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TEVA SIMVASTATIN 80 MG FILM-COATED TABLETS

Active substance(s): SIMVASTATIN

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Patient Information Leaflet
Teva Simvastatin 80 mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.
If you have further questions, please 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Simvastatin 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
Simvastatin is and what it is used for‟).
Simvastatin can cause serious muscle problems in a very small number of patients. If you
suffer 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 erythromycin, 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
simvastatin (See Section 2 ‟Before you take simvastatin‟).
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 simvastatin‟and
Section 4 ‟Possible side effects‟)
In this leaflet
1.
2.
3.
4.
5.
6.

What Simvastatin is and what it is used for
Before you take Simvastatin
How to take
Possible side effects
How to store
Further information

1. What Simvastatin is and what it is used for
Simvastatin is used to lower levels of cholesterol and fatty 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.
Simvastatin is used along with dieting if you have:

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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 suffering from coronary heart disease. You are
more likely to suffer 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 attacks.
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 little 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 Simvastatin
Do not take Simvastatin if you:
are allergic to Simvastatin or to any of the other ingredients (see section 6)
suffer from liver problems
are pregnant or breast feeding
are taking medicines for fungal infections (such as itraconazole, ketoconazole, posaconazole),
HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), antibiotics (such
as erythromycin, 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
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.
Regularly drink large amounts of alcohol
Have to go into hospital for an operation – you might need to stop taking simvastatin
Have severe lung disease
Blood tests

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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 suffer 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 break down 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 affect 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 erythromicin, clarithromycin, telithromycin or fusidic acid
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir
an antidepressant called nefazadone
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 your must tell your doctor and not take
simvastatin because these medicines can make it more likely that will have muscle problems.
Check with your doctor first before taking simvastatin 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 medicine used to treat gout called colchicine
A drug used to treat tuberculosis called rifampicin
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin containing product and are
Chinese.

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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 simvastatin.
Pregnancy and breastfeeding
DO NOT take simvastatin if you are pregnant, think you might be pregnant or are trying to get
pregnant. If you get pregnant whilst taking simvastatin STOP taking the medicine and see your
doctor immediately. You should stop taking simvastatin 1 month before trying to get pregnant.
Do not take simvastatin if you are breastfeeding because it is not known if simvastatin passes into
breast milk.
Driving and using machines
Simvastatin has no known effect on the ability to drive or operate machines. Simvastatin can cause
dizziness so make sure you are not affected before you drive or use machines.
Important information about some of the ingredients
This product contins 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 simvastatin 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 attached 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 maximum dose is 80mg.
People with high levels of blood fats (Hyperlipidaemia)
The usual starting dose is 10mg – 20mg taken in the evening. Your doctor may increase the dose
you take every 4 weeks. The maximum 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 aged 10 – 17 years of age is 10mg. This dose should usually be
taken in the evening. If necessary the dose may be increased to a maximum of 40mg. 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 simvastatin
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 simvastatin works. You must take simvastatin 2
hours before or 4 hours after you have taken colestyramine.

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If you take more Simvastatin 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 Simvastatin
If you forget to take a dose take it as soon as you remember unless it is nearly time for your next
dose. Do not take a double dose.
4. Possible side effects
Like all medicines, Simvastatin can cause side effects. Do not be concerned about this list of side
effects. You may not get any of them, but it is important to know what to do if they occur.
Stop taking Simvastatin and go to hospital at once if you have:
a rare allergic reaction such as swelling of the face, tongue, lips and throat, difficulty 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 attention.
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 palecoloured stools.
Tell your doctor or pharmacist if any of the following side effects persist, get worse or if you
notice any other side effects not listed.
Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are
owerweight and have high blood pressure. Your doctor will monitor you while you are
taking this medicine.
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 difficulty sleeping and nightmares
Poor memory
Sexual difficulties such as erectile dysfunction
Depression
Inflammation of the lungs causing difficulty in breathing, persistent cough and shortness of
breath
5.

How to store
Keep Simvastatin out of the reach and sight of children.
Keep container in the outer carton.
Do not use Simvastatin after the expiry date shown on the outer packaging.
Store below 25°C.
Do not use Simvastatin after the expiry date shown on the outer packaging.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medcines no longer required. These measures will help protect the
environment.
Return all unused medicines to your pharmacist for safe disposal.
6.

Further information

What Simvastatin tablet contains
The active ingredient is Simvastatin. Each film-coated tablet contains 80mg of Simvastastin
The other ingredients are:
tablet core: lactose monohydrate, pregeletinised starch, microcrystalline cellulose, citric
acid monohydrate, ascorbic acid, butylhydroxyanisole, magnesium stearate,
coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol,
triacetin, iron oxide black (E172), iron oxide red (E172) and iron oxide yellow (E172).
What Simvastatin tablet looks like and contents of pack
Simvastatin 80mg tablets are brick red, capsule shaped, film coated tablets engraved “7156” on one
side, and “93” on the other.
Simvastatin 80mg tablets are available in pack sizes of 14, 20, 28, 30, 46, 50, 60, 98, 100 and 300
(30x10) (hospital pack) film coated tablets.
Not all pack sizes may be marketed.
Name and Address of the MAH and the site of batch release.
Teva UK Ltd, Eastbourne, BN22 9AG.
OR
The Product Authorisation holder is Teva UK Ltd, Eastbourne, BN22 9AG and the company
responsible for manufacture is TEVA Pharmaceutical Works Private Limited Company, Debrecen,
Hungary.
*

Only the paragraph containing the details of the current batch release site will be included in the printed version of the
PIL

Distributed by TEVA UK Ltd, Leeds, LS27 0JG.
Revision date: March 2012

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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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