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Patient Information Leaflet

Teva Simvastatin 5, 10, 20 & 40 mg Film-coated Tablets Read all of this leaflet carefully before you start taking this medicine.

•    Simvastatin is used to lower levels of cholesterol and triglycerides in your blood and can help reduce your risk of developing coronary heart disease. (See Section 1 ’What Simvastatin is and what it is used for’).

•    Simvastatin can cause serious muscle problems in a very small number of patients. If you suffer from unexplained pain, tenderness or weakness in your muscles STOP TAKING the medicine and talk to your doctor at once.

•    DO NOT TAKE this medicine if you are already taking medicines for fungal infections (such as itraconazole, ketoconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), antibiotics (such as erythromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression. (See Section 2 ‘Taking other medicines’).

•    If you are pregnant or trying to get pregnant or breast feeding you MUST NOT take simvastatin (See Section 2 ’Before you take simvastatin’).

•    If you have high blood pressure, high levels of fats or sugars in your blood or have a body mass index of more than 30kg/m² you may be at risk of developing diabetes. Your doctor will monitor you closely if this applies. (See section 2 ’Before you take simvastatin’and Section 4 ’Possible side effects’)

In this leaflet:

1.    What Simvastatin is and what it is used for

2.    Before you take Simvastatin

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further 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. Before you take Simvastatin Do not take Simvastatin if you:

•    are allergic to Simvastatin or to any of the other ingredients (see section 6)

•    suffer from liver problems

•    are pregnant or breast feeding

•    are taking medicines for fungal infections (such as itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), antibiotics (such as erythromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression. (See Section 2 ‘Taking other medicines’).

If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment. Check with your doctor or pharmacist before taking these tablets if you:

•    Have previously had problems with your liver

•    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.

•    Regularly drink large amounts of alcohol

•    Have to go into hospital for an operation - you might need to stop taking simvastatin

•    Have severe lung disease

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.

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. Also some other patients are more at risk. Talk to 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 hereditary muscle problems.

Taking other medicines

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.

Do not take Simvastatin and tell your doctor if you are taking:

•    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 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 erythromicin, clarithromycin, telithromycin or fusidic acid

•    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir

•    an antidepressant called nefazadone

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

If you are taking any of the medicines in the list above your must tell your doctor and not take simvastatin because these medicines can make it more likely that will have muscle problems.

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

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

•    A medicine used to treat gout called colchicine

•    A drug used to treat tuberculosis called rifampicin

Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin containing product and are Chinese. 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 might be pregnant or are trying to get pregnant. If you get pregnant whilst taking simvastatin STOP taking the medicine and see your doctor immediately. You should stop taking simvastatin 1 month before trying to get pregnant.

Do not take simvastatin if you are breastfeeding because it is not known if simvastatin passes into breast milk.

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.

Important information about some of the ingredients

This product contins 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

Always take simvastatin exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. 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. Swallow the medicine with plenty of water.

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 - 20mg 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 hypercholesterolaemia)

The usual dose is 40mg taken in the evening. Your doctor may ask you to take 80mg each day in three doses through the day (20mg, 20mg and 40mg). This 80mg dose is only for patients who have very high levels of cholesterol in their blood or are at a high risk of developing heart problems.

Children (10-17 years)

The usual starting dose for children aged 10 - 17 years of age is 10mg. This dose should usually be taken in the evening. If necessary the dose may be increased to a maximum of 40mg. Some patients will need a lower dose particularly if they are also taking medicines such as ciclosporin, danazol, 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 colestyramine 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 colestyramine.

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.

4. Possible side effects

Like all medicines, Simvastatin 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.

Stop taking Simvastatin and go to hospital at once if you have:

•    a rare allergic reaction such as swelling of the face, tongue, lips and throat, difficulty breathing, severe itching of your skin with raised lumps, joint pain, sensitivity to the sun, general feeling of being unwell. You may need urgent medical attention.

•    Unexplained muscle problems such as pain, tenderness or weakness. 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.

•    Inflammation of the liver, with yellowing of the skin and eyes, dark coloured urine or pale- coloured stools.

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

•    Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are owerweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

•    Low red blood cell count (anaemia)

• Numbness in the arms and legs

• Headache or dizziness

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

•    Rash, itching or hair loss

•    Sleep disturbances such as difficulty sleeping and nightmares

•    Poor memory

•    Sexual difficulties such as erectile dysfunction

•    Depression

•    Inflammation of the lungs causing difficulty in breathing, persistent cough and shortness of breath 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.

5.    Storing Simvastatin

•    Keep out of the reach and sight of children.

•    Do not store above 25°C. Keep container in the outer carton.

•    Do not use Simvastatin after the expiry date shown on the outer packaging.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medcines no longer required. These measures will help protect the environment.

6.    Further information

What Simvastatin tablet contains

•    The active ingredient is Simvastatin. Each film-coated tablet contains 5mg, 10mg, 20mg and 40mg of Simvastatin.

•    The other ingredients are:

•    tablet core: lactose monohydrate, pregeletinised starch, microcrystalline cellulose, citric acid monohydrate, ascorbic acid, butylhydroxyanisole, magnesium stearate,

•    coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol 3000, triacetin, iron oxide black (E172), iron oxide red (E172) and iron oxide yellow (E172).

What Simvastatin tablets look like and contents of pack

•    Simvastatin 5mg tablets are white, oval shaped film-coated tablets marked "5" on one side and plain on the other.

•    Simvastatin 10mg tablets are peach-coloured, oval shaped film-coated tablets marked and plain on the other.

•    Simvastatin 20mg tablets are tan-coloured, oval shaped film-coated tablets marked "20 plain on the other.

•    Simvastatin 40mg tablets are pink- coloured, oval shaped, film-coated tablets marked and plain on the other.

•    Simvastatin 5mg, 10mg, 20mg and 40mg tablets are available in pack sizes of 10, 20, 28, 30, 50 and 100 film-coated tablets, calendar pack containing 30 film-coated tablets, unit dose hospital pack containing 50x1 tablets.

Name and Address of the MAH and the site of batch release.

Teva UK Limited, Eastbourne BN22 9AG, England.

Revised: February 2014 PL 00289/0372-0375