Skip to Content

UK Edition. Click here for US version.

SIMVASTATIN 5MG TABLETS

Active substance(s): SIMVASTATIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Product:

Simvastatin 5, 10, 20
& 40 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Chelonia

PL No.:

33414/0101-0104

Pack Size:

-

Dimensions:

148 x 297 mm

Livery:

Genesis

Created By:

DTawde

Manufacturer:

-

Artwork Code:

CL0101-0102-0103-0104/O/PIL/G2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
7.25 pt

Final Preparation Date For Submission: 23/06/2016

Packing Site Technical Approval:

Market:

UK

Component:

Leaflet

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN 5 mg, 10 mg,
20 mg & 40 mg 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 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 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 the 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 belongs to a group of medicines called HMG-CoA
reductase inhibitors, also known as ‘statins’, which work by lowering
the levels of total cholesterol, bad cholesterol (LDL cholesterol) and
fatty substances (triglycerides) in your blood. In addition, Simvastatin
raises levels of good cholesterol (HDL cholesterol).
Cholesterol is one of several fatty substances found in the blood
stream. 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.
Simvastatin is used in addition to your cholesterol-lowering diet while
taking this medicine to:
 treat raised levels of cholesterol (primary hypercholesterolaemia)
or triglycerides (mixed hyperlipidaemia) in your blood.
 treat hereditary illness that increased levels of cholesterol in your
blood (homozygous familial hypercholesterolaemia), together
with dieting and other treatments (e.g. LDL-apheresis), or when
such treatments are not appropriate. You may also receive other
treatments.
 prevent 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 and tell your doctor if you:
 are allergic (hypersensitive) to Simvastatin or any of the other
ingredients in these tablets (listed in section 6)
 have liver problems
 are pregnant or breast-feeding (see the section ‘Pregnancy and
Breast-feeding’ below)
 are taking medicines, with one or more than one of the following
active ingredients (also see the section ‘Taking other medicines’
below)
- itraconazole, ketoconazole, voriconazole or posaconazole
(used to treat fungal infections)
- HIV-protease inhibitors such as ritonavir, indinavir, saquinavir
or nelfinavir (used to treat HIV infections)
- boceprevir or telaprevir (used to treat hepatitis C virus
infection).
- cobicistat
- gemfibrozil (used to lower cholesterol)
- ciclosporin (used in organ transplant patients)
- danazol (used to treat endometriosis, a condition in which the
lining of the uterus grows outside the uterus)
- erythromycin, clarithromycin or telithromycin (used to treat
infections)
- nefazodone (used to treat depression)
- taking lomitapide (used to treat a serious and rare genetic
cholesterol condition)

