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Please read this leaflet carefully before - you start taking your medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

IN THIS LEAFLET

1.    What Simvastatin is and what it is used for

2.    Before you take Simvastatin

3.    How to take Simvastatin

4.    Possible side effects

5.    Storing Simvastatin

Your medicine is called Simvastatin 40mg film-coated tablets referred to throughout the leaflet as Simvastatin.

•    The active substance in this medicine is simvastatin. The brick red coloured film-coated tablets contain 40mg of simvastatin.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, butylated hydroxyanisole (E320), ascorbic acid, anhydrous citric acid, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, red iron oxide (E172), yellow iron oxide (E172), triethylcitrate, titanium dioxide (E171), povidone.

•    Simvastatin 40mg film-coated tablets are supplied in blister packs of 28 tablets. Two blister packs per carton.

The Marketing Authorisation Number is:

PL20395/0006

The Marketing Authorisation Holder and Manufacturer is:

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 ORP, U.K.

Distributed by:

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Simvastatin belong to a group of medicines called 'HMG-CoA reductase inhibitors’. These medicines work by reducing the amount of cholesterol and fatty substances, called triglycerides, in the blood. Cholesterol is vital for the body to function.

Sometimes cholesterol can build up in the blood stream and become deposited in the walls of the blood vessels.

There it forms plaques which will eventually block the blood vessels similar to scale furring up of a water pipe. Your doctor has done some blood tests, which shows that you have high amounts of cholesterol and fatty substances in your blood even though you have been following a low fat diet. Your doctor may have prescribed Simvastatin because you have a high risk of developing heart disease. It is generally accepted that if you have high amounts of cholesterol in your blood it adds to your risk of heart disease. Other factors such as existing heart disease, high blood pressure, high blood sugar (diabetes), increased weight, lack of exercise, smoking and a diet high in fat increase your risk further to the development of heart disease.

Cholesterol may cause coronary heart disease by obstructing the blood vessels that carry oxygen and nutrients to the heart. This obstruction or hardening of arteries is called atherosclerosis. Atherosclerosis may cause chest pain (called angina) and heart attack. If you suffer from coronary heart disease, your doctor has prescribed simvastatin to prolong your life. Simvastatin can decrease the risk of heart attack and decrease the risk of having to undergo surgery in order to increase blood flow to the heart. Simvastatin also delays the progression of atherosclerosis and reduces the development of new atherosclerosis. ^{1 2}

It is important to talk to your doctor if you have any other following conditions:

•    persistent muscles aches or pains

•    have a history of liver disease. Your doctor may want to to do a simple blood test to check your liver is working properly before you take simvastatin. Tell your doctor of your present and past medical problems and any allergies you have. Simvastatin is not recommended for children.

Taking other medicines

Please check with your doctor before taking Simvastatin if you are taking or have recently taken any other medicines even if not prescribed. Some medicines may occasionally interfere with Simvastatin including the following

•    immunosuppressants viz. ciclosporin

•    other cholesterol lowering agents such as fibric acid derivatives (benzafibrate, phenofibrate and gemfibrozil)

•    high doses (> 1 g/day) of niacin if nicotinic acid

•    blood thinning agents such as warfarin

•    digoxin used in the treatment of heart conditions

•    amiodarone a drug used to treat an irregular heartbeat

•    mibefradil, verapamil and diltiazem (drugs used to treat high blood pressure, angina or other heart conditions)

Taking Simvastatin with food and drink

Grapefruit juice has one or more components that alter the metabolism of some medications including Simvastatin. Large volumes of grapefruit juice (more than 1 litre) may have adverse effects, however typical consumption (one 250 ml glass daily) is unlikely to cause problems. If you are unsure ask your doctor for advice. Your doctor will have told you to keep alcohol to a minimum. If you are concerned about how much alcohol you can drink you should discuss this with your doctor.

Driving and using machines

According to current information, Simvastatin does not affect the capacity to drive or use machines.

Important information about some of the ingredients of Simvastatin

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

Take your tablet whole with a glass of water.

Your doctor will inform you how long to take Simvastatin. If you stop taking Simvastatin your cholesterol levels may rise again.

Children (10-17 years old)

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.

While Taking Your Medicine

If you take more Simvastatin than you should: Contact your doctor or pharmacist immediately or go to your nearest casualty department.

If you forget to take Simvastatin

If you forget to take a tablet, wait until the next dose is due then continue as before. Do not take a double dose to make up for forgotten individual doses.

Like all medicines, Simvastatin can have side effects in some people.

The most common side effects are stomach upsets (such as sickness, stomach pain, constipation, diarrhoea and flatulence), rash, itchiness, weakness, headache or indigestion. Other possible but less common side effects include dizziness, hair loss, abdominal pain, abnormal sensations in the arms and legs, sleep disturbances, including insomnia and nightmares, memory loss, sexual difficulties, depression, breathing problems including persistent cough and/or shortness of breath or fever.

Rarely a few patients have experienced liver disease, muscle disease presenting as aches and pains or an allergic reaction which may include swelling of the face or neck, muscle and joint pains, joint and blood vessel inflammation, urticaria, a high temperature, flushing, difficulty in breathing or tiredness.

If you experience any of these side effects or you have any other unusual symptoms or feelings, stop taking the tablets and consult your doctor immediately. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

O Q. ~ CL

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Make sure it is safe for you to take Simvastatin. 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.

Do not take Simvastatin:

•    if you have severe respiratory failure

•    if you think you may be pregnant

•    if you are planning to become pregnant. You should stop taking Simvastatin at least one month before trying to become pregnant

•    if you discover you are pregnant while taking Simvastatin you should stop taking Simvastatin immediately

•    if you are a woman who could bear children unless you are using a reliable form of contraception other than the pill (you may want to discuss this with your doctor)

•    if you are breast feeding

•    if you are hypersensitive (allergic) to any of the ingredients

•    if you have active liver disease

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   if you are taking mibefradil, a drug for the treatment of hypertension and angina

•    if you have a rare inherited disease called porphyria.

If you are taking any of the below medicines:

•    Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin and nefazodone.

•    If you are taking any medicines containing indinavir, nelfinavir, ritonavir or saquinavir.

CP.SIM.40T.RC.V2P1