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<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
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<HEAD weight="bold" >
WHAT YOU SHOULD KNOW ABOUT LESCOL (fluvastatin) CAPSULES
</HEAD>


<BLOCK>
Please read this carefully before you start to take your medicine, even if you have already been taking 
<EMPH weight="bold">
LESCOL
</EMPH>
 for some time. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist).
</BLOCK>

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<HEAD weight="bold" >
WHAT’S IN YOUR MEDICINE
</HEAD>


<BLOCK>
The active ingredient contained in 
<EMPH weight="bold">
LESCOL
</EMPH>
 capsules is fluvastatin sodium.
</BLOCK>


<BLOCK>
Capsules are available in two strengths providing either 20 mg or 40 mg fluvastatin free acid.
</BLOCK>


<BLOCK>
Both capsule strengths contain the following inactive ingredients: magnesium stearate; sodium hydrogen carbonate; talc; cellulose microcrystalline; maize starch; calcium carbonate; gelatine; E171; E172.
</BLOCK>


<BLOCK>
The small half-brown, half-yellow capsules printed with the Sandoz logo in white and XU 20 mg in red contain 20 mg of fluvastatin. The larger half-brown, half-orange capsules printed with the Sandoz logo in white and XU 40 mg in red contain 40 mg of fluvastatin.
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<BLOCK>
Both the 20 mg and 40 mg capsules are contained in calendar packs of 28 capsules. The 40 mg capsules are also available in calendar packs of 56 capsules for 40 mg twice daily dosing.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
LESCOL
</EMPH>
 is one of a group of drugs known as cholesterol lowering agents. (See &quot;Why does your doctor want you to use 
<EMPH weight="bold">
LESCOL
</EMPH>
 capsules? &quot;).
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<HEAD>
Product Licence holders:SANDOZ PHARMACEUTICALS Manufactured by:SANDOZ AG 
</HEAD>


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<HEAD weight="bold" >
WHY DOES YOUR DOCTOR WANT YOU
</HEAD>


<BLOCK>
From the results of your blood tests, your doctor has found that despite your low fat diet you still have too much of one type of fat called cholesterol in your blood. Although cholesterol is vital to the health of your body, too much of it in the blood has been found to be one of the important causes of heart disease.
</BLOCK>


<BLOCK>
Your doctor has therefore prescribed 
<EMPH weight="bold">
LESCOL
</EMPH>
 together with your diet to help lower cholesterol levels and so reduce your risk of heart problems. 
<EMPH weight="bold">
LESCOL
</EMPH>
 is one of a group of cholesterol lowering drugs and exerts its main effect in the liver where cholesterol is made.
</BLOCK>


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<HEAD weight="bold" >
BEFORE TAKING YOUR MEDICINE
</HEAD>


<BLOCK>
Tell your doctor before you start taking 
<EMPH weight="bold">
LESCOL
</EMPH>
 if the answer to any of the following questions is yes:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Have you ever had an allergic reaction to similar products, or any of the ingredients in 
<EMPH weight="bold">
LESCOL
</EMPH>
 capsules (listed in &quot;What’s in your medicine&quot;)?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you have any liver problems, or have you had a disease which may have affected your liver? Your doctor will usually carry out liver function tests before you start therapy and periodically thereafter, as slight increases in liver enzymes have occurred in a small number of patients on 
<EMPH weight="bold">
LESCOL
</EMPH>
 therapy.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you have a history of heavy alcohol consumption?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you have any kidney problems?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you pregnant, or planning to become pregnant? If you do become pregnant whilst taking 
<EMPH weight="bold">
LESCOL
</EMPH>
 tell your doctor.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you breast feeding?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Has this medicine been prescribed for someone less than 18 years of age?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you taking any other medications?
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Are you taking any other medications?
</BLOCK>


<BLOCK>
Some medicines can interfere with your treatment, so make sure to check with your doctor or pharmacist before taking any other medications whether bought or prescribed. In particular tell your doctor if you are taking any immunosuppressive drugs (e.g cyclosporin), gemfibrozil, nicotinic acid, erythromycin or rifampicin.
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<HEAD weight="bold" >
TAKING YOUR MEDICATION
</HEAD>


