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Package leaflet: Information for the user

Simvastatin 10 mg Tablets Simvastatin 20 mg Tablets Simvastatin 40 mg Tablets

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 effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Simvastatin Tablets are and what they are used for

2. What you need to know before you take Simvastatin Tablets

3. How to take Simvastatin Tablets

4. Possible side effects

5. Howto store Simvastatin Tablets

6. Contents of the pack and other information.

I.What Simvastatin Tablets are and what they are used for_

Simvastatin Tablets contain simvastatin, a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, simvastatin 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 Tablets are used along with diet if you have:

• a raised cholesterol level in your blood (primary hypercholesterolemia) 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 Tablets may prolong your life by reducing the risk of heart disease problems, regardless of the 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. What you need to know before you take Simvastatin Tablets

Do not take Simvastatin Tablets

. if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)

« if you are pregnant or breast feeding > if you currently have liver problems . 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)

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

- erythromycin, clarithromycin, or telithromycin (antibiotics for infections)

- nefazodone (a medicine for depression)

- boceprevir or telaprevir (medicines for hepatitis C virus infection)

- gemfibrozil (a medicine for lowering cholesterol)

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

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

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Simvastatin Tablets

. Tell your doctor about all your medical conditions including allergies . Tell your doctor if you drink large amounts of alcohol

• Tell your doctor if you have ever had liver disease. Simvastatin Tablets may not be right foryou

. Your doctor should do a blood test before you start taking Simvastatin Tablets and if you have any symptoms of liver problems while you take Simvastatin 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 Tablets

. Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin Tablets for a short time . 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

• Tell your doctor if you 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.

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 treatthis.

The risk of muscle breakdown is greater at higher doses of Simvastatin Tablets, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

- You have kidney problems

- You have thyroid problems

- You are 65 years or older

- 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

- You are female

- You consume large amounts of alcohol Children

Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see How to take Simvastatin Tablets). Simvastatin Tablets have not been studied in children under the age of 10 years. For more information, talkto your doctor.

Other medicines and Simvastatin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin tablets with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin tablets”).

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

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

. medicines like itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections)

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

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

. HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and 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)

• boceprevir or telaprevir (medicines for hepatitis C virus infection).

In addition to above, tell your doctor if you 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.

You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin Tablets.

Simvastatin Tablets with food and drink

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

Pregnancy and Breast-feeding

Do not take Simvastatin Tablets if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin tablets, stop taking it immediately and contact your doctor. Do not take Simvastatin Tablets if you are breastfeeding, because it is not known if the medicine is passed into breast milk.

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

Driving and using machines

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

Simvastatin Tablets contain lactose

Simvastatin 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 Simvastatin Tablets_

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

The dose is 1 Simvastatin 10 mg, 20 mg, 40 mg or 80 mg 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 Tablets in the evening. You can take it with or without food. The usual starting dose is 10,20 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 if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin Tablets unless your doctortells you to stop.

If your doctor has prescribed Simvastatin Tablets along with any bile acid sequestrants (medicines for lowering cholesterol), you should take Simvastatin Tablets at least 2 hours before or 4 hours after taking the bile acidsequestrant.

If you take more Simvastatin Tablets than you should

. Please contact your doctor or pharmacist.

If you forget to take Simvastatin Tablets

. Do not take an extra dose; just take your normal amount of Simvastatin Tablets at the usual time the next day.

If you stop taking Simvastatin Tablets

. Your cholesterol may rise again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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 liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talkto your doctor or pharmacist or nurse. 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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Simvastatin Tablets_

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.

Do not store above 25°C. Store in the original package.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

. hypersensitivity (allergic) reactions including:

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

- severe muscle pain usually in the shoulders and hips

- rash with weakness of limbs and neck muscles

- painorinflammationofthejoints

- inflammation of the blood vessels

- 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)

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

. inflammation of the pancreas often with severe abdominal pain

. inflammation of the liver with the following symptoms: yellowing of skin and eyes, itching, dark coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite; liverfailure.

Other side effects

Rare (may affect up to 1 in 1,000 people)

. low red blood cell count (anemia)

. hair loss, rash, itching . headache, dizziness . weakness

. digestive disturbances (nausea, vomiting, diarrhoea, constipation, indigestion, flatulence, abdominal pain)

. tingling sensation

. numbness or weakness of the arms and legs

. memory loss, confusion.

Very rare (may affect up to 1 in 10,000 people)

. trouble sleeping . poor memory

Not known (frequency cannot be estimated from the available data)

. erectile dysfunction . depression

. inflammation of lungs causing breathing problems including persistent cough and/or shortness of breath orfever . tendon problems, sometimes complicated by rupture of the tendon.

