LESCOL ® [ l ĕs-cŏl]
(fluvastatin sodium)
C apsules
and
LESCOL ® [ l ĕs-cŏl] XL
(fluvastatin sodium)
Extended-Release Tablets
Rx only
Read the Patient Information that comes with LESCOL or LESCOL XL before you start taking it, and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
If you have any questions about LESCOL or LESCOL XL, ask your doctor or pharmacist.
What are LESCOL and LESCOL XL?
LESCOL and LESCOL XL are prescription medicines called "statins" that lower cholesterol in your blood. They lower the "bad" cholesterol and triglycerides in your blood. They can raise your "good" cholesterol as well.
LESCOL and LESCOL XL are for people whose cholesterol does not come down enough with exercise and a low-fat diet alone.
LESCOL and LESCOL XL may be used in patients with heart disease (coronary artery disease) to:
- lower the chances of heart problems which would require procedures to help
restore blood flow to the heart.
- slow the buildup of too much cholesterol in the arteries of the heart.
Treatment with LESCOL or LESCOL XL has not been shown to prevent heart attacks or stroke.
LESCOL and LESCOL XL have the same active ingredient, fluvastatin. However, LESCOL is a capsule that is taken one or two times a day and LESCOL XL is an extended-release tablet that is only taken one time a day.
Who should not take LESCOL or LESCOL XL?
Do not take LESCOL or LESCOL XL if you:
-
are pregnant or think you may be pregnant, or are planning
to become pregnant. LESCOL and LESCOL XL may harm your unborn baby. If
you get pregnant, stop taking LESCOL or LESCOL XL and call your doctor right
away.
- are breast-feeding. LESCOL and LESCOL XL can pass into your breast milk and may harm your baby
-
have liver problems
- are allergic to LESCOL or LESCOL XL or any of its ingredients. The active ingredient in LESCOL and LESCOL XL is fluvastatin. See the end of this leaflet for a complete list of ingredients in LESCOL and LESCOL XL.
LESCOL and LESCOL XL have not been studied in children under 9 years of age.
Before taking LESCOL or LESCOL XL, tell your doctor if you:
- have muscle aches or weakness
- drink more than 2 glasses of alcohol daily
- have diabetes
- have a thyroid problem
- have kidney problems
Some medicines should not be taken with LESCOL or LESCOL XL. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. LESCOL and LESCOL XL and certain other medicines can interact causing serious side effects. Especially tell your doctor if you take medicines for:
- your immune system
- cholesterol
- infections
- heart failure
- seizures
- diabetes
- heartburn or stomach ulcers
Know all the medicines you take. Keep a list of all the medicines you take with you to show your doctor and pharmacist.
How should I take LESCOL or LESCOL XL?
- Take LESCOL or LESCOL XL exactly as prescribed. Your doctor will prescribe the one that is right for you. Do not change your dose or stop LESCOL or LESCOL XL without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during treatment with LESCOL and LESCOL XL. Your dose of LESCOL or LESCOL XL may be changed based on these blood test results.
- LESCOL XL tablets may be taken at any time of the day. Take LESCOL capsules at the same time every evening. When LESCOL capsules are taken twice daily, the capsules may be taken once in the morning and once in the evening. LESCOL and LESCOL XL can be taken with or without food.
- LESCOL XL tablets must be swallowed whole with a liquid. Do not break, crush or chew LESCOL XL tablets or open Lescol capsules. Tell your doctor if you cannot swallow tablets whole. You may need LESCOL capsules or a different medicine instead of LESCOL XL tablets.
- Your doctor should start you on a low-fat and low-cholesterol diet before
giving you LESCOL or LESCOL XL. Stay on this low-fat and low-cholesterol diet
while taking LESCOL or LESCOL XL.
- If you miss a dose of LESCOL or LESCOL XL, take
it as soon as you remember. Do not take Lescol or Lescol XL if it has been more
than 12 hours since your last dose. Wait and take the next dose at your regular
time. Do not take 2 doses of Lescol or Lescol XL at the same
time.
- If you take too much LESCOL or LESCOL XL or overdose, call your doctor or Poison Control Center right away. Or, go to the nearest emergency room.
What should I avoid while taking LESCOL or LESCOL XL?
- Talk to your doctor before you start any new medicines. This includes
prescription and nonprescription medicines, vitamins and herbal supplements.
LESCOL and LESCOL XL and certain other medicines can interact causing serious
side effects.
- Do not get pregnant. If you get pregnant, stop taking LESCOL or LESCOL XL right away and call your doctor.
What are the possible side effects of LESCOL and LESCOL XL?
When taking LESCOL and LESCOL XL, some patients may develop serious side effects, including:
-
muscle problems. These serious muscle problems can
sometimes lead to kidney problems, including kidney failure. You have a higher
chance for muscle problems if you are taking certain other medicines with LESCOL
or LESCOL XL.
-
liver
problems
. Your doctor may do blood tests to check your liver before
you start taking LESCOL or LESCOL XL, and while you are taking one of
them.
Call your doctor right away if you have:
- muscle problems like weakness, tenderness, or pain that happen without a
good reason, especially if you also have a fever or feel more tired than usual
- nausea and vomiting
- passing brown or dark-colored urine
- you feel more tired than usual
- your skin and whites of your eyes get yellow
- stomach pain
The most common side effects of LESCOL or LESCOL XL are headache, upset stomach and stomach pain, diarrhea, flu-like symptoms, muscle pain, sinus infection, tiredness, or trouble sleeping. These side effects are usually mild and may go away.
Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away.
These are not all the side effects of LESCOL and LESCOL XL. Ask your doctor or pharmacist for a complete list.
How should I store LESCOL and LESCOL XL?
- Store LESCOL and LESCOL XL at room temperature, 59° to 86° F (15° to 30° C).
Protect from light.
- Do not keep medicine that is out of date or that you no longer
need.
- Keep LESCOL and LESCOL XL out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.
General information about LESCOL and LESCOL XL
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use LESCOL or LESCOL XL for a condition for which it was not prescribed. Do not give LESCOL or LESCOL XL to other people, even if they have the same problem you have. It may harm them.
This leaflet summarizes the most important information about LESCOL and LESCOL XL. If you would like more information, talk with your doctor.
For information that is written for health professionals, ask your doctor or pharmacist or call 1-888-669-6682.
What are the ingredients in LESCOL and LESCOL XL?
Active Ingredient: fluvastatin sodium
Inactive Ingredients:
LESCOL Capsules: gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, yellow iron oxide, and other ingredients. The capsules may also contain benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, edetate calcium disodium, methylparaben, propylparaben, silicon dioxide, and sodium propionate.
LESCOL XL Tablets: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, potassium bicarbonate, povidone, magnesium stearate, yellow iron oxide, titanium dioxide and polyethylene glycol 8000.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
Rev: April 2006 T200 6 - 50
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
REV: OCTOBER 2006 PRINTED IN THE U.S.A. T2006-97/T2006-50
5001004
5001006
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146