Lescol lowers the level of cholesterol, particularly low density lipoprotein (LDL) cholesterol, in the blood. Lescol reduces cholesterol production by the liver and induces some changes of cholesterol transport and disposition in the blood and tissues.

Lescol is available only with your physician's prescription. It is to be used as an adjunct to a medically recommended and carefully supervised diet for the long-term treatment of high cholesterol and triglycerides and is not a substitute for such a diet. In addition, depending on your condition, your physician may recommend an appropriate regimen of exercise, weight control and other measures. If you suffer from coronary heart disease and mild to moderate elevation of cholesterol, your physician may also prescribe Lescol to slow the progression of coronary atherosclerosis.

Use only as specifically directed. Do not alter the dosage unless ordered to do so by your physician. Check with your physician before discontinuing medication since this may result in an increase of your blood lipids.

Before using this medication

You should tell your physician if:

• you have already taken Lescol or any other lipid-lowering agent of the same class such as:
  • lovastatin (Mevacor)
  • simvastatin (Zocor)
  • atorvastatin (Lipitor)
  • pravastatin (Pravachol)
  • cerivastatin (Baycol)
• you suffer from liver disease
• you are pregnant, intend to become pregnant, or are breast-feeding, or intend to breast-feed
• you are taking any other medication, particularly:
  • corticosteroids
  • cyclosporines
  • gemfibrozil
  • warfarin
  • phenytoin
  • oral hypoglycemics
  • NSAIDs
  • erythromycin
  • niacin (nicotinic acid)
  • nefazodone (Serzone)

Proper Use of this Medicine:

• Lescol administered as a single dose should be taken with or after the evening meal or at bedtime. Lescol administered in 2 divided doses should be taken in the morning and in the evening, with or after meals. Take only the amount directed by your physician.
  
• Your physician will monitor your clinical condition and your blood tests at regular intervals. It is important to have these check-ups done on schedule. Please keep your appointments accurately.
  
• Avoid excessive alcohol intake.
  
• Notify your physician about any illness which may develop during your treatment with Lescol and about any new prescription or nonprescription medication you may take. If you require medical help for other reasons, inform the attending physician that you are taking Lescol.
  
• Notify your physician if you are going to have major surgery or have sustained a severe injury.
  
• Notify your physician of any muscle pain, tenderness or weakness developing during treatment with Lescol (see Side Effects).
  
• The safety of Lescol in adolescents and children has not been established.
  
• You should be aware that the effects of Lescol in the prevention of heart attacks, arteriosclerosis or heart disease are not yet known.
  
• Lescol is contraindicated during pregnancy since its use in the event of pregnancy may harm the unborn. Only female patients who are highly unlikely to conceive can be candidates for Lescol treatment. In the event of pregnancy during treatment, Lescol should be discontinued and the physician should be informed.
  

Do not take Lescol:

• if you are hypersensitive (allergic) to fluvastatin or any of the other ingredients of Lescol
  
• if you have an active liver disease, or unexplained, persistent elevations in liver function values (transaminases)
  
• during pregnancy and lactation
  

If you take more Lescol than you should:

Tell your doctor immediately or go to the nearest hospital.

If you forget to take Lescol:

• Take one dose as soon as you remember.
  
• Do not take a double dose to make up for the one that you missed.
  

Side Effects

Along with its intended action, any medication may cause unwanted effects.

Tell your doctor immediately if you experience the following undesirable effects:

• aching muscles
• muscle cramping
• tenderness
• weakness

These might be early signs of a potentially serious muscle degradation which can be avoided if your doctor stops your treatment with Lescol as quickly as possible. These side effects have also been found with similar drugs of this class (statins):

• unusual tiredness
• fever
• yellowing of the skin and eyes
• dark colored urine (hepatitis)
• skin rash
• hives
• swelling of the face, eyelids and lips

Other side effects may occasionally occur which usually do not require stopping treatment. They may come and go during treatment without any particular danger, but you should mention them to your physician, without undue delay, if they become persistent or bothersome. Such adverse experiences include:

• abdominal pain/indigestion
• constipation
• diarrhea
• nausea
• headache
• insomnia
• dizziness

Additional Notes:

This medicine is prescribed for your specific medical problem and for your own use only. Do not give to other people.

Keep all medicines out of the reach of children.