If you are not sure, talk to your doctor or pharmacist before taking
Simvastatin.
Warnings and Precautions
Tell your doctor:
 about all your medical conditions including allergies
 if you consume large amounts of alcohol.
 if you have ever had liver disease. Simvastatin may not be right
for you.
 if you are Asian, because a different dose may be applicable to
you.
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 muscle weakness while being
treated with Simvastatin. This is because on rare occasions,
muscle problems can be serious, including muscle breakdown
resulting in kidney damage; and very rare deaths have
occurred.
Simvastatin may cause muscle breakdown (see section 4). The risk
of muscle breakdown is greater at higher doses, particularly the 80
mg dose. This risk of muscle breakdown is also greater in certain
patients. Talk with your doctor if you:
 regularly consume large amounts of alcohol
 have kidney problems
 are female
 have ever had problems with your muscles while using statins or
fibrates (medicines to reduce fat levels in the blood)
 or a close family members suffer from hereditary muscle
disorders
 are 65 years or older
 have thyroid problems which are not being treated
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.
Operations and tests
If you are going to have an operation, tell the doctor, dentist or nurse
that you are taking Simvastatin. You may need to stop taking
Simvastatin tablets for a short time.
Taking Simvastatin may affect the results of some clinical tests. If you
are going to have a test, it is important to tell your doctor or nurse that
you are taking Simvastatin.
Your doctor may want you to have some simple blood tests to check
your liver both before you start taking Simvastatin and during your
treatment. This is to check how well your liver is working.
Other medicines and Simvastatin
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including medicines bought
without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
 medicines to treat irregular heart beat, such as amiodarone
 medicines to treat bacterial infections such as clarithromycin,
erythromycin, telithromycin or fusidic acid. Do not take fusidic
acid while using this medicine. Also see section 4.
 medicines to treat fungal infections such as fluconazole,
itraconazole, ketoconazole, voriconazole or posaconazole
 HIV protease inhibitors used to treat AIDS, such as indinavir,
nelfinavir, ritonavir or saquinavir
 medicines to treat hepatitis C infections such as boceprevir or
telaprevir
 medicines with the active ingredient cobicistat.
 medicines to treat high blood pressure or chest pain associated
with heart disease or other heart conditions, such as diltiazem,
verapamil or amlodipine
 medicines used to thin the blood and stop blood clots from
forming, such as warfarin, phenprocoumon or acenocoumarol
 other cholesterol-lowering medicines known as fibrates, such as
bezafibrate and gemfibrozil
 niacin or nicotinic acid also to lower cholesterol (in doses greater
than 1 gram a day)
 ciclosporin, often used in organ transplant patients.
 colchicine to treat gout
 danazol to treat endometriosis and breast cysts in women
 nefazodone to treat depression
 rifampicin, an antibiotic used to treat tuberculosis
 fenofibrate, used to lower cholesterol
 lomitapide, used to treat a serious and rare genetic cholesterol
condition
Taking Simvastatin with food and drink
You should not drink grapefruit juice whilst you are being treated with
Simvastatin. It may increase the amount of Simvastatin in your blood
and could increase the risk of muscle problems.
Pregnancy and breast-feeding
Do not take Simvastatin if you are pregnant or trying to become
pregnant or think you may be pregnant.
You should stop taking Simvastatin before trying to get pregnant. If
you become pregnant while taking Simvastatin, stop taking it and
see your doctor straight away.
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 and adolescents
Safety and effectiveness 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 4’ below).

Simvastatin has not been studied in children under the age of 10
years. For more information, talk to your doctor.
Driving and using machines
Simvastatin is not expected to interfere with your ability to drive or to
use machinery. Simvastatin may cause dizziness in rare cases. If
you feel dizzy, then do not drive or operate any machines.
Simvastatin tablets contain lactose
This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to lactose or other sugars, contact your
doctor before taking this medicine.

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. Always take Simvastatin exactly as your doctor
has told you. You should check with your doctor or pharmacist if you
are not sure.
Swallow the tablets with water. Simvastatin tablets may be taken with
or without food. Remember to keep to a low-fat diet and exercise
while taking Simvastatin.
Dosage:
The recommended dose is Simvastatin 10 mg, 20 mg, 40 mg or 80
mg by mouth once a day.
Adults:
The usual starting dose is 10, 20 or, in some cases, 40 mg a day.
Your doctor may adjust your dose after at least 4 weeks to a
maximum of 80 mg a day. Do not take more than 80 mg a day.
Your doctor may prescribe lower doses, particularly if you are taking
certain medicinal products listed above or 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.
Taking another medicine for lowering your cholesterol at the
same time as Simvastatin
Your doctor may ask you to take a bile acid sequestrant (another
type of medicine for lowering cholesterol, such as cholestyramine) at
the same time as taking Simvastatin. This type of medicine can
change the way Simvastatin works. You should take Simvastatin at
least two hours before or at least four hours after taking the bile acid
sequestrant.
Patients with severe kidney problems:
Your doctor may prescribe a lower dose, which will usually not be
more than 10 mg per day.
Children and adolescents:
For children (10 -17 years old), the recommended usual starting
dose is 10 mg a day in the evening. The maximum recommended
dose is 40 mg a day.
Method of administration:
Take Simvastatin in the evening. You can take it with or without food.
Keep taking Simvastatin unless your doctor tells you to stop.
If you take more Simvastatin than you should
If you (or someone else) take too many tablets, contact your doctor
or the nearest hospital casualty department immediately. Take this
leaflet and the package with you so they know what has been taken.
If you forget to take Simvastatin
If you forget to take a dose, take it as soon as you remember.
However, if it is nearly time for the next dose, skip the missed dose
and take the next dose when it is due. Do not take a double dose
(two doses at the same time) to make up for a forgotten dose.
If you stop taking Simvastatin
If you suddenly stop taking Simvastatin, your blood cholesterol levels
may rise again. Do not stop taking this medicine without consulting
your doctor beforehand. Your doctor will advise you on how best to
do this.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Simvastatin can cause side effects, although not
everybody gets them.
If you get any of the following side effects, STOP TAKING
Simvastatin and tell your doctor immediately or go to the
nearest hospital emergency department:
 an allergic reaction to Simvastatin
You experience some of the following symptoms;
- swelling of the face, tongue or throat which may cause
difficulty breathing
- Lupus-like syndrome (an inflammatory disease which causes
joint pain, skin rashes and fever)
- severe muscle pain and stiffness usually in the shoulders and
hips
- rash with weakness of the limbs and neck muscles
- inflammation of the blood vessels
- increased incidents of bleeding or bruising
- stiffness, pain or inflammation of the joints
- skin eruptions and swelling (dermatomyositis), red, raised
lumps (hives), skin sensitivity to the sun, fever, flushing,
unusal bruising
- shortness of breath, feeling unwell
 Muscle pain, tenderness, weakness or cramps. On rare
occasions, these muscle problems can be serious, including
muscle breakdown resulting in kidney damage.