<BLOCK>
Your doctor will have chosen the right dose of 
<EMPH weight="bold">
LESCOL
</EMPH>
 for you. Normally the doctor will start you off on 20 mg of 
<EMPH weight="bold">
LESCOL
</EMPH>
 per day, taken in the evening. After that the doctor will periodically check your cholesterol levels and may adjust your dose, up to a maximum of 40 mg twice a day, depending on what the levels are. If this is the case you should take one capsule in the morning and one in the evening. The usual dose however is 20 to 40 mg of 
<EMPH weight="bold">
LESCOL
</EMPH>
 once daily. Follow your doctors instructions exactly and never change the dose yourself.
</BLOCK>


<BLOCK>
In addition to 
<EMPH weight="bold">
LESCOL
</EMPH>
, your doctor may also prescribe you a resin type drug like cholestyramine which also helps to lower your cholesterol. As this type of drug can interfere with the way 
<EMPH weight="bold">
LESCOL
</EMPH>
 is taken up in the body, you should take 
<EMPH weight="bold">
LESCOL
</EMPH>
 at least four hours after the resin.
</BLOCK>


<BLOCK>
Remember to continue with your low fat diet while you are taking 
<EMPH weight="bold">
LESCOL
</EMPH>
. Ask your doctor or pharmacist it you are unsure about how much medicine to take or when to take it.
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<HEAD weight="bold" >
AFTER TAKING YOUR MEDICINE
</HEAD>


<BLOCK>
Most people benefit from taking this medicine, but a few can be upset by it. Side-effects are usually mild and tend to disappear when treatment is continued. If you experience any of the following, or any other unusual effects, tell your doctor at the earliest opportunity:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Indigestion
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Nausea
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Difficulty in sleeping
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Abdominal pain
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Headache Headache
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
If you have muscle weakness, tenderness or pain and particularly if, at the same time, you feel unwell or have a high temperature, stop taking 
<EMPH weight="bold">
LESCOL
</EMPH>
 and tell your doctor immediately.
</BLOCK>


<BLOCK>
In a small number of patients slight increases in liver enzymes have occurred and most patients did not develop any symptoms. In these patients the enzyme levels returned to normal or became more normal when therapy was stopped. Your doctor will usually carry out liver function tests before you start therapy and periodically thereafter.
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<FIGURE></FIGURE>
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<BLOCK>
Remove the capsule from the foil as shown in the picture. Both the 20 mg and 40 mg 
<EMPH weight="bold">
LESCOL
</EMPH>
 capsules are contained in calendar packs of 28 capsules with the days of the week marked on the foil strips.
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<HEAD weight="bold" >
STORING YOUR MEDICINE
</HEAD>


<BLOCK>
Do not use this product after the expiry date printed on the carton.
</BLOCK>


<BLOCK>
Leave your capsules in the foil, and only remove them when it is time for you to take your medicine.
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<BLOCK>
If your doctor has prescribed 
<EMPH weight="bold">
LESCOL
</EMPH>
 40 mg twice a day for you, then you should receive a calendar pack containing 56 capsules. These packs contain folders of capsules which clearly separate the morning and evening doses.
</BLOCK>


<BLOCK>
Place the capsule in your mouth, and swallow whole with a glass of water.
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<HEAD weight="bold" >
MISSED DOSE
</HEAD>


<BLOCK>
If you forget to take a dose, take one as soon as you remember, unless it is almost time for you to take your next dose. Then go on as before.
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<HEAD weight="bold" >
OVERDOSE
</HEAD>


<BLOCK>
If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest Casualty Department.
</BLOCK>

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<BLOCK>
Store your capsules below 25°C.
</BLOCK>


<BLOCK>
Keep your medicine in a safe place where children cannot reach it.
</BLOCK>


<BLOCK>
Your medicine could harm them.
</BLOCK>


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<HEAD weight="bold" >
LEAFLET REVISED: December 1995 FURTHER INFORMATION
</HEAD>


<BLOCK>

<EMPH weight="bold">
REMEMBER
</EMPH>

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<BLOCK>
If you have any questions or are unsure about anything ask your doctor or pharmacist.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
LESCOL
</EMPH>
 20 mg capsules: PL 0101/0360 LESCOL 40 mg capsules: PL 0101/0361 LESCOL is a registered Trade Mark <FIGURE></FIGURE> 
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