SIMVASTATIN 10MG 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. Keep the leaflet. You may need to read it again. If you
have any 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.
• 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), HIV protease inhibitors (such as indinavir,
nelfinavir, ritonavir and saquinavir), antibiotics (such as
ery thromycin, clarithromycin, telithromycin) or nefazodone
which is used to treat depression. (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’).

In This Leaflet
1 What Simvador is and what it is used for
2 Before you take Simvador
3 How to take
4 Possible side ef fects
5 How to store
6 Contents of the pack and further information

1. What Simvador is and what it is used for
Simvador is used to lower levels of cholesterol and fat ty substances
called triglycerides in your blood. 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).
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. Before you take Simvador
Do not take Simvador if you:
• are allergic to simvastatin, or to any of the other ingredients
(see section 6)
• suf fer from liver problems
• are pregnant or breast feeding
• are taking medicines for fungal infections (such as
itraconazole, ketoconazole or posaconazole), HIV
protease inhibitors (such as indinavir, nelfinavir, ritonavir
and sequinavir), antibiotics (such as ery thromycin,
clarithromycin, telithromycin) or nefazodone which is
used to treat depression (See section 2 “ Taking other
medicines”).
If any of these apply to you, do not take this medicine and go back
to your doctor to discuss your treatment.
Check with your doctor or pharmacist before taking these
tablets if you:
• 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 high
doses of simvastatin. 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.
Taking other medicines
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 – used to prevent rejection in organ transplant
patients
• A hormone called danazol
• Antifungal medicines such as ketoconazole, itraconazole,
fluconazole or posaconazole
• Fibrates such as gemfibrozil or bezafibrate which are also
used to treat high cholesterol
• Niacin or nicotinic acid in large doses which are also used
to treat high cholesterol
• Antibiotics such as ery thromycin, clarithromycin,
telithromycin, or fusidic acid
• HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir, or saquinavir.
• an antidepressant called nefazodone
• drugs such as amiodarone, verapamil, diltiazem or
amlodipine which are used to treat heart problems.
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 used to treat blood clots, such as warfarin
because the dose of warfarin may need to be changed.
• A drug used to treat tuberculosis called rifampicin
• A drug used to treat gout called colchicine
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.
Driving and using machinery
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
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.
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. 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).
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 in the arms and legs
• Headache, or dizziness
• Gastrointestinal disturbances such as feeling or being sick,
constipation, wind, diarrhoea, indigestion, stomach pain
• Rash, itching or hair loss
• Sleep disturbances such as dif ficulty sleeping and
nightmares
• Poor memory
• Sexual dif ficulties such as erectile dysfunction
• Depression
• Inflammation of the lungs causing dif ficulty in breathing,
persistent cough and shortness of breath

5. How to store
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 2012
Code No. GO/DRUGS/654

ID#: 227071

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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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