If you get the following rare side effects, see a doctor straight
away:
 inflammation of the liver, (hepatitis), which may cause yellowing
of the skin or whites of the eyes (jaundice), darker urine or paler
stools, feeling tired or weak, loss of appetite; liver failure (very
rare)
 inflammation of the pancreas (pancreatitis), which causes severe
pain in the abdomen and back
Tell your doctor or pharmacist if you get any of these side
effects:
Rare side effects (may affect up to 1 in 1000 people):
 low levels of red blood cells, (anaemia), which can make your
skin pale and cause tiredness and breathlessness
 constipation, stomach pain, wind (flatulence), indigestion,
diarrhoea, feeling sick or being sick (nausea or vomiting)
 weakness
 headache, tingling or ‘pins and needles’, dizziness, a disorder of
the nerves which can cause weakness or numbness of the arms
and legs
 rash, itching, hair loss
Very rare side effects (may affect up to 1 in 10,000 people):
 liver failure
 trouble sleeping, nighmares
 poor memory, memory loss, confusion
Not Known (frequency cannot be estimated from the available
data):
 Muscle weakness that is constant, sometimes complicated by
rupture of tendon.
 depression
 breathing problems including a persistent cough and/or
shortness of breath
 impotence
Additional possible side-effects reported with some statins:
 sleep disturbances, including sleeplessness and 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via 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.

5. How to store Simvastatin
Keep this medicine out of the sight and reach of children.
Do not use the tablets after the expiry date stated on the label [EXP].
The expiry date refers to the last day of that month.
Do not store above 25°C. Store the tablets in the original package.
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. Contents of the pack and other
information
What Simvastatin tablets contain
The active substance is Simvastatin. Each tablet contains 5 mg or 10
mg or 20 mg or 40 mg of the active substance.
The other ingredients are: lactose anhydrous, microcrystalline
cellulose (E460), pregelatinised maize starch, butylhydroxyanisole
(E320),
talc
(E553b),
magnesium
stearate
(E572),
hydroxypropylcellulose (E463), hypromellose (E464) and titanium
dioxide (E171).
The 5 mg tablets also contain yellow iron oxide (E172).
What Simvastatin tablets look like and contents of the pack
Simvastatin 5 mg Tablets are yellow, oblong, scored film-coated
tablets, with ‘SVT’ on one side and ‘5’ on the other.
Simvastatin 10 mg Tablets are white, oblong, biconvex film-coated
tablets, scored on one side, embossed with ‘10’ on the scored side
and with “SVT” and logo on the other side.
Simvastatin 20 mg Tablets are white, oblong, biconvex film-coated
tablets, scored on one side, embossed with “20” on the scored side
and with “SVT” and logo on the other side.
Simvastatin 40 mg Tablets are white, oblong, biconvex film-coated
tablets, scored on one side, embossed with “40” on the scored side
and with “SVT” and logo on the other side.
Simvastatin tablets are available in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited
Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London, SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last approved in 06/2016
CL0101-0102-0103-0104/O/PIL/G2

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