SIMVASTATIN 10 MG TABLET

Active substance: SIMVASTATIN

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• nflammation of the pancreas (severe
i
abdominal pain radiating to the back, nausea
and vomiting)
•  eadache, dizziness, weakness, numbness or
h
loss of sensation in the arms and legs
• hair loss, rash, itchiness
•  uscle aches and pains, tenderness,
M
weakness or cramps, dark coloured urine,
pale coloured stools (see above and section
2)
• iver disease (possibly presenting as yellowing
l
of the eyes and/or skin)
• increase in blood levels of liver enzymes

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.

The following side effects were reported very
rarely (may affect up to 1 in 10,000 people)
• Liver failure
• Trouble sleeping
• Poor memory
The following side effects have also been
reported with frequency not known (cannot
be estimated from the available data):
• Erectile dysfunction
• Depression
• nflammation of the lungs causing breathing
I
problems including persistent cough and/or
shortness of breath or fever
• Tendonitis
•  endon problems, sometimes complicated by
T
rupture of the tendon
Additional possible side effects reported with
some statins:
•  leep disturbances, including sleeplessness
S
and nightmares
• Memory loss
• Sexual dysfunction
•  iabetes. This is more likely if you have high
D
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.

information

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.

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.

Manufacturer
Actavis UK Ltd
Barnstaple
EX32 8NS
UK
This leaflet was last revised in: August 2014

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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

take Simvastatin

Do not take Simvastatin:

• f you are allergic to simvastatin or to any of
i
the other ingredients of this medicine (listed
in section 6).
• f you currently have liver problems or a
i
continuous high level of certain liver enzymes
(serum transaminases)
• if you are pregnant or breast-feeding
• f you are taking one or more of the following
i
medicines at the same time:
-  etoconazole, itraconazole or posaconazole
k
(medicines for fungal infections)
-  IV-protease inhibitors, such as indinavir,
H
nelfinavir, ritonavir and saquinavir (medicines
used for HIV infections)
-  rythromycin, clarithromycin or telithromycin
e
(antibiotics for infections)
- nefazodone (an antidepressant)
-  emofibrozil (a medicine for lowering
g
cholesterol)
-  iclosporin (a medicine often used in organ
c
transplant patients)
-  anazol (a man-made hormone used to treat
d
endometriosis)

Warnings and precautions

Talk to your doctor or pharmacist before taking
Simvastatin
•  ell your doctor about all your medical
T
conditions including allergies.
•  ell your doctor if you drink large amounts of
T
alcohol.
•  ell your doctor if you have ever had liver
T
disease. Simvastatin may not be right for you.
•  ell your doctor if you are due to have an
T
operation. You may need to stop taking
Simvastatin tablets for a short time.
•  our doctor should do a blood test before you
Y
start taking Simvastatin. This is to check how
well your liver is working.
•  our doctor may also want you to have blood
Y
tests to check how well your liver is working
after you start taking Simvastatin.
•  ell your doctor if you have severe lung
T
disease.

page 1

Simvastatin 10mg, 20mg & 40mg 28 Tablets PIL - UK

colours/plates:
1. Black

item no: AAAH0231

dimensions: 296 x 210 Reel Fed

print proof no: 4

pharmacode:

origination date: 04.07.14

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
20/06/14
Technologist: R.Wrey

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

information.

page 4

50813704

Pharmacode: 4493

2  hat you need to know before you
W

used for

AAAH0231 50813704

JDE No.:

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.

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
medicine.

Keep this medicine out of the sight and reach
of children.
Store the tablets in the original package, in
order to protect from light and moisture. Do
not store above 30°C.
Do not use the tablets after the expiry date
which is after ¨do not use after¨ or ¨exp¨. date
stated on the packaging. The wording ¨exp¨
means: ”expiry date”.

