Skip to Content

ZOCOR 10MG TABLETS

Active substance: SIMVASTATIN

View full screen / Print PDF » Download PDF ⇩
Transcript
183 LEAFLET Zocor 20140710

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warnings and precautions
Tell your doctor:

ZOCOR 10mg TABLETS
(simvastatin)



about all your medical conditions including allergies.



if you drink large amounts of alcohol.

Your medicine is known as Zocor 10mg Tablets but will be referred
to as Zocor throughout the following leaflet.



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.



if you are due to have an operation. You may need to stop
taking Zocor tablets for a short time.

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.

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.

-

If you have any further questions, ask your doctor or
pharmacist.

Your doctor may also want you to have blood tests to check how
well your liver is working after you start taking Zocor.

-

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.

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.

What is in this leaflet:
1. What Zocor is and what it is used for
2. What you need to know before you take Zocor
3. How to take Zocor
4. Possible side effects
5. How to store Zocor
6. Contents of the pack and other information

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
greater in certain patients. Talk with your doctor if any of the
following applies:


you consume large amounts of alcohol

1. WHAT ZOCOR IS AND WHAT IT IS USED FOR



you have kidney problems

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.



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.

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 medicine (listed in Section 6: Contents of
the pack and other information).



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 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)



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)



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)



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:

if you are pregnant or breast‑feeding



It is particularly important to tell your doctor if you are taking
medicine(s) with any of the following active ingredients. Taking
Zocor with any of these medicines can increase the risk of muscle
problems (some of these have already been listed in the above
section “Do not take Zocor”).

if you currently have liver problems



Other medicines and Zocor



Ask your doctor if you are not sure if your medicine is listed
above.



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).

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.
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
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.



inflammation of the liver with the following symptoms: yellowing
of the skin and eyes, itching, dark-coloured urine or palecoloured 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:
Driving and using machines



low red blood cell count (anaemia)

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.



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

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.

The following side effects have also been reported but the
frequency cannot be estimated from the available information
(frequency not known):

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.



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.

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

Additional possible side effects reported with some statins:
Adults:



sleep disturbances, including nightmares

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.



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.

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.
Children:
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.

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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.

Method and duration 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.

5. HOW TO STORE ZOCOR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.



Do not store your tablets above 25°C.



Protect from light.



If you take more Zocor than you should

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 ho
will tell you what to do.



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


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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zocor contains


Each tablet contains 10mg of the active ingredient simvastatin.



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

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:

What Zocor looks like and contents of the pack



Rare (may affect up to 1 of 1000 patients)





Very rare (may affect up to 1 of 10,000 patients).

Zocor tablets are peach, oval shaped, film-coated tablets
marked ‘MSD 735’ on one side and plain on the other.



Not known (frequency cannot be estimated from the available
data)



Zocor is available as blister packs of 28 tablets.

Product Licence holder
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.

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



Manufacturer



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 rheumatic)



inflammation of the blood vessels (vasculitis)



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



shortness of breath (dyspnea) and feeling unwell



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

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: 08747/0183

Leaflet revision date: 10 July 2014
Zocor is a registered trade mark of Merck & Co Inc, USA.
183 LEAFLET Zocor 20140710

183 LEAFLET Simvastatin 20140710

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN 10mg TABLETS

Warnings and precautions
Tell your doctor:


about all your medical conditions including allergies.



if you drink large amounts of alcohol.

Your medicine is known as Simvastatin 10mg Tablets but will be
referred to as Simvastatin throughout the following leaflet.



if you have ever had liver disease. Simvastatin may not be right
for you.

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



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

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Your doctor should do a blood test before you start taking
Simvastatin and if you have any symptoms of liver problems while
you take Simvastatin. This is to check how well your liver is
working.

-

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.

What is in this leaflet:
1. What Simvastatin is and what it is used for
2. What you need to know before you take Simvastatin
3. How to take Simvastatin
4. Possible side effects
5. How to store Simvastatin
6. Contents of the pack and other information
1. WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR
Simvastatin 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 raises levels of
“good” cholesterol (HDL cholesterol). Simvastatin 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.

Your doctor may also want you to have blood tests to check how
well your liver is working after you start taking Simvastatin.
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
Simvastatin, particularly the 80-mg dose. The risk of muscle
breakdown is 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.

Other medicines and Simvastatin
It is particularly important to tell your doctor if you are taking
medicine(s) with any of the following active ingredients. Taking
Simvastatin with any of these medicines can increase the risk of
muscle problems (some of these have already been listed in the
above section “Do not take Simvastatin”).

You should stay on a cholesterol-lowering diet while taking this
medicine.
Simvastatin 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). Simvastatin 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
SIMVASTATIN
Do not take Simvastatin


if you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of medicine (listed in Section 6: Contents of
the pack and other information).



if you currently have liver problems



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 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)

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)



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)
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:

if you are pregnant or breast‑feeding







Triglycerides are another form of fat in your blood that may increase
your risk for heart disease.



Ask your doctor if you are not sure if your medicine is listed
above.



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).

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



inflammation of the liver with the following symptoms: yellowing
of the skin and eyes, itching, dark-coloured urine or palecoloured 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:
Driving and using machines



low red blood cell count (anaemia)

Simvastatin 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.



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

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

The following side effects have also been reported but the
frequency cannot be estimated from the available information
(frequency not known):

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.



erectile dysfunction

You should stay on a cholesterol-lowering diet while taking
Simvastatin.



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.

Dosage:
The recommended dose is 1 Simvastatin 10 mg, 20 mg, 40 mg, or
80 mg tablet by mouth once a day.

Additional possible side effects reported with some statins:


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.
Children:
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.

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.

Method and duration of administration:

5. HOW TO STORE SIMVASTATIN

Take Simvastatin in the evening. You can take it with or without
food. Keep taking Simvastatin unless your doctor tells you to stop.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store your tablets above 25°C.

If your doctor has prescribed Simvastatin along with another
medicine for lowering cholesterol containing any bile acid
sequestrant, you should take Simvastatin at least 2 hours before or
4 hours after taking the bile acid sequestrant.



Protect from light.



Do not use Simvastatin 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 ho
will tell you what to do.

If you take more Simvastatin than you should


please contact your doctor or pharmacist.

If you forget to take Simvastatin


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

If you stop taking Simvastatin

6. CONTENTS OF THE PACK AND OTHER INFORMATION



What Simvastatin contains

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.



Each tablet contains 10mg of the active ingredient simvastatin.



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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin 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 patients)



Very rare (may affect up to 1 of 10,000 patients).



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



pain or inflammation of the joints (polymyalgia rheumatic)



inflammation of the blood vessels (vasculitis)



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



shortness of breath (dyspnea) and feeling unwell



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



Simvastatin tablets are peach, oval shaped, film-coated tablets
marked ‘MSD 735’ on one side and plain on the other.



Simvastatin 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: 08747/0183

rash with weakness of limbs and neck muscles



What Simvastatin looks like and contents of the pack

Leaflet revision date: 10 July 2014
183 LEAFLET Simvastatin 20140710

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.

Hide