PACKAGE LEAFLET: INFORMATION FORTHE USER

Simvastatin film-coated 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.

•    Ifyou have any further questions, askyour doctor or pharmacist or nurse.

•    This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    Ifyou get anyofthe side effects,talkto yourdoctoror pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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.    HowtotakeSimvastatin

4.    Possible side effects

5.    HowtostoreSimvastatin

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 "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood.

In addition, Simvastatin raises levels of "good" cholesterol (HDL). While taking this medicine you should stickto a cholesterollowering diet. This medicine belongs to the class of medicine called statins.

Cholesterol is one ofseveral fatty substances found in the bloodstream. Yourtotal cholesterol is made upof mainly LDLand HDL cholesterol. LDLcholesterol is often called"bad"cholesterol because it can build up in the walls ofyourarteries forming plaques. Eventuallythis plaque build-up can lead to narrowing ofthe arteries. This narrowing can slowor block blood flow tovital organs such as the heart or brain. This blocking of blood flow can result in a heart attackofstroke.

HDLcholesterol is often called"good"cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are anotherform offat in your blood that may increase your risk for heart disease.

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 for this condition.

•    Coronary heart disease or at high riskofsuffering from coronary heart disease. You are more likely to sufferfrom coronary heart disease ifyou have diabetes, has previously had a stroke, or have other blood vessel disease.

Most people will not have any symptoms related to raised cholesterol. You doctoror pharmacist can measureyour cholesterol level by means ofasimple blood test. Having too much cholesterol in your bloodstream can lead to coronary heart disease. It can clog up blood vessels leading to hardening ofthe 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.

Ifyou have high levels of cholesterol you are more likely to get heart disease ifyou also:

•    Have high blood pressure (hypertension)

•    Have diabetes (high blood sugar)

•    Do little physical exercise

•    Smoke

•    Areoverweightoreatahighfatdiet

Talk to your doctor or pharmacist ifyou would like advice about any of these factors.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN

Do not take Simvastatin ifyou:

•    Are allergic (hypersensitive) to Simvastatin orto anyofthe other ingredients in this medicine (See section 6)

•    Suffer from liver problems

•    Are pregnant orbreast-feeding

•    Are taking medicine(s) with one or more ofthe following ingredients:

. Intraconazole, ketoconazole, posaconazole orvoriconazole (used to treat fungal infections)

. Erythromycin, clarithromycin or telithromycin (used to treat infections)

. HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to for HIV infection)

. Bocepreviror telaprevir (used to treat hepatitis C virus infection)

. Nefazodone (used to treat depression)

. Ciclosporin (used in organ transplant patients)

. Danazol (a man-made hormone used to treat endometriosis,a condition in which the lining ofthe uterus grows outside the uterus)

. Gemfibrozil used to lower cholesterol levels

. Are taking, or in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infection). If any of these apply to you, do not take this medicine and go back toyour doctor to discuss treatment.

Warnings and precautions

Talkto vourdoctor or pharmacist ifvou:

•    Have any medical conditions, including allergies

•    Have previously had problems with your liver

•    Have high blood pressure or high levels offats and sugars in your blood or ifyou have a body mass indexof more than 30kg/m².You may be at more riskofdeveloping diabetes. You doctorwill monitoryou closely ifthis applies toyou.

•    Regularlydrink large amounts ofalcohol

•    Have to go to hospital for an operation

. You may have to stop taking Simvastatin

•    Haveseverelungdisease

•    Are Asian, because a different dose may be applicable to you.

Blood tests

Before you start taking Simvastatin you doctor willdoa blood test to see how well your liver is working. Once you start taking the medicine yourdoctor will want to have regular blood tests to see how well the medicine is working.

Important- Keep your healthcare professional informed

Contactyourdoctor immediately, ifyou suffer from anyunexplained muscle pain, tenderness orweakness.This is because in a verysmall number of patients, muscle problems can be serious. This can lead to kidneydamageand in very rare cases deaths have occurred.