. muscle weakness that is constant

Additional possible side effects reported with some statins:

• sleep disturbances, including nightmares . sexual difficulties

. diabetes. This is more likely if you have

What Simvastatin tablets contain

The active substance is Simvastatin. Each film-coated tablet contains Simvastatin 10mg/20mgor40 mg.

The other ingredients are: lactose monohydrate, pregelatinised starch, ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460 (i)), butylhydroxyanisole (E320), magnesium stearate (E572).

The film coating materials contain hydroxypropylcellulose (E463), hypromellose 15cp (E464), titanium dioxide (E171), talc (E553(b)), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).

What Simvastatin tablets looks like and contents of the pack

Simvastatin 10 mg tablets are peach coloured, film coated, oval shaped tablets. Simvastatin 20 mg tablets are tan coloured, film coated, oval shaped tablets.

Simvastatin 40 mg tablets are brick-red coloured, film coated, oval shaped tablets. Simvastatin Tablets are available as blister strips of 6, 10, 12, 20, 28, 49, 84 and 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer:

Marketing Authorisation Holder:

Ranbaxy (UK) Limited,

Building 4, Chiswick Park,

566 Chiswick High Road,

London, W4 5YE, United Kingdom

Manufacturers:

Ranbaxy Ireland Ltd, Spafield, Cork Road, Cashel, Co Tipperary, Ireland

Terapia SA, Str. Fabricii nr. 124,

Cluj-Napoca,

Romania

This leaflet was last revised in March 2015.

Package leaflet: Information for the user

Simvastatin 10 mg Tablets Simvastatin 20 mg Tablets Simvastatin 40 mg Tablets

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 anyfurther questions, askyour doctor orpharmacist.

This medicine has been prescribedfor you only. Do notpass it on to others. It may harm them, even iftheir signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Simvastatin Tablets are and what they are used for

2. What you need to know before you take Simvastatin Tablets

3. How to take Simvastatin Tablets

4. Possible side effects

5. Howto store Simvastatin Tablets

6. Contents of the pack and other information.

1. What Simvastatin Tablets are and what they are used for

Simvastatin Tablets are used along with diet if you 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 other treatments

• coranaryheartdisease(CHD)orareathighriskofCHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin Tablets may prolong your life by reducing the risk ofheart disease problems, regardless ofthe amount of cholesterol in your blood.

2. What you need to know before you take Simvastatin Tablets Do not take Simvastatin Tablets

• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)

• ifyouarepregnantorbreastfeeding

• ifyou currently have liverproblems

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

itraconazole, ketoconazole, orposaconazole (medicines for fungal infections)

HTV protease inhibitors such as nelfmavir, indinavir, ritonavir, and saquinavir (HIV

protease inhibitors are used for HTV infections)

erythromycin, clarithromycin, artelithromycin (antibiotics for infections)

nefazodone (a medicine for depression)

boceprevirortelaprevir(medicinesforhepatitis C virus infection)

gemfibrozil (amedicine for lowering cholesterol)

ciclosporin (a medicine often used in organ transplant patients)

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

Askyour doctor ifyou arenot sure ifyourmedicine is listed above.

Warnings and precautions

Talktoyour doctor orpharmacist before taking Simvastatin Tablets

• Tellyourdoctoraboutallyourmedicalconditions including allergies

• Tell your doctor ifyou drink large amounts of alcohol

• Tellyourdoctorifyouhaveeverhadhverdisease. Simvastatin Tablets may not be right for you

• Your doctor should do a blood test before you start taking Simvastatin Tablets and if you have any symptoms of liver problems while you take Simvastatin 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 Tablets

• Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin Tablets for a short time

• 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 ifyou have high levels of sugars and fats in your blood, are overweight and have high blood pressure

• Tellyourdoctorifyouhaveseverelungdisease.

Contact your doctor immediately ifyou 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.

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.

- Youhavekidneyproblems

- Youhavethyroidproblems

- You are 65 years or older

- You have ever had muscle problems during treatment with cholesterol lowering medicines called “statins” or fibrates

- Youoraclosefamilymemberhaveahereditary muscle disorder Youarefemale

You consume large amounts of alcohol Children

Other medicines and Simvastatin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Itisparticularly importanttotell your doctor ifyou are taking any of the following drugs. Taking Simvastatin tablets with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin tablets”).

