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Active substance(s): SIMVASTATIN / SIMVASTATIN

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disorders, and effects on blood cells)
• I nflammation of the liver with yellowing of the
skin and eyes, itching, dark-coloured urine or palecoloured stool, liver failure (very rare)
• I nflammation of the pancreas (severe abdominal
pain radiating to the back, nausea and vomiting).
The following side effects were reported rarely (may
affect up to 1 in 1,000 people).
• Low red blood cells (anaemia)
• Stomach upsets (such as sickness, constipation,
abdominal pain, flatulence, nausea, indigestion,
diarrhoea, vomiting, abdominal pain)
• Headache, dizziness, tingling sensation, weakness,
numbness or loss of sensation in the arms and legs
• Hair loss, rash, itchiness
• Increase in blood levels of liver enzymes
• Confusion
• Memory loss

Do not use the tablets after the expiry date which is
stated after ¨do not use after¨ or ¨exp¨ date on the
packaging. The wording ¨exp¨ means: ”expiry date”.
The first 2 digits denote the month, the last digits
the year.
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 C
 ontents of the pack and other

The following side effects were reported very rarely
(may affect up to 1 in 10,000 people)
• Trouble sleeping
 oor memory
The following side effects have also been reported
with frequency not known (cannot be estimated
from the available data):
• E rectile dysfunction
• 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
 uscle weakness that is constant
Additional possible side effects reported with some
• Sleep disturbances, including nightmares
• Sexual difficulties
 iabetes. 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:
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Simvastatin

Keep this medicine out of the sight and reach of
Store the tablets in the original package, in order
to protect from light and moisture. Do not store
above 30°C.
After first opening of the HDPE container: Store
below 25°C and use within 6 months.

What Simvastatin contains:
The active substance is: Simvastatin, 10mg, 20mg or
40mg The other ingredients are:
Tablet core: Lactose monohydrate, microcrystalline
cellulose (E460), Starch (maize) pregelatinised
1500 butylhydroxyanisole (E320), ascorbic acid
(E300), Citric acid, anhydrous (E330), silica, colloidal
anhydrous (E551), talc (E553b), magnesium stearate
(E470b). Film-coating: Hypromellose (E464),
iron oxide, red (E172), iron oxide, yellow (E172),
triethylcitrate (E1505), titanium dioxide (E171), talc
(E553b), povidone K-30.
What Simvastatin looks like and contents of pack
Simvastatin 10mg is a peach-coloured, oval,
biconvex, film-coated tablet, scored on one side;
The tablets can be divided into equal halves along
the score line.
Simvastatin 20mg is a tan-coloured, oval, biconvex,
film-coated tablet, scored on one side;
The tablets can be divided into equal halves along
the score line.
Simvastatin 40mg is a brick red-coloured, oval,
biconvex, film-coated tablet, scored on one side;
The tablets can be divided into equal halves along
the score line. The tablets are packed in blisters in a
carton box, containing 28 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Actavis UK Ltd
EX32 8NS
This leaflet was last revised in: August 2015

If you would like a
leaflet with larger
text, please contact
01271 385257.

Simvastatin 10mg,
20mg, 40mg Tablets
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
• 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 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

Triglycerides are another form of fat in your blood
that may increase your risk for heart disease.
Simvastatin is used:
• to lower cholesterol and triglycerides in the blood
when a low fat diet and other measures (such
as exercise, weight loss) have failed (primary
hypercholesterolaemia or mixed hyperlipidaemia).
• to lower inherited high levels of cholesterol
in your blood (homozygous familial
hypercholesterolemia), together with dieting and
other treatments (e.g. LDL-apheresis), or
when such treatments are not appropriate.
• to reduce the risk of coronary heart disease if you
have hardening of the arteries (arteriosclerosis) or
diabetes, even if your cholesterol levels are normal,
together with dieting and other treatments.
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

1 W
 hat Simvastatin is and what it is
used for

Simvastatin belongs to a group of medicines known
as statins. These work by reducing the amount of
total cholesterol, ‘bad’ cholesterol (LDL cholesterol),
and certain fatty substances called triglycerides in
your blood. In addition, Simvastatin raises levels
of ‘good’ cholesterol (HDL cholesterol). You should
stay on a cholesterol-lowering diet while taking this
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.