You willbe at more risk of muscle breakdown ifyou are on high doses ofSimvastatin. Also some other patients are more at risk. Talkto yourdoctor ifany ofthe following apply:

•    Youdrinklargeamountsofalcohol

•    You have kidney problems

•    You have thyroid problems

•    Youare65yearsorolder

•    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 doctoror pharmacist ifyou have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Other medicines and Simvastatin

Many medicines affect the way Simvastatin works. You must tell yourdoctor 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 usedtopreventrejectioninorgantransplantpatients

•    Ahormonecalled danazol

•    Antifungal medicines such as ketoconazole, intraconazole, voriconazole, fluconazole or posaconazole

•    Fibrates such as gembibrozil or benzabribrate 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 erythromycin, clarithromycin, telithromycin or fusidic acid

•    Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet

•    HIV protease inhibitors such as indinavirm, nelfinavir, ritonavirorsaquinavir (used to treats AIDS)

•    An antidepressant called nefazodone.

•    Bicoprevir or telaprevir (used to treat hepatitisCvirus infection)

•    Colchicine (used to treat gout)

•    Drugs such as amiodarone, verapamil, diltiazem or amlodipine which are used to treat heart problems.

Ifyou are taking any ofthe medicines in the list above you must tell yourdoctorand 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:

As well the medicines listed above, tell your doctoror pharmacist ifyou are taking any other medicines, including those obtained without a prescription. In particular, tell yourdoctor ifyou are taking medicine(s) with anyofthe following active ingredients:

•    Medicines used to treat blood clots such as warfarin, phenprocoumon or acenocoumarol (anticoagulants) because the dose may need to be changed

•    A drug used to treat tuberculosis called rifampicin

•    Fenofibrate (also used to lower cholesterol).

Simvastatin with Food and Drink

Grapefruitjuice can interfere with the way in which your body handles Simvastatin. You should not drinkgrapefruitjuice ifyou are taking Simvastatin.

Pregnancy and Breast-feeding

DO NOT take Simvastatin ifyou are pregnant, thinkyou might be pregnant orare trying to get pregnant while taking Simvastatin.

Ifyou get pregnant whilst taking Simvastatin STOP taking the medicine and see you doctor immediately.

Do not take Simvastatin ifyou are breast-feeding because it is not known ifSimvastatin passes into breast milk.

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 HOWTO TAKE SIMVASTATIN). Simvastatin has not been studied in children underthe age oflOyears. For more information, talkto yourdoctor.

Driving and using machines

Simvastatin has no known effect on the ability to drive or operate machines. Simvastatin can make you feel dizzy, so make sure you not affected before you drive or operate machines.

Simvastatin tablets contain lactose

Ifyou doctor has told you that you cannot tolerate certain sugars, contact yourdoctor before taking this medicine.

3.    HOW TO TAKE SIMVASTATIN

Always take this medicine exactly as your doctor has told you. Ifyou are not sure,checkwith yourdoctoror pharmacist. Yourdose will be decided byyourdoctorand will depend on the results ofthe blood tests. The dose you should take will be on the label attached by your pharmacist.

Swallowthe medicine with plenty ofwater.

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 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 hypercholesterolemia)

The usual dose is 40mg taken in the evening. Yourdoctor may also askyou to take 80mg each day in three doses through the day (20mg, 20mg and 40mg).This 80mg dose is onlyfor patients who have very high levels cholesterol in their blood or are at high riskofdeveloping heart problems.

Children (10-17 years)

The usual starting dose for 10-17 years ofage is lOmg.This dose should usually be taken in the evening. If necessary the dose may be increased to a maximum of40mg. Some patients will need a lowerdose particularly if they are also taking medicines such as ciclosporin, danazol,fibrates or niacin and also if they have kidney problems.

Instructions for use.

Simvastatin tablets should be taken with water in the evening. Take the tablets eitheron an empty stomach oraftera meal.

Keep taking Simvastatin unless your doctor tells you to stop.

Duration of treatment

You will have to take Simvastatin overa long period oftime. You doctorwill tell you how long you need to take Simvastatin. Ifyou have the impression the effect ofSimvastatin is too strong ortoo weak, talkto yourdoctoror pharmacist.

Taking other cholesterol-lowering medicines at the same time as Simvastatin

Yourdoctor may askyou to take a medicine called colestyramine oranother bile acid sequestrate, whilst you are taking Simvastatin. This medicine can interfere with the way in which Simvastatin works. You must take the Simvastatin 2 hours before or4 hours afteryou have taken colestyramine.

If you take more Simvastatin than you should

Talkto your doctor or go to your nearest casualty department straight away. Take the medicine pack with you.

If you forget to take Simvastatin

Ifyou forget to take a dose, take it as soon as you remember unless it is nearly time foryour next dose.

