ZOCOR 20MG

Active substance: SIMVASTATIN

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199 LEAFLET Zocor 20120716

Take special care with Zocor

PACKAGE LEAFLET: INFORMATION FOR THE USER



ZOCOR 20mg TABLETS
(simvastatin)

Tell your doctor about all your medical conditions including
allergies.



Tell your doctor if you drink large amounts of alcohol.

Your medicine is known as Zocor 20mg Tablets but will be referred
to as Zocor throughout the following leaflet.



Tell your doctor if you have ever had liver disease. Zocor may
not be right for you.

Information for other strength of Zocor also may be present in this
leaflet.



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. 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.

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.

 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.

In this leaflet:

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:

1. What Zocor is and what it is used for



you consume large amounts of alcohol

2. Before you take Zocor



you have kidney problems

3. How to take Zocor



you have thyroid problems

4. Possible side effects



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

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 cholesterollowering diet while taking this medicine. Zocor is member of the
class of drugs called statins.

you or a close family member have a hereditary muscle
disorder.

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.

Zocor is used along with diet if you have:

Using other medicines



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.

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”).

5. How to store Zocor
6. Further information



ciclosporin (a medicine often used in organ transplant patients)



danazol (a man-made hormone used to treat endometriosis)

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.



medicines like itraconazole, ketoconazole, fluconazole, or
posaconazole (medicines for fungal infections)



fibrates like gemfibrozil and bezafibrate (medicines for lowering
cholesterol)

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.



erythromycin, clarithromycin, telithromycin, or fusidic acid
(medicines for bacterial infections)



HIV protease inhibitors such as indinavir, nelfinavir, ritonavir,
and saquinavir (medicines for AIDS)





nefazodone (a medicine for depression)

2. BEFORE YOU TAKE ZOCOR



amiodarone (a medicine for an irregular heartbeat)

Do not take Zocor



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).



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

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.

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 or pharmacist for advice before taking any
medicine.

Children

The following side effects have also been reported rarely:

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



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)

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.



rash, itching, hair loss



weakness



trouble sleeping (very rare)



poor memory (very rare)

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 10 mg a day in the evening. The maximum recommended
dose is 40 mg a day.

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.



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

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.

Additional possible side effects reported with some statins:


sleep disturbances, including nightmares

Your doctor will determine the appropriate tablet strength for you,
depending on your condition, your current treatment and your
personal risk status.



memory loss



sexual difficulties.

Take Zocor in the evening. You can take it with or without food. 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.
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.
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.

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 your tablets above 25°C.



Protect from light.



Do not use Zocor after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



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.

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

6. FURTHER INFORMATION

Like all medicines, Zocor can cause side effects, although not
everybody gets them.

What Zocor contains

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.



Each tablet contains 20mg of the active ingredient simvastatin.

The other ingredients are: lactose, ascorbic acid, citric acid,
butylhydroxyanisole, microcrystalline cellulose, pregelatinised
maize starch, magnesium stearate, hydroxypropylcellulose,
methylhydroxypropylcellulose, 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, oval shaped, film-coated tablets marked
‘MSD 740’ on one side and plain on the other.
Zocor is available as blister packs of 28 tablets.
Product Licence holder



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.

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



hypersensitivity (allergic) reactions including:

This product is manufactured by either of the below manufacturers-



swelling of the face, tongue and throat which may cause
difficulty in breathing



Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de
Henares, Madrid, Spain



severe muscle pain usually in the shoulders and hips





rash with weakness of limbs and neck muscles

Merck Sharp & Dohme, B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands.



pain or inflammation of the joints

POM

PL No: 08747/0199



inflammation of the blood vessels

Leaflet revision date: 16 July 2012



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

Zocor is a registered trade mark of Merck & Co Inc, USA.



shortness of breath and feeling unwell



lupus-like disease picture (including rash, joint disorders,
and effects on blood cells)



inflammation of the liver with yellowing of the skin and eyes,
itching, dark-coloured urine or pale-coloured stool, liver failure
(very rare)



inflammation of the pancreas often with severe abdominal pain.

199 LEAFLET Zocor 20120716

199 LEAFLET Simvastatin 20120716

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN 20mg TABLETS

Take special care with Simvastatin Tablet


Tell your doctor about all your medical conditions including
allergies.



Tell your doctor if you drink large amounts of alcohol.

Your medicine is known as Simvastatin 20mg Tablets but will be
referred to as Simvastatin Tablet throughout the following leaflet.



Tell your doctor if you have ever had liver disease. Simvastatin
Tablet may not be right for you.

Information for other strength of Simvastatin Tablet also may be
present in this leaflet.



Tell your doctor if you are due to have an operation. You may
need to stop taking Simvastatin Tablet tablets for a short time.



Your doctor should do a blood test before you start taking
Simvastatin Tablet. 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 Simvastatin
Tablet.

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.

 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.

