILM-COATED TABLETS

Active substance: SIMVASTATIN

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XXXXXX/XX-X

8148

ZOCOR® 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.
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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).

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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.

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Package leaflet: Information for the patient

XXXXXX/XX-X

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 25°C. 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 (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 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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