Do not take a double dose.

If you stop taking Simvastatin

Ifyou suddenly stop taking this medicine,your cholesterol may rise again. It is therefore important thatyou consult a doctor before stopping treatment, even ifyou sufferfrom physical complaints. He/she can tell you ifyou can stop and the best way to do so.

Ifyou have any furtherquestions on the side effects of this product, askyourdoctoror pharmacist.

4.    POSSIBLE SIDE EFFECTS

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

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

•    Rare(mayaffectupto1 oflOOOpatients)

•    Very rare (may affect up to1of10,000 patients)

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

The following rare serious side effects have been reported.

•    Hypersensitivity (allergic) reactionsincluding

. Swellingoftheface,tongueandthroatwhich maycausedifficultyin breathing . Severe muscle pain usually in the shoulders and hips . Rash with weakness of limbs and neck muscles . Pain orinflammation ofthejoints (polymyalgia rheumatic)

. Inflammation ofthe blood vessels (vasculitis)

. Unusual bruising, skin eruption and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever or flushing . Shortness of breath (dyspnoea) and feeling unwell

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

•    Unexplained muscle problems such as pain, tenderness, weakness or cramps. In rare cases these muscle problems can be veryseriousand resultin muscle breakdownand kidneydamage.

In some cases these problems can be life-threatening

•    Inflammation ofthe liverwith yellowing ofthe skin and eyes,darkcoloured urine or pale-coloured stools, feeling tired or weak, loss ofappetite, liver failure (very rare)

•    Inflammation ofthe pancreas often with severe abdominal pain.

Tell your doctor or pharmacists if any of the following side effects persist, get worse or if you notice any other side effects not listed.

The following side effects have also been reported rarely:

•    Lowredbloodcellcount(anaemia)

•    Numbness or weakness in the arms and legs

•    Headache, tingling sensation or dizziness

•    Gastrointestinal disturbances such as feeling or being sick, constipation, wind, diarrhoea, indigestion and stomach pain

•    Rash,itchingorhairloss

•    Difficulty sleeping (very rare)

•    Poor memory (very rare), memory loss, confusion

•    Weakness

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

•    Erectiledysfunction

•    Depression

•    Inflammation ofthe lungs causing breathing problems including persistent cough and/orshortness of breath or fever

•    Tendon problems,sometimescomplicated byruptureofthetendon

•    Muscleweaknessthatisconstant.

Additional side effects reported with some statins:

•    Sleep disturbances, including nightmares

•    Sexual difficulties

•    Diabetes. This is more likely ifyou have high levels ofsugarand fats in your blood,are overweight and have high blood pressure. Yourdoctorwill monitoryou 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

Ifyou get anyside effects, talkto yourdoctor, 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 Website at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOWTOSTORESIMVASTATIN

Keep out ofthe sight and reach ofchildren.

Store the tablets in the original package in order to protect from light and moisture. Do not store above 30°C. Do not use the tablets afterthe'do not use after" or "exp." date stated on the packaging. The word "exp" means: expirydate".The first 2 digits denote the month, the last digits the year.

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

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Simvastatin Tablets contain

•    The active substance is: Simvastatin, 80 mg per tablet

•    The other active ingredients are:

Tablet core: Lactose, microcrystalline cellulose (E460), pregelatinised maize starch, butylated hydroxyanisole (E320), ascorbic acid (E300). Citric acid (E330), colloidal anhydrous silica (E551), talc (E553b), magnesium stearate (E470b).

Film-coating: Hypromellose (E464), red iron oxide (E172), triethy;citrate (E1505), titanium dioxide (E171), talc (E553b), povidone.

What Simvastatin Tables look like and contents of pack

Simvastatin Tablets are dark pink-coloured,oblong,film-coated tablets, scored on one side. The tablets are packing in blisters in a carton box containing 10,20,28,30,40,50,56,60,98 or 100 tablets. Not all packsizes may be marketed.

Name and Address of the MAH and the manufacturer

Marketing authorisation holder: Chanelle Medical U.K. Ltd.,The Lodge Stanford Bridge Farm, Station Road, Pluckley, Ashford, Kent,TN27 0RU

Manufacturer: Jaba Farmaceutica S.A. Rua daTapada Grande No 2,2710-089 Sintra Portugal Revision Date: This leaflet was last revised in June 2015