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SIMVASTATIN

10 mg, 20 mg, 40 mg AND 80 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Simvastatin Film-coated Tablets are and what they are used for

2.    Before you take Simvastatin Film-coated Tablets

3.    How to take Simvastatin Film-coated Tablets

4.    Possible side effects

5.    How to store Simvastatin Film-coated Tablets

6.    Further information

WHAT SIMVASTATIN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Simvastatin is a medicine used to lower levels oftotal cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, it raises levels of "good" cholesterol (HDL cholesterol). You should stay on a cholesterol lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins.

Simvastatin is used along with diet ifyou have:

•    A raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)

•    A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive othertreatments

•    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 ofthe 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 BEFORE YOU TAKE SIMVASTATIN FILM-COATED TABLETS

Do NOT take Simvastatin Film-coated Tablets

•    Ifyou are allergic (hypersensitive) to simvastatin, or any ofthe other ingredients ofSimvastatin Film-coatedTablets (see Section 6: "Further information")

•    Ifyou currently have liver problems

•    Ifyou are pregnant or breast-feeding

•    If you are taking one or more than one of the following drugs at the same time:

•    itraconazole, ketoconazole or posaconazole (medicines for fungal infections)

•    erythromycin, clarithromycin or telithromycin (antibiotics for infections)

•    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections)

•    nefazodone (a medicine for depression).

Take special care with Simvastatin Film-coated Tablets

Tell your doctor:

•    about all your medical conditions including allergies

•    if you drink large amounts of alcohol

•    ifyouhaveeverhadliverdisease. Simvastatin film-coated tablets may not be right for you

•    ifyou are dueto have an operation.You may need to stop taking Simvastatin Film-coatedTablets for a short time.

Your doctor should do a blood test before you start taking Simvastatin Film-coated Tablets.This is to check how well your liver is working. Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Simvastatin Film-coatedTablets.

Tell your doctor ifyou have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rare deaths have occurred.

REG0080294 Valid For 7 Days from

The risk of muscle breakdown is greater at higher doses of Simvastatin Film-coated Tablets and is greater in certain patients.Talk with your doctor if any ofthe following applies:

•    you consume large amounts of alcohol

•    you have kidney problems

•    youhavethyroidproblems

•    youare65yearsoldorolder

•    youarefemale

•    you have ever had muscle problems during treatment with cholesterol lowering medicines called "statins" orfibrates

•    you or a close family member have a hereditary muscle disorder.

While you are on this medicine your doctor will monitoryou closely ifyou 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.

Using other medicines

It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin Film-coatedTablets with any of these drugs can increase the risk of muscle problems (some ofthese have already been listed in the above section "Do NOT take Simvastatin Film-coatedTablets):

•    ciclosporin (a medicine often used in organ transplant patients)

•    danazol (a man-made hormone used to treat endometriosis)

•    medicines such as itraconazole, ketoconazole, fluconazole or posaconazole (medicines forfungal infections)

•    fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol)

•    erythromycin, clarithromycin,telithromycin or fusidic acid (medicines for treat bacterial infections)

•    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir (medicines for AIDS)

•    nefazodone (a medicine for depression)

•    amiodarone (a medicine for an irregular heartbeat)

•    verapamil, diltiazem or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions)

•    colchicine, (a medicine used to treat gout).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recentlytaken any other medicines, including those obtained without a prescription. In particular, tell your doctor if your are taking any of the following:

•    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.

Taking Simvastatin Film-coated Tablets with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Film-Coated tablets. Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

Do not take simvastatin ifyou are pregnant, trying to get pregnant or think you may be pregnant. Ifyou get pregnant while taking simvastatin, stop taking it immediately and contact your doctor.

Do not take simvastatin ifyou are breastfeeding because it is not known if the medicine is passed into breast milk.

Ask for advice from your doctor or pharmacist before taking any medicine.

Children

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 3. How to take Simvastatin Film-coatedTablets). Simvastatin Film-coated Tablets has not been studied in children under the age of 10 years. For more information, talkto your doctor.

Driving and using machines

Simvastatin Film-coatedTablets is not expected to interfere with your ability to drive or use machinery. However, it should be taken into account that some people get dizzy after taking it.

