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SIMVASTATIN 20MG TABLETS

Active substance: SIMVASTATIN

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PACK AGE LEAFLET: INFORMATION FOR THE USER

Simvador 10mg, 20mg, 40mg and
80mg Tablets
Simvastatin

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 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 ef fects, talk to your doctor or pharmacist.
This includes any possible side ef fects not listed in this leaflet.
See section 4.
• Simvador is used to lower levels of cholesterol and
triglycerides in your blood and can help reduce your risk
of developing coronary heart disease. (See Section 1
’What Simvador is and what it is used for’).
• Simvador can cause serious muscle problems in a very
small number of patients. If you suf fer from unexplained
pain, tenderness or weakness in your muscles STOP
TAKING the medicine and talk to your doctor at once.
• DO NOT TAKE this medicine if you are already taking
medicines for fungal infections (such as itraconazole,
ketoconazole, voriconazole or posaconazole), HIV
protease inhibitors (such as indinavir, nelfinavir, ritonavir
and saquinavir), medicines for Hepatitis C virus infection
(such as boceprevir or telaprevir), antibiotics (such as
ery thromycin, clarithromycin, telithromycin), nefazodone
which is used to treat depression, gemfibrozil used for
lowing cholesterol, ciclosporin a medicine of ten used in
organ transplant patients, danazol a man-made hormone
used to treat endometriosis, fusidic acid (if you are taking,
or in the last 7 days have taken) used to treat bacterial
infections. (See Section 2 ‘Taking other medicines’).
• If you are pregnant or trying to get pregnant or breast
feeding you MUST NOT take Simvador (See Section 2
’Before you take Simvador’).
• If you have high blood pressure, high levels of fats or sugars
in your blood or have a body mass index of more than
30kg/m2 you may be at risk of developing diabetes. Your
doctor will monitor you closely if this applies. (See section
2 ’Before you take Simvador’and Section 4 ’Possible side
ef fects’).

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

1. What Simvador is and what it is used for
Simvador is used to lower levels of total cholesterol, “bad”
cholesterol (LDL cholesterol), and fat ty substances called
triglycerides in your blood. In addition, Simvador raises levels of
“good” cholesterol (HDL cholesterol). While taking this medicine
you should stick to a cholesterol-lowering diet. This medicine
belongs to the class of drugs called statins.

Simvador is used along with dieting if you have:
• A raised cholesterol level in your blood (primary
hypercholesterolaemia) or high fat levels in your blood
(mixed hyperlipidaemia) when exercise and weight loss
have not worked.
• A hereditary illness called homozygous familial
hypercholesterolaemia which causes the cholesterol levels
in your blood to rise. You may get other medicines as well
for this condition.
• Coronary heart disease or are at high risk of suf fering from
coronary heart disease. You are more likely to suf fer from
coronary heart disease if you have diabetes, have previously
had a stroke, or have other blood vessel disease). Simvador
may prolong your life by reducing the risk of heart disease
problems, regardless of the amount of cholesterol in your
blood.
Most people will not have any symptoms related to raised
cholesterol.
Your doctor or pharmacist can measure your
cholesterol level by means of a simple blood test. Having too
much cholesterol in your bloodstream can lead to coronary heart
disease. It can clog up blood vessels leading to hardening of
the arteries (atherosclerosis). Hardened arteries are less able to
carry blood to the heart and around the body. This can lead to
chest pain (angina) and heart at tacks.
If you have high levels of cholesterol you are more likely to get
heart disease if you also:
• Have high blood pressure (hypertension)
• Have diabetes (high blood sugar)
• Do lit tle physical exercise
• Smoke
• Are overweight or eat a high fat diet
Talk to your doctor or pharmacist if you would like advice about
any of these factors.
2. What you need to know before you take Simvador
Do not take Simvador if you:
• are allergic (hypersensitive) to simvastatin, or to any of
the other ingredients (see section 6)
• suf fer from liver problems
• are pregnant or breast feeding
• if you are taking one or more than one of the following drugs
at the same time:
• itraconazole, ketoconazole, posaconazole, or voriconazole
(medicines for fungal infections)
• HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir
and saquinavir), (HIV protease inhibitors are used for HIV
infections)
• boceprevir or telaprevir (medicines for Hepatitis C virus
infection)
• ery thromycin, clarithromycin or telithromycin (antibiotics
for infections)
• nefazodone (a medicine for depression)
• gemfibrozil (a medicine for lowing cholesterol)
• ciclosporin (a medicine of ten used in organ transplant
patients)
• danazol (a man-made hormone used to treat endometriosis).
• If you are taking or, in the last 7 days, have taken or been
given a medicine called fusidic acid (used to treat bacterial
infections).
If any of these apply to you, do not take this medicine and go back
to your doctor to discuss your treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvador if
you:
• Have any medical conditions including allergies
• Have previously had problems with your liver
• Have high blood pressure or high levels of fats and sugars

