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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SIMVASTATIN 10 mg,

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

simvastatin

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 is and what it is used for.

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

3.    How to take Simvastatin.

4.    Possible 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.

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 any of the other ingredients of this medicine (listed in Section 6)

•    suffer from liver problems

•    are pregnant or breast-feeding

•    are taking medicines for fungal infections

(see How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Blood tests

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.

Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin.

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.

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, particularly the 80-mg dose. The risk of muscle break down is also greater in certain patients. Talk with 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 a hereditary muscle problems.

Other medicines and Simvastatin

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:

•    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, fenofibrate 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 erythromycin, clarithromycin, telithromycin, or fusidic acid

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

•    Medicines used to treat hepatitis C (boceprevir, telaprevir).

•    An antidepressant called nefazodone.

•    Drugs such as amiodarone (a medicine for an irregular heartbeat), verapamil, diltiazem or amlodipine (medicines used to treat blood pressure or heart problems).

•    Colchicine (a medicine used to treat gout).

If you are taking any of the medicines in the list above, it is particularly important that you tell your doctor. Taking simvastatin 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').

Check with your doctor first before taking simvastatin if you are taking any of these medicines:

•    A drug used to treat tuberculosis called rifampicin.

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

Also tell your doctor if you are taking niacin (nicotinic acid) or 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

Do NOT take Simvastatin if you are pregnant, think you may be pregnant or trying to get pregnant. If you get pregnant whilst taking Simvastatin, STOP taking the medicine and see your doctor immediately.

Do not take Simvastatin if you are breast-feeding, 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 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 lactose (10 mg, 20 mg,

40 mg, 80 mg strengths), glucose and sorbitol (E420) (40 mg strength only).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE SIMVASTATIN

Always take this medicine exactly as your doctor or pharmacist 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.

Remember to keep to a low-fat diet and to take physical exercise.

People with coronary heart disease (CHD)

The recommended dose is 20 mg - 40 mg which you should take in the evening. Your doctor may increase the dose you take every 4 weeks. The maximum dose is 80 mg. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Keep taking Simvastatin unless your doctor tells you to stop.

People with high levels of blood fats (Hyperlipidaemia)

The recommended starting dose is 10 mg -20 mg taken in the evening. Your doctor may increase the dose you take every 4 weeks. The maximum dose is 80 mg.

People with hereditary high cholesterol (homozygous familial hypercholesterolaemia)

The recommended starting dose is 40 mg taken in the evening. The 80 mg dose is only recommended for adult patients who have very high levels of cholesterol in their blood and are at a high risk of developing heart problems who have not reached their cholesterol goal on lower doses.

Children and adolescents (10-17 years of age) The recommended starting dose for children 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 40 mg. Some patients will need a lower dose particularly if they are also taking medicines such as 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 cholestyramine 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 cholestyramine.

Taking your medicine

Swallow the medicine with plenty of water. For the 10 mg tablet, the score line is only there to help you break the tablet if you have difficulty swallowing it whole. The 20 mg tablet can be divided into equal doses. You can take it with or without food.

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.

If you stop taking Simvastatin

Your doctor will tell you how long you need to keep taking your tablets. Do not suddenly stop taking this medicine without talking to your doctor first because 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

Like all medicines, this medicine 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.

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

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

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

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

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:

•    Unexplained muscle problems such as muscle pain, tenderness, weakness, or cramps. 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 and very rare deaths have occurred.

•    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

*    pain or inflammation of the joints

*    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)

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

•    Inflammation of the pancreas often with severe abdominal pain.

•    Inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever (frequency not known)

Other side effects

The following side effects have also been reported rarely and very rarely:

•    low red blood cell count (anaemia)

•    numbness or weakness of the arms and legs

•    headache, tingling sensation, dizziness

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

•    rash, itching, hair loss

•    weakness

•    trouble sleeping (very rare)

•    poor memory (very rare), memory loss, confusion.

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

•    erectile dysfunction

•    depression

•    tendon problems sometimes complicated by tendon rupture

•    increase in blood glucose.

Additional possible side effects reported with some statins:

•    sleep disturbances, including nightmares

•    sexual difficulties

•    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.

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 talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.

You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. 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.

Do not use this medicine after the expiry date, which is stated on the carton/bottle/blister after 'EXP¹. 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

Simvastatin comes as film-coated tablets in four strengths containing either 10 mg, 20 mg, 40 mg or 80 mg of the active ingredient simvastatin in each tablet. Each film-coated tablet also contains ascorbic acid, butylhxydroxyanisole (E320), citric acid monohydrate, lactose monohydrate (see section 2 'Simvastatin contains lactose'), magnesium stearate, cellulose microcrystalline, maize starch pregelatinised, hypromellose, talc, titanium dioxide (E171), triacetin, iron oxide yellow (E172) (20 mg and 40 mg only), and iron oxide red (E172). The 40 mg film-coated tablets also contain polydextrose (containing small amounts of glucose and sorbitol (E420) (see section 2 'Simvastatin contains glucose and polydextrose') and macrogol 8000.

What Simvastatin looks like and contents of the pack

Simvastatin 10 mg film-coated tablets are dark peach to pink, oval shaped, film-coated tablets with 'G' on one side and 'SM' scoreline '10' on the other. Simvastatin 20 mg film-coated tablets are dark tan, oval shaped, film-coated tablets with 'G' on one side and 'SM' break line '20' on the other. Simvastatin 40mg film-coated tablets are pink, oval shaped, film-coated tablets with 'G' on one side and 'SM40' on the other. Simvastatin 80 mg film-coated tablets are pink to brick-red, modified capsule shaped, film-coated tablets with 'G' on one side and 'SM80' on the other.

Simvastatin Film-coated Tablets come in either plastic bottles (with an optional filler) or blister packs of 10, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 250, 1000 tablets*.

*Not all pack sizes may be marketed

Marketing Authorisation Holder

Mylan, Potters Bar, Herts EN6 1TL

Manufacturer

Generics (UK) Limited, Potters Bar, Herts EN6 1TL, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., H-2900, Komarom,

Mylan utca 1, Hungary.

Mylan B.V., Dieselweg 26, 3752 LB Bunschoten, The Netherlands

This leaflet was last revised in    426073

February 2014    00000000