<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV type=0>

<HEAD weight="bold" >
PLEASE READ BOTH SIDES OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR TABLETS
</HEAD>


<BLOCK>

<EMPH weight="bold">
Keep this leaflet. You may want to read it again.
</EMPH>

</BLOCK>

<DIV type=1>

<HEAD weight="bold"  justified="center" >
ZOCOR (simvastatin, MSD)
</HEAD>

<DIV type=2>

<HEAD weight="bold" >
WHAT IS IN YOUR TABLETS?
</HEAD>

<DIV type=3>

<HEAD slant="italic" >
Active ingredient
</HEAD>


<BLOCK>
The active ingredient in 'Zocor' Tablets is simvastatin. 'Zocor' Tablets are available in three strengths. The peach-coloured tablets contain 10 mg simvastatin, the tan-coloured tablets contain 20 mg simvastatin and the brick-red coloured tablets contain 40 mg simvastatin.
</BLOCK>


</DIV>
<DIV type=3>

<HEAD slant="italic" >
Other ingredients
</HEAD>


<BLOCK>
Ascorbic acid EP, butylated hydroxyanisole BP, citric acid, monohydrate EP, hydroxypropylcellulose EP, lactose EP, magnesium stearate EP, microcrystalline cellulose E460, pregelatinised maize starch BP, talc EP, red iron oxide E172, titanium oxide EP, yellow iron oxide E172, methylhydroxypropylcellulose EP.
</BLOCK>


</DIV>

</DIV>
<DIV type=2>

<HEAD weight="bold" >
HOW DO YOUR TABLETS WORK?
</HEAD>


<BLOCK>
The active ingredient in your tablets is simvastatin. This belongs to a group of medicines known as 'HMG-CoA reductase inhibitors'. These work by reducing the amount of cholesterol your body makes. Cholesterol is vital to the normal functioning of the body, but if levels of cholesterol in the bloodstream are too high it can be deposited on the walls of the arteries. There it builds up to form plaques which can eventually block the blood vessel, just like scale furring-up a water pipe.
</BLOCK>


<BLOCK>
We only get a small amount of cholesterol from our diet; egg yolks and liver contain large amounts of cholesterol, but many foods like fruit, vegetables, and fish are quite low in cholesterol. Nearly all of the cholesterol in our bodies is made by our own livers.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD weight="bold" >
WHO MAKES YOUR TABLETS?
</HEAD>


<BLOCK>
Your tablets are made by Merck Manufacturing Division, Merck Sharp &amp; Dohme Limited, Shotton Lane, Cramlington, Northumberland, for Merck Sharp &amp; Dohme Limited, Hoddesdon, Hertfordshire, UK, who holds the Product Licence in the UK.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD weight="bold" >
WHY DO YOU NEED TO TAKE THESE TABLETS?
</HEAD>


<BLOCK>
Your doctor has done some blood tests which show that, even though you may be taking a low-fat diet, you still have too much of one type of fat - called cholesterol - in your blood.
</BLOCK>


<BLOCK>
You have been prescribed 'Zocor' for the following reason, which your doctor will explain to you:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
You have high cholesterol in your blood; 'Zocor' should lower this level. It is generally accepted that a high cholesterol level in your blood adds to the risk of heart disease. The higher the level, the greater the risk. The presence of other factors, such as existing heart disease, high blood pressure, high <CB n=2> blood sugar (diabetes), increased weight lack of exercise, and smoking, adds greatly to the risk of development or progression of heart disease with high cholesterol.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Your doctor may also have prescribed 'Zocor' because:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
You have coronary heart disease (CHD). Cholesterol can cause CHD by clogging the blood vessels which carry oxygen and. nutrients to the heart. This clogging, or hardening of the arteries, is called atherosclerosis. Atherosclerosis can lead to chest pain (called angina) and heart attack. If you have CHD, your doctor has prescribed 'Zocor' to help prolong your life, to lessen the risk of a heart attack, and to decrease the risk of needing a surgical procedure to increase the blood flow to your heart. 'Zocor' also slows the progression of atherosclerosis and may reduce the development of new atherosclerosis .
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Your doctor will have explained the importance of staying on a low-fat diet as well as taking the tablets.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD weight="bold" >
ARE THERE PATIENTS WHO SHOULD NOT
</HEAD>


</DIV>
<DIV type=2>

<HEAD weight="bold" >
TAKE THESE TABLETS?
</HEAD>


<BLOCK>
Yes; do not take the tablets if:
</BLOCK>


<LIST type="ordered">

<ITEM>

<BLOCK>
You are or think you may be pregnant.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are planning to become pregnant.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are breast-feeding.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are a woman who could bear children unless you are taking a reliable form of contraceptive other than the pill. If you are planning to become pregnant you must stop taking 'Zocor' at least one month before trying to get pregnant.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You have liver problems.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You have a rare inherited disease called porphyria .
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You have had a bad reaction to this or similar medicines or to any of the ingredients in the past.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
If you think any of these apply to you, do not take the tablets, go and talk to your doctor first and follow the advice given.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD weight="bold" >
WHAT ELSE SHOULD YOU KNOW ABOUT
</HEAD>


</DIV>
<DIV type=2>

<HEAD weight="bold" >
TAKING YOUR TABLETS?
</HEAD>


<BLOCK>
You should check with your doctor before taking 'Zocor' if:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
You have persistent muscle aches or pains.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are taking medicines called immunosuppressants, e.g. cyclosporin.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are taking other cholesterol-lowering medicines such as fibric acid derivatives (such as bezafibrate, fenofibrate gemfibrozil).
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are taking an antifungal drug called itraconazole.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You are taking large doses (higher than 1 9 a day) of niacin or nicotinic acid.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
'Zocor' contains lactose as an inactive ingredient and may produce symptoms in lactose-intolerant individuals.
</BLOCK>


<BLOCK>
Your doctor may want to do simple blood tests to check your liver is working properly before and during your treatment with 'Zocor'.
</BLOCK>

<PB n=2>

<BLOCK>
Rarely, a few patients have experienced the following: liver disease, muscle disease presenting as pains and aches, or an allergic reaction to 'Zocor'. The allergic reaction may include some of the following: swelling of the face or neck, muscle and joint pains, joint and
</BLOCK>

</DIV>

</DIV>

</DIV>

</DOCUMENT>