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

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Do not take Simvastatin:
• if you are allergic to Simvastatin or to any of the
other ingredients this medicine (listed in section
• if you currently have liver problems or a
continuous high level of certain liver enzymes
(serum transaminases)
• if you are pregnant or breast-feeding
• if you are taking one or more of the following
medicines at the same time:
- ketoconazole, itraconazole, posaconazole or
voriconazole (medicines for fungal infections)
- HIV-protease inhibitors, such as indinavir,
nelfinavir, ritonavir and saquinavir (medicines
used for HIV infections)
- boceprevir or telaprevir (medicines used to treat
hepatitis C virus infection)
- erythromycin, clarithromycin or telithromycin
(antibiotics for infections)
- nefazodone (an antidepressant)
- gemofibrozil (a medicine for lowering cholesterol)
- ciclosporin (a medicine 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)
• 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)

page 1

Warnings and precautions

Talk to your doctor or pharmacist before taking
• Tell your doctor about all your medical conditions
including allergies.
• Tell your doctor if you drink large amounts of
• Tell your doctor if you have ever had liver disease.
Simvastatin may not be right for you.
• Tell your doctor if you are due to have an
operation. You may need to stop taking
Simvastatin tablets for a short time.
 our doctor should do a blood test before you
start taking Simvastatin. This is to check how well
your liver is working.
 our doctor may also want you to have blood tests
to check how well your liver is working after you
start taking Simvastatin.
 hile 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.
Also tell your doctor or pharmacist if you have a
muscle weakness that is constant. Additional tests
and medicines may be needed to diagnose and
treat this.
Contact your doctor immediately if you
experience unexplained muscle pain, sensitivity
to pressure or muscle weakness. This is because
on rare occasions, muscle problems can be
serious, including muscle breakdown resulting
in kidney damage; and very rare deaths have
You may have a greater risk of muscle breakdown at
higher doses of Simvastatin, particularly the 80mg
dose. The risk of muscle breakdown is also greater
in certain patients.
Talk with your doctor if any of the following applies
to you:
• you are more than 65 years old
• you have kidney problems
• you have thyroid problems
• you or close family members have a hereditary
muscle disorder
• you are female
• you have ever had muscle problems during
treatment with cholesterol-lowering medicines
called ‘statins’ or fibrates
• if you consume large amounts of alcohol
Consult your doctor if any of the above applies to
you or has applied to you in the past.

Please note that the following statements may also
apply to products you took some time ago or
may take at some time in the future.
It is particularly important to tell your doctor if you
are taking any of the following drugs. The risk of
muscle problems can be greater if Simvastatin is
taken with the following medicines: (some of these
have already been listed in the above section “Do
not take the Simvastatin”)
• Fibrates (other cholesterol-lowering medicines,
such as gemfibrozil, bezafibrate)
• Ciclosporin (drug used to suppress the immune
system and often used in organ transplant
• Medicines like itraconazole, ketoconazole,
fluconazole, posaconazole or voriconazole
• Erythromycin, clarithromycin and telithromycin
• Certain medicines for the treatment of HIV
infections (HIV protease inhibitors such as
indinavir, nelfinavir, ritonavir and saquinavir)
• Boceprevir or telaprevir (a medicine used to treat
hepatitis C virus infection)
• Danazol (medicine used to treat endometriosis
and breast cysts in women)
• Nefazodone (medicine for depression)
• Amiodarone, a medicine used for irregular heart
• Verapamil, diltiazem or amlodipine (medicine used
to treat high blood pressure, chest pain associated
with heart disease, or other heart conditions).
• Fusidic acid as a tablet or infusion (a medicine
used to treat bacterial infections). Do not take
Fusidic acid while using this medicine. Also see
section 4 of this leaflet.
• Colchicine (a medicine 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, you
should also tell your doctor if you take
• medicines that prevent blood clots
(anticoagulants, such as phenprocoumon,
acenocoumarol and warfarin). Simvastatin may
increase the effect of these medicines.
• Fenofibrate (another medicine for lowering
• Niacin (another medicine for lowering cholesterol)
• Rifampicin (antibiotic 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

Children and adolescents

Safety and effectiveness have been studied in 1017 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 with food and drink:

Simvastatin has not been studied in children under
the age of 10 years. For more information, talk to
your doctor.