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

• danazol(aman-madehormoneusedtotreatendometriosis)

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

• fibrates like gemfibrozil andbezafibrate (medicines for lowering cholesterol)

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

• HIV protease inhibitors such as indinavir, nelfmavir, ritonavir, and saquinavir (medicines for AIDS)

• nefazodone (a medicine for depression)

• amiodarone(amedicineforanirregularheartbeat)

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

• colchicine(amedicineusedtotreatgout)

• boceprevir ortelaprevir (medicines for hepatitis C virus infection).

In additionto above, tell your doctor ifyou 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 tuberculo si s).

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 Simvastatin Tablets.

Simvastatin Tablets with food and drink

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

Pregnancy and Breast-feeding

Do not take Simvastatin Tablets if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin tablets, stop taking it immediately and contact your doctor. Do not take Simvastatin Tablets if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Askyour doctor orpharmacistfor advice before taking any medicine.

Driving and using machines

Simvastatin Tablets arenot expectedto interfere with your ability to drive or to use machinery. However, it shouldbe taken into account that some peopleget dizzy aftertakingSimvastatinTablets.

Simvastatin Tablets contain lactose

Simvastatin 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 Simvastatin Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

The dose is 1 Simvastatin 10 mg, 20 mg, 40 mg or 8 0 mg 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 ofheart 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 SimvastatinTablets in the evening. You can take it wither without food. The usual starting dose is 10,20 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 if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin Tablets unless your doctor tells youto stop.

Ifyou take more Simvastatin Tablets than you should

• Pleasecontactyourdoctororpharmacist

Ifyou forget to take Simvastatin Tablets

• Do not take an extra dose; just take your normal amount of Simvastatin Tablets at the usual time the next day.

Ifyou stop taking Simvastatin Tablets

• Yourcholesterolmayriseagain.

Ifyou 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. Serious side effects

Ifyou experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

• hypersensitivity (alleigic)reactions including:

swelling ofthe face, tongue and throat which may cause difficulty in breathing severemusclepainusuallyintheshouldersandhips

- rashwithweaknessoflimbsandneckmuscles

- painorinflammationofthejoints inflammation ofthe blood vessels

- musual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing shortness ofbreath and feeling unwell

• lupus-likediseasepictuie(includingrash,jointdisorders, andeffects onbloodcells)

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

• inflammation ofthe pancreas often with severe abdominal pain

• inflammation ofthe liver with the following symptoms: yellowing of skin and eyes, itching, dark coloured urine orpale-coloured stool, feeling tired or weak, loss ofappetite; liver failure.

Other side effects

Rare (may affectupto 1 in 1,000people)

• lowredbloodcellcount(anemia)

• hair loss, rash, itching

• headache, dizziness

• weakness

• digestive disturbances (nausea, vomiting, diarrhoea, constipation, indigestion, flatulence, abdominal pain)

• tingling sensation

• numbness or weakness ofthe arms andlegs

• memory loss, confusion.

Very rare (may affectupto 1 in 10,000people)

• trouble sleeping

• poormemory

Notknown(frequency cannot be estimated from the available data)

• erectile dysfunction

• depression

• inflammation of lungs causing breathing problems including persistent cough and/or shortness ofbreath or fever

• tendon problems, sometimes complicatedby rapture ofthe tendon.

• muscle weakness that is constant

Additional possible side effects reported witii some statins:

• sleep disturbances, includingnightmares

• sexual difficulties

• diabetes. Thisismoielikelyifyouhavehighlevels of sugars andfatsinyourblood, are overweight andhavehighbloodpressure. Your doctor willmonitoryouwhileyouare taking thismedicine.

Laboratoryvalues

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

Ifyou get any side effects, talk to your doctor or pharmacist or nurse. 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 Tablets

Keep this medicine out ofthe sight and reach of children.

Do not use this medicine afterthe expiry date which is stated on the carton.

Do not store above 25°C. Store in the original package.

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. Contentsofthepackandotherinformation What Simvastatin tablets contain

The active substance is Simvastatin. Each film-coated tablet contains Simvastatin 10mg/20mg or 40 mg.

What Simvastatin tablets looks like and contents of the pack

Simvastatin lOmg tablets are peach coloured, film coated, oval shaped tablets.

Simvastatin 20 mg tablets are tan coloured, film coated, oval shaped tablets.

Simvastatin 40 mg tablets are brick-red coloured, film coated, oval shaped tablets.

Simvastatin Tablets are available as blister strips of6,10,12,20,28,49,84 and 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer:

Marketing Authorisation Holder:

Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, London, W4 5YE, United Kingdom

Manufacturers:

Ranbaxy Ireland Ltd, Spafield, Cork Road, Cashel, Co Tipperary, Ireland TerapiaSA,Str.Fabriciinr. 124,Cluj-Napoca, Romania This leafletwas last revised in March 2015.

LSUK025/COM/B