Important information about some of the ingredients of Simvastatin Film-coated Tablets

Simvastatin Film-coatedTablets contain a sugar called lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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©HOW TO TAKE SIMVASTATIN FILM-COATED TABLETS

Always take Simvastatin Film-coatedTablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.

You should stay on a cholesterol lowering diet while taking Simvastatin Film-coated Tablets.

The dose is one Simvastatin 10 mg, 20 mg,

40 mg or 80 mg Film-coated Tablet by mouth once a day.

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.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Take Simvastatin Film-coatedTablets in the evening. You can take it with or without food. The usual starting dose is 10 mg, 20 mg 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 ifyou are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin Film-coatedTablets unless your doctor tells you to stop.

Ifyour doctor has prescribed simvastatin along with a bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin Film-coatedTablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more simvastatin than you should

Please contact your doctor or pharmacist.

If you forget to take Simvastatin Film-coated Tablets

Do not take an extra dose, just take your normal amount ofSimvastatin Film-coated Tablets at the usual time the next day.

If you stop taking Simvastatin Film-coated Tablets.

Your cholesterol may rise again.

Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines. Simvastatin Film-coated Tablets can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

•    rare: affects 1 to 10 users in 10,000

•    very rare: affects less than 1 user in 10,000

•    frequency not known.

The following rare serious side effects were reported. If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

•    muscle pain, tenderness, weakness or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; very rare deaths have occurred

•    hypersensitivity(allergic) reactions including:

•    swelling of the face, tongue and throat which may cause difficulty in breathing

•    severemusclepainusuallyinthe shoulders and hips

•    rashwithweaknessoflimbsandneck muscles

•    painorinflammationofthejoints

•    inflammationofthebloodvessels

•    unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing

•    shortness of breath and feeling unwell

•    lupus-like disease picture (including rash, joint disorders and effects on blood cells).

•    inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liverfailure (very rare)

•    inflammation ofthe pancreas often with severe abdominal pain.

•    rash, itching, hair loss

•    weakness

•    trouble sleeping (very rare)

•    poor memory (very rare).

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

•    erectile dysfunction

•    depression

•    inflammationofthelungscausing breathing problems including persistent cough and/or shortness of breath or fever.

Additional possible side effects reported with some statins:

•    sleep disturbances including nightmares

•    memory loss

•    sexual difficulties

•    diabetes.This is more likely ifyou 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 liverfunction and a muscle enzyme (creatine kinase) have been observed.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

©HOW TO STORE SIMVASTATIN FILM-COATED TABLETS

Keep out of the reach and sight of children.

Store below 25°C.

Do not use after the expiry date which is stated on the carton and blister packs after EXF!The expiry date refers to the last day of that month.

Medicines should not be disposed ofvia wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

^ FURTHER INFORMATION

What Simvastatin Film-coated Tablets contain

The active substance is simvastatin. Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg simvastatin.

The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, butylhydroxyanisole (E320), magnesium stearate, ascorbic acid and citric acid monohydrate, hypromellose, titanium dioxide, macrogol 3350, triacetin (E1518), red iron oxide, 10 mg, 20 mg, 80 mg: yellow iron oxide, 80 mg: black iron oxide.

What Simvastatin Film-coated Tablets look like and contents of the pack

Film-coatedTablets.

• Simvastatin 10 mg Film-CoatedTablets are light pink, oval shaped, film coated tablets with a breakline on one side.

• Simvastatin 20 mg Film-CoatedTablets are tan, oval shaped, film coated tablets with a breakline on one side.

• Simvastatin 40 mg Film-CoatedTablets are pink, oval shaped, film coated tablets with a breakline on one side.

• Simvastatin 80 mg Film-coatedTablets are brick-red, oval shaped, film-coated tablets with a breakline on one side.

• Simvastatin Film-coatedTablets are

available in pack sizes of 28, 30, 50, 60, 90 or 100 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 10 mg Film-coatedTablets are also available in pack sizes of 20 film-coated tablets. Simvastatin 20 mg and 40 mg Film-coated Tablets are also available in pack sizes of 10 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK.

Manufacturer

TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13,4042 Debrecen, Hungary, or

TEVA UK Limited, Eastbourne, BN22 9AG, UK.

This leaflet was last revised in January 2013.

PL 00289/1451 PL 00289/1452 PL 00289/1453 PL 00289/1454