1. What Simvastatin Tablet is and what it is used for

The risk of muscle breakdown is greater at higher doses of
Simvastatin Tablet, 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:

2. Before you take Simvastatin Tablet



you consume large amounts of alcohol

3. How to take Simvastatin Tablet



you have kidney problems

4. Possible side effects



you have thyroid problems

5. How to store Simvastatin Tablet



you are 65 years or older

6. Further information



you are female


1. WHAT SIMVASTATIN TABLET IS AND WHAT IT IS USED
FOR

you have ever had muscle problems during treatment with
cholesterol-lowering medicines called “statins” or fibrates



Simvastatin Tablet is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL cholesterol), and fatty
substances called triglycerides in the blood. In addition, Simvastatin
Tablet raises levels of “good” cholesterol (HDL cholesterol). You
should stay on a cholesterol-lowering diet while taking this
medicine. Simvastatin Tablet is member of the class of drugs called
statins.

you or a close family member have a hereditary muscle
disorder.

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.
Using other medicines

In this leaflet:

Simvastatin Tablet 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). Simvastatin Tablet 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.

It is particularly important to tell your doctor if you are taking any of
the following drugs. Taking Simvastatin Tablet 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
Simvastatin Tablet”).


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)



nefazodone (a medicine for depression)

2. BEFORE YOU TAKE SIMVASTATIN TABLET



amiodarone (a medicine for an irregular heartbeat)

Do not take Simvastatin Tablet



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).



if you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of Simvastatin Tablet 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:

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).

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)

Also tell your doctor if you are taking niacin (nicotinic acid) or a
niacin-containing product and are Chinese.

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.

You should also tell any doctor who is prescribing a new medicine
for you that you are taking Simvastatin Tablet.
Taking Simvastatin Tablet with food and drink
Grapefruit juice contains one or more components that alter how
the body uses some medicinal products, including Simvastatin
Tablet. Consuming grapefruit juice should be avoided.
Pregnancy and Breast-feeding
Do not take Simvastatin Tablet if you are pregnant, trying to get
pregnant or think you may be pregnant. If you get pregnant while
taking Simvastatin Tablet, stop taking it immediately and contact
your doctor. Do not take Simvastatin Tablet 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 SIMVASTATIN TABLET). Simvastatin
Tablet has not been studied in children under the age of 10 years.
For more information, talk to your doctor.

inflammation of the liver with yellowing of the skin and eyes,
itching, dark-coloured urine or pale-coloured stool, liver failure
(very rare)



inflammation of the pancreas often with severe abdominal pain.

The following side effects have also been reported rarely:

Simvastatin Tablet 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 Simvastatin Tablet.
Important information about some of the ingredients of
Simvastatin Tablet
Simvastatin Tablet 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 SIMVASTATIN TABLET
Always take Simvastatin Tablet 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
Simvastatin Tablet.
The dose is 1 Simvastatin Tablet 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 10 mg a day in the evening. The maximum recommended
dose is 40 mg a day.
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.
Your doctor will determine the appropriate tablet strength for you,
depending on your condition, your current treatment and your
personal risk status.
Take Simvastatin Tablet in the evening. You can take it with or
without food. 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. Keep taking Simvastatin Tablet unless your
doctor tells you to stop.



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)



Driving and using machines

poor memory (very rare)

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.



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

Additional possible side effects reported with some statins:


sleep disturbances, including nightmares



memory loss



sexual difficulties.

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.

If your doctor has prescribed Simvastatin Tablet along with any bile
acid sequestrant (medicines for lowering cholesterol), you should
take Simvastatin Tablet at least 2 hours before or 4 hours after
taking the bile acid sequestrant.
If you take more Simvastatin Tablet than you should

5. HOW TO STORE SIMVASTATIN TABLET

 please contact your doctor or pharmacist.
If you forget to take Simvastatin Tablet


do not take an extra dose, just take your normal amount of
Simvastatin Tablet at the usual time the next day.



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



Do not store your tablets above 25°C.



Protect from light.



Do not use Simvastatin Tablet after the expiry date which is
stated on the carton and blister strip. The expiry date refers to
the last day of that month.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



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.

If you stop taking Simvastatin Tablet


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, Simvastatin Tablet can cause side effects,
although not everybody gets them.
The following terms are used to describe how often side effects
have been reported:


Frequency not known



Each tablet contains 20mg of the active ingredient simvastatin.



The other ingredients are: lactose, ascorbic acid, citric acid,
butylhydroxyanisole, microcrystalline cellulose, pregelatinised
maize starch, magnesium stearate, hydroxypropylcellulose,
methylhydroxypropylcellulose, titanium dioxide (E171), talc,
yellow iron oxide (E172) and red iron oxide (E172).

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



What Simvastatin Tablet contains

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



6. FURTHER INFORMATION

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



lupus-like disease picture (including rash, joint disorders,
and effects on blood cells)

What Simvastatin Tablet looks like and contents of the pack
Simvastatin tablets are peach, oval shaped, film-coated tablets
marked ‘MSD 740’ on one side and plain on the other.
Simvastatin Tablet is available as blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer


This product is manufactured by either of the below
manufacturers-Frosst Iberica S.A., Via Complutense 140,
28805 Alcala de Henares, Madrid, Spain



Merck Sharp & Dohme, B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands.

POM

PL No: 08747/0199

Leaflet revision date: 16 July 2012
199 LEAFLET Simvastatin 20120716

Expand view ⇕

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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