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TEVA SIMVASTATIN 5 MG FILM-COATED TABLETS

Active substance(s): SIMVASTATIN

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Package leaflet: Information for the user
Teva Simvastatin 5mg film-coated tablets
Teva Simvastatin 10mg film-coated tablets
Teva Simvastatin 20mg film-coated tablets
Teva Simvastatin 40mg film-coated tablets
Simvastatin
Read all of this leaflet carefully before you start using 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 pr escribed 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 y ou get a ny side effe cts, talk to your do ctor or ph armacist. This includ es an y
possible side effects not listed in this leaflet. See section 4.



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’)

What is in this 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. Po ssible 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 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.

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Simvastatin 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 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. What you need to know before you take Simvastatin
Do not take Simvastatin:
 if you are allergic to Simvastatin or to any of the other ingredients of this medicine (listed in
section 6)
 if you suffer from liver problems
 if you are pregnant or breast feeding
 if you 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 ‘Other medicines and Simvastatin’).
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 Simvastatin if you:







have previously had problems with your liver
have diabetes or are at risk of developing diabetes due to high fat and sugar levels in your
blood, having high blood pressure and being overweight
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
are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for
bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin
can lead to serious muscle problems (rhabdomyolysis).

Blood tests
Before you 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.
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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.
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.
Children and adolescents
Safety and effectiveness have been studied in 10-17-year-old boys and girls who had started their
menstrual period at least one year before (see section 3. ‘How to take Simvastatin’). Simvastatin
has not been studied in children under the age of 10 years. For more information, talk to your
doctor.
Other medicines and Simvastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
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 need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using
this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with
fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information
regarding rhabdomyolysis in section 4.
If you are taking any of the medicines in the list above you must tell your doctor and not take
simvastatin because these medicines can make it more likely that you 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

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Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin containing product and
are Chinese.
Simvastatin 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 simvastatin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
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 breast-feeding 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.
Simvastatin contains lactoseThis product contains 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 Simvastatin
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. 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.
Use in children and adolescents
Children (10-17 years)
The usual starting dose for children aged 10 – 17 years of age is 10 mg. 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 to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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, liver failure.
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.
Rare (may affect up to 1 in 1,000 people):
 Headache, dizziness, numbness or tingling in the fingers and toes, reductions of sensation to
pain or touch
 Constipation, abdominal pain, wind, indigestion, diarrhoea, nausea, vomiting, pancreatitis
(inflammation of the pancreas leading to stomach pain)
 Rash, skin rash and itching, hair loss
 Unexpected bleeding or bruising
 Weakness
Very rare (may affect up to 1 in 10,000 people):
 Problems with memory
 Insomnia
 Increases in liver enzymes and a muscle enzyme creatine kinase
Not known (frequency cannot be estimated from the available data):
 Tendon injury
 Depression
 Breathing problems including persistent cough and/or shortness of breath or fever (interstitial
lung disease)
 Sexual difficulties such as erectile dysfunction
 Muscle weakness that is constant
Possible side effects reported with some statins (medicines of the same type):
 Sleeping problems, including nightmares
 Memory loss
 Sexual difficulties

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 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.
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 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.
5.
How to store Simvastatin
 Keep this medicine out of the sight and reach of children.
 Do not store above 25°C. Keep container in the outer carton.
 Do not use this medicine after the expiry date which is stated on the outer packaging. The
expiry date refers to the last day of that month.
 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 contains
 The active ingredient is Simvastatin. Each film-coated tablet contains 5mg, 10mg, 20mg and
40mg of Simvastatin.
 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 3000, triacetin, iron oxide black (E172), iron oxide red (E172) and iron
oxide yellow (E172).
What Simvastatin looks like and contents of pack
 Simvastatin 5mg tablets are white, oval film-coated tablets debossed "5" on one side and
plain on the other.
 Simvastatin 10mg tablets are peach, oval film-coated tablets debossed "10" on one side and
plain on the other.
 Simvastatin 20mg tablets are tan, oval film-coated tablets debossed "20" on one side and
 plain on the other.
 Simvastatin 40mg tablets are pink, oval film-coated tablets debossed "40" on one side and
plain on the other.
 Simvastatin 5mg, 10mg, 20mg and 40mg tablets are available in pack sizes of 10, 20, 28, 30,

50 and 100 film-coated tablets, calendar pack containing 30 film-coated tablets, unit
dose hospital pack containing 50x1 tablets.

Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Eastbourne BN22 9AG, England.
This leaflet was last revised in January 2016.

PL 00289/0372-0375

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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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