in your blood or if you have a body mass index of more than
30kg/m2. You may be more at risk of developing diabetes. Your
doctor will monitor you closely if this applies to you.
• Regularly drink large amounts of alcohol
• Have to go into hospital for an operation - you may need to stop
taking Simvastatin
• Have severe lung disease
Blood tests
Before your start taking simvastatin your doctor will do a blood
test to see how well your liver is working. Once you start taking
the medicine your doctor will want you to have regular blood tests
to see how well the medicine is working.
Important - Keep healthcare professionals informed
Contact your doctor immediately if you suf fer from any
unexplained muscle pain, tenderness or weakness. This is
because in a very small number of patients, muscle problems
can be serious. This can lead to kidney damage and in very
rare cases deaths have occurred.
You will be more at risk of muscle breakdown if you are on higher
doses of simvastatin particularly the 80 mg dose. Also some other
patients are more at risk. Talk to your doctor if any of the following
apply:
• you drink large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are a woman
• you have ever had muscle problems whilst being treated
with cholesterol-lowering medicines such as “statins” or
fibrates
• you or a close family member have hereditary muscle
problems.
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.
Other medicines and Simvador
Many medicines af fect the way simvastatin works. You must
tell your doctor before you start taking any other medicines
including over the counter medicines, herbal remedies and vitamin
supplements.
Do not take Simvastatin and tell your doctor if you are taking:
• ciclosporin (a medicine of ten used in organ transplant
patients)
• danazol (a man-made hormone used to treat endometriosis)
• medicines such as
ketoconazole, itraconazole,
fluconazole, posaconazole or voriconazole (medicines
for fungal infections)
• fibrates such as gemfibrozil or bezafibrate (medicines for
lowering cholesterol)
• ery thromycin, clarithromycin, telithromycin, or fusidic
acid (medicines for bacterial infections). Do not take fusidic
acid while using this medicine. Also see section 4 of the
leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir, and saquinavir (medicines for AIDS)
• boceprevir or telaprevir (medicines for hepatitis C virus
infection)
• nefazodone (a medicine for depression)
• drugs such as amiodarone, verapamil, diltiazem or
amlodipine (which are used to treat heart problems)
• colchicine (a medicine used to treat gout)
If you are taking any of the medicines in the list above you must
tell your doctor and not take Simvador because these medicines
can make it more likely that you will have muscle problems.
Check with your doctor first before taking Simvador if you are
taking any of these medicines:



medicines to prevent blood clots, such as warfarin,
phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (another medicine for lowering cholesterol)
• niacin (another medicine for lowering cholesterol)
• rifampicin (a medicine used to treat tuberculosis)
Also tell your doctor if you are taking niacin (nicotinic acid) or a
niacin containing product and are Chinese.
You should also tell any doctor who is prescribing a new medicine
for you that you are taking Simvador.
Simvador with food and drink
Grapefruit juice can interfere with the way in which your body
handles simvastatin. You should not drink grapefruit juice if you
are taking Simvador.
Pregnancy and breast-feeding
DO NOT take Simvador if you are pregnant, think you may be
pregnant, or are trying to get pregnant, or if you get pregnant
while taking Simvador STOP taking the medicine and see your
doctor immediately.
You should stop taking simvador 1 month before trying to get
pregnant.
Do not take Simvador if you are breast feeding because it is not
known if simvastatin passes into the breast milk.
Children
Safety and ef fectiveness of Simvador 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
Simvador). Simvador has not been studied in children under the
age of 10 years. For more information, talk to your doctor.
Driving and using machines
Simvador has no known ef fect on the ability to drive or operate
machines. Simvastatin can cause dizziness so make sure you are
not af fected before you drive or use machines.
Important information about some of the ingredients of
Simvador
Simvador 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 Simvador
Always take simvador exactly as your doctor has told you. If you are
not sure, check with your doctor or pharmacist. Your dose will be
decided by your doctor and will depend on the results of the blood
tests. The dose you should take will be on the label at tached by
your pharmacist. Swallow the medicine with plenty of water.
Remember to keep to a low-fat diet and to take physical exercise.
People with coronary heart disease (CHD)
The usual dose is 20mg – 40mg which you should take in the
evening. Your doctor may increase the dose you take every 4
weeks. The ma ximum dose is 80mg.
People with high levels of blood fats (Hyperlipidaemia)
The usual starting dose is 10mg taken in the evening. Your doctor
may increase the dose you take every 4 weeks. The ma ximum
dose is 80mg.
People with hereditary high cholesterol (homozygous familial
hypercholesterolaemia)
The usual dose is 40mg taken in the evening. Your doctor may
ask you to take 80mg each day in three doses through the day
(20mg, 20mg and 40mg). This 80mg dose is only for patients
who have very high levels of cholesterol in their blood or are at a
high risk of developing heart problems who have not reached their
cholesterol goal on lower doses.
Children (10-17 years)
The usual starting dose for children (10 -17 years old) is 10 mg.
This dose should usually be taken in the evening. If necessary the
dose may be increased to a ma ximum of 40 mg. Some patients

will need a lower dose particularly if they are also taking medicines
such as ciclosporin, danazol, fibrates or niacin and also if they
have kidney problems.
Taking other cholesterol-lowering medicines at the same time
as Simvador
Your doctor may ask you to take a medicine called colestyramine
whilst you are taking simvastatin. This medicine can interfere with
the way in which Simvador works. You must take Simvador 2 hours
before or 4 hours af ter you have taken colestyramine.
If you take more Simvador than you should
Talk to your doctor or go to your nearest hospital casualty
department straight away. Take the medicine pack with you.
If you forget to take Simvador
If you forget to take a dose, take it as soon as you remember
unless it is nearly time for your nex t dose. Do not take a double
dose.