Simvastatin Tablets
10, 20 & 40mg x 28’s (UK)

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you
•  eep this leaflet. You may need to read
K
it again
•  f you have any further questions, ask
I
your doctor or pharmacist
•   his medicine has been prescribed for
T
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours
•  f you get any side effects, talk to your
I
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

1  hat Simvastatin is and what it is
W

Marketing Authorisation Holder and
Manufacturer
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland

5 How to store Simvastatin

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Simvastatin 10mg,
20mg and 40mg Tablets

6  ontents of the pack and other
C

min pt size: 8pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 28.08.14

Technical Approval

revised by: dje

date sent: n/a

supplier: Actavis UK

technically app. date:

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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 occurred.
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
•  ou or close family members have a
y
hereditary muscle disorder
• you are female
•  ou have ever had muscle problems during
y
treatment with cholesterol-lowering
medicines called ‘statins’ or fibrates
• if you consume large amounts of alcohol

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.

Consult your doctor if any of the above applies
to you or has applied to you in the past.

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

Children and adolescents

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).
Simvastatin has not been studied in
children under the age of 10 years. For more
information, talk to your doctor.
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 particulary 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”)
•  ibrates (other cholesterol-lowering
F
medicines, such as gemfibrozil, bezafibrate)
•  iclosporin (drug used to suppress the
C
immune system)
•  edicines like itraconazole, ketoconazole,
M
fluconazole, posaconazole (antifungals)
•  rythromycin, clarithromycin and
E
telithromycin (antibiotics)
•  ertain medicines for the treatment of HIV
C
infections (HIV protease inhibitors such as
indinavir, nelfinavir, ritonavir and saquinavir)
•  anazol (medicine used to treat
D
endometriosis and breast cysts in women)
• Nefazodone (medicine for depression)
•  miodarone, a medicine used for irregular
A
heart beat
•  erapamil, diltiazem or amlodipine (medicine
V
used to treat high blood pressure, chest pain
associated with heart disease, or other heart
conditions).
•  usidic acid as a tablet or infusion (a medicine
F
used to treat bacterial infections)
• Colchicine (a medicine to treat gout)

Simvastatin Tablets
10, 20 & 40mg x 28’s (UK)
JDE No.:

You should also tell any doctor who is
prescribing a new medicine for you that you
are taking Simvastatin.
Tell your doctor or pharmacist if you are taking
have recently taken or might take any other
medicines.

Simvastatin with food and drink:

Other medicines and Simvastatin

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

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
•  edicines that prevent blood clots
m
(anticoagulants, such as acenocoumarol and
warfarin). Simvastatin may increase the effect
of these medicines.
•  enofibrate (another medicine for lowering
F
cholesterol)
•  iacin (another medicine for lowering
N
cholesterol)
•  ifampicin (antibiotic used to treat
R
tuberculosis)

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.

Pregnancy and breast-feeding

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

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.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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

If you forget to take Simvastatin:

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.

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

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

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.
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
stop.
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.

Elderly patients

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.

Duration of treatment:

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.

Like 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.
If 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 aches and pains, tenderness,
m
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 occured (see section 2 “Warnings and
precautions”).
•  ypersensitivity (allergic) reactions including:
h
-  welling of the face, tongue and throat which
s
may cause difficulty in breathing
-  evere muscle pain usually in the shoulders
s
and hips
-  ash with weakness of limbs and neck
r
muscles
- pain or inflammation of the joints
- inflammation of the blood vessels
-  nusual bruising, skin eruptions and swelling,
u
hives, skin sensitivity to the sun, fever,
flushing
- shortness of breath and feeling unwell
- upus-like disease picture (including rash,
l
joint disorders, and effects on blood cells)
• nflammation of the liver with yellowing of
i
the skin and eyes, itching, dark-coloured
urine or pale-coloured stool, liver failure (very
rare)
• nflammation of the pancreas often with
i
severe abdominal pain.
The following side effects were reported rarely
(may affect up to 1 in 1,000 people):
• low red blood cells (anaemia)
•  tomach upsets (such as sickness,
s
constipation, abdominal pain, flatulence,
nausea, indigestion, diarrhoea, vomiting,
abdominal pain)

page 3

Simvastatin 10mg, 20mg & 40mg 28 Tablets PIL - UK

colours/plates:
1. Black

item no: AAAH0231

dimensions: 296 x 210 Reel Fed

print proof no: 4

pharmacode:

origination date: 04.07.14

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
20/06/14
Technologist: R.Wrey

If you take more Simvastatin than you
should:

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 medicine.

page 2

50813704

Pharmacode: 4493

Simvastatin contains lactose

min pt size: 8pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 28.08.14

Technical Approval

revised by: dje

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

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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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