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PAGE 1: FRONT FACE (INSIDE OF REEL)

SIMVASTATIN 80 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start

taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

OWHAT SIMVASTATIN IS AND WHAT IT IS USED FOR

Simvastatin belongs to a group of drugs called HMG-CoA reductase inhibitors. These reduce the amount of cholesterol and triglycerides (fatty substances) in your blood.

Simvastatin is used:

•    to reduce your risk in the future of developing coronary heart disease or having a heart attack or stroke, if you have raised levels of cholesterol but do not have coronary heart disease

•    to reduce your risk of having a further heart attack or stroke, if you have already had a heart attack or have unstable angina

•    to reduce increased lipid levels, if you have had an organ transplant and are taking medication to stop your body rejecting the transplant.

Some further information:

•    While cholesterol is vital for the normal functioning of the body, if the level in the blood becomes too high it can build up on the walls of the arteries. Eventually blood vessels can become blocked. Only a small amount of cholesterol comes from our diet, the majority is made by our own livers. The body produces most cholesterol at night.

•    Even though you may be on a low fat diet, your doctor has done some blood tests which show that you still have too much fat (including cholesterol) in your blood. A high cholesterol level is generally recognised as adding to the risk of heart disease. Additional factors such as existing heart disease, high blood pressure, diabetes, being overweight, lack of exercise and smoking can also greatly increase the risk of the development or progression of heart disease.

BEFORE YOU TAKE SIMVASTATIN

Do NOT take Simvastatin if you:

•    are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine

•    have liver disease

•    are pregnant or breast-feeding (see Pregnancy and breast-feeding section)

•    are taking any of the medicines listed under Taking other medicines, Do NOT take Simvastatin in combination with.

Take special care with Simvastatin

Tell your doctor before you start to take this

medicine if you:

•    have kidney problems

•    are over 65 years of age

•    have a history of liver problems

•    have an underactive thyroid gland

•    have an hereditary muscular disorder, or a family history of such problems

•    have previously suffered from side effects affecting your muscles when taking another cholesterol lowering medicine such as a statin or a fibrate e.g. gemfibrozil

•    have problems with alcohol abuse (regularly drinking large amounts of alcohol)

•    have severe respiratory failure

•    are due to have an operation. You may need to stop taking Simvastatin tablets for a short time

•    have severe lung disease

•    are female.

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.

If you have suffered from any of these problems, your doctor will need to carry out a blood test before and possibly during Simvastatin treatment to assess your risk of developing muscle-related side effects.

Taking other medicines

Do NOT take Simvastatin in combination with:

•    itraconazole or ketoconazole (used to treat fungal infections)

•    HIV protease inhibitors e.g. nelfinavir, ritonavir or indinavir (used for treatment of HIV infections)

•    erythromycin, clarithromycin or telithromycin (used to treat infections)

•    nefazodone (an antidepressant).

Talk to your doctor if you are taking any of the following:

•    other drugs to lower your lipid (fat) levels e.g. gemfibrozil, bezafibrate, fenofibrate or large doses (more than 1 g per day) of niacin or nicotinic acid

•    also tell your doctor if you are taking niacin-containing products and are Chinese

•    drugs known as bile acid sequestrants (a class of drugs that prevents bile acids being reabsorbed from the digestive system, so promoting conversion of cholesterol into bile acids) e.g. colestyramine, colestipol. (Please see section 3, Taking in combination with a bile acid sequestrant)

•    ciclosporin (an immunosuppressant used after an organ transplant)

•    amiodarone, verapamil or diltiazem (used to treat abnormal heart rhythms)

•    coumarin derivatives e.g. warfarin (used to stop the blood clotting)

•    danazol (used to correct hormonal imbalances)

•    digoxin (to treat heart conditions).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Simvastatin with food and drink:

•    avoid drinking grapefruit juice as it can affect the way your medicine works

•    keep alcohol intake to a minimum

•    your doctor will have explained the importance of a low fat diet as well as taking Simvastatin.

Pregnancy and Breast-feeding

Do NOT take Simvastatin if you are pregnant or breast-feeding, or if you are planning to become pregnant.

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

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

Driving and using machines

Simvastatin may cause dizziness, if you are affected do NOT drive or operate machinery.

Important information about some of the ingredients in your medicine

Patients who are intolerant to lactose should note that Simvastatin film-coated tablets contain a small amount of 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.

HOW TO TAKE SIMVASTATIN

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

The tablets should be swallowed whole, preferably with a drink of water.

