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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: j What Simvastatin 80mg is and what it is used for What you need to know before you take Simvastatin 80mg How to take Simvastatin 80mg 4| Possible side effects How to store Simvastatin 80mg 6| Contents of the pack and other information

j What Simvastatin 80mg is and what it is used for

Simvastatin is 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 is 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.

•    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 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.

What you need to know before you take Simvastatin 80mg Do not take Simvastatin 80mg:

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

•    if you currently have liver problems

•    if you 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 indnavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections)

-    Nefazodone (a medicine for depression)

-    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 80mg:

•    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 may not be right for you.

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

•    Your doctor should do a blood test before you start taking Simvastatin. 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.

•    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

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problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of Simvastatin, 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 consume large amounts of alcohol

•    you have kidney problems

•    you have thyroid problems

•    you are 65 years old or older

•    you are female

•    you have ever had muscle problems

during treatment with cholesterollowering medicines called "statins" or fibrates

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

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.

Children and adolescents

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 80mg).

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.

It is particularly important to tell your doctor if you are taking any of the following drugs. 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 80mg:")

•    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 or 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 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 recently taken any medicines, including those obtained without a prescription. In particular, 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 80mg.

Simvastatin 80mg with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin 80mg. Consuming grapefruit juice should be avoided.

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, trying to get pregnant or think you may be pregnant. If you get pregnant while taking simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin Actavis if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Driving and using machines

Simvastatin is 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.

Simvastatin 80mg contains lactose monohydrate

Amongst other ingredients, Simvastatin 80mg tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Simvastatin 80mg

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

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

The dose is 1 Simvastatin 5mg, 10mg, 20mg 40mg or 80 mg tablet by mouth once a day.

The 80mg 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 the tablets in the evening. You can take it with or without food. The usual starting dose is 10, 20 or, in some cases, 40mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80mg a day. Do not take more than 80mg 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 unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin at least two hours before or four hours after taking the bile acid sequestrant.

Use in children and adolescents

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 tablet can be divided into equal doses. With simvastatin 80 mg tablets, dosages of 80 mg and 40 mg (=half tablet) can be achieved. To achieve lower dosages, tablets of 5, 10 or 20 mg are commercially available.

If you take more Simvastatin 80mg than you should

Please contact your doctor or pharmacist.

If you forget to take Simvastatin 80mg

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

If you stop taking Simvastatin 80mg

Your cholesterol may rise again.

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

Possible side effects

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

The following rare serious side effects were reported (may affect up to 1 in 1,000 people)

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; 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)

•    i nflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool

•    inflammation of the pancreas often with severe abdominal pain.

The following very rare side effects were reported (may affect up to 1 in 10,000 people).

If this serious side effect happens, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.

•    liver failure

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The following side effects have also been reported rarely (may affect up to 1 in 1,000 people):

•    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.

The following side effects have also been reported very rarely (may affect up to 1 in 10,000 people):

•    trouble sleeping

•    poor memory

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

•    erectile dysfunction

•    depression

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

•    tendon problems, sometimes complicated by rupture of the tendon.

Additional possible side effects reported with some statins:

•    sleep disturbances, including nightmares

•    memory loss

•    sexual difficulties

•    diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure. You 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, 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.

How to store Simvastatin 80mg

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

Store the tablets in the original package in order to protect from light and moisture. Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after "expiry date". The first 2 digits denote the month, the last digits the year. The expiry date refers to the last day of that month.

Do not throw away medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

q Contents of the pack and other information

What Simvastatin 80mg contains:

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

•    The other ingredients are:

Tablet core: Lactose monohydrate, cellulose microcrystalline (E460), pregelatinised maize starch, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica (E551), talc (E553b), magnesium stearate (E470b). Film-coating: Hypromellose (E464), red iron oxide (E172), triethylcitrate (E1505), titanium dioxide (E171), talc (E553b), povidone K-30.

What Simvastatin 80mg looks like and contents of the pack

Simvastatin 80mg is a dark pink-coloured, oblong, film-coated tablet, scored on one side. The tablets are packed in blisters in a carton box, containing 10, 20, 28, 30, 40, 50, 56, 60, 98 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland

Manufacturers Atlantic Pharma -Produces Farmaceuticas, S.A.

Rua da Tapada Grande No.2; 2710-089

Sintra

Portugal

Actavis Nordic A/S

0rnegardsvej 16, DK-2820 Gentofte,

Denmark

Balkanpharma-Dupnitsa AD 3, Samkovsko shosse Str.

2600 Dupnitsa Bulgaria

Distributor

Actavis, Barnstaple, EX32 8NS, UK

This leaflet was last revised in:

October 2014

Actavis, Barnstaple, EX32 8NS, UK

Simvastatin 80mg PIL - UK			colours/plates:
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