Grapefruit juice contains one or more components
which may increase the amount of Simvastatin
in the blood. Therefore, you should not drink
grapefruit juice as it could increase the risk of
muscle damage.

Other medicines and Simvastatin

Pregnancy and breast-feeding

Elderly patients

Ask your doctor or pharmacist for advice before taking
any medicine.

Duration of treatment:

The dose of Simvastatin does not need to be
changed for elderly patients

Instructions for use

Simvastatin tablets should be taken with water.
Take the tablets either on an empty stomach or
after a meal.
You will have to take Simvastatin over a long period
of time. Your doctor will tell you how long you need
to take Simvastatin. If you have the impression that
the effect of Simvastatin is too strong or too weak, talk
to your doctor or pharmacist.

Driving and using machines:

Simvastatin is not expected to interfere with your
ability to drive or use machines.
However, there have been rare cases of dizziness
reported in patients taking Simvastatin tablets
(see section 4). Do not drive vehicles or operate
machines that require attention if you experience
this side-effect.

If you take more Simvastatin than you

If you take too many tablets by mistake, contact a
doctor or pharmacist immediately.

Simvastatin contains lactose:

If you forget to take Simvastatin:

Amongst other ingredients, Simvastatin tablets
contain lactose monohydrate. If your doctor has
informed you that you cannot tolerate certain
sugars, contact your doctor before taking this

If you realise you have forgotten to take a dose
soon after its due time, take it as soon as possible.
However, if it is almost time to take the next dose,
omit the forgotten dose and take the next one
when it is due. Ask your doctor or pharmacist in
case of doubt.
Do not take a double dose to make up for a
forgotten tablet.

3 How to take Simvastatin

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are unsure. You should stay on a cholesterol
lowering diet while taking Simvastatin.

If you stop taking Simvastatin:

If you suddenly stop taking this medicine, your
cholesterol may rise again. It is therefore important
that you consult a doctor before stopping
treatment, even if you suffer from physical
complaints. He/she can tell you if you can stop and
the best way to do so.

The dose is 1 Simvastatin 5mg, 10mg, 20mg 40mg
or 80mg tablet by mouth once a day in the evening.
The 80mg dose is only recommended in 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.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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

4 Possible side effects

Take Simvastatin in the evening. You can take it with
or without food. The usual starting dose is 10, 20 or,
in some cases, 40mg a day. Your doctor may adjust
your dose after at least 4 weeks to a maximum of
80mg a day. Do not take more than 80mg a day.
Your doctor may prescribe lower doses, particularly
if you are taking certain medicinal products listed
above or have certain kidney conditions. Keep
taking Simvastatin unless your doctor tells you to
If your doctor has prescribed a bile acid sequestrant
(another medicine for lowering cholesterol such as
colestyramine) along with Simvastatin you should
take Simvastatin at least two hours before or four
hours after taking the bile acid sequestrant.

Use in children and adolescents

For children (10 -17 years old) with a hereditary
illness called familial hypercholesterolaemia, the
recommended usual starting dose is 10mg a day in
the evening. The maximum recommended
dose is 40mg a day.

Do not take Simvastatin if you are pregnant,
trying to become pregnant or suspect you may be
pregnant, as the safety in pregnant women has not
been established. If you become pregnant while

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other

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using Simvastatin, you must stop taking the tablets
immediately and contact your doctor.
No data on the excretion of Simvastatin in breast
milk are available. Because many medicinal
products are excreted in human milk and because
of the potential for serious side effects, you
must not breast-feed your infant while taking

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page 3

L ike all medicines, this medicine can cause side
effects, although not everybody gets them.
For the most part side effects have been mild and
short lived.
I f any of the following serious side effects
happen, stop taking the medicine and tell your
doctor immediately or go to the emergency
room at your nearest hospital.
 uscle pain, tenderness, weakness or cramps.
This is because on rare occasions, muscle damage
can be serious, including muscle breakdown
resulting in kidney damage and very rare deaths
have occurred (see section 2 “Warnings and
• 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
- rash with weakness of limbs and neck muscles
- pain or inflammation of the joints (polymyalgia
- 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

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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.