4. Possible side ef fects
Like all medicines Simvador can cause side ef fects, although not
everybody gets them. Do not be concerned about this list of side
ef fects. You may not get any of them, but it is important to know
what to do if they occur.
Stop taking Simvador and go to hospital at once if you have:
• a rare allergic reaction such as swelling of the face, tongue, lips
and throat, dif ficulty breathing, severe itching of your skin with
raised lumps, joint pain, sensitivity to the sun, general feeling of
being unwell. You may need urgent medical at tention.
• Unexplained muscle problems such as pain, tenderness or
weakness. In rare cases, these muscle problems can be very
serious and result in muscle breakdown and kidney damage. In
some cases these problems can be life-threatening.
• Inflammation of the liver with yellowing of the skin and eyes,
dark coloured urine or pale coloured stools).
• Inflammation of the pancreas of ten with severe abdominal pain.
Tell your doctor or pharmacist if any of the following side
ef fects persist, get worse or if you notice any other side ef fects
not listed.
• Diabetes. This is more likely if you have high blood pressure,
high levels of sugar or fats in your blood or if you have a
body mass index of more than 30kg/m2. Your doctor will
monitor you more closely if these factors apply to you:
• Low red blood cell count (anaemia)
• Numbness or weakness in the arms and legs
• Headache, tingling sensation, dizziness
• Gastrointestinal disturbances such as feeling or being sick,
constipation, wind, diarrhoea, indigestion, stomach pain
• Rash, itching or hair loss
• Weakness
• Sleep disturbances such as dif ficulty sleeping and
nightmares
• Poor memory, memory loss, confusion
• Sexual dif ficulties such as erectile dysfunction
• Depression
• Inflammation of the lungs causing dif ficulty in breathing,
persistent cough and shortness of breath
• Tendon problems, sometimes complicated by rupture of
the tendon
Side ef fects of unknown frequency: Muscle weakness that is
constant.
Laborator y Values
Elevation in some laboratory blood tests of liver function and a
muscle enzyme (creatine kinase) have been observed.
Reporting of side ef fects
If you get any side ef fects, talk to your doctor or pharmacist. This
includes any possible side ef fects not listed in this leaflet.

You can also report side ef fects directly via the Yellow Card
Scheme Website: w w w.mhra.gov.uk/yellowcard.
By reporting side ef fects you can help provide more information
on the safety of this medicine.
5. How to store Simvador
Keep this medicine out of the sight and reach of children.
Do not store them above 25°C.
Do not use these tablets af ter the expiry date which is stated on
the pack.
The expiry date refers to the last day of that month.
Disposal
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.

6. Contents of the pack and other information
What Simvador Tablets contain
The active substance is simvastatin.
The other ingredients are:
Lactose monohydrate, cellulose microcrystalline (E460), starch
pregelatinised, citric acid monohydrate (E330), ascorbic acid
(E300), butylhydroxyanisole (E320), isopropyl alcohol and
magnesium stearate (E572), hydroxypropylcellulose (E463),
hydroxypropylmethylcellulose (E464), titanium dioxide (E171),
talc (E553b).
In addition Simvador 10mg, 20mg, 40mg, 80mg Tablets contain
iron oxide red (E172), Simvador 10mg, 20mg, 80mg Tablets contain
iron oxide yellow (E172) and Simvador 20mg, 40mg, 80mg Tablets
contain iron oxide black (E172).
What Simvador Tablets look like and the contents of the pack
Simvador Tablets are available in four strengths.
– The peach coloured, oval-shaped, biconvex, film-coated tablets
marked “10” on one side and breakline on the other side contain
10 mg Simvastatin.
– The tan coloured, oval-shaped, biconvex, film-coated tablets
marked “20” on one side and breakline on the other side contain
20mg Simvastatin.
– The brick-red coloured, oval-shaped, biconvex, film-coated
tablets marked “40” on one side and breakline on the other side
contain 40mg Simvastatin.
– The brick-red coloured, capsule-shaped, biconvex, film-coated
tablets marked “80” on one side and breakline on the other side
contain 80mg Simvastatin.
Simvador Tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder & Manufacturer
The Marketing Authorisation Holder is:
Lupin (Europe) Limited,
Victoria Court,
Bex ton Road,
Knutsford,
Cheshire, WA16 0PF
United Kingdom
Distributed by:
Discovery Pharmaceuticals
The Old Vicarage
Market Place
Castle Donington
Derbyshire DE74 2JB
United Kingdom

This leaflet was last revised in March 2015
Code No. GO/DRUGS/654

ID#: 236032

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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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