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

The dose is 1 simvastatin 5 mg, 10 mg, 20 mg,

40 mg, or 80 mg tablet by mouth once 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.

The usual dosage instructions are given below: Adults (including the elderly)

•    High cholesterol (hypercholesterolaemia)

The usual starting dose is 10-20 mg daily taken as a single dose each evening. When a large reduction in cholesterol is required you may be started on 20-40 mg daily taken as a single dose each evening. Your doctor may increase this up to a maximum of 80 mg daily, though this is only recommended in severe cases of very high cholesterol where there is a high risk of heart complications. If your dose needs to be adjusted this will be done at intervals of not less than four weeks.

•    Homozygous familial hypercholesterolaemia (an inherited disorder)

The recommended dosage is 40 mg daily in the evening or 80 mg daily in three divided doses of 20 mg, 20 mg and an evening dose of 40 mg.

•    Prevention of coronary heart disease (CHD)

The usual dose is 20-40 mg daily taken as a single dose in the evening.

•    Taking in combination with a bile acid sequestrant Simvastatin may be given in combination with a bile acid sequestrant e.g. colestyramine or colestipol. Simvastatin should be taken either

2 hours before or 4 hours after you have taken the bile acid sequestrant, as the absorption of Simvastatin can be affected by these medicines if taken too closely together.

For patients taking certain other medicines your doctor may prescribe a lower dose of Simvastatin.

Patients with kidney problems

If you have severe kidney problems, your doctor may prescribe a lower dose.

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.

If you take more Simvastatin than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Simvastatin

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do NOT take a double dose to make up for a forgotten tablet.

If you stop taking Simvastatin

Do NOT stop taking your medicine without talking to your doctor first even if you feel better.

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

POSSIBLE SIDE EFFECTS

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• an allergic reaction (swelling of the face or neck, muscle and joint pain, hives, fever, flushing, shortness of breath).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Contact your doctor as soon as possible and stop taking Simvastatin if you develop:

•    any unexplained or persistent muscle pain, tenderness, weakness or cramps, especially, if at the same time you feel unwell or have a high temperature. In rare cases this can progress to become a serious and potentially life threatening condition, called rhabdomyolysis

•    breathing problems including persistent cough and/or shortness of breath or fever.

The following side effects have been reported at the

approximate frequency shown:

Very Rare (affecting fewer than one person in

10,000)

•    liver failure

•    shortness of breath, dry cough, weight loss, fatigue (Interstitial lung disease).

Rare (affecting fewer than one person in 1,000 but

more than one person in 10,000):

•    muscle pain, cramp, wasting of the muscles with or without acute kidney failure (diagnosed by urine or blood tests), swelling of muscles, muscle weakness

•    headache, dizziness, lethargy

•    constipation, abdominal pain, indigestion, wind, diarrhoea

•    feeling sick or being sick

•    pins-and-needles or numbness, loss of sensation

•    yellowing of the skin and whites of the eyes (jaundice)

•    hepatitis (inflammation of the liver)

•    anaemia, reduction in red blood cells, causing unusual tiredness or weakness

•    hair loss

•    rash, itching

•    pancreatitis (inflammation of the pancreas)

•    increases in certain enzyme levels in the body

•    a hypersensitivity syndrome which includes a number of symptoms together, such as rashes on various parts of the body including the eyelids, bruise like rashes, blood disorders (characterised by fever or chills, sore throat, ulcers in the mouth or throat), stiffness in the muscles and joints, intolerance to light, fever, flushing, difficulty breathing and a general feeling of being unwell.

Uncommon (affecting fewer than one person in 100 but more than one person in 1000):

•    depression

•    sleep disturbances (including insomnia and nightmares)

•    memory loss

•    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.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE SIMVASTATIN

Keep out of the reach and sight of children.

Do not store above 25°C. Do not transfer to another container. Do not use Simvastatin after the expiry date shown on the outer packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^ FURTHER INFORMATION

What Simvastatin tablets contain:

•    The active ingredient is simvastatin 80 mg

•    The other ingredients are ascorbic acid, butyl hydroxyanisole (E320), citric acid monohydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, hypromellose, macrogol, triacetin, and titanium dioxide (E171). The tablets also contain red, yellow and black iron oxides (E172).

What Simvastatin tablets look like and contents of the pack:

•    Brick-red, capsule shaped, film-coated tablet. Engraved "7156" on one side and "93"on the other

•    The product is available in packs of 14, 28, 30, 46, 50, 60, 98, 100, and 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: August 2012.

PL 00289/0525

TEVA UK LIMITED

63339-ZD 160x323